Drug Catalog - Product Detail
ACYCLOVIR OINTMENT 5% 15GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0746-17 | GLENMARK PHARMACEUTICALS | 15 | 5% | OINTMENT |
PACKAGE FILES
Generic Name
ACYCLOVIR
Substance Name
ACYCLOVIR
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA205510
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 USP in a polyethylene glycol (PEG) base. Acyclovir USP is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.2. 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 USP is 2-amino-1, 9-dihydro-9- [(2-hydroxyethoxy)methyl]-6 H purin-6-one; it has the following structural formula: acyclovir structural formula
How Supplied
HOW SUPPLIED Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir USP in a polyethylene glycol base. Acyclovir ointment USP, 5% is a white to off-white translucent ointment. It is supplied as follows: NDC 68462-746-17 15 gram tubes (1 tube per carton) NDC 68462-746-35 30 gram tubes (1 tube per carton) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa September 2016
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 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.