Acyclovir (Page 2 of 2)

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.

Observed During Clinical Practice: Based on clinical practice experience in patients treated with acyclovir ointment 5% in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process. Voluntary reports of adverse events that have been received since market introduction include:

General: Edema and/or pain at the application site.

Skin: Pruritus, rash.

OVERDOSAGE

Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment 5% to prevent autoinoculation of other body sites and transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.

HOW SUPPLIED

Acyclovir Ointment USP, 5% is supplied as a white to off-white color ointment. Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base.

It is supplied as follows:

30-g tubes NDC 46708-248-30

Store at 15° to 25°C (59° to 77°F). [See USP Controlled Room Temperature]. Store in a dry place.

Manufactured by:
Encube Ethicals Pvt. Ltd.
Madkaim, Ponda, Goa, India-403404

Manufactured for:

Alembic Pharmaceuticals Limited
(Formulation Division),
Village Panelav, P.O. Tajpura,
Near Baska, Taluka-Halol,
Panchmahal 389350, Gujarat, India

Revised: 06/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acyclovir Ointment USP, 5%(30 g in 1 tube)
Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base.
46708-248-30

Acyclovir Ointment USP
(click image for full-size original)
ACYCLOVIR
acyclovir ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-248
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-248-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (46708-248-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209000 04/16/2018
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Encube Ethicals Pvt. Ltd. 725076298 MANUFACTURE (46708-248)

Revised: 10/2019 Alembic Pharmaceuticals Limited

Page 2 of 2 1 2

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 © 2021. All Rights Reserved.