Drug Catalog - Product Detail
ACYCLOVIR OINTMENT OINT 0.05 15GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-8700-06 | MYLAN | 15 | 5% | OINTMENT |
PACKAGE FILES
Generic Name
ACYCLOVIR
Substance Name
ACYCLOVIR
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202459
Description
DESCRIPTION Acyclovir ointment, USP is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment 5% is a formulation for topical administration. Each gram of acyclovir ointment 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir, USP is a white to off-white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula: Acyclovir Structural Formula
How Supplied
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: 0378-8700-06 carton of one 15 g tube 0378-8700-49 carton of one 30 g tube Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Inc. Sugar Land, TX 77478 U.S.A. Revised: 7/2018 ACYCO:R4 1193.4 [pharmacode 1934]
Indications & Usage
INDICATIONS AND USAGE Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
Dosage and Administration
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.