Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Aidarex Pharmaceuticals LLC
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.
Acyclovir capsules USP are available containing 200 mg acyclovir. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N 940 and 200 on opposing cap and body portion of the capsule. They are supplied as follows: NDC 33261-419-30 Bottles of 30 Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 943 on one side and 400 on the other side. They are supplied as follows: NDC 33261-491-21 Bottles of 21 NDC 33261-491-25 Bottles of 25 NDC 33261-491-28 Bottles of 28 NDC 33261-491-30 Bottles of 30 NDC 33261-491-60 Bottles of 60 NDC 33261-491-90 Bottles of 90 Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 947 on one side and 800 on the other side. They are supplied as follows: NDC 33261-227-16 Bottles of 30 NDC 33261-227-30 Bottles of 30 NDC 33261-227-35 Bottles of 30 NDC 33261-227-40 Bottles 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: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Rev. F 9/2008
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR CAPSULE ACYCLOVIR- ACYCLOVIR TABLET AIDAREX PHARMACEUTICALS LLC ---------- ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 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 8 11 5 3 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. T Đọc toàn bộ tài liệu