AMANTADINE HYDROCHLORIDE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Morton Grove Pharmaceuticals, Inc.

INN (nemzetközi neve):

Amantadine Hydrochloride

Összetétel:

Amantadine Hydrochloride 50 mg in 5 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 e

Termék összefoglaló:

Amantadine Hydrochloride Oral Solution USP, 50 mg/5 mL is a colorless to pale yellow, raspberry-flavored oral solution available in:     1 Pint (473 mL) bottles NDC 60432-093-16 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].                                                                                               KEEP TIGHTLY CLOSED Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Rx Only

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
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AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP
50 MG/5 ML
RX ONLY
DESCRIPTION
Amantadine hydrochloride, USP is designated chemically as
1-adamantanamine hydrochloride.
C10H17N • HCL M.W. 187.71
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: anhydrous citric acid,
artificial raspberry flavor,
methylparaben, propylene glycol, propylparaben, purified water,
saccharin sodium, sodium citrate
dihydrate, and sorbitol solution.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Mechanism 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/mL
to 25.0 µg/mL) depend