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    Metmin

    Metformin Hydrochloride
    Tablet 500 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metmin

    Metformin Hydrochloride
    Tablet 850 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metmin XR

    Metformin Hydrochloride
    Tablet (Extended Release) 500 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metnil

    Metformin Hydrochloride
    Tablet 500 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metnor

    Metformin Hydrochloride
    Tablet 500 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metocard

    Metoprolol Tartrate
    IV Injection 5 mg/5 ml Allopathic
    Indication detailsView
    ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
    PharmacologyView
    Metoprolol is a selective beta1-blocker. Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by Metoprolol. Metoprolol interferes less with Insulin release and carbohydrate metabolism than do non-selective beta-blockers. Metoprolol interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.
    DosageView
    Film-coated tablet-
    • Hypertension: Total daily dosage Metoprolol 100-400 mg to be given as a single or twice-daily dose. The starting dose is 100 mg (two Metoprolol-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other antihypertensive agents may also be considered.
    • Angina: Usually Metoprolol 50 mg (one Metoprolol-50 tablet) to 100 mg (two Metoprolol-50 tablets) twice or three times daily.
    • Cardiac arrhythmias: Metoprolol 50 mg (one Metoprolol-50 tablet) b.i.d or t.i.d should usually control the condition. It is necessary the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50 mg t.i.d.
    • Hyperthyroidism: Metoprolol 50 mg (one Metoprolol-50 tablet) four times a day. The dose should be reduced as the euthyroid state is achieved.
    • Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance- The usual maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise healthy elderly patients. Significant hepatic dysfunction: A reduction in dosage may be necessary.
    Extended-release tablet-
    • Hypertension: The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic.
    • Angina Pectoris: The dosage of extended-release Metoprolol Succinate should be individualized. The usual initial dosage is 100 mg daily, in a single dose.
    • Heart Failure: The recommended starting dose of sustained-release Metoprolol Succinate is 25 mg once daily for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1-2 weeks.
    IV Injection-
    • Arrhythmias: By intravenous injection, up to 5 mg at a rate of 1-2 mg/minute, repeated after 5 minutes if necessary, total dose 10-15 mg.
    • In surgery: By slow intravenous injection 2-4 mg at induction or to control arrhythmias developing during anaesthesia; 2 mg doses may be repeated to a maximum of 10 mg.
    • Myocardial Infarction: Early intervention within 12 hours of infarction, by intravenous injection 5 mg every 2 minutes to a maximum of 15 mg, followed after 15 minutes by 50 mg by mouth every 6 hours for 48 hours; maintenance 200 mg daily in divided doses.
    Side effectsView
    Tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, slow heart rate, mental confusion, headache, somnolence, nightmares, insomnia, dyspnea, Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported, intensification of AV block.
    ContraindicationsView
    AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when myocardial infarction is complicated by significant bradycardia, first-degree heart block, systolic hypotension (<100mmHg) and/or severe heart failure.
    PrecautionsView
    Bronchospastic Diseases: Because of its relative beta 1 ‐selectivity, however, Metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate other antihypertensive treatment.

    Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

    Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
    InteractionsView
    Catecholamine‐depleting drugs (e.g. Reserpine, Monoamine Oxidase (MAO) inhibitors) may have an additive effect when given with beta‐blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol. Concomitant use of digitalis glycosides and beta‐blockers can increase the risk of bradycardia. Beta‐blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well‐controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprolol is administered to a nursing woman.
    Pediatric usageView
    Hepatic impaired patient: Metoprolol should be used with caution in patients with impaired hepatic function.

    Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.

    Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
    Overdose effectsView
    Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to 2 hours after drug ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine). Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10 mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be effectively removed by haemodialysis.
    StorageView
    Store in a cool and dry place, protected from light.

    Metocol

    Metoclopramide Hydrochloride
    Pediatric Drops 1 mg/ml Allopathic Anti-emetic drugs

    Indications

    Vomiting

    Indication detailsView
    Metoclopramide nasal spray: This is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

    Metoclopramide tablet:
    • This is indicated in the treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
    • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
    Metoclopramide Injection:
    • Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide Injection is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
    • The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
    • The Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
    • Small Bowel Intubation: Metoclopramide Injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
    • Radiological Examination: Metoclopramide Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
    Therapeutic classView
    Anti-emetic drugs, Prokinetic drugs
    PharmacologyView
    Metoclopramide blocks dopamine receptors and in higher doses, it also blocks serotonin receptors in chemoreceptor trigger zone of the CNS. It enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying w/o stimulating gastric, biliary, or pancreatic secretions. It also increases lower esophageal sphincter tone.
    DosageView
    Metoclopramide Spray:

    Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.

    Adults 65 years of age and older: Metoclopramide is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.

    Metoclopramide tablet:

    Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:
    • Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
    • Intermittent: Single doses up to 20 mg prior to provoking situation.
    Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.

