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Metrona

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metropill

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metropill

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metropill

Metronidazole

Tablet 200 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metrosil

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metrosil

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metroson

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metroson

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metrozen

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metrozen

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metryl

Metronidazole

IV Infusion 500 mg/100 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metryl

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metryl

Metronidazole

Tablet 500 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metryl

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metryl

Metronidazole

Tablet 200 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Metsa

Metformin Hydrochloride

Tablet 850 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.

In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Therapeutic classView

Biguanides

PharmacologyView

Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
Children: Metformin extended release tablet has not been studied in children.
Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m². Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m².

Side effectsView

Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients.
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
Severe renal failure (GFR <30 mL/min).
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.

PrecautionsView

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.

InteractionsView

Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.

Pregnancy & lactationView

Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.

Pediatric usageView

Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

At least annually in patients with normal renal function,
At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.

Overdose effectsView

Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Metsa

Metformin Hydrochloride

Tablet 500 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.

In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Therapeutic classView

Biguanides

PharmacologyView

Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
Children: Metformin extended release tablet has not been studied in children.
Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m². Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m².

Side effectsView

Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients.
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
Severe renal failure (GFR <30 mL/min).
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.

PrecautionsView

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.

InteractionsView

Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.

Pregnancy & lactationView

Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.

Pediatric usageView

Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

At least annually in patients with normal renal function,
At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.

Overdose effectsView

Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Metsa XR

Metformin Hydrochloride

Tablet (Extended Release) 1000 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.

In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Therapeutic classView

Biguanides

PharmacologyView

Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
Children: Metformin extended release tablet has not been studied in children.
Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m². Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m².

Side effectsView

Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients.
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
Severe renal failure (GFR <30 mL/min).
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.

PrecautionsView

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.

InteractionsView

Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.

Pregnancy & lactationView

Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.

Pediatric usageView

Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

At least annually in patients with normal renal function,
At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.

Overdose effectsView

Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Metsa XR

Metformin Hydrochloride

Tablet (Extended Release) 500 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.

In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Therapeutic classView

Biguanides

PharmacologyView

Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
Children: Metformin extended release tablet has not been studied in children.
Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m². Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m².

Side effectsView

Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients.
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
Severe renal failure (GFR <30 mL/min).
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.

PrecautionsView

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.

InteractionsView

Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.

Pregnancy & lactationView

Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.

Pediatric usageView

Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

At least annually in patients with normal renal function,
At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.

Overdose effectsView

Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Metsina

Metronidazole

IV Infusion 500 mg/100 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.