Amantadine Hydrochloride Solution
NDC Package 62135-010-47

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

473 ML

Amantadine Hydrochloride

Amantadine Hydrochloride

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Oral - Administration to or by way of the mouth.

Amantadine hydrochloride oral solution is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.Influenza A ProphylaxisAmantadine hydrochloride oral solution is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride oral solution 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 hydrochloride oral solution prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response.Influenza A TreatmentAmantadine hydrochloride oral solution is 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 oral solution 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 oral solution is 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 oral solution:Amantadine hydrochloride oral solution is 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 oral solution.Parkinson’s Disease/SyndromeAmantadine hydrochloride oral solution is 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 hydrochloride oral solution is less effective than levodopa, (-)-3-(3,4­dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.Drug-Induced Extrapyramidal ReactionsAmantadine H\hydrochloride oral solution is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine hydrochloride oral solution 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.

Chartwell Rx, Llc

Human Prescription Drug

ANDA074028

ANDA - A product marketed under an approved Abbreviated New Drug Application.

06-28-1993

12-31-2026

N

No