Acyclovir (Page 2 of 2)

Geriatric Use

Clinical studies of Acyclovir Ointment USP, 5% 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 USP, 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 USP, 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 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 50 mg acyclovir in a polyethylene glycol base. Acyclovir Ointment USP, 5% is a smooth, white, cream-like ointment supplied in 15 gram (NDC 51672-1360-1) and 30 gram (NDC 51672-1360-2) tubes.

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

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532

March 2015
PK-7262-1
422
000
0/00/00RX-

PRINCIPAL DISPLAY PANEL — 30 g Tube Carton

NDC 51672-1360-2

Acyclovir

30 g

Ointment USP, 5%

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

Rx only

TARO

PRINCIPAL DISPLAY PANEL -- 30 g Tube Carton
(click image for full-size original)
ACYCLOVIR
acyclovir ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-1360
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-1360-1 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (51672-1360-1)
2 NDC:51672-1360-2 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (51672-1360-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205469 12/21/2016
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (51672-1360)

Revised: 12/2016 Taro Pharmaceuticals U.S.A., Inc.

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