ROACCUTANE CAPSULE 10 MG [SIN04920P]

Product Info

ROACCUTANE CAPSULE 10 MG

[SIN04920P]

2.1 Therapeutic Indication(s)
Roaccutane is indicated for the treatment of severe forms of acne (nodulo-cystic forms) and acne, which has failed to respond to other therapies.
Roaccutane should only be prescribed by physicians who are experienced in the use of systemic retinoids- preferably dermatologists- and understand the risk of teratogenicity if Roaccutane is used during pregnancy.

2.2 Dosage and Administration
Standard dosage
The therapeutic response to Roaccutane and its adverse events are dose-related and varies between patients. This necessitates individual dosage adjustment during therapy. Roaccutane therapy should be started at a dose of 0.5 mg/kg daily. For most patients the dose ranges from 0.5–1.0 mg/kg per day. Patients with very severe disease or with truncal acne may require higher daily doses up to 2.0 mg/kg.
A cumulative dose of 120 mg/kg per treatment has been documented to increase remission rates and prevent relapse. The therapy duration in individual patients therefore varies as a function of the daily dose. Complete remission of the acne is often achieved by a therapy course of 16–24 weeks. In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequence of a longer therapy duration.
In the majority of patients complete clearing of the acne is obtained with a single treatment course. In case of a definite relapse, a renewed course of Roaccutane therapy should be given with the same daily dose and cumulative treatment dose as previously. Since further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, retreatment should not be initiated until after this period.
The capsules should be taken with food once or twice daily.

2.2.1 Special Dosage Instructions
Renal impairment
In patients with severe renal insufficiency, Roaccutane treatment should be started at a lower dose (e.g. 10 mg/day) and afterwards individually adjusted according to tolerance.

2.3 Contraindications
Roaccutane is contraindicated in:
Women of child-bearing potential

• Women of child-bearing potential unless the female patient meets all the conditions of the Pregnancy Prevention Programme (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pregnant or breastfeeding women

• Roaccutane is contraindicated in women who are pregnant or who may become pregnant while undergoing treatment or breastfeeding (see section 2.5 Use in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Tetracylines

• Patients receiving concomitant treatment with tetracyclines (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic insufficiency

• Patients with hepatic insufficiency (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hypervitaminosis A

• Patients with pre-existing hypervitaminosis A. (see section 2.6 Undesirable Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elevated blood lipid values

• Patients with excessively elevated blood lipid values (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hypersensitivity

Roaccutane is also contraindicated in patients with known hypersensitivity to isotretinoin or to any of the excipients. Roaccutane contains soya oil, partially hydrogenated soya oil, and hydrogenated soya oil. Therefore, Roaccutane is contraindicated in patients allergic to soya.