Glimet Adverse Effects
Diarrhoea, Headache, Nausea / Vomiting, Abdominal pain and Dizziness may be encountered with the Glimet therapy.
Drug Interactions
When the drugs like the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid are administered to a patient receiving Glimet, the patient should be closely observed for loss of blood glucose control. When such drugs are .withdrawn from a patient receiving Glimet, the patient should be observed closely for hypoglycemia. Metformin HCI is negligibly bound to plasma proteins and is; therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid as compared to sulfonylureas, which are extensively bound to serum proteins.
Warnings
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to Metformin HCI accumulation.
Precautions
General
Hypoglycemia - As with other hypoglycemic agent, Glimet (Metformin HCI and Glibenclamide) Tablets is also capable of producing hypoglycemia or hypoglycemic symptoms, therefore, proper patient selection, dosing, and instructions are important to avoid potential hypoglycemic episodes.
Renal or hepatic insufficiency may cause elevated drug levels of both Metformin Hydrochloride and Glibenclamide and the hepatic insufficiency may also diminish gluconeogenic capacity, both of which increase the risk of hypoglycemic reactions.
Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects.
Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta- adrenergic blocking drugs.
Pregnancy
Teratogenic Effects: Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women with Glimet or its individual components. No animal studies have been conducted with the combined products in Glimet The foitowing data are based on findings in studies performed with the individual products.
Metformin Hydrochloride
Metformin HCI alone was not teratogenic in rats or rabbits at doses up to 600 mg/kg/day.
Glibenclamide
Reproduction studies were performed in rats and rabbits at doses up to 500 times the maximum recommended human daily dose of 20 mg of the Glibenclamide component of Glimet based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to Glibendamide.
Nursing Mothers
Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue Glimet, taking into account the importance of the drug to the mother. If Glimet is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
