Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Clinical Solutions Wholesale
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 USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N943 on one side and 400 on the other side. They are supplied as follows: NDC 58118-8943-08 Blister cards of 30 Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N947 on one side and 800 on the other side. They are supplied as follows: NDC 58118-8947-08 Blister cards of 30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA North Wales, PA 19454 Rev. H 8/2012 Repackaged by: CLINICAL SOLUTIONS WHOLESALE Franklin, TN 37067
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR TABLET CLINICAL SOLUTIONS WHOLESALE ---------- ACYCLOVIR TABLETS USP 8943 8947 RX ONLY DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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: C H N O M.W. 225 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 vira Lugege kogu dokumenti