Ormin 500: Each film coated tablet contains Metformin Hydrochloride BP 500 mg.

Ormin 850: Each film coated tablet contains Metformin Hydrochloride BP 850 mg.

BP 

Antidiabetic

In NIDDM (Non-insulin dependent diabetes mellitus or type-2 diabetes): As monotherapy, as an adjunct to diet to lower blood glucose in patients with NIDDM whose hyperglycemia can not be satisfactorily managed on diet alone. Ormin® (Metformin Hydrochloride) may be used concomitantly with a sulphonylurea when diet and metformin or sulphonylurea alone do not result in adequate glycemic control.

In IDDM (Insulin dependent diabetes mellitus or type-1 diabetes): As an adjunct therapy in combination with insulin.

Ormin (Metformin Hydrochloride) is contraindicated in 

• Renal disease or dysfunction which may also result from conditions such as cardiovascular collapse (shock), acute MI & septicemia.
• Patients undergoing radiologic studies involving parenteral administration of iodinated contrast meals.
• Hypersensitivity to Ormin (Metformin Hydrochloride).
• Acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma.

There is no fixed dosage regimen for the management of hyperglycemia in diabetes mellitus with Ormin (Metformin Hydrochloride). Dosage must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 2550 mg.

Ormin (Metformin Hydrochloride) 500 mg: The usual starting dose is one 500 mg tablet twice daily, given with the morning or evening meals. Dosage increase should be made in increments of 500 mg every week, given in divided dose, up to a maximum of 2550 mg/day. Metformin can be administered twice a day up to 2000 mg/day (e.g. 1000 mg twice daily with morning & evening meals). If a 2500 mg daily dose is required, it may be better tolerated given three times daily with meals.

Ormin (Metformin Hydrochloride) 850 mg: The usual starting dose is one 850 mg tablet daily given with the morning meals. Dosage increases should be made in increments of 850 mg every other week, given in divided doses, up to a maximum of 2550 mg/day. The usual maintenance dose is 850 mg twice daily with the morning and evening meals. When necessary, patients may be given 850 mg 3 times daily with meals. 

Or as directed by the physicians.

Metformin Hydrochloride, the active ingredient in Ormin® (Metformin Hydrochloride) can cause a rare but serious condition called lactic acidosis that can cause death. Common side effects include diarrhea, nausea and upset stomach. Ormin® (Metformin Hydrochloride) rarely causes hypoglycemia.

• Monitoring: Before initiation of therapy and at least annually thereafter, renal function must be assessed and verified. Patients previously well controlled by Ormin® (Metformin Hydrochloride) but develop abnormalities in medical tests should be further evaluated for evidence of ketoacidosis or lactic acidosis. Response to all diabetic therapies by periodic measurement of blood glucose and glycosylated hemoglobin should be monitored. Initial and periodic monitoring of haematologic parameters and renal function should be performed at least on annual basis.

• Hypoxic states: Cardiovascular collapse (shock), acute CHF, acute MI and other conditions characterized by hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. If such events occur, Ormin® (Metformin Hydrochloride) must be discontinued.

• Surgical procedure: Temporarily Ormin® (Metformin Hydrochloride) has to be suspended for surgical procedures.

• Vitamin B12 levels: Certain individuals with inadequate Vitamin B12 or calcium intake or absorption may be predisposed to developing subnormal Vitamin B12 levels. In these patients, routine serum Vitamin B12 measurements as 2 or 3-years intervals may be useful.

Drugs that may affect Ormin (Metformin Hydrochloride) include Alcohol, cationic drugs, Cimetidine, Furosemide, Iodinated contrast material and Nifedipine. Drugs that may be affected by Ormin (Metformin Hydrochloride) include Glyburide and Furosemide. Certain drugs tend to produce hyperglycemia and may lead to loss fo glycemic control such as Thiazide and other diuretics, corticosteroids, phenothiazines thyroid products, estrogens, oral contraceptives, Phenytoin, Nicotinic acid, Sympathomimetics, Calcium channel blockers, Isoniazide and Beta adrenergic blockers.

Safety & efficacy of Ormin® (Metformin Hydrochloride) in children have not been established. Use of Ormin® (Metformin Hydrochloride) in adolescents is supported by evidences from clinical studies, demonstrating a similar response in glycemic control to that seen in adults.

Pregnancy Category B. The drug has been used in pregnant women without any particular problem. Nevertheless, it is generally regarded as a contraindication in pregnancy and insulin should be used in all pregnant diabetic women.

Ormin® (Metformin Hydrochloride) enters breast milk in small amounts and is best avoided in lactating mothers.

Hypoglycemia has not been seen even with ingestion of amounts greater than 50 grams of Metformin Hydrochloride, although lactic acidosis has occurred in such circumstances. Hemodialysis may be useful for removal of accumulated drug from patients to whom Metformin Hydrochloride overdose is suspected.

Ormin® 500 tablet: Each box contains 5x10’s tablets in Alu-PVC blister packs.

Ormin® 850 tablet: Each box contains 5x10’s tablets in Alu-PVC blister packs.

Store below 30 ºC, protected from light and moisture. Keep all medicines out of the reach of children.