PROVIGIL- modafinil tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

modafinil (UNII: R3UK8X3U3D) (modafinil - UNII:R3UK8X3U3D)

Tilgjengelig fra:

Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC

INN (International Name):

modafinil

Sammensetning:

modafinil 200 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, PROVIGIL 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 PROVIGIL. If PROVIGIL 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 modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluate

Produkt oppsummering:

PROVIGIL® (modafinil) Tablets 100 mg: Each capsule-shaped, white, uncoated tablet is debossed with "PROVIGIL" on one side and "100 MG" on the other. NDC 63459-101-30 - Bottles of 30 200 mg: Each capsule-shaped, white, scored, uncoated tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other. NDC 63459-201-30 - Bottles of 30 Store at 20° - 25° C (68° - 77° F).  Distributed by: Cephalon, Inc. Frazer, PA 19355 U.S. Patent Nos. RE37,516; 7,297,346 PROVIGIL® is a trademark of Cephalon, Inc. or its affiliates. © 1998-2010 Cephalon, Inc., or its affiliates. All rights reserved. October 2010 PROV-013

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC
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MEDICATION GUIDE
PROVIGIL (pro-vij-el) C-IV
(modafinil)
Tablets
Read the Medication Guide that comes with PROVIGIL 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 PROVIGIL?
PROVIGIL 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 PROVIGIL 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 PROVIGIL, stopping the medicine may not
keep the rash from becoming
life-threatening or causing you to be permanently disabled or
disfigured.
PROVIGIL is not approved for use in children for any medical
condition.
It is not known if PROVIGIL is safe or if it works in children under
the age of 17.
What is PROVIGIL?
PROVIGIL 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). PROVIGIL is used with other medical
treatments for this sleep
disorder. PROVIGIL 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)
PROVIGIL will not cure these sleep disorders. PROVIGIL may help the
sleepiness cause

Preparatomtale

PROVIGIL- MODAFINIL TABLET
LAKE ERIE MEDICAL SURGICAL & SUPPLY DBA QUALITY CARE PRODUCTS LLC
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PROVIGIL (MODAFINIL) TABLETS [C-IV]
DESCRIPTION
PROVIGIL (modafinil) is a wakefulness-promoting agent for oral
administration. Modafinil is a racemic
compound. The chemical name for modafinil is
2-[(diphenylmethyl)sulfinyl]acetamide. The molecular
formula is C
H NO S and the molecular weight is 273.35.
The chemical structure is:
Modafinil is a white to off-white, crystalline powder that is
practically insoluble in water and
cyclohexane. It is sparingly to slightly soluble in methanol and
acetone. PROVIGIL tablets contain 100
mg or 200 mg of modafinil and the following inactive ingredients:
lactose monohydrate,
microcrystalline cellulose, pregelatinized starch, croscarmellose
sodium, povidone, and magnesium
stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION AND PHARMACOLOGY
The precise mechanism(s) through which modafinil promotes wakefulness
is unknown. Modafinil has
wake-promoting actions similar to sympathomimetic agents like
amphetamine and methylphenidate,
although the pharmacologic profile is not identical to that of
sympathomimetic amines.
Modafinil has weak to negligible interactions with receptors for
norepinephrine, serotonin, dopamine,
GABA, adenosine, histamine-3, melatonin, and benzodiazepines.
Modafinil also does not inhibit the
activities of MAO-B or phosphodiesterases II-V.
Modafinil-induced wakefulness can be attenuated by the α -adrenergic
receptor antagonist prazosin;
however, modafinil is inactive in other in vitro assay systems known
to be responsive to α-adrenergic
agonists, such as the rat vas deferens preparation.
Modafinil is not a direct- or indirect-acting dopamine receptor
agonist. However, in vitro, modafinil
binds to the dopamine transporter and inhibits dopamine reuptake. This
activity has been associated in
vivo with increased extracellular dopamine levels in some brain
regions of animals. In genetically
engineered mice lacking the dopamine transporter (DAT), modafinil
lacked w