AMANTADINE HYDROCHLORIDE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0) (AMANTADINE - UNII:BF4C9Z1J53)

Fáanlegur frá:

Cardinal Health 107, LLC

INN (Alþjóðlegt nafn):

AMANTADINE HYDROCHLORIDE

Samsetning:

AMANTADINE HYDROCHLORIDE 50 mg in 5 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Amantadine hydrochloride oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride 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 prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Amantadine hydrochloride 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 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 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: Amantadine hydrochloride 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 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. Amantadine hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine hydrochloride when used in patients with drug-induced extrapyramidal reactions, there is lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs. Amantadine hydrochloride oral solution USP is contraindicated in patients with known hypersensitivity to amantadine hydrochloride or any of the other ingredients in the drug.

Vörulýsing:

Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL is colorless with a raspberry flavor and is supplied in the following oral dosage forms: Overbagged with 5 Unit dose cups of 100 mg/10 mL per bag, NDC 55154-9444-5. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. *Dyazide is a registered trademark of GlaxoSmithKline.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE SOLUTION
CARDINAL HEALTH 107, LLC
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AMANTADINE HYDROCHLORIDE ORAL SOLUTION USP
50 MG/5 ML
RX ONLY
DESCRIPTION
Amantadine Hydrochloride Oral Solution USP is designated generically
as amantadine
hydrochloride and chemically as 1-adamantanamine hydrochloride.
Amantadine hydrochloride is a stable white or nearly white crystalline
powder, freely
soluble in water and soluble in alcohol and in chloroform.
Amantadine hydrochloride has pharmacological actions as both an
anti-Parkinson and an
antiviral drug.
Amantadine Hydrochloride Oral Solution USP contains 50 mg of
amantadine
hydrochloride per 5 mL and has the following inactive ingredients:
artificial raspberry
flavor, citric acid, methylparaben, propylene glycol, propylparaben,
purified water,
sorbitol solution. May contain sodium hydroxide to adjust pH to
approximately 2.3.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
MECHANISMS OF ACTION: ANTIVIRAL
The mechanism by which amantadine hydrochloride exerts its antiviral
activity is not
clearly understood. It appears to mainly prevent the release of
infectious viral nucleic
acid into the host cell by interfering with the function of the
transmembrane domain of
the viral M2 protein. In certain cases, amantadine hydrochloride is
also known to prevent
virus assembly during virus replication. It does not appear to
interfere with the
immunogenicity of inactivated influenza A virus vaccine.
_ANTIVIRAL ACTIVITY_
Amantadine hydrochloride inhibits the replication of influenza A virus
isolates from each
of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no
activity against
influenza B virus isolates. A quantitative relationship between the
_in vitro_ susceptibility of
influenza A virus to amantadine hydrochloride and the clinical
response to therapy has
not been established in man. Sensitivity test results, expressed as
the concentration of
amantadine hydrochloride required to inhibit by 50% the growth of
virus (ED50) in tissue
culture vary greatly (from 0.1 µg/