AMANTADINE HYDROCHLORIDE tablet AMANTADINE HYDROCHLORIDE capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Marlex Pharmaceuticals Inc

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Amantadine Hydrochloride are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. Amantadine Hydrochloride are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. Because Amantadine Hydrochloride 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 prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response. Amantadine Hydrochloride are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when a

Produkt oversigt:

Amantadine Hydrochloride Tablets are available as white to off-white, round tablet, engraved “IT 75”on one side, other side is plain. Bottles of 100 (NDC 10135-0692-01) Bottles of 500 (NDC 10135-0692-05) 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: Bottles of 100 (NDC 10135-0693-01) Bottles of 500 (NDC 10135-0693-05) Store at controlled room temperature 20 to 25°C (68 to 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 child-resistant closure (as required). Keep out of reach of children. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 1 10/21 IT

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE TABLET
AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN
COATED
MARLEX PHARMACEUTICALS INC
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AMANTADINE HYDROCHLORIDE CAPSULES-TABLETS
AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE TABLET/ CAPSULES
MARLEX PHARMACEUTICALS, INC.
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AMANTADINE HYDROCHLORIDE TABLETS
AMANTADINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Amantadine hydrochloride is designated generically as amantadine
hydrochloride and
chemically as 1-adamantanamine hydrochloride.
C10H17N•HCl
Amantadine hydrochloride 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 tablet intended for oral administration contains 100 mg
amantadine hydrochloride
and has the following inactive ingredients: microcrystalline
cellulose, povidone, sodium
starch glycolate, magnesium stearate, and colloidal silicon dioxide.
Each capsule intended for oral administration contains 100 mg
amantadine
hydrochloride and has the following 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.
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 isolat