MODAFINIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

INN (International Name):

MODAFINIL

Composition:

MODAFINIL 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] .  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 arm

Product summary:

Modafinil Tablets USP 100 mg: White to off-white color, round shape, biconvex, uncoated tablets with ‘L233’ debossed on one side and plain on other side. NDC 46708-385-30      bottle of 30 tablets NDC 46708-385-60      bottle of 60 tablets NDC 46708-385-90      bottle of 90 tablets NDC 46708-385-91      bottle of 1000 tablets NDC 46708-385-10      100 (10 x 10) unit dose blisters tablets 200 mg: White to off-white color, round shape, biconvex, uncoated tablets with ‘L234’ debossed on one side and breakline on other side.  NDC 46708-386-30      bottle of 30 tablets NDC 46708-386-60      bottle of 60 tablets NDC 46708-386-90      bottle of 90 tablets NDC 46708-386-91      bottle of 1000 tablets NDC 46708-386-10      100 (10 x 10) unit dose blisters tablets Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature] 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MODAFINIL - MODAFINIL TABLET
Alembic Pharmaceuticals Limited
----------
MEDICATION GUIDE
Modafinil
(moe daf’ i nil)
Tablets, USP 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 pre

Summary of Product characteristics

MODAFINIL - MODAFINIL TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
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, C-IV
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) (1)
(1)
Limitations of Use (1)
In OSA, modafinil tablets are indicated to treat excessive sleepiness
and not as treatment for the
underlying obstruction. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of modafinil tablets for each indication is as
follows: (2)
· Narcolepsy or OSA: 200 mg once a day in the morning. (2.1) (2)
· SWD: 200 mg once a day, taken approximately one hour prior to start
of the work shift. (2.2) (2)
· Severe Hepatic Impairment: reduce dose to half the recommended
dose. (2.3, 12.3) (2)
· Geriatric Patients: consider lower dose. (2.4, 12.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 200 mg. (3) (3)
CONTRAINDICATIONS
Modafinil tablets are contraindicated in patients with known
hypersensitivity to modafinil or armodafinil. (4)
(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) (5)
· Angioedema and Anaphylaxis Reactions: If suspected, discontinue
modafinil. (5.2) (5)
· Multiorgan Hypersensitivity Reactions: If suspected, discontinue
modafinil. (5.3) (5)
· Persistent Sleepiness: Assess patients frequently for degree of
sleepinessand, if appropriate, advise
patients to avoid driving or engaging in any other potentially
dangerous activity. (5.4) (5)
· Psychiatric Symptoms: Use caution in patients with a history of
psychosis, depression, or mania.
Consider discontinuing modafinil if psychiatric symptoms d