Should be taken with food. XR tab: Swallow whole, do not split/crush/chew.
Administration
Should be taken with food. XR tab: Swallow whole, do not split/crush/chew.
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Contraindications
Acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma); diabetic pre-coma; acute conditions which may alter renal function (e.g. dehydration, severe infection, shock), acute or chronic conditions which may cause tissue hypoxia (e.g. acute unstable heart failure; respiratory failure, recent MI; pulmonary embolism, acute significant blood loss, sepsis, gangrene, pancreatitis), acute alcohol intoxication or alcoholism. Hepatic or severe renal impairment (eGFR <30 mL/min). Concomitant intravascular administration of iodinated contrast agents.
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Special Precautions
Patients with risk factors for lactic acidosis, stable chronic heart failure, prerenal azotaemia. Mild to moderate renal impairment. Children and elderly. Pregnancy and lactation. Not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis. Patients undergoing surgical procedures. Monitoring Parameters Monitor urine for glucose and ketones, fasting blood sugar, HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting therapy goals or with changes in treatment); renal function prior to initiation of therapy and then annually or more frequently in the elderly and patients at risk for renal impairment; liver function at baseline; haematologic parameters at baseline and annually thereafter; vitamin B12 serum concentration every 2-3 years (prolonged use). Monitor for signs and symptoms of lactic acidosis and vitamin B12 deficiency.
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Adverse Reactions
Significant: Vitamin B12 deficiency (prolonged use).
Gastrointestinal disorders:
Potentially Fatal: Lactic acidosis. |
Drug Interactions
Increased risk of lactic acidosis with carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide, topiramate, zonisamide), NSAIDs, including cyclo-oxygenase (COX) II inhibitors; ACE inhibitors, angiotensin II receptor antagonists, and loop diuretics. Increased risk of hypoglycaemia with other antidiabetic agents (e.g. sulfonylurea, meglitinides, insulin). Increased plasma concentration with organic cation transporters (OCT)2 inhibitors (e.g. cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Reduced efficacy with OCT1 inhibitors (e.g. verapamil). Increased gastrointestinal absorption and efficacy with OCT1 inducers (e.g. rifampicin). Altered efficacy and renal elimination with OCT1 and OCT2 inhibitors (e.g. crizotinib, olaparib). May produce hyperglycaemia with corticosteroids, thiazide diuretics, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers, and isoniazid. May diminish the therapeutic effect of anticoagulants (e.g. warfarin).
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CIMS Class
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ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
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