Mega Lifesciences


DCH Auriga - Healthcare
Four Star
Concise Prescribing Info
Severe forms of nodulo-cystic acne resistant to previous therapy especially cystic acne & acne conglobata.
Dosage/Direction for Use
Adult & adolescent 0.5-1 mg/kg/day in 2 divided doses for 15-20 wk. Max: 2 mg/kg/day.
Should be taken with food.
Pregnancy & lactation. Hepatic & renal insufficiency, hypervitaminosis A, hyperlipidaemia. Avoid blood donation by patients during & w/in 1 mth of cessation of treatment to women of childbearing potential.
Special Precautions
Should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, & understand the risk of teratogenicity if isotretinoin is used during pregnancy. Perform baseline & periodic liver function test & fasting serum lipid level. History of depression. Avoid contraceptives containing an androgen progestational substance especially in the presence of gynaeco-endocrinological problems. Avoid dermabrasion & wax epilation. Frequent checking required for relevant laboratory parameters in high risk patients (w/ diabetes, obesity, alcoholism or disorders of lipid metabolism). Avoid sun exposure. Employ effective contraception starting 1 mth pre-treatment, during treatment, & for 1 mth post-treatment. Keep regular dental appointments. Use of sugarless candy or saliva substitute or melting ice in mouth may be necessary to lessen dental problems. May cause depression, psychosis & rarely, suicidal ideation, suicide attempts, suicide & aggressive &/or violent behaviors. Assess patients for symptoms of depression, mood disturbance, psychosis or aggression. Closely monitor patients for erythema multiforme & severe skin reactions; discontinue isotretinoin if warranted.
Adverse Reactions
Cheilitis, epistaxis, skin infection; dry skin, eyes & mouth, skin reactions, photosensitivity, reversible alopecia, hyperpigmentation, myalgia, joint pain, hyperostosis, behavioral disorders, depression, headache, increased intracranial pressure, seizures, visual disturbances, GI disturbances, transient & reversible rise in transaminases, bronchospasm, blood dyscrasias, hypertriglyceridaemia, hypercholesterolaemia.
Drug Interactions
Vit A, tetracyclines, progesterone.
MIMS Class
Acne Treatment Preparations
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Acnotin cap 10 mg
Acnotin cap 20 mg
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