What Makes OSMOLEX® ER (amantadine) Unique?

OSMOLEX ER has a consistent pharmacokinetic profile with the Osmodex® delivery system that delivers amantadine throughout the day1,2

When taken in the morning, amantadine plasma levels are higher during the day and lower during the night,
without any mid-day trough effect.2

Comparison of OSMOLEX ER to immediate-release amantadine2

Hourglass Icon The Osmodex delivery system can provide a controlled and steady increase in amantadine after administration.2

These data come from a single-center, laboratory-blinded, randomized, 2-treatment, 2-period, 2-sequence, multiple oral dose crossover study was conducted in 24 healthy volunteers to compare 258-mg OSMOLEX ER tablets to 258-mg amantadine oral syrup.2

The efficacy of OSMOLEX ER has been established based on bioavailability studies that compared OSMOLEX ER to immediate-release amantadine.1,2

The pharmacokinetics of OSMOLEX ER across 3 different dosage strengths were shown to be dose proportional.1,2

DOSING AND ADMINISTRATION

Multiple dosing options

Every patient is unique, so multiple dosing options allow you to tailor treatment to each individual patient’s needs.

Chart comparing the size and dosing options available for OSMOLEX® ER (amantadine) Chart comparing the size and dosing options available for OSMOLEX® ER (amantadine)

Actual tablet size relative to a penny.

The recommended initial dose of OSMOLEX ER is 129 mg taken orally once-a-day in the morning.1


The dosage may be increased in weekly intervals to a maximum daily dose of 322 mg (administered as a 129-mg and a 193-mg tablet).1

Warning icon

OSMOLEX ER is not interchangeable
with other amantadine immediate-
or extended-release products1

Kidney icon

There are no modifications for the recommended initial
and maximum dosage in patients with renal impairment;
however, modifications are recommended for the
titration interval and frequency of dosing in patients
with moderate and severe renal impairment1

Food and drink icon

OSMOLEX ER can be taken with or
without food. OSMOLEX ER should be
swallowed whole. Do not crush, chew,
or divide the tablet1

Quick Reference Dosing: OSMOLEX ER Amantadine HCl Equivalence1

OSMOLEX® ER (amantadine) logo Amantadine HCI Equivalent
129 mg 160 mg
193 mg 240 mg
258 mg 320 mg
322 mg
(taken as 2 tablets: 129 mg + 193 mg)
400 mg

NOTE: The USP Salt Policy (May 2013) requires the name and strength of the active ingredient in a drug product to be expressed in terms of the active moiety rather than the salt strength equivalent.3

Incidence of Adverse Reactions From Pooled Studies of Immediate-Release Amantadine1

Incidence Rate Adverse Reaction
5% to 10% Nausea, dizziness/lightheadedness, insomnia
1% to 5% Depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea, fatigue
0.1% to 1% Congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, visual disturbance, punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, optic nerve palsy
Less than 0.1% Convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, suicidal ideation

References:

  1. OSMOLEX ER. Prescribing information. Vertical Pharmaceuticals, LLC; 2020.
  2. DeVries T, Dentiste A, Handiwala L, Jacobs D. Bioavailability and pharmacokinetics of once-daily amantadine extended-release tablets in healthy volunteers: results from three randomized, crossover, open-label phase 1 studies. Neurol Ther. 2019. DOI: 10.1007/s40120-019-0144-1.
  3. Center for Drug Evaluation and Research. Naming of drug products containing salt drug substances: guidance for industry. US Food and Drug Administration website. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm379753.pdf. Published June 2015. Accessed March 23, 2018.

INDICATION

OSMOLEX® ER (amantadine) extended-release tablets is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2).

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Before initiating treatment with OSMOLEX ER, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk of somnolence with OSMOLEX ER, such as concomitant sedating medications, alcohol, or the presence of a sleep disorder. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (eg, driving a motor vehicle, conversations, eating), OSMOLEX ER should ordinarily be discontinued. If a decision is made to continue OSMOLEX ER, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if they become somnolent.

Suicidality and Depression: Suicide, suicide attempts, and suicidal ideation have been reported in patients with and without prior history of psychiatric illness while treated with amantadine. Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits of treatment with OSMOLEX ER outweigh the risks in patients with a history of suicidality or depression.

Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER due to the risk of exacerbating psychosis. Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased.

Dizziness and Orthostatic Hypotension: Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose.

Withdrawal-Emergent Hyperpyrexia and Confusion: Abrupt discontinuation of OSMOLEX ER may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. It is recommended that patients avoid sudden discontinuation of OSMOLEX ER.

Impulse Control/Compulsive Behaviors: Patients can experience increased sexual urges, and intense urges to gamble, spend money, binge eat, and/or other intense urges, and the inability to control these urges while taking one or more medications that increase central dopaminergic tone, including OSMOLEX ER. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Other Anticholinergic Drugs: The dose of anticholinergic drugs or of OSMOLEX ER should be reduced if atropine-like effects appear when these drugs are used concurrently.

Drugs Affecting Urinary pH: The pH of urine has been reported to influence the excretion rate of amantadine. Alterations in urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Monitor for efficacy or adverse reactions under conditions that alter the urine pH to more acidic or alkaline, respectively.

Live Attenuated Influenza Vaccines: Amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live vaccines are not recommended during treatment with OSMOLEX ER. Inactivated influenza vaccines may be used as appropriate.

Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for central nervous system effects such as somnolence, dizziness, confusion, lightheadedness, and orthostatic hypotension.