MODAFINIL tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

NuCare Pharmaceuticals,Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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)] . Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled

Ürün özeti:

Modafinil Tablets USP, 100 mg are white to off-white, capsule-shaped, uncoated tablets, debossed with 41 on one side and J on the other side. NDC 68071-5121-3 BOTTLES OF 30 Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Modafinil Tablets, USP CIV
(moe daf' i nil)
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 importa

Ürün özellikleri

MODAFINIL- MODAFINIL TABLET
NUCARE 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 USP, FOR ORAL USE, CIV
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 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 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