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  • Glucophage Caplets
    / Abic


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Caplets

    30 X 850 mg

    full basket chart 7797 7197

    Related information


    Dosage

    Note: It is important to assess the effect of diet regulation before treatment with Glucophage is initiated.
    ‘Glucophage is not indicated in children and adolescents.
    Glucophage is indicated in the elderly, but not when renal function is impaired.
    There is no fixed dosage regimen for the management of hyperglycemia in diabetes mellitus with metformin hydrochloride or any other pharmacologic agent. Dosage must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose of 2550 mg.
    It is important that Glucophage be taken in divided doses with or after meals to
    avoid gastrointestinal side effects. The dose should be increased gradually. 1 caplet twice a day is often enough to provide good diabetic control. As a rule an adequate blood sugar reduction can be obtained within a few days, up to 2 weeks. If control is incomplete, a cautious increase in dosage to 3 times daily is justified. At least 1 week must pass between dose adjustments. Once control has been obtained, it may be possible to reduce the dosage.
    See prescribing information for full details.


    Indications

    Glucophage is indicated in diet-failed, non-insulin dependent diabetic patients,
    especially if overweight, either alone as initial therapy or in combination with a
    sulfonylurea.
    Occasionally, as adjuvant therapy in insulin-dependent diabetic patients particularly who are usually obese and not well controlled with insulin.


    Contra-Indications

    Known hypersensitivity to the drug, or to any other ingredients of the preparation.
    • Moderate (stage 3b) and severe renal failure or renal dysfunction (CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m²).
    • Renal disease or renal dysfunction (e.g. as suggested by serum creatinine levels > 15 mg/L for the adults or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute disease such as dehydration (diarrhea, vomiting, fever), severe infectious and/or hypoxic states (septicemia, urinary infection, pneumopathy).
    • Hypoxic states: cardiovascular collapse (shock) from whatever cause, acute
    congestive heart failure, acute myocardial infarction and other conditions
    characterized by hypoxemia (any severe respiratory disturbances).
    • Hepatic failure, since severe hepatic dysfunction has been associated with some cases of lactic acidosis. Glucophage should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.
    • Glucophage should be temporarily withheld in patients undergoing radiologic
    studies involving parenteral administration of iodinated contrast materials except for fluorescein photoretinography which does not necessitate metformin withhold, because use of such products may result in acute alteration of renal function.
    • Excessive alcohol intake, acute or chronic.
    • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
    • 2 days before elective major surgery, and for 2 days following surgery or any
    traumatic condition.
    • History of lactic acidosis.
    • Lactation.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea,
    abdominal pain and loss of appetite.
    Common: Taste disturbance
    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Metformin should not be used during pregnancy.
    Lactation: Metformin is excreted into milk in lactating rats. Similar data are not available in humans. Therefore safety of use in lactation has not been established and a decision should be made whether to discontinue breast-feeding or to discontinue metformin taking into account the importance of the medicinal product for the mother.
    See prescribing information for full details.


    Overdose

    Manifestations: Hypoglycemia has not been seen with ingestion up to 85g of metformin although lactic acidosis has occurred in such circumstances. In combination therapy with a sulfonylurea or insulin or with alcohol, hypoglycemia can occur.
    In excessive dosage, particularly if there is a possibility of accumulation, lactic
    acidosis should be suspected. Some of the signs and symptoms suggestive of this condition are nausea, diarrhea, abdominal pain and dyspnea.
    Treatment: Intensive supportive therapy is recommended. It should be particularly directed at correcting fluid loss and metabolic disturbance.
    Metformin is dialyzable with a clearance of up to 170 ml/min under good
    hemodynamic conditions. Therefore hemodialysis may be useful for removal of
    accumulated drug from patients in whom metformin overdosage is suspected.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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