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Drug Catalog - Product Detail

ACYCLOVIR TABLET 800MG 500X1

NDC Mfr Size Str Form
61442-0113-05 CARLSBAD TECHNOLOGIES 500 800MG TABLET
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Generic Name
ACYCLOVIR
Substance Name
ACYCLOVIR
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075382
Description
DESCRIPTION SECTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. 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 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:
How Supplied
HOW SUPPLIED SECTION Acyclovir Tablets, 800 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100 (NDC 61442-113-01) Bottle of 500 (NDC 61442-113-05) Acyclovir Tablets, 400 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100 (NDC 61442-112-01) Bottle of 500 (NDC 61442-112-05) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep this and all medication out of the reach of children. Manufactured and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA OR Manufactured by: Yung Shin Pharm. Ind. (KS) Co., Ltd. No.191 Jin Yang West Road, Lujia, Kunshan, Jiangsu, China Packaged and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA CTI-10 REV. C REVISED: APRIL 2013
Indications & Usage
INDICATIONS & USAGE SECTION Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir is indicated for the treatment of chickenpox (varicella).
Dosage and Administration
DOSAGE & ADMINISTRATION SECTION Acute Treatment of Herpes Zoster 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days. Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir. Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence. Treatment of Chickenpox Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in TABLE 3: Table 3. Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance mL/min/1.73 m 2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours >10 0-10 200 200 every 4 hours, 5x daily every 12 hours 400 mg every 12 hours >10 0-10 400 200 every 12 hours every 12 hours 800 mg every 4 hours >25 10-25 0-10 800 800 800 every 4 hours, 5x daily every 8 hours every 12 hours Hemodialysis For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis. Peritoneal Dialysis No supplemental dose appears to be necessary after adjustment of the dosing interval. Bioequivalence of Dosage Forms Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).