Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0) (AMANTADINE - UNII:BF4C9Z1J53)
Preferred Pharmaceuticals Inc.
AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE 100 mg
ORAL
PRESCRIPTION DRUG
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
Amantadine Hydrochloride Capsules, USP, 100 mg are white to off-white powder filled in size "2" empty hard gelatin capsule having red opaque colored cap imprinted with "652" in white ink and red opaque colored body and are supplied as follows: NDC 68788-6975-6975- in bottles of 10 capsules NDC 68788-6975-6975- in bottles of14 capsules NDC 68788-6975-6975- in bottles of 20 capsules NDC 68788-6975-6975- in bottles of 30 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Abbreviated New Drug Application
AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE PREFERRED PHARMACEUTICALS INC. ---------- AMANTADINE HYDROCHLORIDE CAPSULES, USP RX ONLY DESCRIPTION Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.7 with a molecular formula C H N.HCl. It has the following structural formula: Amantadine hydrochloride, USP is a white or almost white, crystalline powder, freely soluble in water, ethanol and methanol; soluble in chloroform; sparingly soluble in methylene chloride; practically insoluble in ether. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg of amantadine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: crosscarmellose sodium, ethyl cellulose, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide. Meets USP Dissolution Test 2 CLINICAL PHARMACOLOGY 10 17 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 Przeczytaj cały dokument