País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Apotheca Inc.
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, USP. 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 12634-520-00 Bottles of 10 NDC 12634-520-01 Bottles of 100 NDC 12634-520-09 Bottles of 35 NDC 12634-520-40 Bottles of 40 NDC 12634-520-52 Blister Pack of 12 NDC 12634-520-54 Blister Pack of 14 NDC 12634-520-57 Blister Pack of 20 NDC 12634-520-59 Blister Pack of 30 NDC 12634-520-60 Bottles of 60 NDC 12634-520-61 Blister Pack of 10 NDC 12634-520-63 Blister Pack of 3 NDC 12634-520-66 Blister Pack of 6 NDC 12634-520-67 Blister Pack of 7 NDC 12634-520-69 Blister Pack of 9 NDC 12634-520-71 Bottles of 30 NDC 12634-520-74 Bottles of 24 NDC 12634-520-78 Bottles of 28 NDC 12634-520-79 Bottles of 25 NDC 12634-520-80 Bottles of 20 NDC 12634-520-81 Bottles of 21 NDC 12634-520-82 Bottles of 12 NDC 12634-520-85 Bottles of 15 NDC 12634-520-91 Blister Pack of 1 NDC 12634-520-94 Bottles of 4 NDC 12634-520-95 Bottles of 5 NDC 12634-520-96 Bottles of 6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Repackaged and Distributed by: Apotheca Inc. Phoenix, AZ 85006
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR TABLET APOTHECA INC. ---------- ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 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 cellular enzymes. _In vitro_, acyclovir triphosphate Leia o documento completo