Amantadine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Black Box Warning
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Warning Title
See full prescribing information for complete Boxed Warning.
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Overview
Amantadine is a adrenergic receptor agonist that is FDA approved for the treatment of Influenza A, Influenza A prophylaxis, parkinson’s disease/syndrome, drug-Induced extrapyramidal reactions. There is a Black Box Warning for this drug as shown here. Common adverse reactions include orthostatic hypotension, peripheral edema, constipation, diarrhea, loss of appetite, nausea, xerostomia,ataxia, confusion, dizziness, headache, Insomnia, somnolence, agitation, anxiety, depression. dream disorder, feeling nervous, hallucinations, Irritability and fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response.
Influenza A Treatment Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients.
There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.
The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules.
Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules. Parkinson’s Disease/Syndrome Amantadine hydrochloride capsules are indicated in the treatment of idiopathic Parkinson’s disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson’s disease, amantadine is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.
Drug-Induced Extrapyramidal Reactions Amantadine hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Non–Guideline-Supported Use
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
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Contraindications
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Warnings
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Warning Title
See full prescribing information for complete Boxed Warning.
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Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
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Cardiovascular
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Condition 2
Central Nervous System
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Postmarketing Experience
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Drug Interactions
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Use in Specific Populations
Pregnancy
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Females of Reproductive Potential and Males
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Administration and Monitoring
Administration
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Monitoring
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IV Compatibility
Solution
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Y-Site
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Admixture
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Syringe
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TPN/TNA
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Overdosage
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Chronic Overdose
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Pharmacology
Amantadine
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Mechanism of Action
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Structure
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Nonclinical Toxicology
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Clinical Studies
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How Supplied
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Storage
There is limited information regarding Amantadine Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Amantadine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
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Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Amantadine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Amantadine Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
Drug Shortage
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References
The contents of this FDA label are provided by the National Library of Medicine.