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:

Proficient Rx LP

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules 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. Influenza A Treatment Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illne

Dettagli prodotto:

Amantadine hydrochloride capsules for oral administration are available as: 100 mg: Hard gelatin capsules with Red cherry colored cap and body, imprinted "S 493" in both body and cap with white ink containing white to off-white granular powder and supplied as: NDC 71205-223-20: Bottles of 20 capsules NDC 71205-223-30: Bottles of 30 capsules NDC 71205-223-60: Bottles of 60 capsules NDC 71205-223-90: Bottles of 90 capsules Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
PROFICIENT RX LP
----------
AMANTADINE HYDROCHLORIDE CAPSULES USP
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 white or practically 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, FD&C
Blue #1, FD&C Red #40,
gelatin, magnesium stearate, microcrystalline cellulose, potassium
hydroxide, pregelatinized starch,
propylene glycol, shellac, sodium lauryl sulfate, strong ammonia
solution 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 (