    Metoclopramide injection:

    For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.

    For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

    For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.
    Side effectsView
    Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.
    ContraindicationsView
    Metoclopramide is contraindicated:
    • In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
    • When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
    • In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
    • In patients with epilepsy. Reglan may increase the frequency and severity of seizures.
    • In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
    PrecautionsView
    Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue Reglan and seek immediate medical attention.  

    Depression and suicidal ideation/suicide: Avoid use.
    Pregnancy & lactationView
    Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. 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.

    Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.
    StorageView
    Store between 20-25°C. Protect from light.

    Metocol

    Metoclopramide Hydrochloride
    Syrup 5 mg/5 ml Allopathic Anti-emetic drugs

    Indications

    Vomiting

    Indication detailsView
    Metoclopramide nasal spray: This is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

    Metoclopramide tablet:
    • This is indicated in the treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
    • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
    Metoclopramide Injection:
    • Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide Injection is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
    • The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
    • The Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
    • Small Bowel Intubation: Metoclopramide Injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
    • Radiological Examination: Metoclopramide Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
    Therapeutic classView
    Anti-emetic drugs, Prokinetic drugs
    PharmacologyView
    Metoclopramide blocks dopamine receptors and in higher doses, it also blocks serotonin receptors in chemoreceptor trigger zone of the CNS. It enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying w/o stimulating gastric, biliary, or pancreatic secretions. It also increases lower esophageal sphincter tone.
    DosageView
    Metoclopramide Spray:

    Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.

    Adults 65 years of age and older: Metoclopramide is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.

    Metoclopramide tablet:

    Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:
    • Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
    • Intermittent: Single doses up to 20 mg prior to provoking situation.
    Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.

    Metoclopramide injection:

    For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.

    For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

    For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.
    Side effectsView
    Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.
    ContraindicationsView
    Metoclopramide is contraindicated:
    • In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
    • When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
    • In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
    • In patients with epilepsy. Reglan may increase the frequency and severity of seizures.
    • In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
    PrecautionsView
    Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue Reglan and seek immediate medical attention.  

    Depression and suicidal ideation/suicide: Avoid use.
    Pregnancy & lactationView
    Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. 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.

    Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.
    StorageView
    Store between 20-25°C. Protect from light.

    Metodex

    Dextromethorphan Hydrobromide
    Syrup 10 mg/5 ml Allopathic Cough suppressant

    Indications

    Non-productive cough

    Indication detailsView
    Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.
    Therapeutic classView
    Cough suppressant
    PharmacologyView
    Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    DosageView
    Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
    Children between 6 and 12 years: 5-15 mg up to four times per day.
    Children between 2 and 6 years: 2.5-5 mg up to four times per day.
    Side effectsView
    Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.
    ContraindicationsView
    Hypersensitivity to Dextromethorphan or any other component.
    PrecautionsView
    Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).
    InteractionsView
    The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.
    Pregnancy & lactationView
    Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.

    Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.
    Overdose effectsView
    Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.

    Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.
    StorageView
    Store at 15-30° C

    Metomin

    Metformin Hydrochloride
    Tablet 500 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metomin

    Metformin Hydrochloride
    Tablet 850 mg Allopathic Biguanides

    Indications

    Type 2 DM

    Indication detailsView
    Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
    • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
    • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
    A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
    Therapeutic classView
    Biguanides
    PharmacologyView
    Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
    DosageView
    Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
    • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
    • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
    Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
    • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
    • Children: Metformin extended release tablet has not been studied in children.
    • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
    Side effectsView
    Blood and lymphatic system disorders: Not known: Hemolytic anemia

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

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

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

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

    Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
    ContraindicationsView
    • Hypersensitivity to the active substance or to any of the excipients.
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
    • Severe renal failure (GFR <30 mL/min).
    • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
    • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
    PrecautionsView
    Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
    InteractionsView
    Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
    Pregnancy & lactationView
    Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

    Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
    Pediatric usageView
    Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

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

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

    Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
    • At least annually in patients with normal renal function,
    • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
    Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
    Overdose effectsView
    Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
    StorageView
    Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

    Metonid

    Metronidazole
    IV Infusion 500 mg/100 ml Allopathic Amoebicides

    Indications

    Vaginal trichomoniasis

    Indication detailsView
    Metronidazole is indicated in the treatment of following diseases:
    • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
    • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
    • In the treatment of urogenital trichomoniasis.
    • Bacterial vaginosis (also known as non-specific vaginitis).
    • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
    • Giardiasis.
    • Acute ulcerative gingivitis.
    • Anaerobically infected leg ulcers and pressure sores.
    • Acute dental infections due to anaerobic organisms.
    • Antibiotic associated pseudomembranus colitis.
    Therapeutic classView
    Amoebicides, Anti-diarrhoeal Antiprotozoal
    PharmacologyView
    Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
    DosageView

    Tablet and Suspension:

