Glyformet

Metformin Hydrochloride 500 mg: White to off-white film coated tablet, round, biconvex and plain on both sides.
Metformin Hydrochloride 850 mg: White to off-white film coated tablet, capsule shaped, biconvex and plain on one side and bisected on the other side.
Each film-coated tablet contains: Metformin Hydrochloride, USP 500 mg or 850 mg.

Oral Hypoglycemic (Biguanide).
Pharmacology: Pharmacodynamics: Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and daylong plasma insulin response may actually decrease.
Pharmacokinetics: Metformin hydrochloride is slowly and incompletely absorbed from the gastrointestinal tract; the absolute bioavailability of a single dose 500 mg dose is reported to be about 50 to 60%, although this is reduced somewhat if taken with food. Following absorption, plasma protein binding is negligible and is excreted unchanged in the urine. The plasma elimination half-life is reported to range from about 2 to 6 hours after oral administration.

Diet-failed, non-insulin dependent diabetes mellitus patient, especially if overweight, along with initial therapy using sulphonylurea.

Initial: 500 mg once daily or as prescribed by the physician.
Dose may be increased to 1,000 mg daily as a single dose or in two divided doses or as prescribed by the physician.

Overdose can cause lactic acidosis. Symptoms of overdose may include: severe drowsiness, severe nausea/vomiting/diarrhea, rapid breathing, slow/irregular heartbeat. 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.

Metformin is contraindicated in patients with: Renal disease or renal dysfunction which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
Known hypersensitivity to metformin hydrochloride.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, severe muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If symptoms of lactic acidosis occur, patient should get immediate emergency medical help.
This may cause some premenopausal women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If the patient is a woman of childbearing potential, patient should discuss birth control options with the doctor.
This may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes the patient to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important to learn which symptoms the patient usually has so it can be treated quickly. Talk to the doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if the patient does not take enough or skips a dose of the medicine, overeats or does not follow the meal plan, has a fever or infection, or does not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important to learn which symptoms the patient has in order to treat it quickly. Talk to the doctor about the best way to treat high blood sugar.
High blood sugar may occur if the patient does not exercise as much as usual, has a fever or infection, does not take enough or skips a dose of the diabetes medicine, or overeats or does not follow the meal plan.

Pregnancy: Oral hypoglycemic agents (including metformin) are not recommended during pregnancy. Maintaining blood glucose levels as close to normal as possible is necessary during pregnancy since abnormal blood glucose levels are associated with a higher incidence of congenital abnormalities. Insulin is recommended during pregnancy.
Lactation: Metformin is excreted into human milk and should therefore not be used by breastfeeding mothers. The importance of metformin to the mother should be considered when deciding whether to discontinue breastfeeding or discontinue metformin because the potential for hypoglycemia in breastfeeding infants may exist. Consider insulin therapy for adequate glycemic control if metformin is discontinued.

Metformin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with the doctor or pharmacist about whether the dose of other diabetes medication(s) needs to be lowered.
A very serious allergic reaction to this drug is rare. However, get medical help right away if any of the following symptoms of a serious allergic reaction are noticed: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat the patient would usually feel when the blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Store at temperatures not exceeding 30°C.

Antidiabetic Agents

A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.

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