Roaccutane Dosage & Drug Information

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Core Prescribing Info

Contents

Isotretinoin

Indications/Uses

Severe forms of acne (nodulo-cystic forms) & acne which has failed to respond to other therapies.

Dosage/Direction for Use

Initially 0.5 mg/kg daily. Dose range: 0.5-1 mg/kg/day. Patient w/ very severe disease or truncal acne Higher doses up to 2 mg/kg/day. Cumulative dose: 120 mg/kg/treatment to increase remission rates & prevent relapse. Patient w/ severe renal insufficiency Start at a lower dose (eg, 10 mg/day) & afterwards individually adjusted according to tolerance.

Administration

Should be taken with food.

Contraindications

Hypersensitivity to isotretinoin or soya. Pre-existing hypervitaminosis A. Patient w/ excessively elevated blood lipid values. Concomitant use w/ tetracyclines. Hepatic insufficiency. Women of childbearing potential. Pregnancy & lactation.

MIMS Class

Acne Treatment Preparations

ATC Classification

D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.

Regulatory Classification

POM

Presentation/Packing

Form

Roaccutane cap 10 mg

Packing/Price

1's

Form

Roaccutane cap 20 mg

Packing/Price

1's

Roaccutane

isotretinoin

Manufacturer:

Catalent Germany Eberbach