Provigil 100mg Tablet

PROVIGIL is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, as defined by either of the two following DSM IV criteria in the absence of other clinically significant medical or psychotic conditions: 1) Recurrent daytime naps or lapses into sleep that occur almost daily for at least three months, plus sudden bilateral loss of postural muscle tone in association with intense emotion (cataplexy), or 2) a Complaint of excessive sleepiness or sudden muscle weakness with associated features: sleep paralysis, hypnagogic hallucinations, automatic behaviours, disrupted major sleep episodes; and polysomnography demonstrating one of the following: sleep latency less than 10 minutes or rapid eye movement (REM) sleep latency less than 20 minutes. The effectiveness of PROVIGIL has not been evaluated in placebo-controlled studies of more than 9 weeks.

The dose of PROVIGIL is 200 mg/day, given as a single dose in the morning. Doses of 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose.

• Patients with a known hypersensitivity to PROVIGIL.
• Major anxiety (outside specialised units).
• Children and adolescents under the age of 16 years.
• Severe renal impairment.

Periodic specialist clinical assessment is necessary. Patients with major anxiety should only receive treatment with PROVIGIL in a specialist unit.

Blood pressure and heart rate should be monitored in hypertensive patients. It is recommended that PROVIGIL not be used in patients with a history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use.

Although PROVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgement, thinking or motor skills. Patients should be cautioned about operating a vehicle or other hazardous machinery until they are reasonably certain that PROVIGIL therapy will not adversely affect their ability to engage in such activities.

In clinical studies of PROVIGIL, signs and symptoms including chest pain, palpitations, dyspnoea and transient ischaemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. It is recommended that PROVIGIL tablets not be used in patients with a history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use. PROVIGIL 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. PROVIGIL has not been systematically evaluated in patients with hypertension. Periodic monitoring of hypertensive patients may be appropriate.

One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of PROVIGIL and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation. Caution should be exercised when PROVIGIL is given to patients with a history of psychosis.

Because modafinil is a reversible inhibitor of the enzyme CYP2C19, co-administration of modafinil with medicines such as diazepam, phenytoin and propranolol, which are largely eliminated via that pathway, may increase the circulating levels of those compounds. In addition, in individuals deficient in the enzyme CYP2D6 (i.e. 7 to 10 % of the caucasian population; similar or lower in other populations), the levels of CYP2D6 substrates such as tricyclic antidepressants and selective serotonin reuptake inhibitors, which have ancillary routes of elimination through CYP2C19 may be increased by co-administration of modafinil. Dose adjustments may be necessary for patients being treated with these and similar medications.

Chronic administration of modafinil may also cause modest induction of the metabolising enzyme CYP3A4, thus reducing the levels of co-administered substrates for that enzyme system, such as steroidal contraceptives, cyclosporin and, to a lesser degree, theophylline. Dose adjustments may be necessary for patients being treated with these and similar medications.

An apparent concentration-related suppression of CYP2C9 activity was observed in human hepatocytes after exposure to modafinil in vitro. Although no other indication of CYP2C9 suppression has been observed, the in vitro results suggest that there is potential for metabolic interaction between PROVIGIL and CYP2C9 substrates, such as warfarin or phenytoin.

Safety in pregnancy and lactation has not been established. Animal studies to assess the effects of PROVIGIL on reproduction and the developing foetus were not conducted at adequately high doses or according to guidelines which would ensure a comprehensive evaluation of the potential of PROVIGIL to adversely affect fertility, or cause embryo lethality or teratogenicity. Patients should be advised to notify their doctor 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 PROVIGIL tablets and for one month after discontinuation of therapy.

Although PROVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgement, thinking or motor skills. Patients should be cautioned about operating a vehicle or other hazardous machinery until they are reasonably certain that PROVIGIL therapy will not adversely affect their ability to engage in such activities.

The most adverse experiences with PROVIGIL were mild to moderate. The most common observed adverse events (u2265 5 %) associated with the use of PROVIGIL more frequently than placebo-treated patients in controlled US and foreign studies were headache, infection, nausea, nervousness, anxiety and insomnia. Refer to the following tabulated summary of adverse experiences that occurred in narcolepsy patients at a rate of 1 % or more and were more frequent in patients treated with PROVIGIL than in placebo patients in US placebo-controlled clinical studies.

See u201cSIDE - EFFECTSu201d. Treatment is symptomatic and supportive. Main symptom following massive ingestion is insomnia. Management: Induced emesis or gastric lavage should be considered. Hospitalisation and surveillance of psychomotor status, cardiovascular monitoring or surveillance until the patientu2019s symptoms have resolved.