Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Carlsbad Technology, Inc.
ACYCLOVIR
ACYCLOVIR 400 mg
ORAL
PRESCRIPTION DRUG
Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Acyclovir is indicated for the treatment of chickenpox (varicella). Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Acyclovir Tablets, 800 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100 (NDC 61442-113-01) Bottle of 500 (NDC 61442-113-05) Acyclovir Tablets, 400 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100 (NDC 61442-112-01) Bottle of 500 (NDC 61442-112-05) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep this and all medication out of the reach of children. Manufactured and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA OR Manufactured by: Yung Shin Pharm. Ind. (KS) Co., Ltd. No.191 Jin Yang West Road, Lujia, Kunshan, Jiangsu, China Packaged and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA CTI-10 REV. C REVISED: APRIL 2013
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR TABLET CARLSBAD TECHNOLOGY, INC. ---------- ACYCLOVIR TABLETS USP RX ONLY DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400- mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C H N O and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula: VIROLOGY MECHANISM OF ANTIVIRAL ACTION Acyclovir is a synthetic purine nucleoside analogue with _in vitro_ and _in vivo_ inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. _In vitro_, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. ANTIVIRAL ACTIVITIES The quantitative relationship between the _in vit Izlasiet visu dokumentu