AMANTADINE HCL hydrochloride capsule liquid filled

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Preferred Pharmaceuticals, Inc.

INN (Nome Internazionale):

AMANTADINE HYDROCHLORIDE

Composizione:

AMANTADINE HYDROCHLORIDE 100 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AMANTADINE HCL- AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
PREFERRED PHARMACEUTICALS, INC.
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AMANTADINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Amantadine hydrochloride, USP 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.
Each capsule intended for oral administration contains 100 mg
amantadine hydrochloride and has the
following inactive ingredients: Yellow Iron Oxide, gelatin, glycerin,
hydrogenated vegetable oil,
lecithin-bleached, soybean oil, sorbitol, sorbitan, mannitol, titanium
dioxide, white beeswax, vegetable
shortening, simethicone and iron oxide (black imprint ink).
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 mcg/mL to 25.0 mcg/mL) depending upon the assay
protocol used, size of virus
inoculum, isolates of influ