MODAFINIL- modafinil tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Par Pharmaceutical Inc.

INN (Nome Internazionale):

MODAFINIL

Composizione:

MODAFINIL 100 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Modafinil 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, modafinil 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 modafinil for excessive sleepiness. Modafinil 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 modafi

Dettagli prodotto:

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 49884-534-11 – Bottles of 30      NDC 49884-534-09 – Bottles of 90 200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other.      NDC 49884-535-11 – Bottles of 30      NDC 49884-535-09 – Bottles of 90 Store at 20o ‑ 25o C (68o ‑ 77o F).

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Foglio illustrativo

Par Pharmaceutical Inc.
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MEDICATION GUIDE
Modafinil Tablets C-IV
Read this Medication Guide before you start taking modafinil tablets
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 modafinil
tablets?
Modafinil tablets 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 modafinil tablets 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 modafinil tablets, stopping the
medicine may not keep the rash from
becoming life-threatening or causing you to be permanently disabled or
disfigured.
Modafinil tablets are not approved for use in children for any medical
condition.
It is not known if modafinil tablets are safe or effective in children
under 17 years of age.
What are modafinil tablets?
Modafinil tablets are 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). Modafinil tablets are 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 modafinil tablets and
during treatment with modafinil
tablets. Modafinil tablets do not take the place of treatments that
your doctor has prescribed for
OSA. It is important that you continue to us

Scheda tecnica

MODAFINIL- MODAFINIL TABLET
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MODAFINIL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MODAFINIL.
MODAFINIL TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Modafinil 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, modafinil is indicated to treat excessive sleepiness and not
as treatment for the underlying obstruction.
DOSAGE AND ADMINISTRATION
The recommended dosage of modafinil 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
Modafinil is contraindicated in patients with known hypersensitivity
to modafinil or armodafinil. (4)
WARNINGS AND PRECAUTIONS
Serious Rash, including Stevens-Johnson Syndrome: Discontinue
modafinil at the first sign of rash, unless the rash is
clearly not drug-related. (5.1)
Angioedema and Anaphylaxis Reactions: If suspected, discontinue
modafinil. (5.2)
Multi-organ Hypersensitivity Reactions: If suspected, discontinue
modafinil. (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
modafinil if psychiatric symptoms develop. (5.5)
Known Cardiovascular Disease: Consider increased monitoring. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (≥5%): headache,