Drug Catalog - Product Detail
ACYCLOVIR OINTMENT 0.05 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 70700-0107-16 | XIROMED | 30 | 5% | OINTMENT |
PACKAGE FILES
Generic Name
ACYCLOVIR
Substance Name
ACYCLOVIR
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA201501
Description
DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a 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 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: Chemical Structure
How Supplied
HOW SUPPLIED Each gram of Acyclovir Ointment USP, 5% contains 50 mg acyclovir in a polyethylene glycol base. It is supplied as follows: 15 g tubes (NDC 70700-107-15) 30-g tubes (NDC 70700-107-16) Store at 15° to 25°C (59° to 77°F) in a dry place.
Indications & Usage
INDICATIONS AND USAGE Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV 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 USP, 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.