Rx Item-Osmolex ER 190mg 90 Tab By Vertical Pharma

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER.

OSMOLEX ERTM (amantadine) extended-release tablets, for oral use

Initial U.S. Approval: 1966
INDICATIONS AND USAGE
OSMOLEX ER is indicated for the treatment of:

Parkinson's disease (1)
Drug-induced extrapyramidal reactions in adult patients (1)
DOSAGE AND ADMINISTRATION
The initial dosage is 129 mg orally once daily in the morning (2.1)
The dosage may be increased in weekly intervals to a maximum daily dose of 322 mg once daily in the morning (2.1)
Swallow tablets whole; do not chew, crush, or divide (2.2)
Dosing frequency reduction and monitoring required for renal impairment (2.3, 8.6)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets containing 129 mg, 193 mg, or 258 mg amantadine (3)

CONTRAINDICATIONS
OSMOLEX ER is contraindicated in patients with end-stage renal disease (4)

WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: Advise patients prior to treatment; ordinarily discontinue if occurs (5.1)
Suicidality and Depression: Monitor patients for depressed mood, depression, or suicidal ideation or behavior (5.2)
Hallucinations/Psychotic Behavior: Patients with major psychotic disorder should ordinarily not be treated with OSMOLEX ER; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases (5.3)
Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting OSMOLEX ER or increasing the dose (5.4)
Withdrawal-Emergent Hyperpyrexia and Confusion: Avoid sudden discontinuation (5.5)
Impulse Control/Compulsive Behaviors: Ask patients about increased gambling urges, sexual urges, uncontrolled spending or other urges; consider dose reduction or discontinuation if occurs (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5%) are nausea, dizziness/lightheadedness, and insomnia (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Vertical Pharmaceuticals, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH

DRUG INTERACTIONS
Anticholinergic Drugs: Increased risk of anticholinergic effects; the dose of anticholinergic drugs or OSMOLEX ER may require reduction (7.1)
Drugs Affecting Urinary pH: Excretion increases with acidic urine; possible accumulation with urine change towards alkaline (7.2)
Live Attenuated Influenza Vaccines: Not recommended during use (7.3)
Alcohol: Concomitant use is not recommended; increased potential for CNS effects (7.4)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2019

OSMOLEX ER 190MG 90 TAB By Ver
OSMOLEX ER 190MG 90 TAB By Vertical Pharma

OSMOLEX ER 190MG 30 TAB By Ver
OSMOLEX ER 190MG 30 TAB By Vertical Pharma NDC Code(s): 68025-075-07, 68025-075-14, 68025-075-30, 68025-075-90, view more Packager: Vertical Pharmaceuticals, LLC Category: HUMAN PRESCRIPTION DRUG L

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OSMOLEX ER 190MG 90 TAB By Ver
OSMOLEX ER 190MG 90 TAB By Vertical Pharma

OSMOLEX ER 190MG 30 TAB By Ver
OSMOLEX ER 190MG 30 TAB By Vertical Pharma NDC Code(s): 68025-075-07, 68025-075-14, 68025-075-30, 68025-075-90, view more Packager: Vertical Pharmaceuticals, LLC Category: HUMAN PRESCRIPTION DRUG L