Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Bryant Ranch Prepack
ACYCLOVIR
ACYCLOVIR 200 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.
Product: 63629-7001 NDC: 63629-7001-1 30 CAPSULE in a BOTTLE NDC: 63629-7001-2 50 CAPSULE in a BOTTLE Product: 63629-6349 NDC: 63629-6349-1 30 TABLET in a BOTTLE NDC: 63629-6349-2 35 TABLET in a BOTTLE NDC: 63629-6349-3 50 TABLET in a BOTTLE Product: 63629-6376 NDC: 63629-6376-1 60 TABLET in a BOTTLE NDC: 63629-6376-2 30 TABLET in a BOTTLE NDC: 63629-6376-3 50 TABLET in a BOTTLE
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR CAPSULE ACYCLOVIR- ACYCLOVIR TABLET BRYANT RANCH PREPACK ---------- ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 RX ONLY DESCRIPTION Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. 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 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP 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, USP are 2.27 and 9.25. The chemical name of acyclovir, USP 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 ce Lire le document complet