Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Actavis Pharma, Inc.
ACYCLOVIR
ACYCLOVIR 200 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir is indicated for the treatment of chickenpox (varicella). Acyclovir oral suspension is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Acyclovir oral suspension, USP (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL). Bottle of 1 pint (473 mL) NDC 0472-0082-16. Store between 15° to 25°C (59° to 77°F). Protect from light. Dispense in a tight container as defined in the USP. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 1/2020 3701602-1120 GW7331
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR SUSPENSION ACTAVIS PHARMA, INC. ---------- ACYCLOVIR ORAL SUSPENSION, USP RX ONLY DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C H N O , and a molecular weight of 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine; 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 three 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 vitro_ susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, Прочетете целия документ