Acyclovir (Topical)

Simplovir cream is indicated for the treatment of initial and recurrent labial and genital Herpes simplex infections. Treatment should begin as early as possible.

Aciclovir is a synthetic purine derivative. It exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via other cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. Percutaneous absorption of Aciclovir appears to be minimal following topical application of the drug to intact skin.

Acyclovir cream should be applied to lesions 5 times daily for 5-10 days. The affected area should be kept clean and dry; patients should be instructed to wear loose-fitting clothing to avoid irritation to the lesion. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Simplovir cream. Due to minimal systemic absorption of Simplovir cream, systemic drug interactions are unlikely.

Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.

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 Simplovir cream and placebo. Three patients on Simplovir cream and one patient on placebo discontinued treatment due to an adverse event.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Simplovir 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. Simplovir cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. Cream has a potential for irritation and contact. The effect of Simplovir cream has not been established in immunocompromised patients.

Store Simplovir cream at room temperature between 20°C to 25°C