AMANTADINE HCL- amantadine hydrochloride capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bionpharma Inc.

INN (International Name):

AMANTADINE HYDROCHLORIDE

Composition:

AMANTADINE HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride 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 Hydrochloride Capsules, USP 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 are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with Amantadine Hydrochloride Capsules, USP will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that Amantadine Hydrochloride Capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with Amantadine Hydrochloride Capsules, USP: - Amantadine Hydrochloride Capsules, USP is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. - Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness.  Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs.  Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Amantadine Hydrochloride Capsules, USP. Parkinson's Disease/Syndrome:  Amantadine Hydrochloride Capsules, USP are indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, Amantadine Hydrochloride Capsules, USP are less effective than levodopa, (-),-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. Drug-Induced Extrapyramidal Reactions:  Amantadine Hydrochloride Capsules, USP are indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with Amantadine Hydrochloride Capsules, USP when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs. Amantadine Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine Hydrochloride Capsules.

Product summary:

Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride, in bottles of 100's (NDC 69452-142-20) and 500's (NDC 69452-142-30). Each capsule is imprinted with "A1" in black ink. Store at 20 to 25°C (68 to 77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMANTADINE HCL- AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
BIONPHARMA INC.
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AMANTADINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Amantadine hydrochloride, USP is designated chemically as
1-adamantanamine
hydrochloride.
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 capsule intended for oral administration contains 100 mg
amantadine
hydrochloride and has the following inactive ingredients: Yellow Iron
Oxide, gelatin,
glycerin, hydrogenated vegetable oil, lecithin-bleached, soybean oil,
sorbitol, sorbitan,
mannitol, titanium dioxide, white beeswax, vegetable shortening,
simethicone and iron
oxide (black imprint ink).
USP Dissolution Test Pending.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION: ANTIVIRALThe 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
50
greatly (from 0.1 mcg/mL to 25.0 mcg/mL) depending upon the assay
protocol used,
size of virus inoculum, iso