Zovirax

2 DOSAGE AND ADMINISTRATION ZOVIRAX Cream should be applied 5 times per day for 4 days. e. during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults. • Apply 5 times a day for 4 days.

( 2 ) • Administer immediately following the onset of cold sore lesions. ( 2 )

6 ADVERSE REACTIONS • The most common adverse reactions reported were local skin reactions at the application site. 1 ) • Angioedema, anaphylaxis, contact dermatitis and eczema have been reported. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice.

In five double-blind, placebo-controlled trials, 1124 patients were treated with ZOVIRAX Cream and 1161 with placebo (vehicle) cream. Local application site reactions were reported by 5% of patients receiving ZOVIRAX Cream and 4% of patients receiving placebo.

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 adverse reaction occurred in less than 1% of patients receiving ZOVIRAX Cream and placebo.

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.

Both ZOVIRAX Cream and placebo 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, possible cutaneous sensitization reactions were observed in the same 4 (2%) subjects with both ZOVIRAX Cream and placebo, and these reactions to both ZOVIRAX Cream and placebo were confirmed in 3 subjects upon rechallenge.

5 WARNINGS AND PRECAUTIONS • Only for topical use of recurrent HSV lesions on the external aspect of lips and the face. ZOVIRAX Cream should not be applied on mucous membranes including in the eye or inside the mouth or nose. 1 ) • There is a potential for irritation and contact sensitization.

1 General ZOVIRAX Cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. ZOVIRAX Cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose.

1) ] . The effect of ZOVIRAX Cream has not been established in immunocompromised patients.

4 CONTRAINDICATIONS ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation. • ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir or any component of the formulation.

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