AMANTADINE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Alembic Pharmaceuticals Limited

INN (nemzetközi neve):

AMANTADINE HYDROCHLORIDE

Összetétel:

AMANTADINE HYDROCHLORIDE 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 are also indicated in the treatment of uncomplicated respiratory tract illn

Termék összefoglaló:

Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg: Red opaque / red opaque, hard gelatin capsules size “2” imprinted with “A226” on cap in white ink, filled with white to off-white powder. NDC 46708-246-30                bottles of 30  NDC 46708-246-31                bottles of 100 NDC 46708-246-71                bottles of 500 NDC 46708-246-91                bottles of 1000 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container as defined in the USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088  or www.fda.gov/medwatch

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMANTADINE - AMANTADINE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
----------
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
NCl. It has the following
structural formula:
Amantadine hydrochloride is a stable white or almost 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.
Amantadine hydrochloride is available as 100 mg capsules for oral
administration.
Inactive ingredients: microcrystalline cellulose, hydroxypropyl
cellulose, croscarmellose
sodium, colloidal silicon dioxide, magnesium stearate, gelatin,
titanium dioxide, FD&C
Blue #1, FD&C Red #40. The non-volatile components of imprinting ink
are shellac,
propylene glycol, potassium hydroxide and titanium oxide.
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
10
18
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