AMANTADINE HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Lake Erie Medical DBA Quality Care Products LLC

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 HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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AMANTADINE HYDROCHLORIDE CAPSULES, USP
DESCRIPTION
Amantadine hydrochloride is designated chemically as 1-adamantanamine
hydrochloride. Its molecular
weight is 187.71 with a molecular formula C
H NCl. It has the following structural formula:
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 is available as 100 mg capsules for oral
administration. Inactive ingredients:
corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C
Red #40, gelatin,
magnesium stearate, methylparaben, microcrystalline cellulose,
pregelatinized starch, propylparaben,
sodium lauryl sulfate and titanium dioxide.
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) d