Accutane Capsules with 20 mg isotretinoin.

Description

Accutane should only be prescribed by, or under the supervision of, physicians familiar with the use of systemic retinoids in the treatment of severe acne and who have a thorough understanding of the risks of isotretinoin therapy and the necessary controls.

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Usual dosage
The therapeutic response to Accutane and some of its side effects are dose dependent and not the same in all patients. Individual dose adjustments during therapy are therefore necessary. Therapy with Accutane capsules should be initiated at a dose of 0.5 mg/kg body weight per day. The dose for most patients is between 0.5-1.0 mg/kg body weight per day. In patients with very severe acne or acne on the trunk, a higher daily dose of up to 2.0 mg/kg body weight may be required.

With a cumulative dose of 120 mg/kg body weight per treatment, it could be shown that the remission rates were increased and recurrences were prevented and that no additional substantial benefit is to be expected above this (120 – 150 mg/kg body weight). The duration of therapy in a patient therefore varies depending on the daily dose used. Complete remission of acne is usually achieved after 16-24 weeks of therapy .

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Special dosage instructions
Patients of reproductive age
pregnancy tests
In patients of childbearing potential, pregnancy tests must be performed before starting Accutane treatment, during treatment, and for 5 weeks after stopping treatment.

contraception
Because Accutane is teratogenic, patients of childbearing potential must comply with the Pregnancy Prevention Program (see ?Warning and Precautions – Pregnancy Prevention Program?).

Patients of childbearing potential must use at least one highly effective method of contraception (ie a user-independent method) or two, preferably complementary, user-dependent methods of contraception (including a barrier method). Contraception must be used for at least 1 month before starting treatment and throughout treatment, and continued for at least 1 month after stopping Accutane treatment, even in patients with amenorrhoea.