| a) Generic Name |
Metformin hydrochloride USP
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| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Tablet (Film Coated).
Each tablet contains Metformin hydrochloride USP 850 mg.
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| b) Indications |
Type-II diabetes (non-insulin dependent diabetes); Type-I diabetes (insulin dependent diabetes) as adjuvant therapy in combination with insulin; obesity and insulin resistance; hyperlipoproteinemia.
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| c) Dosage & administration |
Treatment is usually initiated with 500-1000 mg daily, followed by a gradual increase if necessary. No further effect on blood glucose can be expected from doses above 3 gm daily. When good control has been achieved, the dose may be gradually reduced. An adequate blood glucose control may not be apparent until after 1-2 weeks. In order to minimize gastrointestinal side effects, Metformin HCl should be taken together with meals. Metformin HCl is usually given in two or three daily doses.
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| d) Side Effects |
Lactic acidosis, vitamin B12 and folate malabsorption, hypoglycemia, diarrhoea, skin reactions, other hypersensitivity reactions.
|
| e) Precautions and
Warnings
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Metformin should be used with caution to patients with hepatic and renal disease, elderly patients and cardiac failure.
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| f) Contraindications
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Impaired renal function, acute complications (severe infections, major operations and trauma), before X-ray examinations with iodinated contrast materials, liver damage, alcoholism, deficiencies of vitamin B12, folic acid and iron, ketosis prone diabetes, severe cardiovascular or respiratory disease, general ill health (malnutrition, dehydration, etc), diabetes with significant late complications (nephropathy, retinopathy).
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| g)Drug Interactions |
Phenprocoumon (increases elimination of phenprocoumon); Cimetidine (increases the availability of metformin and reduces its renal clearance, therefore, the dose of metformin should be reduced); Hyperglycemic agents (thiazides, corticosteroids may partly offset the antihyperglycemic action of metformin); Alcohol (alcohol potentiates the action of metformin)
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| h)Use In Pregnancy and Lactation |
Metformin- HCl may enter the breast milk and is best avoided in nursing mothers. Pregnancy is generally regarded as a contraindication, and insulin should be used in all pregnant diabetic women.
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| i) Storage Conditions |
• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.
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| j) Package Quantity |
To be submitted at the time of inclusion.
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