AMANTADINE HYDROCHLORIDE syrup

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mikart, LLC

INN (Rahvusvaheline Nimetus):

AMANTADINE HYDROCHLORIDE

Koostis:

AMANTADINE HYDROCHLORIDE 50 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 oral solution USP is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Amantadine hydrochloride oral solution USP 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 oral solution USP is also indicated in the treatment of uncomplicated respirator

Toote kokkuvõte:

Amantadine hydrochloride oral solution USP is available as a clear, fruit punch flavored oral solution containing 50 mg amantadine hydrochloride per 5 mL (1 teaspoonful). It is supplied in containers of 16 fl oz (473 mL). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE SYRUP
MIKART, LLC
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DESCRIPTION
Amantadine hydrochloride is designated 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: citric acid (anhydrous),
methylparaben, propylene glycol,
propylparaben, purified water, sorbitol solution, and natural and
artificial flavoring.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Mechanism of Action: Antiviral
The mechanism by which amantadine 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 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 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 and the clinical
response to therapy has not been established in man. Sensitivity test
results, expressed as the
concentration of amantadine required to inhibit by 50% the growth of
virus (ED
) in tissue culture
vary greatly (from 0.1 μg/mL to 25.0 μg/mL) depending upon the assay
protocol used, size of virus
inoculum, isolates of influenza A virus strains tested, and the cell
type used. Host cells in tissue culture
readily tolerated amantadine up to a concentration of 100 μg/mL.
Drug Resi