| a) Generic Name |
Pioglitazone hydrochloride INN .
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| b) Trade/Brand Name |
To be submitted at the time of inclusion.
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| a) Presentation |
Film Coated Tablet.
Each tablet contains Pioglitazone hydrochloride INN 30 mg.
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| b) Indications |
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes (NIDDM). Pioglitazone is indicated for monotherapy. Pioglitazone is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent does not result in adequate glycemic control.
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| c) Dosage & administration |
Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone 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 pioglitazone, the dose can be increased upto 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
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| d) Contraindications |
Pioglitazone is contraindicated in patients with known hypersensitivity to this product or any of its components.
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| e) Side Effects |
Headache, sinusitis, myalgia, tooth disorder, pharyngitis.
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| f) Warnings & Precautions
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Pioglitazone should not be used in patients with type-I diabetes or for the treatment of diabetic ketoacidosis. Patients receiving pioglitazone in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia.
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| g) Drug Interactions |
Additional caution regarding contraception should be exercised in patients receiving pioglitazone and an oral contraceptive. Ketoconazole appears to significantly inhibit the metabolism of pioglitazone.
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| h) Use in Pregnancy & Lactation |
There is no adequate and well controlled study in pregnant women. Pioglitazone should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus. Pioglitazone should not be administered to the lactating mother.
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| i) Over dosage |
Hypoglycemia may occur in combination with sulphonylureas or insulin. Symptomatic and general supportive measures should be taken in case of overdose.
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| j) Package Quantity |
To be submitted at the time of inclusion.
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