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Although Nuvigil has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that Armodafinil (Nuvigil) tablets therapy will not adversely affect their ability to engage in such activities.

Cardiovascular System

Nuvigil has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable angina, and such patients should be treated with caution.

In clinical studies of Provigil, signs and symptoms including chest pain, palpitations, dyspnea and transient ischemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. It is recommended that Nuvigil (Armodafinil) tablets not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. Signs of mitral valve prolapse syndrome include but are not limited to ischemic ECG changes, chest pain, or arrhythmia. If new onset of any of these symptoms occurs, consider cardiac evaluation.

Blood pressure monitoring in short-term ( <= 3 months) controlled trials showed only small average increases in mean systolic and diastolic blood pressure in patients receiving Armodafinil (Nuvigil) as compared to placebo (1.2 to 4.3 mmHg in the various experimental groups). There was also a slightly greater proportion of patients on Nuvigil requiring new or increased use of antihypertensive medications (2.9%) compared to patients on placebo (1.8%). Increased monitoring of blood pressure may be appropriate in patients on Nuvigil (Armodafinil).

Patients Using Steroidal Contraceptives

The effectiveness of steroidal contraceptives may be reduced when used with Nuvigil and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients treated with Nuvigil (Armodafinil) tablets and for one month after discontinuation of this medication treatment.

Patients Using Cyclosporine

The blood levels of cyclosporine may be reduced when used with Nuvigil. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when these drugs are used concomitantly.

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