MODAFINIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

MODAFINIL

Composition:

MODAFINIL 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, modafinil 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 modafinil. If modafinil 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 e

Product summary:

200 mg Each capsule-shaped, white, scored, uncoated tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other. NDC 42549-678-30 - Bottles of 30 NDC 42549-678-60 - Bottles of 60 Store at 20o to 25o C (68o to 77o F). Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

STAT Rx USA LLC
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MEDICATION GUIDE
Modafinil Tablets C-IV
Read the Medication Guide that comes with modafinil tablets 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 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 if they work in
children under the age of 17.
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 with other
medical treatments for this
sleep disorder. Modafinil tablets do 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)
Modafinil tablets will not cure these sleep disorders.

Summary of Product characteristics

MODAFINIL - MODAFINIL TABLET
STAT RX USA LLC
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MODAFINIL TABLETS C-IV 200 MG
DESCRIPTION
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. Modafinil 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
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 wake-promoting activity,
suggesting that this activity was DAT-dependent. However, the
wake-promoting