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Oralmet


COMPOSITION
Each film-coated tablet contains: Metformin HCI B.P. 850 mg

Colouring agent: Titanium oxide
Oralmet is a off-white to slightly yellow, 14 mm in diameter tablet, film-coated, inscribed with "SL" logo on one side.


PHARMACODYNAMICS
Metformin is a biguanide with antihyperglycaemic effects, lowing both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.


Metformin act via 3 mechanisms:
(i) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
(ii) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation

(iii) and delay of intestinal glucose absorption.


Metformin stimulates intracellular glycogen syntheses and increase the transport capacity of all types of membrane glucose transporters.


PHARMACOKINETICS
Metformin hydrochloride is slowly and incompletely absorbed from the gastrointestinal tract; the absolute bioavailability of a 500 mg dose is reported to be about 50% to 60%, although this is reduced somewhat if taken with food. Once absorbed plasma protein binding is negligible, and it is excreted unchanged in the urine. The plasma elimination half life is reported to range from about 2 to 6 hours after oral doses. Metformin is distributed into breast milk in small amount.


INDICATIONS
Hypoglycaemic agent used in non-insulin-dependent diabetes and also sometimes used in combination with insulin in overweight insulin-dependent diabetes.


CONTRA-INDICATIONS
It is contra-indicated in patients with ketoacidosis, severe infection, stress, trauma; in severe impairment of renal, hepatic, or thyroid function; heart failure, dehydration, acute or chronic alcoholism.


WARNING & PRECAUTIONS
Care is necessary during excessive exercise as hypoglycaemia may be provoked.


Drug interactions:
(a) Drugs which tend to produce hyperglycaemia (e.g diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid) may lead to a loss of glycaemic control.
(b) Furosemide increased metformin plasma and blood CBmaxB without altering metformin renal clearance in a single dose study.
(c) Cationic drugs (e.g. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) which are eliminated by renal tubular secretion could have the potential for interaction with metformin by competing for common renal tubular transport systems.
(d) Cimetidine increases peak metformin plasma and whole blood concentrations.
 

INTERACTION WITH OTHER MEDICAMENTS
Drug interactions:
(a) Drugs which tend to produce hyperglycaemia (e.g diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid) may lead to a loss of glycaemic control.
(b) Furosemide increased metformin plasma and blood CBmaxB without altering metformin renal clearance in a single dose study.
(c) Cationic drugs (e.g. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) which are eliminated by renal tubular secretion could have the potential for interaction with metformin by competing for common renal tubular transport systems.
(d) Cimetidine increases peak metformin plasma and whole blood concentrations.


PREGNANCY AND LACTATION
The use of Oralmet during pregnancy is not advisable.


DOSAGE
Initially, 850 mg twice or three times daily with or after meal, gradually increased if necessary to a maximum of 3g daily.
 

SIDE EFFECTS
Gastro-intestinal side effects with anorexia, nausea, and vomiting; absorption of vitamin B12 may be impaired. Patients may experience a weight loss.


SYMPTOMS & TREATMENT OF OVERDOSE
Hypoglycaemia. Treatment include stomach aspiration and lavage. Lactic acidosis is treated with sodium bicarbonate. Hypoglycaemia should be treated by the oral administration of sugar lumps or a glucose-based drink.


SUPPLY
Packs of 100's in HDPE bottle Blister pack of 10x10's Blister pack of 50x10's Blister pack of 100x10's


STORAGE/SHELF-LIFE
Store in a dry place, protected from direct light and humidity and at below 25C. The shelf-life of ORALMET 850 mg is 3 years.

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