Taking
OSMOLEX® ER
(amantadine)

Because every patient is unique, OSMOLEX ER is available in multiple dose strengths.1

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.

Actual tablet size relative to a penny.

The recommended starting dose is 129 mg with options to increase from there.

The maximum daily dose is 322 mg administered as a 129‑mg and a 193‑mg tablet.

All options are taken once daily in the morning with or without food.


Talk to your doctor to determine which dosing option is best for you.

Image of a doctor discussing treatment with a patient Image of a doctor discussing treatment with a patient

Things to know before you start taking OSMOLEX ER:

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Take OSMOLEX ER exactly as your doctor tells you
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Start OSMOLEX ER with 1 tablet in the morning. Your doctor may change your dose if needed
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Do not stop taking OSMOLEX ER or change your dose before talking with your doctor. Tell your doctor if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness
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OSMOLEX ER may be taken with or without food
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Swallow OSMOLEX ER tablets whole. Do not chew, crush, or divide OSMOLEX ER tablets
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If you miss a dose of OSMOLEX ER, do not make up the missed dose. Take your usual dose of OSMOLEX ER on the next day in the morning
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If you take too much OSMOLEX ER, call your doctor or go to the nearest hospital emergency room right away
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OSMOLEX ER should not be used instead of other immediate-release amantadine medicines or other extended-release amantadine medicines
OSMOLEX® ER tablet shell icon
The OSMOLEX ER tablet shell does not dissolve completely even after all the drug has been released. The tablet shell may be seen in your stool

Reference:

  1. OSMOLEX ER. Prescribing information. Vertical Pharmaceuticals, LLC; 2020.

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

WHAT IS OSMOLEX® ER (AMANTADINE) EXTENDED RELEASE TABLETS?

OSMOLEX ER is a prescription medicine used to treat adults with:

  • Parkinson’s disease
  • Drug-induced extrapyramidal reactions

It is not known if OSMOLEX ER is safe and effective in children.

BEFORE TAKING OSMOLEX ER, TELL YOUR DOCTOR ABOUT ALL MEDICAL CONDITIONS, INCLUDING IF YOU:

  • have kidney problems. Do not take OSMOLEX ER if you have severe kidney problems
  • have unexpected sleepiness, take medicine to help you sleep or that makes you drowsy
  • have mental problems, such as suicidal thoughts, depression, or hallucinations
  • have unusual urges, including gambling, increased sex drive, compulsive eating, or compulsive shopping
  • drink alcoholic beverages
  • are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. OSMOLEX ER may harm your unborn baby and can pass into your breastmilk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take sodium bicarbonate, a medicine that contains sodium bicarbonate, or are planning to receive the flu vaccine.

WHAT SHOULD I AVOID WHILE TAKING OSMOLEX ER?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how OSMOLEX ER affects you
  • You should not drink alcohol while taking OSMOLEX ER because it can increase your chances of serious side effects
  • Do not stop taking OSMOLEX ER or change your dose before talking with your doctor. Tell your doctor if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness
  • You may receive the flu vaccine (shot or injection) but should not get the live flu vaccine (nasal spray) while taking OSMOLEX ER

WHAT ARE THE POSSIBLE SIDE EFFECTS OF OSMOLEX ER?

OSMOLEX ER may cause serious side effects, including:

  • falling asleep during normal activities, such as driving, talking, or eating, while taking OSMOLEX ER. You may fall asleep without being drowsy or warning. The risk is greater if you take OSMOLEX ER with other medicines that cause drowsiness or drink alcohol. Tell your doctor right away if this happens
  • suicidal thoughts or actions and depression. Tell your doctor right away if you have significant changes in your mood, behaviors, or thoughts, including thoughts about hurting yourself or ending your life
  • hallucinations (seeing, or hearing things that are not real) while you are taking OSMOLEX ER or if you suddenly stop taking OSMOLEX ER
  • feeling dizzy, faint, or light-headed, especially when you stand up too quickly, when you first start OSMOLEX ER, or if your dose has been increased. Tell your doctor if you become dizzy, light-headed, or faint when standing up
  • unusual urges, including gambling, sexual, spending money, and binge eating, and the inability to control these urges. If you notice or your family notices that you are developing any unusual behaviors, talk to your doctor

The most common side effects of OSMOLEX ER include nausea, dizziness, lightheadedness, and trouble sleeping.

These are not all the possible side effects of OSMOLEX ER. Call your doctor for medical advice about side effects.You may report side effects to the FDA. Visit www.fda.gov/medwatch or call at 1-800-FDA-1088.