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Amodis
Metronidazole
Amodis
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amodis
Metronidazole
Amodis
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amodis
Metronidazole
Amodis
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amogit
Metronidazole
Amogit
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amorox
Ambroxol Hydrochloride
Amorox
Ambroxol Hydrochloride
Indications
Sore throat
Indication detailsView
This is indicated in-
- Productive cough
- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
- Asthmatic bronchitis bronchial asthma with thick expectoration
- Bronchiectasis
- Chronic pneumonia etc.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
DosageView
Average daily dose (preferably after meal):
Pediatric Drops:
Pediatric Drops:
- 0-6 months: 0.5 ml 2 times a day
- 6-12 months: 1 ml 2 times a day
- 1-2 years: 1.25 ml 2 times a day
- 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
- 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
- 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
Side effectsView
Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
ContraindicationsView
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
PrecautionsView
Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
InteractionsView
Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Pregnancy & lactationView
Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
StorageView
Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.
Amotid
Amoxicillin Trihydrate
Amotid
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amotid
Amoxicillin Trihydrate
Amotid
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amotid
Amoxicillin Trihydrate
Amotid
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amotid
Amoxicillin Trihydrate
Amotid
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amotid CL
Amoxicillin + Clavulanic Acid
Amotid CL
Amoxicillin + Clavulanic Acid
Indications
Severe or recurrent respiratory tract infections
Indication detailsView
Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
- Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
- Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
- Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
- Skin and soft tissue infections.
- Bone and joint infections e.g.osteomyelitis.
- Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.
Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
DosageView
Adults and children over 12 years:
Tablet:
Mild to moderate infections:
Adults-
Tablet:
- The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
- For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
- Children 6-12 years: 2 teaspoonful every 8 hours.
- Children 1-6years: 1 teaspoonful every 8 hours.
- Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
- The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
- For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
Mild to moderate infections:
- 25/3.6 mg/kg/day (Suspension)
- 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
- 7-12years (22-40kg) 5 ml suspension b.i.d
- 45/6.4 mg/kg/day (Forte Suspension)
- 2-6 years (13-21 kg) 5 ml suspension b.i.d
- 7-12 years (22-40 kg) 10 ml suspension b.i.d
Adults-
- Usually, 1.2 gm every 8 hours
- Increased in more serious infections to 1.2 gm every 6 hours
- For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
- 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
- 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
AdministrationView
Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
Side effectsView
Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
ContraindicationsView
History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
PrecautionsView
Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
InteractionsView
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
Pregnancy & lactationView
Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
Pediatric usageView
The dose should be adjusted in case of patients with renal impairment
Adult:
Adult:
- Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
- Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
- Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
- A similar reduction in dosage should be made for children.
- Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
Overdose effectsView
Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
ReconstitutionView
IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
StorageView
This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.
Amotid CL
Amoxicillin + Clavulanic Acid
Amotid CL
Amoxicillin + Clavulanic Acid
Indications
Severe or recurrent respiratory tract infections
Indication detailsView
Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
- Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
- Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
- Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
- Skin and soft tissue infections.
- Bone and joint infections e.g.osteomyelitis.
- Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.
Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
DosageView
Adults and children over 12 years:
Tablet:
Mild to moderate infections:
Adults-
Tablet:
- The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
- For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
- Children 6-12 years: 2 teaspoonful every 8 hours.
- Children 1-6years: 1 teaspoonful every 8 hours.
- Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
- The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
- For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
Mild to moderate infections:
- 25/3.6 mg/kg/day (Suspension)
- 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
- 7-12years (22-40kg) 5 ml suspension b.i.d
- 45/6.4 mg/kg/day (Forte Suspension)
- 2-6 years (13-21 kg) 5 ml suspension b.i.d
- 7-12 years (22-40 kg) 10 ml suspension b.i.d
Adults-
- Usually, 1.2 gm every 8 hours
- Increased in more serious infections to 1.2 gm every 6 hours
- For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
- 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
- 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
AdministrationView
Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
Side effectsView
Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
ContraindicationsView
History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
PrecautionsView
Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
InteractionsView
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
Pregnancy & lactationView
Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
Pediatric usageView
The dose should be adjusted in case of patients with renal impairment
Adult:
Adult:
- Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
- Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
- Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
- A similar reduction in dosage should be made for children.
- Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
Overdose effectsView
Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
ReconstitutionView
IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
StorageView
This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.
Amotid F
Amoxicillin Trihydrate
Amotid F
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amotrex
Metronidazole
Amotrex
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amotrex
Metronidazole
Amotrex
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amotrex
Metronidazole
Amotrex
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amotrex
Metronidazole
Amotrex
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amotrex DS
Metronidazole
Amotrex DS
Metronidazole
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
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- 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
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- 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.
- 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).
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.
Amovast
Amlodipine Besilate + Atorvastatin
Amovast
Amlodipine Besilate + Atorvastatin
Indications
Stroke
Indication detailsView
Patients in whom treatment with Amlodipin and Atorvastatin is appropriate at the dose presented, which include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolemia and in hypertensive patients with multiple risk factors for CHD to reduce the risk of nonfatal MI and nonfatal stroke.
Amlodipine:
Amlodipine:
- Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
- Coronary Artery Disease (CAD): Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal or antihypertensive agents; Vasospastic
- Angina (Prinzmetal's or Variant Angina): Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs.
- Angiographically Documented CAD: In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
Therapeutic classView
Anti-anginal & lipid lowering drugs
PharmacologyView
It is a combination product containing Amlodipine Besilate BP equivalent to 5 mg Amlodipine, a calcium channel blocker and Atorvastatin calcium INN equivalent to 10 mg Atorvastatin, a statin (HMG-CoA reductase inhibitor). Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Atorvastatin calcium is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoAto mevatonate, an early and rate limiting step in the synthesis of cholesterol.
DosageView
Amlodipine: The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. The recommended dose for chronic stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Atorvastatin:
Atorvastatin:
- The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of Atorvastatin is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day with or without food.
- Homozygous Familial Hypercholesterolemia: The dosage of Atorvastatin in patients with homozygous FH is 10 to 80 mg daily.
- Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required. Hemodialysis is not expected to significantly enhance the clearance of Atorvastatin since the drug is extensively bound to plasma proteins.
- Patients with hepatic dysfunction: In patients with moderate to severe hepatic dysfunction, the therapeutic response to Atorvastatin is unaffected but exposure to the drug is greatly increased.
Side effectsView
Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure. Beta-blocker Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class.
Atorvastatin: Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Side effects: Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia.
Atorvastatin: Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Side effects: Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia.
ContraindicationsView
Amlodipine: Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. Atorvastatin: Contraindicated in hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceed three times the upper limit of normal.
PrecautionsView
Warning: Increased Angina and/or Myocardial Infarction Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated. Liver Dysfunction. HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Precaution
Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure.
Atorvastatin: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure.
Atorvastatin: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
Drug interaction with atorvastatin: The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals. When atorvastatin and antacid suspension containing magnesium and aluminum hydroxide were co administered, plasma concentrations of atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered. Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone. When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately. In healthy individuals, plasma concentrations of atorvastatin increased approximately 40% with co- administration of atorvastatin and erythromycin. Co- administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinylestradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking atorvastatin.
Drug interaction with amlodipine: Amlodipine may potentiate the effect of other antihypertensive (e.g.Beta-blockers, ACE inhibitors, Alpha-1-blockers and Diuretics). In clinical interaction studies, Amlodipine did not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin or Cyclosporine.
Drug interaction with amlodipine: Amlodipine may potentiate the effect of other antihypertensive (e.g.Beta-blockers, ACE inhibitors, Alpha-1-blockers and Diuretics). In clinical interaction studies, Amlodipine did not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin or Cyclosporine.
Pregnancy & lactationView
Safety in pregnancy has not been established. Use of HMG-CoA reductase inhibitors during breastfeeding is not recommended.
Pediatric usageView
Pediatrics: Safety and efficacy of Atorvastatin have not been established in children.
Geriatrics: Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.
Geriatrics: Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.
StorageView
Store in a cool and dry place. Protect from light and moisture. Keep all medicines out of the reach of children.
Amox
Amoxicillin Trihydrate
Amox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amox
Amoxicillin Trihydrate
Amox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.