AMANTADINE HYDROCHLORIDE- amantadine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

AMANTADINE HYDROCHLORIDE

Composition:

AMANTADINE HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg: Red capsules imprinted GG 634 and supplied as: Unit dose packages of 100 (10 x 10) NDC 68084-611-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
AMERICAN HEALTH PACKAGING
----------
AMANTADINE HYDROCHLORIDE CAPSULES, USP
8261101/0117
RX ONLY
DESCRIPTION:
Amantadine hydrochloride, USP 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, USP is a stable white or nearly white
crystalline powder, freely soluble in
water and soluble in alcohol and in chloroform.
Amantadine hydrochloride, USP has pharmacological actions as both an
anti-Parkinson and an antiviral
drug.
Amantadine hydrochloride, USP is available as 100 mg capsules for oral
administration. Inactive
ingredients: corn starch, croscarmellose sodium, ethylcellulose,
magnesium stearate, microcrystalline
cellulose, and pregelatinized starch. The capsule shells and
imprinting ink contain: ammonium
hydroxide, FD&C Blue #1, FD&C Red #40, gelatin, methylparaben, ,
propylene glycol, propylparaben,
shellac, simethicone, 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
co