AMANTADINE HYDROCHLORIDE capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Cipla USA Inc.

INN (इंटरनेशनल नाम):

AMANTADINE HYDROCHLORIDE

रचना:

AMANTADINE HYDROCHLORIDE 100 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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. Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A vi

उत्पाद समीक्षा:

Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg: Size '1' hard gelatin maroon opaque capsules printed with 'A' on cap '100' on body in white color and supplied as: NDC 69097-926-07 bottles of 100 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, with a child-resistant closure (as required)

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE
CIPLA USA INC.
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AMANTADINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Amantadine hydrochloride 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 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 capsules contains 100 mg of amantadine hydrochloride and the
following Inactive ingredients:
microcrystalline cellulose, povidone, FD&C yellow # 6 aluminum lake,
sodium starch glycolate and
magnesium stearate. The capsule shells and imprinting ink contain:
gelatin, sodium lauryl sulfate, FD&C
red #40, titanium dioxide, shellac, propylene glycol, strong ammonia
solution and potassium hydroxide.
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 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