GLUCOZON

Pioglitazone

Composition:

Glucozon Tablet: Each film coated tablet contains Pioglitazone Hydrochloride INN equivalent to pioglitazone 15 mg.

Glucozon-30 Tablet: Each film coated tablet contains Pioglitazone Hydrochloride INN equivalent to pioglitazone 30 mg.

Pharmacology:

Pioglitazone is a thiazolidinedione derivative oral antidiabetic agent that depends on the presence of insulin for its mechanism. Glucozon decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is a potent and highly selective agonist for PPAR-Gamma (Peroxisome Proliferator Activated Receptor- Gamma) receptor. Activation of PPAR-Gamma nuclear receptors modulates the transcription of number insulin responsive genes involved in the control of glucose and lipid metabolism.

Indications:

Glucozon is indicated as an adjunct to diet and exercise to improve glycemic control in patients with NIDDM. Glucozon is indicated for monotherapy and also indicated for use in combination with sulfonylureas, metformin, repaglinide or insulin when diet and exercise plus the single agent does not result in adequate glycemic control.

Dosage & administration:

Glucozon can be taken once daily regardless of meals. The management of antidiabetic therapy should be individualized. Glucozon monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. For patients who respond inadequately to the initial dose of Glucozon, the dose can be increased up to 45 mg once daily. For patients not responding to monotherapy, combination therapy should be considered.

Maximum recommended dose: The dose of Glucozon should not exceed 45 mg once daily since dose higher than 45 mg once daily have not been studied in placebo-controlled clinical studies. No placebo-controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy. Dosage adjustment in patients with renal insufficiency is not recommended.

Side effects:

The overall incidence and types of adverse effects reported in placebo-controlled clinical trial of pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).

Contraindications:

Contraindicated in patients with known hypersensitivity to Pioglitazone Hydrochloride or any of its inactive components.

Use in Pregnancy and Lactation:

Pregnancy:

There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactation:

It is not known whether pioglitazone is secreted in human milk. Because many drugs are excreted in human milk, pioglitazone should not be administered to breast-feeding women.

Precautions:

Pioglitazone exerts its antihyperglycaemic effect only in the presence of insulin. Therefore, Pioglitazone should not be used in patients with Type-1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of comination antidiabetic therapy and hepatic insufficiency.

Drug Interactions:

Administration of any thiazolidinedione with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both hormones by approximately 30%, which could result in loss of contraception. Ketoconazole may decrease the effect of pioglitazone.

Overdosage:

In the event of overdosage, appropriate supportive treatment should be initiated according to patients clinical signs and symptoms.

Storage:

Store at room temperature away from moisture and direct sunlight.

Packing:

Glucozon Tablet: Box containing 3X10's tablets in blister pack.

Glucozon-30 Tablet: Box containing 2X10's tablets in blister pack.