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Glucomet

Ingredient(s)
Each tablet contains: Metformin HCI ............. 500mg

Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics)
1. The biguanide Metformin is an oral antihyperglycemic agent used in the management of non-insulin-dependent diabetes mellitus (NIDDM). It reduces blood glucose levels, predominantly by improving hepatic and peripheral tissue sensitivity to insulin without affecting the secretion of this hormone.

Since Metformin does not promote weight gain or hypoglycemia, it should be considered first-line pharmacotherapy in obese patients with NIDDM that is inadequately controlled by nonpharmacological measures.

2. Metformin decrease gluconeogenesis from lactate (pyruvate) and elevates the glucose utilization of peripheral tissues.

3. Metformin reduces elevated blood glucose concentrations in patients with diabetes, but it does not increase insulin secretion. This is probably the reason why it does not cause hypoglycemia.

4. Metformin has no effect on the pancreatic beta cells. It has been postulated that Metformin may potentiate the effect of insulin or enhance insulin's effect on peripheral receptor sites.

5. A lipolytic action of Metformin has been suggested and a lipid-lowering effect has been demonstrated, including reduction of plasma triglycerides and, to a lesser degree, of total cholesterol.

6. Metformin improves the blood lipoprotein profile not only in diabetics but also in non-diabetic subjects with hyperlipoproteinemia.

7. Metformin oral bioavailability of usual doses is 50 ~ 60%, and the mean plasma elimination half-life ranges from 1.5 ~ 4.5 hours.

Indication(s)
Treatment of type 2 diabetes mellitus in adults, when dietary management and exercise alone does not result in adequate glycemic control. Metformin may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. A reduction of diabetic complications has been shown in overweight type-2 diabetic patients treated with metformin as 1st line therapy after diet failure. In type 1 diabetes, Metformin may be given as an adjuvant to patients whose symptoms are poorly controlled.

Dosage and Administration
The usual dose is 500mg three times daily, taken with food or after meals; maximum 3g daily in divided doses.

Contraindication(s)
1. Hypersensitivity to biguanides.
2. Diabetic coma and serious ketoacidosis.
3. Impaired renal function, impaired hepatic function, and impaired cardiovascular function including cardiac failure and recent myocardial infarction.
4. History of, or state associated with lactic acidosis, eg. shock or pulmonary insufficiency, alcoholism.

5. Condition associated with hypoxaemia.

Precaution(s) / Warning(s)
1. Metformin is excreted by the kidney and regular monitoring of renal function is advised in all diabetics.
2. Care must be taken when administering this drug in conditions which may cause dehydrations or in patients suffering from serious infection or trauma, and in those undergoing surgery.
3. Metformin may impair absorption of Vitamin B12. Patients receiving Metformin continuously should have an annual check up of vitamin B12 levels.
4. Use in pregnancy and lactation: The use of Metformin during pregnancy is not advisable. It is not known if Metformin is excreted in
breast milk; however, hypoglycemia in infant is possible.
5. Use in children: Metformin is not recommended for use in children.
6. Use in the elderly: Metformin is indicated in the elderly but not when renal function is impaired.

Drug Interaction(s)
1. Alcohol causes enhanced hypoglycemic effect and risk of lactic acidosis with Metformin.
2. Concomitant therapy with sulfonylurea may cause hypoglycemia, therefore blood glucose should be monitored.
3. Reduced renal clearance of Metformin has been reported during Cimetidine therapy, so a dose reduction should be considered.
4. An interaction of Metformin with anticoagulants is a possibility and the dosage of anticoagulants may need adjustment.

Side Effect(s) / Adverse Reaction(s)
Concomitant therapy with sulfonylurea may cause hypoglycemia, therefore blood glucose should be monitored.

Metformin may impair absorption of Vitamin B12. Patients receiving Metformin continuously should have an annual check up of vitamin B12 levels.

Reduced renal clearance of Metformin has been reported during Cimetidine therapy, so a dose reduction should be considered.
An interaction of Metformin with anticoagulants is a possibility and the dosage of anticoagulants may need adjustment.

The most frequently reported adverse effects are: metallic taste in the mouth, epigastric discomfort, nausea and vomiting, lactic acidosis, decreased vitamin B12 absorption: rarely diarrhea and anorexia. Most of these reactions are transient and can be controlled by reducing the dosage or by discontinuing therapy.

Symptoms and Treatment for Overdosage, and Antidote(s)
Hypoglycemia may occur when Metformin is given concomitantly with a sulfonylurea, insulin or alcohol. In excessive dosage, lactic acidosis may develop. Intensive supportive therapy is recommended which should be particularly directed at correcting fluid loss and metabolic disturbance.

Shelf-Life
3 years from the date of manufacture.

Storage Condition(s)
Keep in a tight container. Store at temperature below 30C. Protect from light and moisture.

Product Description & Packing(s)
A white to off-white round tablet, one side impressed with a score and the other side with a mark
Plastic bottle of 1000's (for export only).

Blister packing of 10's x 10 and 10's x 100.

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