Sotret Capsules

Sotret Capsules

isotretinoin

Manufacturer:

Ranbaxy

Distributor:

DKLL
Concise Prescribing Info
Contents
Isotretinoin
Indications/Uses
Cystic & conglobate acne & severe acne resistant to systemic antimicrobial agent therapy.
Dosage/Direction for Use
Adult Initially 0.5 mg/kg body wt daily as a single or in 2 divided doses for 4 wk. Maintenance: Patient who show early improvement Continue w/ initial dose. Patient who show little or no initial improvement & tolerates the drug well Increase up to 1 mg/kg body wt daily. Patient intolerant to initial dose Reduce dose to 0.1-0.2 mg/kg body wt daily. Duration of treatment: 12-16 wk.
Administration
Should be taken with food.
Contraindications
Hepatic & renal impairment. Hypervitaminosis A, hyperlipidemia. Supplementary treatment w/ tetracyclines. Pregnancy & lactation. Women of childbearing potential.
Special Precautions
Perform liver function & blood lipids tests at the start of treatment, after 1st mth of administration & thereafter at 3-mthly intervals before discontinuation of therapy. Do not donate blood during or for at least 4 wk following discontinuation of therapy.
Adverse Reactions
Dryness of skin, nasal mucosa & conjunctivae. Granulomatous lesions, decreased tolerance to contact lenses, keratitis, acne fulminans, facial hyperpigmentation, visual disturbances, hearing deficiency, hair thinning, allergic vasculitis, mood changes, epileptiform seizures, myalgia & arthralgia, raised serum CPK values, menstrual irregularities, elevation of serum triglycerides & cholesterol, hyperuricemia, inflammatory bowel disease, paronychia, local or systemic infections, elevated blood glucose levels in diabetics, haematologic disorders, lymphadenopathy, bone changes, haematuria & proteinuria.
Drug Interactions
Other anti-acne prep eg, antibiotics, keratolytics & exfoliants. Avoid vit A prep (high doses).
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Presentation/Packing
Form
Sotret Capsules soft-gelatin cap 20 mg
Packing/Price
3 × 10's
Form
Sotret Capsules soft-gelatin cap 10 mg
Packing/Price
3 × 10's
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