Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/76
| Predicate | Object |
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| rdf:type | |
| rdfs:label |
ZOVIRAX (Cream)
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| dailymed-instance:dosage |
ZOVIRAX Cream should
be applied 5 times per day for 4 days. Therapy should be initiated
as early as possible following onset of signs and symptoms (i.e., during the
prodrome or when lesions appear). For adolescents 12 years of age and
older, the dosage is the same as in adults.
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| dailymed-instance:descripti... |
ZOVIRAX is the brand
name for acyclovir, a synthetic nucleoside analogue active against herpesviruses.
ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of
ZOVIRAX Cream 5% contains 50 mg of acyclovir and the following inactive
ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol,
sodium lauryl sulfate, water, and white petrolatum. 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... |
Pharmacokinetics:<br/>Adults: A clinical pharmacology study was performed with ZOVIRAX
Cream in adult volunteers to evaluate the percutaneous absorption of acyclovir.
In this study, which included 6 male volunteers, the cream was applied
to an area of 710 cmon the backs of the volunteers 5 times
daily at intervals of 2 hours for a total of 4 days. The weight
of cream applied and urinary excretion of acyclovir were measured daily. Plasma
concentration of acyclovir was assayed 1 hour after the final application.
The average daily urinary excretion of acyclovir was approximately 0.04% of
the daily applied dose. Plasma acyclovir concentrations were below the limit
of detection (0.01��M) in 5 subjects and barely detectable
(0.014��M) in 1 subject. Systemic absorption of acyclovir
from ZOVIRAX Cream is minimal in adults.<br/>Pediatric Patients: The systemic absorption of acyclovir following topical application
of cream has not been evaluated in patients<18 years of age.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
ZOVIRAX Cream is
contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir,
or any component of the formulation.
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| dailymed-instance:supply |
Each gram of ZOVIRAX Cream
5% contains 50 mg acyclovir in an aqueous cream base. ZOVIRAX Cream is
supplied as follows: 2-g tubes (NDC 64455-994-42). 5-g
tubes (NDC 64455-994-45). Store
at or below 25��C (77��F); excursions permitted to 15��to 30��C
(59��to 86��F) (see USP Controlled Room Temperature). Manufactured
by GlaxoSmithKline Research Triangle
Park, NC 27709 for Bridgewater,
NJ 08807 ��2004, GlaxoSmithKline. All rights reserved. January
2004 RL-2061
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: ZOVIRAX Cream is intended for cutaneous use only and
should not be used in the eye or inside the mouth or nose. ZOVIRAX Cream
should only be used on herpes labialis on the affected external aspects of
the lips and face. Because no data are available, application to human mucous
membranes is not recommended. ZOVIRAX Cream has a potential for irritation
and contact sensitization (see ADVERSE REACTIONS). The effect of ZOVIRAX Cream
has not been established in immunocompromised patients.<br/>Information for Patients: Please see Patient Information
About ZOVIRAX Cream.<br/>Drug Interactions: Clinical experience has identified no interactions resulting
from topical or systemic administration of other drugs concomitantly with
ZOVIRAX Cream.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic exposure following topical administration of acyclovir
is minimal. Dermal carcinogenicity studies were not conducted. Results from
the studies of carcinogenesis, mutagenesis and fertility are not included
in the full prescribing information for ZOVIRAX Cream due to the minimal exposures
of acyclovir that result from dermal application. Information on these studies
is available in the full prescribing information for ZOVIRAX Capsules, Tablets,
and Suspension and ZOVIRAX for Injection.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category
B. Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures
greatly in excess of human exposure. There are no adequate and well-controlled
studies of systemic acyclovir in pregnant women. A prospective epidemiologic
registry of acyclovir use during pregnancy was established in 1984 and completed
in April 1999. There were 749 pregnancies followed in women exposed to systemic
acyclovir during the first trimester of pregnancy resulting in 756 outcomes.
The occurrence rate of birth defects approximates that found in the general
population. However, the small size of the registry is insufficient to evaluate
the risk for less common defects or to permit reliable or definitive conclusions
regarding the safety of acyclovir in pregnant women and their developing fetuses.
Systemic acyclovir should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.<br/>Nursing Mothers: It is not known whether topically applied acyclovir is excreted
in breast milk. Systemic exposure following topical administration is minimal. After
oral administration of ZOVIRAX, acyclovir concentrations have been documented
in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding
plasma levels. These concentrations would potentially expose the nursing infant
to a dose of acyclovir up to 0.3 mg/kg/day. Nursing mothers who have
active herpetic lesions near or on the breast should avoid nursing.<br/>Geriatric Use: Clinical studies of acyclovir cream did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients. Systemic
absorption of acyclovir after topical administration is minimal (see CLINICAL
PHARMACOLOGY).<br/>Pediatric Use: Safety and effectiveness in pediatric patients less than
12 years of age have not been established.
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| dailymed-instance:overdosag... |
Overdosage by topical
application of ZOVIRAX Cream is unlikely because of minimal systemic
exposure (see CLINICAL PHARMACOLOGY).
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| dailymed-instance:genericMe... |
acyclovir
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| dailymed-instance:fullName |
ZOVIRAX (Cream)
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| dailymed-instance:adverseRe... |
In 5 double-blind,
placebo-controlled trials, 1,124 patients were treated with ZOVIRAX Cream
and 1,161 with placebo (vehicle) cream. ZOVIRAX Cream was well tolerated;
5% of patients on ZOVIRAX Cream and 4% of patients on placebo reported local
application site reactions. The most common adverse
reactions at the site of topical application were dry lips, desquamation,
dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin,
and stinging on skin; each event occurred in less than 1% of patients receiving
ZOVIRAX Cream and vehicle. Three patients on ZOVIRAX Cream and 1 patient on
placebo discontinued treatment due to an adverse event. An
additional study, enrolling 22 healthy adults, was conducted to evaluate
the dermal tolerance of ZOVIRAX Cream compared with vehicle using single
occluded and semi-occluded patch testing methodology. Both ZOVIRAX Cream and
vehicle showed a high and cumulative irritation potential. Another study,
enrolling 251 healthy adults, was conducted to evaluate the contact sensitization
potential of ZOVIRAX Cream using repeat insult patch testing methodology.
Of 202 evaluable subjects, possiblecutaneous sensitization reactions
were observed in the same 4 (2%) subjects with both ZOVIRAX Cream and
vehicle, and these reactions to both ZOVIRAX Cream and vehicle were confirmed
in 3 subjects upon rechallenge. The sensitizing ingredient(s) has not
been identified. The safety profile in patients 12
to 17 years of age was similar to that observed in adults.<br/>Observed During Clinical Practice: In addition to adverse events reported from clinical trials,
the following events have been identified during post-approval use of acyclovir
cream. Because they are reported voluntarily from a population of unknown
size, estimates of frequency cannot be made. These events have been chosen
for inclusion due to a combination of their seriousness, frequency of reporting,
or potential causalconnection to acyclovir cream.<br/>General: Angioedema, anaphylaxis.<br/>Skin: Contact dermatitis, eczema, application site reactions including
signs and symptoms of inflammation.
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| dailymed-instance:indicatio... |
ZOVIRAX Cream is indicated
for the treatment of recurrent herpes labialis (cold sores) in adults and
adolescents (12 years of age and older).
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ZOVIRAX
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