Composition: Each Soft Gelatin Capsule Contains Isotretinoin USP 10mg.
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.
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.
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.
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.
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
Packing: Each box contains 15’s soft capsule in blister pack.