MODAFINIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Modafinil tablets, USP 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, USP 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, USP 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

Product summary:

Modafinil Tablets, USP are supplied as follows: 100 mg White, round, biconvex tablets, engraved "MOD" over "100" on one side, "APO" on the other side. 200 mg White, oval, biconvex tablets, scored and engraved "MOD" bisect "200" on one side, "APO" on the other side. 55700-695-30 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MODAFINIL- MODAFINIL TABLET
Quality Care Products, LLC
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MEDICATION GUIDE
Modafinil Tablets, USP
100 mg and 200 mg
(moe daf' i nil)
Rx Only
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
prescrib

Summary of Product characteristics

MODAFINIL- MODAFINIL TABLET
QUALITY CARE PRODUCTS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MODAFINIL TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MODAFINIL TABLETS, USP.
MODAFINIL TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Modafinil tablets, USP 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, USP s 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:
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 tablets are contraindicated in patients with known
hypersensitivity to modafinil or armodafinil. (4)
WARNINGS AND PRECAUTIONS
Serious Rash, including Stevens-Johnson Syndrome: Discontinue
modafinil tablets at the first sign of
rash, unless the rash is clearly not drug-related. (5.1)
Angioedema and Anaphylaxis Reactions: If suspected, discontinue
modafinil tablets. (5.2)
Multi-organ Hypersensitivity Reactions: If suspected, discontinue
modafinil tablets. (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 tablets if psychiatric symptoms
develop. (5.5)
Known Cardiovascular Dise