Acyclovir (Page 2 of 2)

Nursing Mothers

It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal. After oral administration of acyclovir, acyclovir concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg per day. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.

Geriatric Use

Clinical studies of acyclovir ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY).

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 in the U.S., 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 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:

Each gram of Acyclovir Ointment USP, 5% contains acyclovir USP, 50 mg in a polyethylene glycol base. Acyclovir Ointment USP, 5% is an opaque white to off-white ointment available as follows:

51079-550-68
carton of two 5 g tubes

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Store in a dry place.

Manufactured for:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional Inc.
Sugar Land, TX 77478 U.S.A.

Revised: 7/2018
ACYCO:5G:R4
1343.4

[pharma code: 3434]

PRINCIPAL DISPLAY PANEL – 5%

NDC 51079-550-68

Rx only

Acyclovir 5%
Ointment, USP
2 Pack (5 g Each)

Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base.

Usual Dosage: Apply 6 times a day (every 3 hours) for 7 days.
See prescribing information for dosage information.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room
Temperature.]

Store in a dry place.

Manufactured for:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional Inc.
Sugar Land, TX 77478 U.S.A.

Mylan.com

MI550:68:0C:R4 1234.4

Acyclovir Ointment, USP 5% Carton Label
(click image for full-size original)
ACYCLOVIR
acyclovir ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-550
Route of Administration TOPICAL 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 (opaque white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-550-68 2 TUBE in 1 CARTON contains a TUBE (51079-550-67)
1 NDC:51079-550-67 5 g in 1 TUBE This package is contained within the CARTON (51079-550-68)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202459 11/27/2013
Labeler — Mylan Institutional Inc. (039615992)

Revised: 05/2019 Mylan Institutional Inc.

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