AMANTADINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Major Pharmaceuticals

INN (International Name):

AMANTADINE HYDROCHLORIDE

Sammensetning:

AMANTADINE HYDROCHLORIDE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine 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 prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A vi

Produkt oppsummering:

Amantadine Hydrochloride Capsules, USP, 100 mg are white to off-white powder filled in size "2" empty hard gelatin capsule having red opaque colored cap imprinted with "652" in white ink and red opaque colored body and are supplied as follows: Carton of 100 Capsules (10 tablets each blister pack x 10), NDC 0904-6630-61 Carton of 50 Capsules ( 10 tablets each blister pack x 5), NDC 0904-6630-06 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
MAJOR PHARMACEUTICALS
----------
AMANTADINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Amantadine hydrochloride is designated chemically as 1-adamantanamine
hydrochloride.
Its molecular weight is 187.7 with a molecular formula C
H
N.HCl. It has the following
structural formula:
Amantadine hydrochloride, USP is a white or almost white, crystalline
powder, freely
soluble in water, ethanol and methanol; soluble in chloroform;
sparingly soluble in
methylene chloride; practically insoluble in ether.
Amantadine hydrochloride has pharmacological actions as both an
anti-Parkinson and an
antiviral drug.
Each amantadine hydrochloride capsule, USP intended for oral
administration contains
100 mg of amantadine hydrochloride, USP. In addition, each capsule
contains the
following inactive ingredients: crosscarmellose sodium, ethyl
cellulose, FD&C blue #1,
FD&C red #40, gelatin, magnesium stearate, microcrystalline cellulose,
pregelatinized
starch, sodium lauryl sulfate and titanium dioxide. Each capsule is
printed with white
pharmaceutical ink which contains potassium hydroxide, shellac and
titanium dioxide.
Meets USP Dissolution Test 2
CLINICAL PHARMACOLOGY
10
17
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 amanta