MODAFINIL- modafinil tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceutical

INN (International Name):

MODAFINIL

Composition:

MODAFINIL 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Modafinil Tablets,USP 100 mg – White oval-shaped tablets engraved with “WW1”. Bottles of 30 Bottles of 90 Bottles of 100 200 mg – White oval-shaped tablets engraved with “WW969” and bisected. Bottles of 30 Bottles of 90 Bottles of 100 Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 USA Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Revised July 2014

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Hikma Pharmaceutical
----------
MEDICATION GUIDE
Modafinil Tablets, USP
Rx Only
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 it works 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 along with
other medical treatments for
this sleep disorder. Modafinil tablets 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)
Modafinil tablets will not cure the

Summary of Product characteristics

MODAFINIL- MODAFINIL TABLET
HIKMA PHARMACEUTICAL
----------
MODAFINIL TABLETS USP
MODAFINIL TABLETS, USP
CIV
Rev. 07/14
Rx Only
DESCRIPTION
Modafinil tablets, USP are 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, USP contain
100 mg or 200 mg of modafinil and the following inactive ingredients:
lactose monohydrate, low
substituted hydroxypropyl cellulose, pregelatinized starch, sodium
lauryl sulphate, talc, crospovidone
and sodium stearyl fumarate.
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 α1-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 transporte