Cycloherp 5%

Description:

Acyclovir 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.

Pharmacokinetics:

Systemic absorption of acyclovir after topical application is minimal.

Indications:

It is indicated in the management of initial genital herpes and in limited non-life threatening

mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Contraindications

It is contraindicated in patients who develop hypersensitivity to the components of the formulation. Warnings & Precautions:

-Acyclovir Cream 5% is intended for cutaneous use only and should not be used in the eye -The recommended dosage, frequency of applications and length of treatment should not be exceeded.

-There are no data to support the use of Acyclovir Cream 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. It should not be used for the prevention of recurrent HSV infections.

-Although clinically significant viral resistance associated with the use of Acyclovir Cream 5% has not been observed, this possibility exists.

Drug Interactions:

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Cream 5%.

Carcinogenesis:

Systemic exposure following topical administration of acyclovir is minimal, Dermal carcinogenicity studies were not conducted.

Pregnancy:

Teratogenic Effects: Category B

There are no adequate and well controlled studies of systemic acyclovir in pregnant women. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topically applied acyclovir is excreted in breast milk. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.

Geriatric Use:

Clinical experience has not identified differences in responses between the elderly and younger patients.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established

Adverse Reactions:

Mild pain (including transient burning and stinging), Local pruritus

Dosage and Administration:

Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a 1.25 cm of cream per 25 cm2 of surface area.

A finger cot or rubber glove should be used when applying Acyclovir Cream to prevent

autoinoculation of other body sites and transmission of infection to other persons. Therapy should

be initiated as early as possible following onset of signs and symptoms.

Overdosage:

Overdosage by topical application of Acyclovir Cream 5% is unlikely because of limited

transcutaneous absorption

Packaging: Internally coated metallic tube of 5 g or 20 g/carton box.

Storage Conditions:

“Keep out of Reach of Children”

Do not refrigerate

Store below 25° C.

Rx Only