Acyclovir (Page 4 of 4)

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).

HOW SUPPLIED

Acyclovir Tablets, 800 mg (white to off-white, unscored, oval and engraved with “ Figure”)

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

PRINCIPAL DISPLAY PANEL

NDC 53217-0313

Acyclovir

Tablets USP

800 mg

Rx Only

Carlsbad Technology, Inc.

Repackaged by:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

53217-0313_Acyclovir_800MG.JPG
(click image for full-size original)

53217-0313_Acyclovir_800MG

ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-313(NDC:61442-113)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 800 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white) Score no score
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code CTI;113
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-313-50 50 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075382 05/19/2017
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 05/2018 Aidarex Pharmaceuticals LLC

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