Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0) (AMANTADINE - UNII:BF4C9Z1J53)
Heritage Pharmaceuticals Inc. d/b/a Avet 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. 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 tr
Amantadine hydrochloride capsules USP, 100 mg are available as swedish orange capsules, cap and body imprinted HP 362 in white ink. Each capsule is filled with white to off white powder. They are supplied as follows: Bottles of 30: NDC 23155-362-03 Bottles of 100: NDC 23155-362-01 Bottles of 500: NDC 23155-362-05 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 using a child-resistant closure. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. REFERENCES 1. W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can Med Assoc J. 129:974-975, 1983. 2. D.F. Casey, N. Engl. J. Med. 298:516, 1978. 3. C.D. Berkowitz, J. Pediatr. 95:144, 1979. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000257US06 Revised: 04/2023
Abbreviated New Drug Application
AMANTADINE HYDROCHLORIDE- AMANTADINE HYDROCHLORIDE CAPSULE HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- 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 N.HCl. It has the following structural formula: 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 has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg amantadine hydrochloride, USP. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The capsule shell contains the following: FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: potassium hydroxide, shellac and titanium dioxide. Product meets USP _Dissolution Test 2_. CLINICAL PHARMACOLOGY PHARMACODYNAMICS MECHANISM OF ACTION _ANTIVIRAL_ The mechanism by which amantadine exerts its antiviral activity is not clearly 10 17 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 Կարդացեք ամբողջական փաստաթուղթը