Isotane

Isotane

isotretinoin

Manufacturer:

Shanghai Sine Yanan

Distributor:

Premier Pharma Supply
Concise Prescribing Info
Contents
Isotretinoin
Indications/Uses
Severe forms of nodulocystic acne resistant to previous therapy.
Dosage/Direction for Use
Initially 0.5 mg/kg daily. Maintenance dose: 0.1-1 mg/kg daily after 4 wk. Max dose: 1 mg/kg daily for limited time period. Treatment duration: 16 wk. Resume treatment after at least 8 wk interval.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Hypervitaminosis. Patients w/ excessively elevated blood lipid values. Concomitant use w/ vit A. Hepatic & renal insufficiency. Pregnancy & lactation.
Special Precautions
Check liver function before & 1 mth after starting treatment & subsequently at 3-mth intervals; serum lipids (fasting value) prior to, 1 mth after initiation & at the end of therapy. Risk of teratogenicity.
Adverse Reactions
Dryness of skin & lips, epistaxis, hoarseness, conjunctivitis; pruritus, facial erythema, dermatitis, sweating, pyogenic granuloma, nail dystrophy, persistent hair thinning, reversible alopecia, hyperpigmentation, photosensitivity; muscle & joint pain, hyperostosis & other bone changes; depression, headache, increased ICP, seizures; visual disturbances, decreased night vision, photophobia; nausea, inflammatory bowel disease; corneal opacities. Rarely, bronchospasm.
Drug Interactions
Intensified symptoms of hypervitaminosis w/ vit A. Rare case of benign intracranial HTN (pseudotumor cerebri) w/ tetracyclines. More dry skin & peeling action w/ other keratolytic or exfoliative anti-acne agent.
MIMS Class
Acne Treatment Preparations
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Presentation/Packing
Form
Isotane softcap 10 mg
Packing/Price
10 × 5's
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