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Provigil
Please remember that Provigil is a prescription
medication and should only be taken under the supervision of
a licensed physician. There is no such thing as an
"online consultation" and nothing can replace
visiting your doctor in person.
Provigil
is an FDA approved medication indicated to improve
wakefulness in patients with excessive sleepiness and help
treat the following sleep disorders:
In these conditions it is common to feel sleepy during the day (or at night if you work night shifts) and/or to
have uncontrollable sleep attacks, even at inappropriate times e.g., when eating, talking etc.
This medicine treats the symptoms of sleepiness. Other treatments intended to help your underlying
medical condition should still be used regularly, unless your doctor tells you otherwise.
Indications:
PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shiftwork sleep disorder.
In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous
positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal
effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and
periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying
sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one
sleep disorder contributing to their excessive sleepiness.
Dosage:
The recommended dose of PROVIGIL is 200 mg given once a day.
For patients with narcolepsy and OSAHS, PROVIGIL should be taken as a single dose in the morning.
For patients with SWSD, PROVIGIL should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 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 (See CLINICAL PHARMACOLOGY, CLINICAL TRIALS).
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS and Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with PROVIGIL and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic
impairment, the dose
of PROVIGIL should be reduced to one-half of that recommended for
patients with normal
hepatic function (see CLINICAL PHARMACOLOGY
and PRECAUTIONS).
There is inadequate information to determine safety and efficacy
of dosing in patients with severe renal
impairment (see CLINICAL
PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination
of PROVIGIL 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
(see CLINICAL PHARMACOLOGY
and PRECAUTIONS).
Side Effects:
Side effects cannot be
anticipated. If any develop or change in intensity, tell your doctor as
soon as possible. Only your doctor can determine if it is safe for you
to continue taking Provigil
More common side effects may include:
Anxiety,
depression, diarrhea, difficulty sleeping, dizziness, dry mouth,
headache, infection, loss of appetite, loss of muscle strength, lung
problems, nausea, nervousness, prickling or tingling feeling, runny
nose, sore throat.
Less common side effects may include:
Abnormal
ejaculation, amnesia, asthma, chest pain, chills, confusion, difficulty
breathing, difficulty urinating, dry skin, face muscle spasms,
fainting, fever, gum inflammation, herpes simplex, high blood pressure,
irregular heartbeat, joint difficulties, low blood pressure, loss of
muscle coordination, mood swings, mouth ulcer, neck pain, nosebleed,
stiff neck, tense muscles, thirst, tremor, vision problems, vomiting.
Warnings:
Patients with abnormal levels of sleepiness who take
PROVIGIL should be advised that their level of wakefulness may not
return to normal. Patients with excessive sleepiness, including those
taking PROVIGIL, should be frequently reassessed for their degree
of sleepiness and, if appropriate, advised to avoid driving or any
other potentially dangerous activity. Prescribers should also be aware
that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities.
Overdose:
In clinical
trials, a total of 151 protocol-specified doses ranging from
1000 to 1600 mg/day (5 to 8 times the recommended daily dose
of 200 mg) have been administered to 32 subjects, including
13 subjects who received doses of 1000 or 1200 mg/day for 7
to 21 consecutive days. In
addition, several intentional acute
overdoses occurred; the two largest being 4500 mg
and 4000 mg taken
by two subjects participating in foreign depression
studies. None of these study subjects experienced any
unexpected or life-threatening effects. Adverse experiences
that were reported at these doses included excitation
or agitation, insomnia, and slight or moderate elevations in
hemodynamic parameters. Other observed high-dose effects in clinical
studies have included anxiety, irritability, aggressiveness,
confusion, nervousness, tremor, palpitations, sleep
disturbances, nausea, diarrhea
and decreased prothrombin
time.
Patient Information:
Physicians are advised to discuss the following issues with patients for whom they prescribe PROVIGIL.
Provigil is indicated for patients who have abnormal levels of sleepiness. Provigil has been shown to improve, but not eliminate this abnormal tendency to fall asleep. Therefore, patients should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment
with Provigil has been shown to produce levels of wakefulness that
permit such activities. Patients should be advised that PROVIGIL is not
a replacement for sleep.
Patients should be informed that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSAHS receiving CPAP should continue to do so).
Patients should be informed of the availability of a patient
information leaflet, and they should be instructed to read the leaflet
prior to taking PROVIGIL. See Patient Information at the end of this labeling for the text of the leaflet provided for patients.
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