Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2018

Amantadine extended-release

(Osmolex ER—Osmotica Pharmaceutical)
New ER formulation for treatment of Parkinson disease, drug-induced involuntary movements in adults

Osmotica Pharmaceutical announced FDA approval of an amantadine extended-release tablet for the treatment of Parkinson disease and of drug-induced involuntary movements in adult patients. Extrapyramidal symptoms are known adverse effects of many common medications.

The tablet is taken once daily in the morning, releasing amantadine throughout the day. Dosage options are 129 mg, 193 mg and 258 mg, with a maximum daily dose of 322 mg.

The most common adverse reactions reported in clinical trials (≥5% of patients) at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.