Generic Name and Formulations:
Amantadine HCl 68.5mg, 137mg; ext-rel caps.
Adamas Pharmaceuticals, Inc.
Indications for GOCOVRI:
Treatment of dyskinesia in Parkinson's disease patients receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
Swallow whole. May open caps and sprinkle contents on a teaspoonful of soft food (eg, applesauce) if needed. Initially 137mg once daily at bedtime; increase to 274mg once daily at bedtime after 1 week. Renal impairment (CrCl 30–59mL/min/1.73m2): initially 68.5mg once daily; increase to max 137mg once daily after 1 week; (CrCl 15–29mL/min/1.73m2): 68.5mg once daily.
End-stage renal disease (CrCl <15mL/min/1.73m2).
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. 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.
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.
Hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, orthostatic hypotension; drowsiness, suicidality, depression, withdrawal-emergent hyperpyrexia/confusion, impulse control/compulsive behavior.