AMANTADINE HYDROCHLORIDE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

amantadine hydrochloride (UNII: M6Q1EO9TD0) (amantadine - UNII:BF4C9Z1J53)

Available from:

Upsher-Smith Laboratories, LLC

INN (International Name):

amantadine hydrochloride

Composition:

amantadine hydrochloride 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hydrochloride capsules 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 capsules 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 t

Product summary:

Amantadine hydrochloride capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride and imprinted C-122 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN
COATED
UPSHER-SMITH LABORATORIES, LLC
----------
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.
C
H
NCl
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.
Each capsule intended for oral administration contains 100 mg
amantadine
hydrochloride and has the following inactive ingredients: D&C Yellow
No. 10, gelatin,
glycerin, hydrogenated vegetable oil, lecithin, simethicone, soybean
oil, titanium dioxide
and white wax. The black imprint ink ingredients are hypromellose,
iron oxide black,
propylene glycol and purified water.
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
10
18
10
18
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