Osmolex ER

• Generic Name: amantadine
• Brand Name: Osmolex ER
• Drug Class:

Osmolex ER(Amantadine) side effects drug center

• Related Drugs
  Fluorodopa FDOPA F 18 Kynmobi Nourianz
• Drug Comparison
  Nourianz vs. Osmolex ER

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

Osmolex ER Side Effects Center

Osmolex ER (amantadine extended-release tablets) is indicated for the treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's disease.

The initial dosage of Osmolex ER is 129 mg orally once daily in the morning. The dosage may be increased in weekly intervals to a maximum daily dose of 322 mg once daily in the morning. Osmolex ER may interact with anticholinergic drugs, drugs affecting urinary pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate), live influenza vaccines, and alcohol. Tell your doctor all medications and supplements you use. Osmolex ER is not recommended for use during pregnancy; it may harm a fetus. Osmolex ER passes into breast milk but its effects on nursing infants is unknown. Consult your doctor before breastfeeding.

 

Osmolex ER Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly even after feeling alert;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself;
• a seizure; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Side effects may be more likely in older adults.

Common side effects may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Osmolex ER (Amantadine)

 

Osmolex ER Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

• Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
• Suicidality and Depression [see WARNINGS AND PRECAUTIONS]
• Hallucinations/Psychotic Behavior [see WARNINGS AND PRECAUTIONS]
• Dizziness and Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
• Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
• Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Immediate-Release Amantadine

The adverse reactions listed in Table 2 were identified in clinical studies of immediate-release amantadine. The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

Table 2: Incidence of Adverse Reactions from Pooled Studies of Immediate-Release Amantadine

5 to 10%	1 to 5%	0.1 to 1%	Less than 0.1%
Nausea	Depression	Congestive heart failure	Convulsion
Dizziness/ lightheadedness	Anxiety and irritability	Psychosis	Leukopenia
Insomnia	Hallucinations	Urinary retention	Neutropenia
	Confusion	Dyspnea	Eczematoid dermatitis
	Anorexia	Skin rash	Oculogyric episodes
	Dry mouth	Vomiting	Suicidal attempt
	Constipation	Weakness	Suicide
	Ataxia	Slurred speech	Suicidal ideation
	Livedo reticularis	Euphoria
	Peripheral edema	Thinking abnormality
	Orthostatic hypotension	Amnesia
	Headache	Hyperkinesia
	Somnolence	Hypertension
	Nervousness	Decreased libido
	Dream abnormality	Visual disturbance
	Agitation	Punctate subepithelial or other corneal opacity
	Dry nose	Corneal edema
	Diarrhea	Decreased visual acuity
	Fatigue	Sensitivity to light
		Optic nerve palsy

Read the entire FDA prescribing information for Osmolex ER (Amantadine)

&Copy; Osmolex ER Patient Information is supplied by Cerner Multum, Inc. and Osmolex ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.