AMANTADINE HYDROCHLORIDE capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

AMANTADINE HYDROCHLORIDE

Samsetning:

AMANTADINE HYDROCHLORIDE 100 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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. 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 tr

Vörulýsing:

Amantadine hydrochloride capsules USP, 100 mg are available as swedish orange capsules, cap and body imprinted HP 362 in white ink. Each capsule is filled with white to off white powder. They are supplied as follows: Bottles of 30: NDC 23155-362-03 Bottles of 100: NDC 23155-362-01 Bottles of 500: NDC 23155-362-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000257US06 Revised: 04/2023

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
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
N.HCl. 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 has pharmacological actions as both an
anti-Parkinson and an
antiviral drug.
Each amantadine hydrochloride capsule, USP intended for oral
administration contains
100 mg amantadine hydrochloride, USP. Each capsule also contains the
following
inactive ingredients: croscarmellose sodium, magnesium stearate,
microcrystalline
cellulose and pregelatinized starch. The capsule shell contains the
following: FD&C Blue
No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium
dioxide. The
imprinting ink contains the following: potassium hydroxide, shellac
and titanium dioxide.
Product meets USP _Dissolution Test 2_.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
_ANTIVIRAL_
The mechanism by which amantadine exerts its antiviral activity is not
clearly
10
17
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