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NUVIGIL (ARMODAFINIL) TABLETS: PRECAUTIONS FOR SPECIAL POPULATIONS

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be cautioned regarding the potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with Nuvigil and for one month after discontinuation of therapy.

Nursing

Patients should be advised to notify their physician if they are breastfeeding an infant.

Concomitant Medication

Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between Nuvigil (Armodafinil) and other drugs.

Patients with Severe Hepatic Impairment

In patients with severe hepatic impairment, with or without cirrhosis, Armodafinil (Nuvigil) tablets should be administered at a reduced dose.

Patients with Severe Renal Impairment

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

Elderly Patients

In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.

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