GEDIMADEL (Glimepiride) from GEDCO

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

GEDIMADEL Composition

Each tablet contains: Glimepiride 1 mg, 2 mg, 3 mg, 4 mg or 6 mg.

GEDIMADEL Properties

Glimepiride, the active ingredient of GEDIMADEL, is an oral blood-glucose-lowering drug of the sulfonylurea class.

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 administration can lead to increased sensitivity of peripheral tissues to insulin.

GEDIMADEL is effective as initial drug therapy.

In patients where monotherapy with Glimepiride or metformin has not produced adequate glycemic control, the combination of GEDIMADEL and metformin may have a synergistic effect.

GEDIMADEL Pharmacokinetics

After oral administration, Glimepiride is completely (100%) absorbed from the GI tract.

Significant absorption of Glimepiride takes place within 1 hour after administration and peak drug levels are reached after 2-3 hours.

Glimepiride is metabolized by oxidative biotransformation after either an I.V. or oral dose .

When Glimepiride was given orally , approximately 60 % of total dose was recovered in urine.

Approximately 40 % of the dose was recovered in feces.

GEDIMADEL Indications

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

GEDIMADEL may be used concomitantly with metformin when diet, exercise, and GEDIMADEL or metformin alone do not result in adequate glycemic control.

GEDIMADEL is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.

GEDIMADEL Dosage

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

Those patients who may be more sensitive to hypoglycaemic drugs should be started at 1 mg once daily, and should be titrated carefully.

The maximum starting dose of GEDIMADEL should be no more than 2 mg.

Usual maintenance dose

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

The maximum recommended dose is 8 mg once daily.

After reaching a dose of 2 mg, dosage increases should be made in increments of no more than 2 mg at 1-2 week intervals.

Forgetting to take a dose, must never be corrected by subsequently taking a larger dose.

Contraindications

GEDIMADEL is contraindicated in patients with:

  • Known hypersensitivity to the drug
  • Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Precautions

Hypoglycemia

all sulfonylurea drugs are capable of producing hypoglycaemia, however GEDIMADEL has the least risk to produce hypoglycemia.

Proper patient selection, dosage, and instructions are important to avoid hypoglycaemic episodes

Loss of control of blood glucose

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

Pregnancy and lactation

To avoid risk of harm to the featus, GEDIMADEL should not be taken during pregnancy; a changeover to insulin is necessary.

Ingestion of Glimepiride with the breast milk may harm the child. Therefore, GEDIMADEL should not be taken by breast-feeding women. Either a changeover to insulin or a complete discontinuation of breast­feeding is necessary.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

GEDIMADEL Warnings

This drug can be useful in some diabetic patients and must not be used except under close medical supervision and should only be dispensed with a medical prescription

Interactions

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including: Nonsteroidal anti-inflammatory drugs.Drugs that are highly protein bound may potentiate GEDIMADEL hypoglycaemic action, such as:Salicylates,Sulphonamides,Chloramphenicol,Coumourins,Probenecid,Monoamineoxidase inhibitors,Beta adrenergic blocking agents.

Certain drugs tend to produce hyperglycemia and may lead to loss of control.

These drugs include : thiazides and other diuretics,Corticosteroids,Phenothiazines,thyroid products,Estrogens,oral contraceptives,Phenytoin,nicotinic acid,Sympathomimetics,isoniazid.

GEDIMADEL Adverse reactions

Hypoglycemia

Gastrointestinal reactions:Vomiting,gastrointestinal pain,diarrhea,isolated transaminase elevations have been reported,Cholestatic jaundice has been reported to be rare with sulfonylureas.

Dermatologic reactions: allergic skin reactions, e.g., pruritus, erythema, and maculopapular eruptions, may occur in less than 1 % of treated patients.

Hematologic Reactions

Leukopenia, agranulocytosis, thrombocytopenia, anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas

Storage conditions

Store at a temperature not exceeding 25 .