PROVIGIL- modafinil tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D)

Предлага се от:

Cephalon, LLC

INN (Международно Name):

MODAFINIL

Композиция:

MODAFINIL 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment 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 and during treatment with PROVIGIL for excessive sleepiness. PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1, 5.2, 5.3)] . Pregnancy Category C There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R- and S-modafinil) and armodafinil (the R-enantiomer of modafinil). Although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. Certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. Whether the cases reported with modafinil are drug-related is unknown. In studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. PROVIGIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose tested. The higher no-effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) was associated with a plasma modafinil AUC less than that in humans at the recommended human dose (RHD) of PROVIGIL (200 mg/day). However, in a subsequent study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. Oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weight at the highest dose tested. The highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the RHD of PROVIGIL. Modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development.  In a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose. The highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma modafinil AUC similar to that in humans at the RHD of PROVIGIL. Modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma modafinil AUC less than that in humans at the RHD of PROVIGIL. No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. Pregnancy Registry A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to PROVIGIL. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106 (toll free). It is not known whether modafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PROVIGIL is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. PROVIGIL is not approved in this population for any indication. Serious skin rashes, including erythema multiforme major (EMM) and Stevens-Johnson Syndrome (SJS) have been associated with modafinil use in pediatric patients [see Warnings and Precautions (5.1)] . In a controlled 6-week study, 165 pediatric patients (aged 5-17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42). There were no statistically significant differences favoring modafinil over placebo in prolonging sleep latency as measured by MSLT, or in perceptions of sleepiness as determined by the clinical global impression-clinician scale (CGI-C). In the controlled and open-label clinical studies, treatment emergent adverse reactions of the psychiatric and nervous system included Tourette’s syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations, and suicidal ideation. Transient leukopenia, which resolved without medical intervention, was also observed. In the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo. There were three 7 to 9 week, double-blind, placebo-controlled, parallel group studies in children and adolescents (aged 6-17 years) with Attention-Deficit Hyperactivity Disorder (ADHD). Two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg). Although these studies showed statistically significant differences favoring modafinil over placebo in reducing ADHD symptoms as measured by the ADHD-RS (school version), there were 3 cases of serious rash including one case of possible SJS among 933 patients exposed to modafinil in this program. Modafinil is not approved for use in treating ADHD. In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. 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 Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . PROVIGIL contains modafinil, a Schedule IV controlled substance. In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like. Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior). The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate). In one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use. There were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.

Каталог на резюме:

PROVIGIL®  (modafinil) tablets are available as follows: 100 mg: Each capsule-shaped, white to off white tablet is debossed with "PROVIGIL" on one side and "100 MG" on the other. NDC 63459-101-30 – Bottles of 30 200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other. NDC 63459-201-30 – Bottles of 30 Store at 20o ‑ 25o C (68o ‑ 77o F).

Статус Оторизация:

New Drug Application

Листовка

Cephalon, LLC
----------
MEDICATION GUIDE
PROVIGIL® (pro-vij-el) C-IV
(modafinil)
Tablets
Read this Medication Guide before you start taking PROVIGIL and each
time you get a refill. There may be
new information. This information does not take the place of talking
with your doctor about your medical
condition or treatment.
What is the most important information I should know about PROVIGIL?
PROVIGIL may cause serious side effects including a serious rash or a
serious allergic reaction that may
affect parts of your body such as your liver or blood cells. Any of
these may need to be treated in a hospital
and may be life-threatening.
Stop taking PROVIGIL and call your doctor right away or get emergency
help if you have any of these
symptoms:
•
skin rash, hives, sores in your mouth, or your skin blisters and peels
•
swelling of your face, eyes, lips, tongue, or throat
•
trouble swallowing or breathing
•
fever, shortness of breath, swelling of the legs, yellowing of the
skin or whites of the eyes, or dark
urine
If you have a severe rash with PROVIGIL, stopping the medicine may not
keep the rash from becoming life-
threatening or causing you to be permanently disabled or disfigured.
PROVIGIL is not approved for use in children for any medical
condition.
It is not known if PROVIGIL is safe or effective in children under 17
years of age.
What is PROVIGIL?
PROVIGIL is a prescription medicine used to improve wakefulness in
adults who are very sleepy due to one
of the following diagnosed sleep disorders:
•
narcolepsy
•
obstructive sleep apnea (OSA). PROVIGIL is used to treat excessive
sleepiness, but not the
obstruction or medical condition that is causing OSA. You should talk
with your doctor about
treatments for OSA before you start taking PROVIGIL and during
treatment with PROVIGIL.
PROVIGIL does not take the place of treatments that your doctor has
prescribed for OSA. It is
important that you continue to use these treatments as prescribed by
your doctor.
•
shift work disorder (SWD)
PROVIGIL will not cure t

Данни за продукта

PROVIGIL- MODAFINIL TABLET
CEPHALON, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROVIGIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROVIGIL.
PROVIGIL
(MODAFINIL) TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in adult patients with
excessive sleepiness associated with
narcolepsy, obstructive sleep apnea (OSA), or shift work disorder
(SWD). (1)
Limitations of Use
In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as
treatment for the underlying
obstruction.
DOSAGE AND ADMINISTRATION
The recommended dosage of PROVIGIL for each indication is as follows:
Narcolepsy or OSA: 200 mg once a day in the morning. (2.1)
SWD: 200 mg once a day, taken approximately one hour prior to start of
the work shift. (2.2)
Severe Hepatic Impairment: reduce dose to half the recommended dose.
(2.3, 12.3)
Geriatric Patients: consider lower dose. (2.4, 12.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 200 mg. (3)
CONTRAINDICATIONS
PROVIGIL is contraindicated in patients with known hypersensitivity to
modafinil or armodafinil. (4)
WARNINGS AND PRECAUTIONS
Serious Rash, including Stevens-Johnson Syndrome: Discontinue PROVIGIL
at the first sign of rash,
unless the rash is clearly not drug-related. (5.1)
Angioedema and Anaphylaxis Reactions: If suspected, discontinue
PROVIGIL. (5.2)
Multi-organ Hypersensitivity Reactions: If suspected, discontinue
PROVIGIL. (5.3)
Persistent Sleepiness: Assess patients frequently for degree of
sleepiness and, if appropriate, advise
patients to avoid driving or engaging in any other potentially
dangerous activity. (5.4)
Psychiatric Symptoms: Use caution in patients with a history of
psychosis, depression, or mania.
Consider discontinuing PROVIGIL if psychiatric symptoms develop. (5.5)
Known Cardiovascular Disease: Consider increased monitoring. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (≥5%): headache, nausea, n