    Trichomoniasis (Adults & Children over 10 yrs)-
    • 200 mg tid or 400 mg bid for 7 days
    • 800 mg in the morning and 1-2 gm at night for 2 days
    • 2 gm as a single dose for 1 days
    Trichomoniasis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Intestinal amoebiasis (Adults & Children over 10 yrs)- 
    • 800 mg tid for 5 days
    Intestinal amoebiasis (Children)-
    • Children 7-10 yrs: 400 mg tid
    • Children 3-7 yrs: 200 mg qid
    • Children 1-3 yrs: 200 mg tid
    Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
    • 400-800 mg tid for 5-10 days
    Extra-intestinal & Asymptomatic amoebiasis (Children)-
    • Children 7-10 yrs: 200-400 mg tid
    • Children 3-7 yrs: 100-200 mg qid
    • Children 1-3 yrs: 100-200 mg tid
    Giardiasis (Adults & Children over 10 yrs)-
    • 2 gm once daily for 3 days
    Giardiasis (Children)-
    • Children 7-10 yrs: 1 gm once daily
    • Children 3-7 yrs: 600-800 mg once daily
    • Children 1-3 yrs: 500 mg once daily
    Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
    • 200 mg tid for 3 days
    Acute ulcerative  gingivitis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Acute dental infections (Adults & Children over 10 yrs)-
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid

    Vaginal Gel:

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


    Suppository:

    Anaerobic Infections-
    • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
    • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
    Surgical Prophylaxis-
    • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
    • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


    IV Infusion:

    Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
    • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
    • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
    Side effectsView
    Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
    ContraindicationsView
    Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
    PrecautionsView
    • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
    • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
    • Patients should be warned that metronidazole may darken urine.
    InteractionsView
    • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
    • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
    • Lithium: Plasma levels of lithium may be increased by metronidazole.
    • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
    • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
    • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
    • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
    Pregnancy & lactationView
    US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
    Pediatric usageView
    Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

    Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
    Overdose effectsView
    Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
    StorageView
    Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

    Metoprol-XL

    Metoprolol Tartrate
    Tablet (Extended Release) 100 mg Allopathic
    Indication detailsView
    ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
    PharmacologyView
    Metoprolol is a selective beta1-blocker. Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by Metoprolol. Metoprolol interferes less with Insulin release and carbohydrate metabolism than do non-selective beta-blockers. Metoprolol interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.
    DosageView
    Film-coated tablet-
    • Hypertension: Total daily dosage Metoprolol 100-400 mg to be given as a single or twice-daily dose. The starting dose is 100 mg (two Metoprolol-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other antihypertensive agents may also be considered.
    • Angina: Usually Metoprolol 50 mg (one Metoprolol-50 tablet) to 100 mg (two Metoprolol-50 tablets) twice or three times daily.
    • Cardiac arrhythmias: Metoprolol 50 mg (one Metoprolol-50 tablet) b.i.d or t.i.d should usually control the condition. It is necessary the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50 mg t.i.d.
    • Hyperthyroidism: Metoprolol 50 mg (one Metoprolol-50 tablet) four times a day. The dose should be reduced as the euthyroid state is achieved.
    • Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance- The usual maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise healthy elderly patients. Significant hepatic dysfunction: A reduction in dosage may be necessary.
    Extended-release tablet-
    • Hypertension: The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic.
    • Angina Pectoris: The dosage of extended-release Metoprolol Succinate should be individualized. The usual initial dosage is 100 mg daily, in a single dose.
    • Heart Failure: The recommended starting dose of sustained-release Metoprolol Succinate is 25 mg once daily for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1-2 weeks.
    IV Injection-
    • Arrhythmias: By intravenous injection, up to 5 mg at a rate of 1-2 mg/minute, repeated after 5 minutes if necessary, total dose 10-15 mg.
    • In surgery: By slow intravenous injection 2-4 mg at induction or to control arrhythmias developing during anaesthesia; 2 mg doses may be repeated to a maximum of 10 mg.
    • Myocardial Infarction: Early intervention within 12 hours of infarction, by intravenous injection 5 mg every 2 minutes to a maximum of 15 mg, followed after 15 minutes by 50 mg by mouth every 6 hours for 48 hours; maintenance 200 mg daily in divided doses.
    Side effectsView
    Tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, slow heart rate, mental confusion, headache, somnolence, nightmares, insomnia, dyspnea, Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported, intensification of AV block.
    ContraindicationsView
    AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when myocardial infarction is complicated by significant bradycardia, first-degree heart block, systolic hypotension (<100mmHg) and/or severe heart failure.
    PrecautionsView
    Bronchospastic Diseases: Because of its relative beta 1 ‐selectivity, however, Metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate other antihypertensive treatment.

    Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

    Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
    InteractionsView
    Catecholamine‐depleting drugs (e.g. Reserpine, Monoamine Oxidase (MAO) inhibitors) may have an additive effect when given with beta‐blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol. Concomitant use of digitalis glycosides and beta‐blockers can increase the risk of bradycardia. Beta‐blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well‐controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprolol is administered to a nursing woman.
    Pediatric usageView
    Hepatic impaired patient: Metoprolol should be used with caution in patients with impaired hepatic function.

    Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.

    Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
    Overdose effectsView
    Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to 2 hours after drug ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine). Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10 mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be effectively removed by haemodialysis.
    StorageView
    Store in a cool and dry place, protected from light.

    Metoprol-XL

    Metoprolol Tartrate
    Tablet (Extended Release) 50 mg Allopathic
    Indication detailsView
    ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
    PharmacologyView
    Metoprolol is a selective beta1-blocker. Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by Metoprolol. Metoprolol interferes less with Insulin release and carbohydrate metabolism than do non-selective beta-blockers. Metoprolol interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.
    DosageView
    Film-coated tablet-
    • Hypertension: Total daily dosage Metoprolol 100-400 mg to be given as a single or twice-daily dose. The starting dose is 100 mg (two Metoprolol-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other antihypertensive agents may also be considered.
    • Angina: Usually Metoprolol 50 mg (one Metoprolol-50 tablet) to 100 mg (two Metoprolol-50 tablets) twice or three times daily.
    • Cardiac arrhythmias: Metoprolol 50 mg (one Metoprolol-50 tablet) b.i.d or t.i.d should usually control the condition. It is necessary the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50 mg t.i.d.
    • Hyperthyroidism: Metoprolol 50 mg (one Metoprolol-50 tablet) four times a day. The dose should be reduced as the euthyroid state is achieved.
    • Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance- The usual maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise healthy elderly patients. Significant hepatic dysfunction: A reduction in dosage may be necessary.
    Extended-release tablet-
    • Hypertension: The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic.
    • Angina Pectoris: The dosage of extended-release Metoprolol Succinate should be individualized. The usual initial dosage is 100 mg daily, in a single dose.
    • Heart Failure: The recommended starting dose of sustained-release Metoprolol Succinate is 25 mg once daily for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1-2 weeks.
    IV Injection-
    • Arrhythmias: By intravenous injection, up to 5 mg at a rate of 1-2 mg/minute, repeated after 5 minutes if necessary, total dose 10-15 mg.
    • In surgery: By slow intravenous injection 2-4 mg at induction or to control arrhythmias developing during anaesthesia; 2 mg doses may be repeated to a maximum of 10 mg.
    • Myocardial Infarction: Early intervention within 12 hours of infarction, by intravenous injection 5 mg every 2 minutes to a maximum of 15 mg, followed after 15 minutes by 50 mg by mouth every 6 hours for 48 hours; maintenance 200 mg daily in divided doses.
    Side effectsView
    Tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, slow heart rate, mental confusion, headache, somnolence, nightmares, insomnia, dyspnea, Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported, intensification of AV block.
    ContraindicationsView
    AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when myocardial infarction is complicated by significant bradycardia, first-degree heart block, systolic hypotension (<100mmHg) and/or severe heart failure.
    PrecautionsView
    Bronchospastic Diseases: Because of its relative beta 1 ‐selectivity, however, Metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate other antihypertensive treatment.

    Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

    Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
    InteractionsView
    Catecholamine‐depleting drugs (e.g. Reserpine, Monoamine Oxidase (MAO) inhibitors) may have an additive effect when given with beta‐blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol. Concomitant use of digitalis glycosides and beta‐blockers can increase the risk of bradycardia. Beta‐blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well‐controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprolol is administered to a nursing woman.
    Pediatric usageView
    Hepatic impaired patient: Metoprolol should be used with caution in patients with impaired hepatic function.

    Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.

    Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
    Overdose effectsView
    Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to 2 hours after drug ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine). Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10 mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be effectively removed by haemodialysis.
    StorageView
    Store in a cool and dry place, protected from light.

    Metorax

    Methotrexate
    Tablet 10 mg Allopathic Immunosuppressant

    Indications

    Vasculitis

    Indication detailsView
    Neoplastic Diseases: Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast  cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas.

    Psoriasis: Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.

