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Isotane Capsule (Isotretinoin)

  • Each Capsule contains Isotretinoin 10mg /20 mg
  • For the treatment of cystic & conglobate acne, severe nodular acne unresponsive to antibiotic therapy.
  • Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The improvement in severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore isotretinoin has a dermal anti-inflammatory effect.
  • 0.5 to 1 mg/kg/day given in two divided doses.
  • Pregnancy, Lactation Hypersensitivity to active ingredient or any other excipients of the formulation,
  • Psychiatric Disorders, Contraception, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, Acute pancreatitis, Lipid abnormalities, Hepatotoxicity, Skeletal Abnormalities, Inflammatory Bowel Disease, Glucose and CPK abnormalities, Ocular Abnormalities.
  • Pregnancy Category X. Isotretinoin must not be used in pregnancy since here is an extremely high risk that severe birth defects to the foetus. Isotretinoin is not indicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age due to a lack of data on efficacy and safety.
  • Concurrent administration with Vitamin A, tetracyclines and topical keratolytic or exfoliative anti-acne agents should be avoided.
  • chapped lips, dry eye, dry skin, back pain, arthralgia and headache.
  • Dermatologicals and Cosmetologicals