Condylox

DOSAGE AND ADMINISTRATION

The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated. Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one-week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles.

If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. 5 g ram of the gel per day. Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions.

Patients should be instructed to wash their hands thoroughly before and after each application.

ADVERSE REACTIONS

5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.

7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.

The most common systemic adverse event reported during the clinical studies was headache (7%).

WARNINGS

Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. 5% is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.

Drug Product is Flammable. Keep Away f rom Open Flame.

CONTRAINDICATIONS

5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.