MODAFINIL tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Mylan Pharmaceuticals Inc.

INN (Tarptautinis Pavadinimas):

MODAFINIL

Sudėtis:

MODAFINIL 100 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Modafinil tablets are 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 tablets are 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 tablets for excessive sleepiness. Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1, 5.2, 5.3)] . 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-ena

Produkto santrauka:

Modafinil Tablets, USP are available containing 100 mg or 200 mg of modafinil, USP. The 100 mg tablets are white to off-white, round, unscored tablets debossed with M over 573 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5573-93 bottles of 30 tablets NDC 0378-5573-05 bottles of 500 tablets The 200 mg tablets are white to off-white, oval, scored tablets debossed with M on the left of the score and 575 on the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5575-93 bottles of 30 tablets NDC 0378-5575-05 bottles of 500 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

MODAFINIL- MODAFINIL TABLET
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
MODAFINIL TABLETS, USP CIV
(moe daf′ i nil)
100 mg and 200 mg
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
yo

Prekės savybės

MODAFINIL- MODAFINIL TABLET
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MODAFINIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MODAFINIL TABLETS.
MODAFINIL TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Modafinil tablets are 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 tablets are indicated to treat
excessive sleepiness and not as treatment for the
underlying obstruction.
DOSAGE AND ADMINISTRATION
The recommended dosage of modafinil tablets for each indication is as
follows:
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 200 mg. (3)
CONTRAINDICATIONS
Modafinil tablets are contraindicated in patients with known
hypersensitivity to modafinil or armodafinil. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 5%): headache, nausea, nervousness,
rhinitis, diarrhea, back pain, anxiety, insomnia,
dizziness, and dyspepsia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 3/2016
Narcolepsy or OSA: 200 mg once a day in the morning. (2.1)
SWD: 200 mg once a day, taken approximately 1 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)
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