    Rheumatoid Arthritis Including Polyarticular-Course Juvenile Rheumatoid Arthritis: Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

    Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
    Therapeutic classView
    Antidote preparations, Immunosuppressant
    PharmacologyView
    Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of p.r.n. nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues
    DosageView
    Oral-
    • Choriocarcinoma: 15-30 mg daily for 5 days, repeat after an interval of ≥1 wk for 3-5 courses.
    • Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
    • Burkitt's lymphoma: 10-25 mg daily for 4-8 days, repeated after 7-10 days.
    • Psoriasis: 10-25 mg wkly as a single dose, adjust subsequent doses based on response.
    • Rheumatoid arthritis: 7.5 mg once wkly, adjust by response. Not more than 20 mg/wk.
    • Mycosis fungoides: 2.5-10 mg daily to induce remission.
    • Crohn's disease: 12.5-22.5 mg once wkly for up to 1 yr.
    Parenteral-
    • Psoriasis: 10-25 mg wkly as a single dose. Adjust subsequent doses based on response. May be given via IV/IM admin.
    Intramuscular-
    • Choriocarcinoma: 15-30 mg daily for 5 days. Repeat after at least 1 wk for 3-5 courses. Alternatively, 0.25-1 mg/kg (max: 60 mg) every 48 hr for 4 doses followed by folinic acid rescue, repeat at intervals of 7 days for 4 or more courses.
    • Mycosis fungoides: 50 mg wkly as a single dose or 2 divided doses.
    • Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
    • Crohn's disease: 25 mg once wkly for 16 wk. Maintenance: 15 mg wkly.
    Intrathecal-
    • Meningeal leukaemia: 12 mg/m2 (max 15 mg) once wkly for 2-3 wk, then once mthly. Alternatively, 200-500 mcg/kg every 2-5 day until CSF cell count is normalised.
    Intravenous-
    • Osteosarcoma: Initial recommended dose: 12 g/m2 as a 4-hr infusion, followed by folinic acid, as part of combined therapy. May increase dose to 15 g/m2 in subsequent treatments if initial dosage is insufficient to achieve peak serum methotrexate levels of 454 mcg/mL at the end of the infusion. Methotrexate infusion is administered on postoperative wk 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44 and 45; in combination with other chemotherapy agents. Folinic acid can be given orally, IM or IV inj starting 24 hr after the beginning of the methotrexate infusion. Give via parenteral routes If patient experiences GI toxicity (e.g., nausea, vomiting). Usual dosage of folinic acid: 15 mg every 6 hr for a total of 60 hr or a total of 10 doses.
    • Breast cancer: 10-60 mg/m2 often with cyclophosphamide and fluorouracil.
    • Advanced lymphosarcoma: Up to 30 mg/kg, followed by folinic acid rescue.
    • Acute lymphoblastic leukaemia: Maintenance: 2.5 mg/kg every 14 days.
    AdministrationView
    Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.
    Side effectsView
    Ulceration of the mouth and GI disturbances (e.g. stomatitis and diarrhoea), bone marrow depression, hepatotoxicity, renal failure, skin reactions, alopecia, ocular irritation, arachnoiditis in intrathecal use, megaloblastic anaemia, osteoporosis, precipitation of diabetes, arthralgias, necrosis of soft tissue and bone, anaphylaxis, impaired fertility.
    ContraindicationsView
    Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding.
    PrecautionsView
    Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly.
    InteractionsView
    Decreased effectiveness with folic acid and its derivatives.
    Pregnancy & lactationView
    Pregnancy category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
    Overdose effectsView
    Nausea, vomiting, alopecia, melena, and renal failure.
    ReconstitutionView
    Intramuscular: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

    Intrathecal:     Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.

    Intravenous:     Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

    Parenteral:     Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
    StorageView
    Store at room temperature (15-25°C).

    Metra

    Metronidazole
    Oral Suspension 200 mg/5 ml Allopathic Amoebicides

    Indications

    Vaginal trichomoniasis

    Indication detailsView
    Metronidazole is indicated in the treatment of following diseases:
    • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
    • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
    • In the treatment of urogenital trichomoniasis.
    • Bacterial vaginosis (also known as non-specific vaginitis).
    • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
    • Giardiasis.
    • Acute ulcerative gingivitis.
    • Anaerobically infected leg ulcers and pressure sores.
    • Acute dental infections due to anaerobic organisms.
    • Antibiotic associated pseudomembranus colitis.
    Therapeutic classView
    Amoebicides, Anti-diarrhoeal Antiprotozoal
    PharmacologyView
    Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
    DosageView

    Tablet and Suspension:

    Trichomoniasis (Adults & Children over 10 yrs)-
    • 200 mg tid or 400 mg bid for 7 days
    • 800 mg in the morning and 1-2 gm at night for 2 days
    • 2 gm as a single dose for 1 days
    Trichomoniasis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Intestinal amoebiasis (Adults & Children over 10 yrs)- 
    • 800 mg tid for 5 days
    Intestinal amoebiasis (Children)-
    • Children 7-10 yrs: 400 mg tid
    • Children 3-7 yrs: 200 mg qid
    • Children 1-3 yrs: 200 mg tid
    Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
    • 400-800 mg tid for 5-10 days
    Extra-intestinal & Asymptomatic amoebiasis (Children)-
    • Children 7-10 yrs: 200-400 mg tid
    • Children 3-7 yrs: 100-200 mg qid
    • Children 1-3 yrs: 100-200 mg tid
    Giardiasis (Adults & Children over 10 yrs)-
    • 2 gm once daily for 3 days
    Giardiasis (Children)-
    • Children 7-10 yrs: 1 gm once daily
    • Children 3-7 yrs: 600-800 mg once daily
    • Children 1-3 yrs: 500 mg once daily
    Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
    • 200 mg tid for 3 days
    Acute ulcerative  gingivitis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Acute dental infections (Adults & Children over 10 yrs)-
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid

