Isotretinoin USP

Composition: Each Soft Gelatin Capsule Contains Isotretinoin USP 10mg.

Indication: It is indicated in severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy.

Dosage and administration: The capsules should be taken with food once or twice daily. Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of Isotretinoin therapy and monitoring requirements.

Adults including adolescents and the elderly: Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to Isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.

Patients with severe renal impairment: In patients with severe renal insufficiency treatment should be started at a lower dose (e.g. 10 mg/day). The dose should then be increased up to 1 mg/kg/day or until the patient is receiving the maximum tolerated dose.

Patients with intolerance: In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequences of alonger therapy duration and a higher risk of relapse. In order to achieve the maximum possible efficacy in these patients the dose should normally be continued at the highest tolerated dose. Or, as directed by the registered physician.

Use in pregnancy and lactation : Pregnancy is an absolute contraindication to treatment with isotretinoin: If pregnancy does occur in spite of these precautions during treatment with Isotretinoin or in the month following: there is a great risk of very severe and serious malformation of the foetus.|f pregnancy occurs in a woman treated with isotretinoin, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice ‘ Isotretinoin is highly lipophilic, therefore the passage of isotretinoin into human milk is very likely. Due to the potential for adverse effects in the child exposed via mother’s milk, Isotretinoin is contraindicated during breast-feeding.

Packing: Each box contains 15’s soft capsule in blister pack.

Prescribing Description

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