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ACCUTANE™ Roche® (isotretinoin) is indicated for the treatment of:
Severe Nodular and/or Inflammatory Acne
Acne Conglobata
Recalcitrant Acne
Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies.
ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing age and who are experienced in counselling young adults for whom ACCUTANE is generally indicated (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS: Serious Warnings and Precautions and Special Populations, Pregnant Women).
A careful assessment of the patient’s mental state should be made, including whether or not they have a history of previous psychiatric illness (see WARNINGS AND PRECAUTIONS, Serious Warnings and Precautions, Psychiatric).
It is strongly recommended that each ACCUTANE prescription be limited to a one-month supply in order to encourage patients to return for follow-up to monitor side-effects. Prescriptions of ACCUTANE for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription.
Consult the product monograph at www.rochecanada.com/PMs/Accutane/Accutane_PM_E.pdf (French: www.rochecanada.com/PMs_Fr/Accutane/Accutane_PM_F.pdf) for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monograph is also available through our Medical Information Department by calling us at 1-888-762-4388.
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