Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
American Health Packaging
ACYCLOVIR
ACYCLOVIR 200 mg
ORAL
PRESCRIPTION DRUG
Acyclovir capsule is indicated for the acute treatment of herpes zoster (shingles). Acyclovir capsule is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Acyclovir capsule 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 hard gelatin capsules with a white opaque body and an aqua blue opaque cap. “APO 042” is imprinted on each capsule in black ink. They are supplied as follows:Unit dose packages of 100 (10 x 10) NDC 68084-107-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Apotex Corp. as follows: (200 mg / 100 UD) NDC 68084-107-01 packaged from NDC 60505-0042 Distributed by: American Health Packaging Columbus, OH 43217 8210701/0813A
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR CAPSULE AMERICAN HEALTH PACKAGING ---------- ACYCLOVIR CAPSULES USP 8210701/0813A RX ONLY DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir capsule is a formulation for oral administration. Each capsule of acyclovir contains 200 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell consists of FD&C blue #1, gelatin and titanium dioxide. The capsule black imprinting ink contains the following inactive ingredients: ammonium hydroxide, black iron oxide, n-butyl, ethyl alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. Acyclovir is a white, crystalline powder with the molecular formula C H N O and a molecular weight of 225.2. 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 8 11 5 3 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 Přečtěte si celý dokument