XYREM CIII

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XYREM

Sleep-wake disorders
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Generic Name and Formulations:

Sodium oxybate 500mg/mL; soln; contains sodium 91mg/mL.

Select therapeutic use:

Indications for XYREM:

Excessive daytime sleepiness and cataplexy associated with narcolepsy.

Adult:

Take on empty stomach. Dilute each dose with 2oz of water. Initially 4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals; usual range: 6–9g/night; max 9g/night. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Hepatic impairment: reduce dose by ½, titrate and monitor closely. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.

Children:

Not established.

Contraindications:

Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.

Warnings/Precautions:

Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. History of depression or suicidal ideation (monitor). Consider sodium intake with heart failure, hypertension, renal insufficiency (see full labeling). Hepatic impairment. Drug abusers. Reevaluate every 3 months. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Interactions:

See Contraindications. CNS depression potentiated by other CNS depressants (eg, opioids, benzodiazepine, antidepressants, antipsychotics, general anesthetics, muscle relaxants). Potentiated by divalproex sodium.

Pharmacological Class:

Antinarcoleptic (CNS depressant).

Adverse Reactions:

Nausea, dizziness, vomiting, somnolence, enuresis, tremor; CNS and respiratory depression, sleepwalking, depressive symptoms, confusion, anxiety, other neuropsychiatric reactions.

Note:

Only available through the Xyrem REMS Program. For more information call (866) 997-3688.

REMS:

YES

Generic Availability:

NO

How Supplied:

Soln—180mL (w. oral dispensing syringe)

XYREM 180ml of 500mg/ml bottle of oral solutions (Qty:1)

appx. price $3759.00