    Vaginal Gel:

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


    Suppository:

    Anaerobic Infections-
    • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
    • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
    Surgical Prophylaxis-
    • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
    • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


    IV Infusion:

    Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
    • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
    • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
    Side effectsView
    Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
    ContraindicationsView
    Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
    PrecautionsView
    • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
    • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
    • Patients should be warned that metronidazole may darken urine.
    InteractionsView
    • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
    • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
    • Lithium: Plasma levels of lithium may be increased by metronidazole.
    • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
    • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
    • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
    • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
    Pregnancy & lactationView
    US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
    Pediatric usageView
    Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

    Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
    Overdose effectsView
    Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
    StorageView
    Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

    Metra

    Metronidazole
    Tablet 400 mg Allopathic Amoebicides

    Indications

    Vaginal trichomoniasis

    Indication detailsView
    Metronidazole is indicated in the treatment of following diseases:
    • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
    • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
    • In the treatment of urogenital trichomoniasis.
    • Bacterial vaginosis (also known as non-specific vaginitis).
    • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
    • Giardiasis.
    • Acute ulcerative gingivitis.
    • Anaerobically infected leg ulcers and pressure sores.
    • Acute dental infections due to anaerobic organisms.
    • Antibiotic associated pseudomembranus colitis.
    Therapeutic classView
    Amoebicides, Anti-diarrhoeal Antiprotozoal
    PharmacologyView
    Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
    DosageView

    Tablet and Suspension:

    Trichomoniasis (Adults & Children over 10 yrs)-
    • 200 mg tid or 400 mg bid for 7 days
    • 800 mg in the morning and 1-2 gm at night for 2 days
    • 2 gm as a single dose for 1 days
    Trichomoniasis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Intestinal amoebiasis (Adults & Children over 10 yrs)- 
    • 800 mg tid for 5 days
    Intestinal amoebiasis (Children)-
    • Children 7-10 yrs: 400 mg tid
    • Children 3-7 yrs: 200 mg qid
    • Children 1-3 yrs: 200 mg tid
    Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
    • 400-800 mg tid for 5-10 days
    Extra-intestinal & Asymptomatic amoebiasis (Children)-
    • Children 7-10 yrs: 200-400 mg tid
    • Children 3-7 yrs: 100-200 mg qid
    • Children 1-3 yrs: 100-200 mg tid
    Giardiasis (Adults & Children over 10 yrs)-
    • 2 gm once daily for 3 days
    Giardiasis (Children)-
    • Children 7-10 yrs: 1 gm once daily
    • Children 3-7 yrs: 600-800 mg once daily
    • Children 1-3 yrs: 500 mg once daily
    Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
    • 200 mg tid for 3 days
    Acute ulcerative  gingivitis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Acute dental infections (Adults & Children over 10 yrs)-
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid

    Vaginal Gel:

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


    Suppository:

    Anaerobic Infections-
    • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
    • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
    Surgical Prophylaxis-
    • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
    • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


    IV Infusion:

    Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
    • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
    • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
    Side effectsView
    Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
    ContraindicationsView
    Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
    PrecautionsView
    • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
    • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
    • Patients should be warned that metronidazole may darken urine.
    InteractionsView
    • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
    • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
    • Lithium: Plasma levels of lithium may be increased by metronidazole.
    • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
    • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
    • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
    • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
    Pregnancy & lactationView
    US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
    Pediatric usageView
    Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

    Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
    Overdose effectsView
    Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
    StorageView
    Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

    Metrinor

    Dienogest
    Tablet 2 mg Allopathic Female Sex hormones

    Indications

    Endometriosis

    Indication detailsView
    Dienoaest is indicated for the treatment of endometriosis. This is the preparation of Dienogest which belongs to the class of medications called progestins. Progestins reduce the effects of estrogen on tissues such as the endometrium (lining of the uterus) and the breast. By reducing the growth effect of estrogen on the endometrium, Dienogest helps to reduce the pelvic pain experienced by women with endometriosis.
    Therapeutic classView
    Female Sex hormones
    PharmacologyView
    Dienogest acts as an agonist at the progesterone receptor (PR) with weak affinity that is comparable to that of progesterone but has a very potent progestagenic effect in the endometrium, causing endometrial atrophy after prolonged use. It promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue. Dienogest reduces the level of endogenous production of oestradiol and thereby suppressing the trophic effects of oestradiol on both the eutopic and ectopic endometrium. Continous administration of dienogest results in hyperprogestogenic and moderately hypoestrogenic endocrine environment, which causes initial decidualization of endometrial tissue. It is an antagonist at androgen receptors, improve androgenic symptoms such as acne and hirsutism [A16570].
    DosageView
    Tablet-taking can be started on any day of the menstrual cycle. The dosage of Dienogest is 2 mg daily without any break, taken preferably at the same time each day with some liquid as needed. Tablet must be taken continuously without regard to vaginal bleeding. When a pack is finished, the next one should be started without interruption.

