Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Chartwell RX, LLC
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 is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Acyclovir Capsules, USP 200 mg are available for oral administration as white opaque body, powder blue opaque cap with black ‘Y211’. They are supplied as follows: Bottle of 50 (NDC 62135-039-50) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture. Acyclovir Tablets, USP 800 mg are available for oral administration as white capsule-shaped tablets, engraved Y213 on one side and plain on other side. They are supplied as follows: Bottle of 50 (NDC 62135-019-50) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: Yiling Pharmaceutical Ltd No.36 Zhujiang Road, Shijiazhuang, 050035, China Manufactured For: Chartwell RX, LLC. Congers, NY 10920 Revised: 06/2022 L70960
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR CAPSULE ACYCLOVIR- ACYCLOVIR TABLET CHARTWELL RX, LLC ---------- ACYCLOVIR CAPSULES, USP 200 MG ACYCLOVIR TABLETS, USP 800 MG DESCRIPTION Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP 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 2.5mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2- hydroxyethoxy)methyl]-6H-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 8 11 5 3 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 Lugege kogu dokumenti