Drug Facts
Composition & Profile
Identifiers & Packaging
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 ointment, free of foreign matters, free of lumps, translucent, homogeneous, and no phase separation. It is supplied as follows: 15 g tubes NDC 43547-499-42 30 g tubes NDC 43547-499-41 Store at 15° to 25°C (59° to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 30351, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 L187-01; Package/Label Display Panel Carton Label-15 g Rx only NDC 43547-499-42 Acyclovir Ointment, USP 5% 15 g 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 15°C to 25°C (59°F to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 Container Label 15 g; Package/Label Display Panel Carton Label-30 g Rx only NDC 43547-499-41 Acyclovir Ointment, USP 5% 30 g 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 15°C to 25°C (59°F to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 Container Label 30 g
- 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 ointment, free of foreign matters, free of lumps, translucent, homogeneous, and no phase separation. It is supplied as follows: 15 g tubes NDC 43547-499-42 30 g tubes NDC 43547-499-41 Store at 15° to 25°C (59° to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 30351, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 L187-01
- Package/Label Display Panel Carton Label-15 g Rx only NDC 43547-499-42 Acyclovir Ointment, USP 5% 15 g 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 15°C to 25°C (59°F to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 Container Label 15 g
- Package/Label Display Panel Carton Label-30 g Rx only NDC 43547-499-41 Acyclovir Ointment, USP 5% 30 g 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 15°C to 25°C (59°F to 77°F) in a dry place. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 Container Label 30 g
Overview
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 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base. Acyclovir 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 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: structural formula
Indications & Usage
Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immune compromised patients.
Dosage & 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.
Warnings & Precautions
WARNINGS Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.
Contraindications
Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
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. To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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