    In the event of missed tablet(s), the woman should take 2 mg only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by 2 mg.
    Side effectsView
    Undesirable effects are more common during the 1st months after start of intake of Dienogest, and subside with duration of treatment. The following undesirable effects have been reported in users of Dienogest. The most frequently reported undesirable effects during treatment that were considered at least possibly related to Dienogest were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
    • Nervous System Disorders: Headache, migraine.
    • Cardiac Disorders: Uncommon: Unspecified circulatory system disorder, palpitations.
    • Vascular Disorders: Uncommon: Hypotension.
    • Gastrointestinal Disorders: Common: Nausea, abdominal pain, flatulence.
    • Metabolism and nutrition disorders: Weight increase (3.6%)
    • Psychiatric Disorders: Depressed mood, irritability, nervousness, altered mood.
    ContraindicationsView
    Hypersensitivity to dienogest or to any of the excipients of Dienogest. Dienogest should not be used in the presence of any of the conditions such as, Active venous thromboembolic disorder; arterial and cardiovascular disease, (e.g, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies and undiagnosed vaginal bleeding.
    PrecautionsView
    Before starting Dienogest treatment, pregnancy must be excluded. During treatment, patients are advised to use nonhormonal methods of contraception (e.g, barrier method) if contraception is required.

    As Dienogest is a progestogen-only preparation, it can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Dienogest .
    • Changes in Bleeding Pattern: Dienogest treatment affects the menstrual bleeding pattern in the majority of women.
    • Hepatic Impairment: Dienogest is contraindicated in patients with present or past severe hepatic disease.
    • Impairment of Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Dienogest. However, Dienogest is not a contraceptive. If contraception is required, a nonhormonal method should be used.
    InteractionsView
    Progestogens including Dienogest are metabolized mainly by the cytochrome P450 3A4 system . Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism. Known CYP3A4 inhibitors like azole antifungals (e.g, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (e.g, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (e.g, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (e.g, nefazodone, fluvoxamine, fluoxetine) may increase plasma levels of progestogens and result in adverse reactions.
    Pregnancy & lactationView
    There are limited data from the use of Dienogest in pregnant women. Animal studies and data from women exposed to Dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Dienogest should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.

    Treatment with Dienogest during lactation is not recommended. Physiochemical properties and animal data indicate excretion of Dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Dienogest therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
    Pediatric usageView
    Use in Children: Dienogest is not indicated in children prior to menarche. The safety and efficacy of Dienogest in adolescents (menarche to 18 years) has not yet been established.

    Use in the Elderly: There is no relevant indication for the use of Dienogest in the geriatric population.
    Overdose effectsView
    Acute toxicity studies performed with Dienogest did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. Dienogest 20-30 mg/day (10-15 times higher dose than in Dienogest) over 24 weeks of use were very well tolerated.
    StorageView
    Keep in a cool and dry place. Protect from light. Keep out of the reach of children.

    Metrion

    Metronidazole
    IV Infusion 500 mg/100 ml Allopathic Amoebicides

    Indications

    Vaginal trichomoniasis

    Indication detailsView
    Metronidazole is indicated in the treatment of following diseases:
    • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
    • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
    • In the treatment of urogenital trichomoniasis.
    • Bacterial vaginosis (also known as non-specific vaginitis).
    • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
    • Giardiasis.
    • Acute ulcerative gingivitis.
    • Anaerobically infected leg ulcers and pressure sores.
    • Acute dental infections due to anaerobic organisms.
    • Antibiotic associated pseudomembranus colitis.
    Therapeutic classView
    Amoebicides, Anti-diarrhoeal Antiprotozoal
    PharmacologyView
    Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
    DosageView

    Tablet and Suspension:

    Trichomoniasis (Adults & Children over 10 yrs)-
    • 200 mg tid or 400 mg bid for 7 days
    • 800 mg in the morning and 1-2 gm at night for 2 days
    • 2 gm as a single dose for 1 days
    Trichomoniasis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Intestinal amoebiasis (Adults & Children over 10 yrs)- 
    • 800 mg tid for 5 days
    Intestinal amoebiasis (Children)-
    • Children 7-10 yrs: 400 mg tid
    • Children 3-7 yrs: 200 mg qid
    • Children 1-3 yrs: 200 mg tid
    Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
    • 400-800 mg tid for 5-10 days
    Extra-intestinal & Asymptomatic amoebiasis (Children)-
    • Children 7-10 yrs: 200-400 mg tid
    • Children 3-7 yrs: 100-200 mg qid
    • Children 1-3 yrs: 100-200 mg tid
    Giardiasis (Adults & Children over 10 yrs)-
    • 2 gm once daily for 3 days
    Giardiasis (Children)-
    • Children 7-10 yrs: 1 gm once daily
    • Children 3-7 yrs: 600-800 mg once daily
    • Children 1-3 yrs: 500 mg once daily
    Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
    • 200 mg tid for 3 days
    Acute ulcerative  gingivitis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Acute dental infections (Adults & Children over 10 yrs)-
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid

