Glucomet Tablets 28’s

Description

Composition

Metformin Hydrochloride, Biguamide antidiabetic

Glucomet 500mg film coated tablet – White circular, biconvex, film coated tablet embossed “GLUCOMET” on one side and “500” on the other side. Each film coated tablet contains; Metformin Hydrochloride 500mg.

Glucomet 850mg film coated tablet – White, oblong shaped, biconvex, film coated tablet embossed “COSMOS” on one side and a breakline on the other side. Each film coated tablet contains; Metformin Hydrochloride 850mg.

Clinical Pharmacology

Metformin Hydrochloride is a biguamide anti-diabetic. Glucomet is given orally for the treatment of type 2 diabetes mellitus. Glucomet does not stimulate insulin release and requires that some insulin be present in order to exert anti-diabetic effect. Possible mechanisms of action include delay in the absorbtion of glucose from the gastrointestinal tract, an increase in insulin sensitivity and glucose uptake into cells, and inhibition of hepatic gluconeogenesis. Glucomet does not produce hypoglycemia in either normal subjects or patients with type 2 diabetes and does not cause hyperinsulinemia.

Pharmacokinetics

Metformin Hydrochloride is slowly and incompletely absorbed from the gastrointestinal tract; the absolute bioavailability of a single 500mg dose is reported to be about 50 to 60%, although this is reduced somewhat if taken with food. Following absorption 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 administration.

Uses

Glucomet as monotherapy is indicated as an adjunct to diet and exercise in the management of type 2 diabetes. Glucomet may be used in combination with sulphonylureas, thiazolidnediones and insulin to improve glycaemic control in adults.

Metformin is also used in cases of polycystic ovary syndrome (PCOS) to improve insulin resistance and support hormonal balance. Additionally, it may be prescribed off-label for weight management or to reduce the risk of diabetes progression in prediabetic individuals.

Dosage and Administration

Children 10 years and over and adolescents

The usual starting dose is 500 or 850mg once a day. The maximum daily dose is 2000mg taken as 2 or 3 divided doses.

Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age is limited.

Adults

The usual starting dose is 500mg 2-3 times daily or 850mg 1-2 times daily. The maximum daily dose is 2-3g taken in divided doses.

If you are taking insulin too, the doctors will advice you how to start Glucomet.

Contra-indications and Warnings

Glucomet is contraindicated in:

• Patients with renal disease or renal dysfunction.
• Patients with known hypersensitivity to metformin.
• Acute and chronic metabolic acidosis with or without coma.
• Patients with kidney and liver problems.
• If you are dehydrated.

Precautions

Biguamides are inappropriate for patients with diabetic coma and ketoacidosis, or for those with severe infection, trauma or other severe conditions where the biguamide is unlikely to control the hyperglycaemia; insulin should be administered in such situation. Glucomet should also not be given to patients with heart failure, recent myocardial infarction, dehydration alcoholism, or any other condition likely to predispose to lactic acidosis.

Adverse Effects

Gastrointestinal adverse effects include anorexia, nausea and diarrhea. Patients may experience a metallic taste and there may be weight loss, Absorption of various substances including vitamin B12 may be impaired. Lactic acidosis, sometimes, fatal has occurred.

Over dosage

Acute poisoning may lead to the development of lactic acidosis and calls for intensive supportive therapy.

Interactions

Use of glucomet with other drugs that lower blood glucose concentrations increases the risk of hypoglycemia, while drugs that increase blood glucose may reduce the effect of Glucomet therapy.

Taking other medicines

If you are taking any of the following medicines, your blood sugar levels may need to be checked more often and your dose adjusted.

• Diuretics
• Beta-2-agonists such as salbutamol or terbutaline
• Corticosteroids

Alcohol may increase the risk of lactic acidosis as well as of hypoglycemia. Care should be taken if glucomet is given with drugs that may impair renal function.

Pregnancy and Breastfeeding

Tell your doctor if you are or you think you might be or are planning to become pregnant, so that he or she may change your treatment.

This medicine is not recommended if you are breastfeeding or if you are planning to feed your baby.

Manufacturer

Cosmos Limited, Rangwe Rd; Off Lunga Lunga Rd, Nairobi, Kenya.