NUVIGIL- armodafinil tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ARMODAFINIL (UNII: V63XWA605I) (ARMODAFINIL - UNII:V63XWA605I)

Beschikbaar vanaf:

Cephalon, LLC

INN (Algemene Internationale Benaming):

ARMODAFINIL

Samenstelling:

ARMODAFINIL 50 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL 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 NUVIGIL for excessive sleepiness. NUVIGIL 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 Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUVIGIL during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106. Risk Summary Limited available d

Product samenvatting:

NUVIGIL® (armodafinil) Tablets are available as follows: 50 mg: Each round, white to off-white tablet is debossed with   on one side and "205" on the other. NDC 63459-205-30 – Bottles of 30 150 mg: Each oval, white to off-white tablet is debossed with   on one side and "215" on the other. NDC 63459-215-30 – Bottles of 30 200 mg: Each rounded, rectangular, white to off-white tablet is debossed with   on one side and "220" on the other. NDC 63459-220-30 – Bottles of 30 250 mg: Each oval, white to off-white tablet is debossed with   on one side and "225" on the other. NDC 63459-225-30 – Bottles of 30 Store at 20o - 25o C (68o - 77o F).

Autorisatie-status:

New Drug Application

Bijsluiter

Cephalon, LLC
----------
MEDICATION GUIDE
NUVIGIL (nu-vij-el)
(armodafinil)
tablets, for oral use, C-IV
What is the most important
information I should know
about NUVIGIL?
NUVIGIL is a federal
controlled substance (C-IV)
because it can be abused or
lead to dependence. Keep
NUVIGIL in a safe place to
prevent misuse and abuse.
Selling or giving away
NUVIGIL may harm others,
and is against the law. Tell
your doctor if you have ever
abused or been dependent on
alcohol, prescription
medicines or street drugs.
NUVIGIL 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 NUVIGIL 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,
breathing, or
hoarseness
•
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
NUVIGIL, stopping the
medicine may not keep the
rash from becoming life-
threatening or causing you to
be permanently disabled or
disfigured.
NUVIGIL is not approved for
use in children for any
medical condition.
It is not known if NUVIGIL
is safe and effective in
children under the age of 18.
What is NUVIGIL?
NUVIGIL is 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).
NUVIGIL is used
with other medical
treatments for this
sleep disorder.
NUVIGIL does not
take the place of using
your CPAP machine
or other treatments
that your doctor has
prescribed for this
condition. It is
important that you
continue to use these
treatments as
prescribed by your
doctor.
•
shift work disorder
(SWD)
NUVIGIL will not cure these
s

Productkenmerken

NUVIGIL- ARMODAFINIL TABLET
CEPHALON, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUVIGIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NUVIGIL.
NUVIGIL
(ARMODAFINIL) TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
NUVIGIL is indicated to improve wakefulness in adult patients with
excessive sleepiness associated with
obstructive sleep apnea (OSA), narcolepsy, or shift work disorder
(SWD). (1)
Limitations of Use
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as
treatment for the underlying
obstruction.
DOSAGE AND ADMINISTRATION
The recommended dosage of NUVIGIL for each indication is as follows:
OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning. (2.1)
SWD: 150 mg once a day, taken approximately one hour prior to start of
the work shift. (2.2)
Hepatic Impairment: reduced dose in patients with severe hepatic
impairment. (2.3, 12.3)
Geriatric Patients: consider lower dose. (2.4, 12.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 150 mg, 200 mg, and 250 mg. (3)
CONTRAINDICATIONS
NUVIGIL is contraindicated in patients with known hypersensitivity to
modafinil or armodafinil. (4)
WARNINGS AND PRECAUTIONS
Serious Rash, including Stevens-Johnson Syndrome: discontinue NUVIGIL
at the first sign of rash, unless
the rash is clearly not drug-related. (5.1)
DRESS/Multi-organ Hypersensitivity Reactions: if suspected,
discontinue NUVIGIL. (5.2)
Angioedema and Anaphylaxis Reactions: if suspected, discontinue
NUVIGIL. (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 particular caution in treating patients with
a history of psychosis,
depression, or mania. Consider discontinuing NUVIGIL if psychiatric
symptoms develop. (5.5)
Known Cardiovascular Disease: consider increased monitoring. (5.7)
ADVERSE REACTIONS
Most c