Aldibet

COMPOSITION

ALDIBET 1 TAB

Each tablet contains:

Glimepiride                             1mg

ALDIBET 2 TAB

Each tablet contains:

Glimepiride                             2mg

DESCRIPTION

Glimepiride is a very potent hypoglycaemic agent belonging to second generation sulfonylurea and has long duration of action.

PHARMACOLOGY

Pharmacodynamics

The primary mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, glimepiride also induces increased activity of peripheral insulin.

Pharmacokinetics

Absorption
After oral administration, glimepiride is completely (100%) absorbed from the GI tract. Protein binding was greater than 99.5%. Glimepiride is completely metabolized by oxidative biotransformation after either an IV or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2).

Indications
ALDIBET is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with non-insulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.

DOSAGE AND ADMINISTRATION

General
Dosage should be individualized on the basis of both effectiveness and tolerance. There is no fixed dosage regimen for the management of diabetes mellitus with glimepiride or any other hypoglycaemic agent.

Usual starting dose

The usual starting dose of ALDIBET as initial therapy is 1-2 mg once daily, administered with breakfast or the first main meal.

Usual Maintenance Dose

The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily.

CONTRAINDICATIONS

Glimepiride is contraindicated in patients with

1.        Known hypersensitivity to the drug.

2.        Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

WARNING AND PRECAUTIONS

Cardiac EffectsThe administration of oral hypoglycaemic drugs (tolbutamide) has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. In view of close similarities between the oral hypoglycaemic drugs, this warning also applies for glimepiride.

General
Hypoglycaemia
All sulfonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycaemic episodes.

Loss of control of blood glucose

When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with glimepiride or even use insulin monotherapy.

Renal impairment

The use of glimepiride is contraindicated in patients with renal impairment.

Hepatic impairment

The use of glimepiride is contraindicated in patients with hepatic impairment.

Pregnancy
The use of glimepiride is not recommended for use in pregnancy.

Lactation
Glimepiride should not be used by breast-feeding mothers.

Paediatric use

Safety and effectiveness of glimepiride in paediatric patients have not been established.

Geriatric use

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection of glimepiride, and it may be useful to monitor renal function.

ADVERSE EFFECTS

Gastrointestinal disturbances Dermatological effects Hypoglycaemia.

DRUG INTERACTIONS

·         The hypoglycaemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs that are highly protein bound, such as salicylates, sulfonamides, chloramphenicol, coumarins, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents.

·         Certain drugs like thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics and isoniazid tend to produce hyperglycaemia and may lead to loss of control.

·         A potential interaction between oral miconazole and oral hypoglycaemic agents leading to severe hypoglycaemia has been reported. Potential interactions of glimepiride with other drugs metabolized by Cytochrome P450 II C9 also include phenytoin, diclofenac, ibuprofen, naproxen and mefenamic acid.