NUVIGIL- armodafinil tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

armodafinil (UNII: V63XWA605I) (armodafinil - UNII:V63XWA605I)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

armodafinil

Composition:

armodafinil 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder. In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) 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. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of NUVIGIL in long-term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe NUVIGIL for an e

Product summary:

NUVIGIL® (armodafinil) Tablets [C-IV] 50 mg: Each round, white uncoated tablet is debossed with "C" on one side and "205" on the other. NDC 63459-205-30 - Bottles of 30 150 mg: Each oval, white uncoated tablet is debossed with "C" on one side and "215" on the other. NDC 63459-215-30 - Bottles of 30 250 mg: Each oval, white uncoated tablet is debossed with "C" on one side and "225" on the other. NDC 63459-225-30 - Bottles of 30 Store at 20° - 25° C (68° - 77° F).  Distributed by: Cephalon, Inc. Frazer, PA 19355 U.S. Patent Nos. RE37,516; 7,132,570; 7,297,346 NUVIGIL is a trademark of Cephalon, Inc. or its affiliates. © 2007-2010 Cephalon, Inc. All rights reserved. October 2010 NUV-006

Authorization status:

New Drug Application

Patient Information leaflet

Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
NUVIGIL (nu-vij-el) C-IV
(armodafinil)
Tablets
Read the Medication Guide that comes with NUVIGIL before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking with your
doctor about your condition or treatment.
What is the most important information I should know about NUVIGIL?
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 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 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 or if it works in children under
the age of 17.
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 sleep disorders. NUVIGIL may help the
sleepiness caused by these
conditions, but it m

Summary of Product characteristics

NUVIGIL- ARMODAFINIL TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NUVIGIL (ARMODAFINIL) TABLETS [C-IV]
DESCRIPTION
NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral
administration. Armodafinil is the
R-enantiomer of modafinil which is a mixture of the R- and
S-enantiomers. The chemical name for
armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The
molecular formula is C
H NO S and
the molecular weight is 273.35.
The chemical structure is:
Armodafinil exists in multiple crystalline forms. Form I, which is
used in NUVIGIL, is the least soluble
form of armodafinil and is a white to off-white, crystalline powder
that is very slightly soluble in water,
sparingly soluble in acetone and soluble in methanol. At least 90% of
the armodafinil particles used in
NUVIGIL have a diameter less than 200 microns.
NUVIGIL tablets contain 50, 150, or 250 mg of armodafinil and the
following inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
povidone, and pregelatinized starch.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION AND PHARMACOLOGY
The precise mechanism(s) through which armodafinil (R-enantiomer) or
modafinil (mixture of R- and S-
enantiomers) promote wakefulness is unknown. Both armodafinil and
modafinil have shown similar
pharmacological properties in nonclinical animal and in vitro studies,
to the extent tested.
At pharmacologically relevant concentrations, armodafinil does not
bind to or inhibit several receptors
and enzymes potentially relevant for sleep/wake regulation, including
those for serotonin, dopamine,
adenosine, galanin, melatonin, melanocortin, orexin-1, orphanin, PACAP
or benzodiazepines, or
transporters for GABA, serotonin, norepinephrine, and choline or
phosphodiesterase VI, COMT,
GABA transaminase, and tyrosine hydroxylase. Modafinil does not
inhibit the activity of MAO-B or
phosphodiesterases II-IV.
Modafinil-induced wakefulness can be attenuated by the α1-adrenergic
receptor antagonist, prazosin;
however