Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Rebel Distributors Corp
ACYCLOVIR
ACYCLOVIR 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older). ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
Each gram of ZOVIRAX Cream 5% contains 50 mg acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows: 5-g tubes (NDC 42254-149-05). Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Manufactured by GlaxoSmithKline Research Triangle Park, NC 27709 for BTA Pharmaceuticals, Inc. (subsidiary of Biovail Corporation) Bridgewater, NJ 08807 ©2009, GlaxoSmithKline. All rights reserved. July 2009 ZVC:2PI Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
New Drug Application
ZOVIRAX- ACYCLOVIR CREAM REBEL DISTRIBUTORS CORP ---------- ZOVIRAX (ACYCLOVIR) CREAM 5% USE ONLY FOR COLD SORES DESCRIPTION ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAX Cream 5% contains 50 mg of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum. 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 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6_H_-purin-6-one; 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 with VZV is due to its more efficient phosphorylation by the viral TK. ANTIVIRAL ACTIVITIES: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in hu Lestu allt skjalið