Linked Life Data

ZOVIRAX (Ointment)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1053

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SubjectPredicateObjectContext
dailymed-drugs:1053rdf:typehttp://www4.wiwiss.fu-berli...lld:dailymed
dailymed-drugs:1053rdf:typedailymed-instance:drugslld:dailymed
dailymed-drugs:1053rdfs:labelZOVIRAX (Ointment)lld:dailymed
dailymed-drugs:1053dailymed-instance:dosageApply 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 ZOVIRAX 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.lld:dailymed
dailymed-drugs:1053dailymed-instance:descripti...ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpes viruses. ZOVIRAX Ointment 5% is a formulation for topical administration. Each gram of ZOVIRAX Ointment 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula CHNOand 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]-6H-purin-6-one; it has the following structural formula:lld:dailymed
dailymed-drugs:1053dailymed-instance:clinicalP...Two clinical pharmacology studies were performed with ZOVIRAX Ointment 5% in immunocompromised adults at risk of developing mucocutaneous Herpes simplex virus infections or with localized varicella-zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In 1 of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches. No local intolerance, systemic toxicity, or contact dermatitis were observed. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL). The other study included 11 patients with localized varicella-zoster infections. In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Acyclovir levels in plasma ranged from<0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from<0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir excreted in the urine ranged from<0.02% to 9.4% of the daily dose. Therefore, systemic absorption of acyclovir after topical application is minimal.lld:dailymed
dailymed-drugs:1053dailymed-instance:activeIng...dailymed-ingredient:acyclov...lld:dailymed
dailymed-drugs:1053dailymed-instance:contraind...ZOVIRAX Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.lld:dailymed
dailymed-drugs:1053dailymed-instance:supplyEach gram of ZOVIRAX Ointment 5% contains 50 mg acyclovir in a polyethylene glycol base. It is supplied as follows: 15-g tubes (NDC 64455-993-94) Store at 15��to 25��C (59��to 77��F) in a dry place. Manufactured by GlaxoSmithKline Research Triangle Park, NC 27709 for BIOVAIL Pharmaceuticals, Inc. Bridgewater, NJ 08807 ��2006, GlaxoSmithKline. All rights reserved. April 2006 RL-2277lld:dailymed
dailymed-drugs:1053dailymed-instance:activeMoi...dailymed-ingredient:acyclov...lld:dailymed
dailymed-drugs:1053dailymed-instance:inactiveI...dailymed-ingredient:polyeth...lld:dailymed
dailymed-drugs:1053dailymed-instance:overdosag...Overdosage by topical application of ZOVIRAX Ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY).lld:dailymed
dailymed-drugs:1053dailymed-instance:genericMe...acyclovirlld:dailymed
dailymed-drugs:1053dailymed-instance:fullNameZOVIRAX (Ointment)lld:dailymed
dailymed-drugs:1053dailymed-instance:adverseRe...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.<br/>Observed During Clinical Practice: Based on clinical practice experience in patients treated with ZOVIRAX Ointment 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.lld:dailymed
dailymed-drugs:1053dailymed-instance:warningZOVIRAX Ointment 5% is intended for cutaneous use only and should not be used in the eye.lld:dailymed
dailymed-drugs:1053dailymed-instance:indicatio...ZOVIRAX (acyclovir) Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threateningmucocutaneous Herpes simplex virus infections in immunocompromised patients.lld:dailymed
dailymed-drugs:1053dailymed-instance:represent...http://www4.wiwiss.fu-berli...lld:dailymed
dailymed-drugs:1053dailymed-instance:routeOfAd...http://www4.wiwiss.fu-berli...lld:dailymed
dailymed-drugs:1053dailymed-instance:nameZOVIRAXlld:dailymed
http://www4.wiwiss.fu-berli...dailymed-instance:producesD...dailymed-drugs:1053lld:dailymed