NEW
Nuvigil

Nuvigil

Manufacturer:

Anesta LLC

Distributor:

DKLL

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
Armodafinil
Indications/Uses
Improves wakefulness in patients w/ excessive daytime sleepiness associated w/ narcolepsy. Excessive sleepiness associated w/ moderate to severe chronic shift work sleep disorder where non-pharmacological interventions are unsuccessful or inappropriate. Adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.
Dosage/Direction for Use
Narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSAHS) 150 mg or 250 mg once daily in the morning. Shift work sleep disorder (SWSD) 150 mg daily approx 1 hr prior to the start of work shift.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity to modafinil or armodafinil. Patients who are pregnant or may become pregnant.
Special Precautions
Discontinue treatment if multi-organ hypersensitivity reaction is suspected, if any signs/symptoms suggesting angioedema or anaphylaxis (eg, swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness) is observed, occurrence of serious rash, including Stevens-Johnson syndrome. Frequently reassess the degree of sleepiness & advise to avoid driving or any potentially dangerous activity in patients w/ excessive sleepiness. History of psychosis, depression, or mania. Recent history of MI or unstable angina. Should not be used in patients w/ history of left ventricular hypertrophy or w/ mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. Increased monitoring of heart rate & BP during therapy. Patients w/ known CV disease. History of drug &/or stimulant abuse; observe for signs of misuse or abuse. Severe hepatic impairment (w/ or w/o cirrhosis); renal impairment. Caution in operating an automobile or other hazardous machinery. Potential increased risk of pregnancy when using steroidal contraceptives during therapy & for 2 mth after discontinuation of therapy. Higher mean plasma levels of γ-glutamyltransferase & alkaline phosphatase following administration of Nuvigil. Pregnancy & lactation.
Adverse Reactions
Headache, nausea, dizziness & insomnia. Palpitations; diarrhoea, dry mouth, dyspepsia, upper abdominal pain constipation, vomiting, loose stools; fatigue, thirst, influenza-like illness, pain, pyrexia; seasonal allergy; increased γ-glutamyltransferase & heart rate; anorexia, decreased appetite; disturbance in attention, tremor, migraine, paresthesia; anxiety, depression, agitation, nervousness, depressed mood; polyuria; dyspnea; rash, contact dermatitis, hyperhydrosis. 
Drug Interactions
Altered plasma conc w/ potent CYP3A4/5 inducers (eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifabutin, rifampin & St. John's Wort) or CYP3A4/5 inhibitors (eg, PIs; ritonavir, indinavir, nelfinavir, saquinavir; clarithromycin, erythromycin, chloramphenicol, ketoconazole, itraconazole, nefazodone, diltiazem & verapamil). May reduce blood levels & effectiveness of CYP3A enzyme substrates (eg, steroidal contraceptives, cyclosporine, midazolam & triazolam). Reduced mean systemic exposure of carbamazepine & quetiapine. May reduce blood levels of cyclosporine. May increase exposure of omeprazole. MAIOs. May increase levels of clomipramine & its active metabolite desmethylclomipramine in narcolepsy.
ATC Classification
N06BA13 - armodafinil ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Presentation/Packing
Form
Nuvigil 250 mg tab
Packing/Price
30's
Form
Nuvigil 150 mg tab
Packing/Price
30's
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