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Amantadine

    DEA Class;  Rx

    Common Brand Names; Osmolex ER, Gocovri

    •  Antiparkinson Agents, Dopamine Agonists; 
    • Antivirals, Influenza

    Synthetic antiviral agent with dopamine agonist properties
    Used primarily for motor symptoms of Parkinson’s disease (PD) or drug-induced EPS; an extended-release product can be used as an adjunct to carbidopa-levodopa in PD patients experiencing ‘off’ episodes
    Not recommended by CDC for treatment or prophylaxis of influenza A infection due to resistant strains

    Indicated for the treatment of idiopathic Parkinson disease (Paralysis Agitans), postencephalitic Parkinsonism, and symptomatic Parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication

    Indicated for treatment of Parkinson disease

    Indicated for adjunctive treatment to levodopa/carbidopa for Parkinson disease in patients experiencing “off” episodes

    Indicated for dyskinesia in patients with Parkinson disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

    Indicated in the treatment of drug-induced extrapyramidal reaction

    Tablet, syrup, capsule

    • Hypersensitivity to amantadine, rimantadine
    • Untreated narrow-angle glaucoma
    • Breastfeeding

    Extended-release capsule or tablet

    • End-stage renal disease (CrCl<15 mL/min/1.73m²)

    Extended-release capsule (Gocovri)

    • Hallucinations (21%)
    • Dizziness (16%)
    • Dry mouth (16%)
    • Peripheral edema (16%)
    • Constipation (13%)
    • Fall (13%)
    • Orthostatic hypotension (13%)
    • Urinary tract infection (10%)
    • Nausea (8%)
    • Anxiety (7%)
    • Insomnia (7%)
    • Livedo reticularis (6%)
    • Contusion (6%)
    • Depression/depressed mood (6%)
    • Headache (6%)
    • Benign prostate hyperplasia (6%)
    • Decreased appetite (6%)
    • Abnormal dreams (4%)
    • Blurred vision (4%)
    • Cough (3%)
    • Pigmentation disorder (3%)
    • Dystonia (3%)
    • Confusional state (3%)
    • Vomiting (3%)
    • Gait disturbance (3%)
    • Cataract (3%)
    • Dry eye (3%)
    • Joint swelling (3%)
    • Muscle spasms (3%)

    Immediate-release tablet/capsule or syrup

    • Nausea
    • Dizziness/lightheadedness
    • Insomnia
    • 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

    Reports of falling asleep while engaged in activities of daily living (eg, operation of motor vehicles); patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event; advise patients of the potential to develop drowsiness

    Avoid abrupt withdrawal; abrupt discontinuation of amantadine may cause an increase in symptoms of Parkinson disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech

    In clinical trials, suicidal ideation, depression, and/or depressed mood were reported; monitor for depression, including suicidal ideation or behavior

    No adequate data on developmental risk associated with amantadine use in pregnant women; animal studies suggest a potential risk for fetal harm with amantadine; in mice and rats, adverse developmental effects (embryo lethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses

    Amantadine is excreted into human milk, but amounts have not been quantified; there is no information on the risk to a breastfed infant; amantadine may alter breast milk production or excretion

    Adults

    400 mg/day PO for immediate-release capsules, oral solution, or tablets; 274 mg/day PO for extended-release capsules; 322 mg/day PO for extended-release tablets.

    Geriatric

    400 mg/day PO for immediate-release capsules, oral solution, or tablets; 274 mg/day PO for extended-release capsules; 322 mg/day PO for extended-release tablets.

    Adolescents

    Immediate-release capsules, oral solution or tablets: 200 mg/day PO.
    Extended-release capsules or tablets: Safety and efficacy have not been established.

    Children

    9 years and older: 200 mg/day PO for immediate-release capsules, oral solution, or tablets. Safety and efficacy of extended-release capsules and tablets have not been established.
    1 to 8 years: 8.8 mg/kg/day PO or 150 mg/day PO, whichever is less for immediate-release capsules, oral solution, or tablets. Safety and efficacy of extended-release capsules and tablets have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Amantadine hydrochloride

    capsule or tablet, immediate-release (generic)

    • 100mg

    syrup (generic)

    • 50mg/5mL

    capsule, extended-release (Gocovri)

    • 68.5mg

    • 137mg

    tablet, extended-release (Osmolex ER)

    • 129mg

    • 193mg

    • 258mg