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METINIM 850 - Film coated tablet 15/04/2011


Packing: Box of 1 blister of 10 film coated tablets. Box of 10 blisters of 10 film coated tablets.

Active ingredients: Metformin hydrochloride 850 mg

METINIM 850

Metformin hydrochloride


Film coated tablet

 

COMPOSITION

Each film coated tablet contains:

Active ingredient: Metformin hydrochloride 850 mg.

INDICATIONS

It is used for the treatment of non-insulin dependent diabetes (type 2) particularly in overweight patients when diet and exercise does not result in adequate glycaemic control.

It is also used in combination with a sulphonylurea when diet and exercise plus the single agent not result in adequate glycaemic control.

DOSAGE AND ADMINISTRATION

Adults:

- Initial dosage is 850 mg once daily at breakfast, gradually increased if necessary, at intervals of at least 1 week, to 2550 mg daily. The usual maintenance dose is 850 mg twice daily with meals.

Children: As directed by a physician.

Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin.

CONTRAINDICATIONS

Hypersensitivity to any ingredient of drug.

Renal disease or renal dysfunction (e.g. serum creatinine levels ≥ 1.5 mg/dL in males, ≥ 1.4 mg/dL in females or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.

Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).

Severe hepatic diseases, severe cardiovascular diseases, severe respiratory diseases with hypoxia.

Congestive heart failure, severe infection, gangrene, alcoholism, malnutrition.

Pregnancy.

WARNINGS AND PRECAUTIONS

Do not use this product with any other product containing metformin.

Should maintain an appropriate diet during the treatment.

Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

Metformin should be discontinued 48 hours before elective surgery.

Metformin is excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, renal function need to be regularly monitored particularly in elderly.

Concomitant medications that may affect renal function may interfere with the distribution of metformin.

Use in pregnancy and lactation: Metformin is contraindicated in pregnancy. The use of insulin is generally recommended for patients with diabetes during pregnancy. Adequate data are not available for metformin during lactation in humans. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Effects on the ability to drive or operate machinery: Metformin alone does not cause hypoglycaemia and therefore has no effect on the ability to drive or use machines. However, caution is advised when it is used in combination with insulin or sulfonylureas.

DRUG INTERACTIONS

Certain drugs tend to produce hyperglycaemia (e.g. diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium-channel blocking drugs, and isoniazid) may lead to loss of glycaemic control.

Furosemide may increase the metformin plasma and blood Cmax, without any significant change in metformin renal clearance.

Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) have the potential for interaction with metformin by competing for common renal tubular transport systems.

Cimetidine increased peak metformin plasma and whole blood concentrations by 60%.

Co-administration with alcohol may increase the risk of lactic acidosis as well as of hypoglycaemia.

ADVERSE DRUG REACTIONS

Gastrointestinal disorders such as anorexia, nausea, vomiting, diarrhoea, constipation, heartburn are the most frequently reported adverse effects and usually occur at the start of treatment, but usually transient.

Other undesirable effects reported include erythema, pruritus, urticaria, decreased vitamin B12 absorption, megaloblastic anaemia, lactic acidosis.

Stop use and ask a doctor if if you have any of these symptoms of lactic acidosis such as weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain.

Inform your physician in case of any adverse reaction related to drug use.

PHARMACOLOGY AND PHARMACOKINETICS

-   Metformin is a biguanide with antihyperglycaemic effects which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.

-   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 stimulate insulin secretion and therefore does not produce hypoglycaemia.

Pharmacokinetics

-   Metformin is slowly and incompletely absorbed from the gastrointestinal tract. The absolute bioavailability of a single 500 mg dose is reported to be about 50 to 60% on an empty stomach. There is a lack of dose proportionality with increasing doses due to decreased absorption. Food decreases the extent of and slightly delays the absorption of metformin.

-   Metformin is negligibly bound to plasma proteins. Metformin partitions into erythrocytes, most likely as a function of time. Metformin is distributed into breast milk in small amounts.

-   Metformin is excreted unchanged in the urine and does not undergo hepatic metabolism nor biliary excretion. Following oral administration, approximately 90% of the absorbed drug is eliminated unchanged via the renal route within the first 24 hours. The plasma elimination half-life is reported to range from about 1.5 to 4.5 hours after oral doses.

OVERDOSAGE

Symptoms: High overdose of metformin may lead to lactic acidosis. hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances.

Treatment: Metformin is dialysable with a clearance of up to 170 mL/min under good haemodynamic conditions. Therefore, haemodialysis may be useful for removal of accumulated metformin from patients in whom metformin overdosage is suspected.

PRESENTATION          

               Box of 1 blister of 10 film coated tablets.

               Box of 10 blisters of 10 film coated tablets.

STORAGE

Store at the temperature not more than 30oC, in a dry place, protect from light.

SPECIFICATION: BP 2007.

SHELF-LIFE: 24 months from manufacturing date.

PRESCRIPTION ONLY

KEEP OUT OF REACH OF CHILDREN

READ CAREFULLY THE LEAFLET BEFORE USE

FOR MORE INFORMATION, CONSULT YOUR PHYSICIAN.

Manufactured by: GLOMED PHARMACEUTICAL Co., INC

Address: 35 Tu Do Boulevard, Vietnam – Singapore Industrial Park, Thuan An District, Binh Duong Province.

Tel: (0650)3768824 - (0650)3768825    Fax: (0650)3769095


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