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";s:4:"text";s:5419:"In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to acyclovir cream.Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Zovirax Cream. Keep out of reach of children.Common skin-related side effects that occurred when Zovirax Cream was applied include application site reactions. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. Subjects were instructed to initiate treatment within 1 hour of noticing signs or symptoms and continue treatment for 4 days, with application of study medication 5 times per day. Zovirax Cream is a herpes simplex virus (HSV) nucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.Zovirax Cream should be applied 5 times per day for 4 days. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Patients should be advised to apply Zovirax Cream topically 5 times per day for 4 days. In those subjects that developed ulcerative lesions, the mean episode duration was 5.7, 5.9 and 6.5 days, for Zoviduo cream, aciclovir 5% in vehicle cream or vehicle alone, respectively (p=0.008 for the comparison between Zoviduo with vehicle cream alone). In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. Three patients on Zovirax Cream and one 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. Zovirax Cream is supplied as follows:Advise the patient to read the FDA-approved patient labeling (Patient Information).Patients should be informed that Zovirax Cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. 3296 0 obj <>/Filter/FlateDecode/ID[<9445EE5A5EC6254084CC94A5206B54E1><4146C920A5CCE643868501954AB83902>]/Index[3275 40]/Info 3274 0 R/Length 97/Prev 258243/Root 3276 0 R/Size 3315/Type/XRef/W[1 2 1]>>stream betamethasone valerate .1% cream, ointment *Generic product is available and is also excluded from coverage. In the first trial, the median age of subjects was 37 years (range 18 to 81 years), 74% were female, and 94% were Caucasian. In this study, which included 6 male volunteers, the cream was applied to an area of 710 cmThe systemic absorption of acyclovir following topical application of cream has not been evaluated in patients <18 years of age.The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. Zovirax Cream has the potential for irritation and contact sensitization.Zovirax is a trademark of GlaxoSmithKline LLC used under license.Before using Zovirax Cream, tell your healthcare provider about all of your medical conditions, including if you:The most common side effects of Zovirax Cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching.These are not all the possible side effects of Zovirax Cream. Select one or more newsletters to continue. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.An open-label, uncontrolled trial with Zovirax Cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. Patients should be instructed to wash their hands with soap and water after using Zovirax Cream. Acyclovir cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure.It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal.However, after oral administration of ZOVIRAX, acyclovir concentrations have been documented in breast milk in two women and ranged from 0.6 to 4.1 times the corresponding plasma levels. %PDF-1.5 %���� The safety profile was similar to that observed in adults.Each gram of Zovirax Cream 5% contains 50 mg acyclovir in an aqueous cream base. The safety profile was similar to that observed in adults. Due to minimal systemic absorption of Zovirax Cream, systemic drug interactions are unlikely.There are no adequate and well-controlled studies of acyclovir cream in pregnant women. 0 DOSAGE & INDICATIONS. Do not give Zovirax Cream to other people, even if they have the same symptoms you have. The maximum solubility in water at 37°C is 2.5 mg/mL. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.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. 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