Acyclovir (Page 4 of 4)

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, 400 mg (white to off-white, unscored, oval and engraved with “Figure
”) are supplied in bottles of 100 and 500.

Boxes of 10×10 UD 100 NDC 63739-682-10

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 by:
Carlsbad Technology, Inc.
5922 Farnsworth Court Suite 102
Carlsbad, CA 92008


Distributed by:
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddingotn Rd., Concord, NC 28027

IS-4014573August 2014

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-682(NDC:61442-112)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 400 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 15mm
Flavor Imprint Code CTI;112;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-682-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-682-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075382 10/22/2009
Labeler — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Packaging Services a business unit of McKesson Corporation 140529962 REPACK (63739-682)

Revised: 03/2015 McKesson Packaging Services a business unit of McKesson Corporation

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.