Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1053
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
ZOVIRAX (Ointment)
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| dailymed-instance:dosage |
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 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.
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| dailymed-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:
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| dailymed-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.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
ZOVIRAX Ointment 5% is contraindicated in patients
who develop hypersensitivity to the components of the formulation.
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| dailymed-instance:supply |
Each 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-2277
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:overdosag... |
Overdosage by
topical application of ZOVIRAX Ointment 5% is unlikely because of
limited transcutaneous absorption (see CLINICAL PHARMACOLOGY).
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| dailymed-instance:genericMe... |
acyclovir
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| dailymed-instance:fullName |
ZOVIRAX (Ointment)
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| dailymed-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.
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| dailymed-instance:warning |
ZOVIRAX Ointment
5% is intended for cutaneous use only and should not be used in the
eye.
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| dailymed-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.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ZOVIRAX
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