Osmolex ER

Osmolex ER is a prescription medication used to treat Parkinson's disease and drug-induced extrapyramidal reactions (feelings of restlessness, involuntary movements of the face or tongue, involuntary muscle spasms) in adult patients. 

Osmolex ER belongs to a group of drugs called anti-Parkinson agents. The exact way this medication helps to treat Parkinson's disease and drug-induced extrapyramidal reactions is unknown. 

This medication comes in tablet form and is taken by mouth once daily in the morning, with or without food. Do not chew, divide, or break Osmolex ER. Swallow Osmolex ER tablets whole.

Common side effects of Osmolex ER include nausea, lightheadedness and insomnia. 

Osmolex ER can also cause dizziness. Do not drive or operate heavy machinery until you know how Osmolex ERaffects you.

Osmolex ER is a prescription medication used to treat: 

• Parkinson's disease. This is a disorder that affects movement and gradually gets worse over time. 
• Drug-induced extrapyramidal symptoms (movement disorders) in adult patients. These symptoms include feelings of restlessness (akathisia), involuntary movements of the face and tongue (tardive dyskinesia), involuntary muscle spasms (dystonia), tremor and slow movements. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function
• your age
• your weight

Parkinson's disease:

The recommended initial dose of Osmolex ER is 129 mg once daily in the morning. The dose may be increased once weekly up to a maximum dose of 322 mg once daily in the morning. Osmolex ER is not interchangable with other amantadine products. The dose should be gradually decreased over 1-2 weeks before stopping the medicine. 

Dosage for drug-induced extrapyramidal reactions: 

The recommended initial dose of Osmolex ER is 129 mg once daily in the morning. The dose may be increased once weekly up to a maximum dose of 322 mg once daily in the morning. Osmolex ER is not interchangable with other amantadine products. Osmolex ER should not be stopped suddenly. The dose should be gradually decreased over 1-2 weeks before stopping the medicine. 

Serious side effects have been reported with Osmolex ER including the following:

• Falling asleep during normal daily activities. Feelings of sleepiness may occur. This can result in falling asleep during normal daily activities. This may affect your ability to drive and operate machinery safely. Tell your healthcare provider right away if you feel more tired than usual or fall asleep during your normal daily activities, such as eating, working or exercising. 
• Suicidal thoughts or feelings of depression. Tell your healthcare provider right away if you have some or all of the following symptoms of depression or suicidal thoughts:
  • feelings of sadness
  • feeling anxious
  • feeling hopeless
  • loss of interest or happiness in activities that used to make you happy
  • crying more than normal
  • feeling angry
  • not sleeping well or sleeping more than normal
  • talking about suicide
  • thinking about death and dying more than you used to
  • doing risky things such as driving recklessly or doing drugs
• Hallucinations. Tell your healthcare provider right away if you have some or all of the following symptoms of hallucinations:
  • hearing voices that your friends or family cannot hear
  • seeing things your friends or family cannot see
• Dizziness and orthostatic hypotension (low blood pressure that occurs when standing up quickly after sitting or lying down). Do not stand up quickly after sitting down or lying down for long periods of time. 
• Fever and confusion after stopping the medication. Do not stop taking Osmolex ER without talking to your healthcare provider. Tell your healthcare provider right away if you stop taking Osmolex ER and develop withdrawal symptoms such as:
  • fever
  • confusion
  • severe muscle stiffness
• Impulse Control/Compulsive Behaviors. Patients treated with amantadine can experience intense urges (sexual, gambling, spending money uncontrollably).

Osmolex ER can cause drowsiness. Do not drive or operate heavy machinery until you know how amantadine affects you.

Do not take Osmolex ER if you:

• are allergic to Osmolex or to any of its ingredients
• have end-stage renal (kidney) disease 

Serious side effects have been reported with Osmolex ER. See the “Osmolex ER Precautions” section.

Common side effects of Osmolex ER include the following:

• nausea
• dizziness or lightheadedness
• inability to sleep at night
• depression (feelings of sadness)
• anxiety and irritability
• hallucinations (seeing, hearing or feeling things your family and friends cannot see, hear or feel)
• confusion
• weight loss
• dry mouth
• constipation
• loss of control of body movements
• dizziness upon rising from a sitting position
• headache
• feeling more tired than normal
• diarrhea
• swelling of arms, legs, or feet
• high blood pressure
• new problems with your vision
• thoughts of suicide 

This is not a complete list of Osmolex ER side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)
• medications that affect the acidity (pH) of the urine (pee) such as sodium bicarbonate and carbonic anhydrase inhibitors (acetazolamide, methazolamide)
• live attenuated influenza (flu) vaccines
• alcohol

This is not a complete list of Osmolex ER drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Osmolex ER falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Osmolex ER has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Osmolex ER, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.