Active Ingredient And Chemical structure - The active ingredient contained in Isotroin Capsules is Isotretinoin. Isotretinoin, a retinoid, is a yellow to orange crystalline powder with a molecular weight of 300.44. It is available as Isotroin Capsules (Generic Accutane) in 10 mg and 20 mg capsules for oral administration.
Uses - Accutane in the form of Isotroin Capsules is used for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic.
Generic Forms and Brand names of Accutane - Isotroin Capsules manufactured by Cipla Ltd., India is an effective treatment for moderate to severe acne that has failed other therapies. Accutane which has the active ingredient Isotretinoin is also sold as Sotret, Claravis, Amnesteem, Roaccutane, Clarus, Decutan, Isotane, Izotek, Oratane, Isotret and under various other brand names.
Preparations - Isotroin Capsules (Generic Accutane) is available as tablets of 10 mg and 20 mg.
Storage Requirements - Isotroin Capsules are to be stored at controlled room temperature (15oC to 30oC). Protect from light. Store away from heat and moisture.
Isotroin Capsules (Generic Accutane) must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
As there are significant adverse effects associated with its use, Isotroin Capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Generic Accutane should always be administered with a meal. The recommended dosage range for Isotroin Capsules is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks.
In studies which compared 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of the disease, but there was a greater need for retreatment with the lower dosages. During treatment, the Generic Accutane dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related.
Side Effects Of Isotroin Capsules (Generic Accutane) The most common side effects of Isotroin Capsules are listed below :
Body as a Whole - Allergic reactions, including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, weight loss
Musculoskeletal - Skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal symptoms including back pain, myalgia, and arthralgia, transient pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis.