Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Zydus Lifesciences Limited
ACYCLOVIR
ACYCLOVIR 400 mg
ORAL
PRESCRIPTION DRUG
Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella). Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Acyclovir Tablets USP, 400 mg are white to off-white colored, round shaped, biconvex, uncoated tablets, debossed with "791" on one side and plain on the other side and are supplied as follows: NDC 65841-802-06 in bottles of 30 tablets with child-resistant closure NDC 65841-802-16 in bottles of 90 tablets with child-resistant closure NDC 65841-802-01 in bottles of 100 tablets with child-resistant closure NDC 65841-802-05 in bottles of 500 tablets NDC 65841-802-10 in bottles of 1000 tablets NDC 65841-802-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Acyclovir Tablets USP, 800 mg are white to off-white colored, oval shaped, biconvex, uncoated tablets, debossed with "792" on one side and plain on the other side and are supplied as follows: NDC 65841-803-06 in bottles of 30 tablets with child-resistant closure NDC 65841-803-16 in bottles of 90 tablets with child-resistant closure NDC 65841-803-01 in bottles of 100 tablets NDC 65841-803-05 in bottles of 500 tablets NDC 65841-803-10 in bottles of 1000 tablets NDC 65841-803-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage 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 (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd., Baddi, India Rev.: 10/23
Abbreviated New Drug Application
ACYCLOVIR- ACYCLOVIR TABLET ZYDUS LIFESCIENCES LIMITED ---------- ACYCLOVIR TABLETS, USP RX ONLY DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C H N O and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. 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]-_6H-_purin-6-one; it has the following structural formula: Each acyclovir tablet intended for oral administration contains 400 mg and 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate. 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 8 11 5 3 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 more efficient phosphorylation by the vir Citiți documentul complet