Indications for: OSMOLEX ER

Treatment of Parkinson's disease and drug-induced extrapyramidal reactions.

Adult Dosage:

Swallow whole. Initially 129mg once daily in the AM; may increase in weekly intervals to max 322mg once daily in the AM. Renal impairment (CrCl 30–59mL/min/1.73m2): initially 129mg once every 48hrs; increase every 3 weeks to max 322mg; (CrCl 15–29mL/min/1.73m2): initially 129mg once every 96hrs; increase every 4 weeks to max 322mg. Taper gradually from high doses to 129mg daily for 1–2 weeks before discontinuing.

Children Dosage:

Not established.

OSMOLEX ER Contraindications:

End-stage renal disease (CrCl <15mL/min/1.73m2).

OSMOLEX ER Warnings/Precautions:

Not interchangeable with other amantadine products. Sleep disorders. Discontinue if daytime sleepiness or episodes of falling asleep during activities that require full attention develops. Monitor for depression, suicidal ideation or behavior. Psychotic disorders: not recommended. Monitor for hallucinations, dizziness, orthostatic hypotension (esp. at initiation and after dose increases). Monitor for new or increased urges or compulsive behaviors; consider reducing dose or discontinuing if develops. Avoid abrupt cessation. Monitor conditions (eg, renal tubular acidosis, severe UTIs) that can alter the urine pH (acidic or alkaline). Renal impairment. Elderly: monitor renal function. Pregnancy. Nursing mothers.

OSMOLEX ER Classification:

Dopamine agonist.

OSMOLEX ER Interactions:

Concomitant alcohol, live attenuated vaccines: not recommended. Increased somnolence with concomitant sedatives. Potentiated by anticholinergics; reduce dose. Concomitant drugs affecting urinary pH (eg, carbonic anhydrase inhibitors, sodium bicarbonate); monitor.

Adverse Reactions:

Nausea, dizziness/lightheadedness, insomnia; drowsiness, suicidality, depression, psychosis, withdrawal-emergent hyperpyrexia/confusion, impulse control/compulsive behavior.

Drug Elimination:

Renal (~85%). Half-life: ~16 hours.

Generic Drug Availability:


How Supplied:

Ext-rel tabs—30