AMANTADINE HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Rising Pharma Holdings, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg: Hard gelatin capsule, orange cap and orange body imprinted “IT 76” in black ink and supplied as: NDC 16571-834-01 bottles of 100 NDC 16571-834-50 bottles of 500 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. 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: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Iss. 03/2022

授权状态:

Abbreviated New Drug Application

产品特点

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
RISING PHARMA HOLDINGS, INC.
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AMANTADINE HYDROCHLORIDE CAPSULES, USP
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: magnesium stearate, microcrystalline cellulose,
Povidone , Sodium
Starch Glycolate, Colloidal Silicon Dioxide. The capsule shells and
imprinting ink contain
FD&C Blue #1, FD&C Red #40, gelatin, FD&C Yellow #6, sodium lauryl
sulfate, and
titanium dioxide.
It meets USP Dissolution Test 2.
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
10
18
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 t