AMANTADINE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Alembic Pharmaceuticals Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Amantadine hydrochloride tablets  are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets  are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride tablets  are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do 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 hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride tablets  are also indicated in the treatment

Ապրանքի ամփոփագիր:

Amantadine hydrochloride tablets are available as peach color, round, flat face, beveled-edge mottled tablets, debossed with ‘L 75’ on one side and plain on other side as follows: Bottle of 100 tablets with child resistant closure, NDC 62332-586-31 Bottle of 500 tablets, NDC 62332-586-71 Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). REFERENCES 1 W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974-975, 1983. 2 D.F. Casey, N. Engl. J. Med. 298:516, 1978. 3 C.D. Berkowitz, J. Pediatr. 95:144, 1979. Brands listed are trademarks of their respective owners. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 04/2023

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

AMANTADINE - AMANTADINE TABLET
ALEMBIC PHARMACEUTICALS INC.
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AMANTADINE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Amantadine hydrochloride, USP is designated generically as amantadine
hydrochloride
and chemically as 1-adamantanamine hydrochloride.
Amantadine hydrochloride, USP is a stable white or practically white
crystalline powder,
freely soluble in water, soluble in alcohol and in chloroform.
Amantadine hydrochloride, USP has pharmacological actions as both an
anti-Parkinson
and an antiviral drug.
Each tablet intended for oral administration contains 100 mg
amantadine hydrochloride,
USP and has the following inactive ingredients: microcrystalline
cellulose, povidone K-30,
povidone K-90, sodium starch glycolate, colloidal silicon dioxide,
magnesium stearate
and FD&C Yellow No. 6 Aluminium Lake.
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 μg/mL
to 25 μg/mL) depending upon the assay protocol used, size of virus
inoculum, isolates
of influenza A virus strains tested, and the cell typ