MetforminTablet 500 mg

Drug Classification : Antidiabetic Agents
COMPOSITIONS :
Metformin Tablets, each tablet contains : Metformin HCI 500 mg.
Metformin Caplets, each tablet contains : Metformin HCI 850 mg.

PHARMACOLOGY :
Pharmacodynamics :

Metformin is oral antihyperlycemic drug used in the management of Type 2 diabetes mellitus. Is not chemically or pharmacologically related to the oral Sulfonylureass. Metformin improves glucose tolerance in Type 2 diabetes subjects, lowering both basal and postpandial plasma glucose. It’s pharmacologic mechanism of action are different those of Sulfolureas. Metformin decrease hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity ( increases peripheral glucose uptake and utilization ). Unlike Sulfolureass, Metformin does not produce hypoglycemia in either diabetic or nondiabetic subjects ( except in special circumstance, see Precaution ) and does not cause hyperinsulinemia.

Pharmocokinetics :
- Absorption
The absolute bioavailability of 500 mg Metformin given under fasting conditions is approximately 50-60 %. Food decrease the extent and slightly delays the absorption of Metformin.
- Distribution
Metformin is negligibly bound to plasma proteins in contrast to Sulfolureass, which are > 90 % protein bound.
- Metabolism
Metformin does not undergo hepatic metabolism ( no metabolites have been identified in humans ) nor biliary excretion.
- Excretion
Metformin is excreted unchanged in the urine.


INDICATIONS :

- Type 2 diabetes mellitus ( non-insulin-dependent diabetes ) who are either overweight of normal weight, and in whom diet has failed.
- Type 1 diabetes mellitus ( insulin-dependent diabetes ) combination with insulin.
- Adjuvant therapy in insulin-dependent iabets to reduce the dosage of insulin required.
- Solo therapy in primary or secondary Sulfonylurea failures.
- Combined therapy with Sulfonylurea.

DOSAGE AND ADMINISTRATION :
Adults :
- Metformin 500 mg : one 500 mg tab 3 times a day with meals or after meals
If needed the dose can be increased until 3 gram a day.
- Metformin 850 mg : one caplet 850 mg 2 times a day with meals or after meals.

CONTRAINDICATIONS :
- Renal disease or renal dysfunction ( eg. As suggested by serum creatinine level > 1.g mg/dl. [males], > 1.4 mg/dl. [females] or abnormal creatinine clearance ) which may also result from condition such as cardiovascular collapse ( shock ), acute myocardial infarction and septicemia.
- Congestive heart failure requiring pharmacologic treatment.
- Hypersensitivity to Metformin.
- Acule or chronic metabolic acidosis, including diabetic ketoaciodsis, with or without coma.
-
WARNING AND PRECAUTION :
- Care is advised in cases of renal insufficiency.
- While it is advisable that patients on long-term Metformin therapy have a prophylactic annual serum B12 evaluation, no case of pemicious anemia has been attributed to Metformin therapy > 15 years old of wide scale use.
- Because of possibility of hypoglycemia in combination therapy with Sulfonylurea or insulin, diabetic control should be monitored by blood sugar readinds.
- Metformin should be given cautiously in elderly patients, serious infections and traumatic condisitions.
- Safety and efficacy in children have not been established.

DRUG INTERACTIONS :
- Recent work has indicated the possibility of an onteractions between Metformin and certain anticoagulant.
- May cause hypoglycemiawith Sulfonylurea or insulin.
- Risk of lactic acidosis is increased by alcohol.
- Impairs absorption of vitamin B12.
- Reduced renal clearance if given with Cimetidine.

ADVERSE REACTIONS :
- Gastrointestinal symptoms ( eg. Diarrhea, nausea, vomiting, abdominal bloating, anorexia ) are the most common reactions to Metformin.
- Patient may complain of unpleasant or metallic taste.
- Lactic acidosis.

PRESENTATION :
- Metformin Tablet 500 mg……………….Box. 10 Blisters @ 10 tablets
- Metformin Caplet 850 mg……………….Box. 10 Blisters @ 10 caplets

STORE AT ROOM TEMPERATURES ( 25º – 30º ) AND DRY PLACES