    Vaginal Gel:

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


    Suppository:

    Anaerobic Infections-
    • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
    • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
    Surgical Prophylaxis-
    • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
    • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


    IV Infusion:

    Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
    • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
    • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
    Side effectsView
    Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
    ContraindicationsView
    Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
    PrecautionsView
    • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
    • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
    • Patients should be warned that metronidazole may darken urine.
    InteractionsView
    • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
    • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
    • Lithium: Plasma levels of lithium may be increased by metronidazole.
    • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
    • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
    • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
    • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
    Pregnancy & lactationView
    US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
    Pediatric usageView
    Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

    Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
    Overdose effectsView
    Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
    StorageView
    Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

    Metrion

    Metronidazole
    Tablet 400 mg Allopathic Amoebicides

    Indications

    Vaginal trichomoniasis

    Indication detailsView
    Metronidazole is indicated in the treatment of following diseases:
    • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
    • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
    • In the treatment of urogenital trichomoniasis.
    • Bacterial vaginosis (also known as non-specific vaginitis).
    • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
    • Giardiasis.
    • Acute ulcerative gingivitis.
    • Anaerobically infected leg ulcers and pressure sores.
    • Acute dental infections due to anaerobic organisms.
    • Antibiotic associated pseudomembranus colitis.
    Therapeutic classView
    Amoebicides, Anti-diarrhoeal Antiprotozoal
    PharmacologyView
    Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
    DosageView

    Tablet and Suspension:

    Trichomoniasis (Adults & Children over 10 yrs)-
    • 200 mg tid or 400 mg bid for 7 days
    • 800 mg in the morning and 1-2 gm at night for 2 days
    • 2 gm as a single dose for 1 days
    Trichomoniasis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Intestinal amoebiasis (Adults & Children over 10 yrs)- 
    • 800 mg tid for 5 days
    Intestinal amoebiasis (Children)-
    • Children 7-10 yrs: 400 mg tid
    • Children 3-7 yrs: 200 mg qid
    • Children 1-3 yrs: 200 mg tid
    Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
    • 400-800 mg tid for 5-10 days
    Extra-intestinal & Asymptomatic amoebiasis (Children)-
    • Children 7-10 yrs: 200-400 mg tid
    • Children 3-7 yrs: 100-200 mg qid
    • Children 1-3 yrs: 100-200 mg tid
    Giardiasis (Adults & Children over 10 yrs)-
    • 2 gm once daily for 3 days
    Giardiasis (Children)-
    • Children 7-10 yrs: 1 gm once daily
    • Children 3-7 yrs: 600-800 mg once daily
    • Children 1-3 yrs: 500 mg once daily
    Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
    • 200 mg tid for 3 days
    Acute ulcerative  gingivitis (Children)-
    • Children 7-10 yrs: 100 mg tid
    • Children 3-7 yrs: 100 mg bid
    • Children 1-3 yrs: 50 mg tid
    Acute dental infections (Adults & Children over 10 yrs)-
    • 200 mg tid for 3-7 days
    Bacterial Vaginosis (Adults & Children over 10 yrs)-
    • 400 mg bid for 7 days
    • 2 gm as a single dose for 1 days
    Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
    • 400 mg tid for 7 days
    Anaerobic infections (Adults & Children over 10 yrs)-
    • 800 mg initially and then 400 mg tid for 7 days
    Anaerobic infections (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid
    Surgical prophylaxis (Adults & Children over 10 yrs)-
    • 400 mg tid started 24  hours before  surgery for 1 days
    Surgical prophylaxis (Children)-
    • Children 1-10 yrs: 7.5 mg/kg tid

    Vaginal Gel:

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


    Suppository:

    Anaerobic Infections-
    • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
    • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
    Surgical Prophylaxis-
    • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
    • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


    IV Infusion:

    Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
    • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
    • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
    Side effectsView
    Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
    ContraindicationsView
    Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
    PrecautionsView
    • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
    • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
    • Patients should be warned that metronidazole may darken urine.
    InteractionsView
    • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
    • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
    • Lithium: Plasma levels of lithium may be increased by metronidazole.
    • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
    • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
    • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
    • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
    Pregnancy & lactationView
    US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
    Pediatric usageView
    Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

    Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
    Overdose effectsView
    Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
    StorageView
    Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.