ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older). Your doctor or pharmacist can give you additional information about ZOVIRAX Cream that was written for healthcare professionals.BTA Pharmaceuticals, Inc. (subsidiary of Biovail Corporation) 0000059841 00000 n
The most common skin-related side effects of ZOVIRAX Cream are dry or cracked lips, flakiness or dryness of skin, a burning or stinging feeling, or itching of the skin.
Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.It is not known whether topically applied acyclovir is excreted in breast milk. In 5 double-blind, placebo-controlled trials, 1,124 patients were treated with ZOVIRAX Cream and 1,161 with placebo (vehicle) cream.
In the first study, median age was 37 years (range 18 to 81 years), 74% were female, and 94% were Caucasian.
In a rat peri- and post-natal study at 50 mg/kg/day, s.c., there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (1 to 3 times human levels) or in dogs given 60 mg/kg/day orally for 1 year (the same as human levels). There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Another study, enrolling 251 healthy adults, was conducted to evaluate the contact sensitization potential of ZOVIRAX Cream using repeat insult patch testing methodology. However, ZOVIRAX Cream is not a cure for cold sores.Do not use ZOVIRAX Cream if you are allergic to ZOVIRAX (also known as acyclovir), VALTREXBefore you start using ZOVIRAX Cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast feeding.The safety and efficacy of ZOVIRAX Cream have not been studied in patients younger than 12 years of age or in patients whose immune system is not normal.ZOVIRAX Cream is most effective when used early, at the start of a cold sore. Acyclovir is most active in vitro against HSV, with activity against VZV being approximately 10-fold less but still substantial. ZOVIRAX Cream is supplied as follows: 5-g tubes (NDC 42254-149-05). ��$q�#�a�S� {�R,�������q��.V����i�����|WLv�5!T9���qD�U���RB�p�}\=��JQ�H&½�t$t��X�g�s��qu_r�������������������4�����.Q�\ x�b```�K��/@(�����q������E�����le�`)``
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J�0O# ����o&�. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Each event occurred in fewer than 1 in 100 patients in clinical studies. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. 0000008385 00000 n
The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6
GlaxoSmithKline Research Triangle Park, NC 27709. for
DSM Pharmaceuticals, Inc. Greenville, NC 27834. for GlaxoSmithKline. * SEM refers to localized infection with disease limited to skin, eye, and/or mouth.A multicenter trial of ZOVIRAX for Injection at a dose of 500 mg/mZOVIRAX for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients.ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients.ZOVIRAX for Injection is indicated for the treatment of herpes simplex encephalitis.ZOVIRAX for Injection is indicated for the treatment of neonatal herpes infections.ZOVIRAX for Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.ZOVIRAX for Injection is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.ZOVIRAX for Injection is intended for intravenous infusion only, and should not be administered topically, intramuscularly, orally, subcutaneously, or in the eye. The sensitizing ingredient(s) has not been identified. The occurrence rate of birth defects approximates that found in the general population. Further dilution in any appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION: Method of Preparation and Administration).Acyclovir sodium is a white, crystalline powder with the molecular formula CThe chemical name of acyclovir sodium is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV).The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV.
In vitro, acyclovir triphosphate stops replication of herpes viral DNA. Store at 15° to 25°C (59° to 77°F).
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