Dosage and Administration

The cream should not be applied to the eye. The recommended doses, frequency of application and duration of treatment should not be exceeded.

No data demonstrates that Acyclovir will either prevent transmission of infection to other persons or prevent recurrent infections where applied in the absence of signs and symptoms. Should not be used to prevent recurrent HSV infections.

Therapy should be initiated as early as possible following onset of signs and symptoms. Rubber gloves should be used when applying Aciclovir to prevent autoinoculation of other body sites and transmission of infection to other persons. The cream should be applied in sufficient quantity to adequately cover all lesions. The dose per application will vary depending on the total lesion area. The usual dose is approximately 1.25 cm ribbon of cream per 2.5 sq.cm surface area. It should be gently rubbed into the affected area six times daily at three hourly intervals. Treatment should be continued for five days and if healing is not complete, treatment may be continued for a further five days.

2. THERAPEUTIC/DIAGNOSTIC CLAIMS

Health 2000 Aciclovir 5% cream is indicated for the treatment of Herpes simplex virus infections of the skin including initial episodes of genital herpes and treatment of herpes labialis.

3. DESCRIPTION OF DOSAGE FORM

Aciclovir is a synthetic purine analogue with in vitro and in vivo inhibitory activity against human herpes viruses including Herpes simplex virus (HSV) type 1 and 2, Varicella zoster virus (VZV), Epstein-Barr virus (EBV) and Cytomegalovirus (CMV).

The enzyme thymidine kinase encoded by HSV, VZV and EBV converts Acyclovir into Acyclovir monophosphate, a nucleotide analogue, which is further converted to diphosphate and triphosphate by cellular enzymes. Acyclovir triphosphate interferes with DNA polymerase and inhibits viral DNA replication with resultant chain termination following its incorporation into the growing viral DNA chain.

4. CONTRAINDICATIONS

Hypersensitivity to acyclovir or components of the formulation.

Warnings and Precautions
Health 2000 Aciclovir 5% cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina as it may cause irritation.

DRUG INTERACTIONS
No drug interactions have been identified following topical administration of acyclovir.

PREGNANCY
Acyclovir should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS
It is not known whether topically applied acyclovir is secreted in breast milk. Caution should be exercised when Health 2000 Aciclovir 5% cream is administered to a nursing woman.

PAEDIATRIC USE
Safety and effectiveness in children less than two years of age have not been adequately studied.

5. SIDE EFFECTS

Side effects are uncommon. Mild pain with or without transient burning and stinging may occur. Pruritus, rash, erythema, mild flaking and drying of the skin have been reported.

6. TOXIC EFFECTS

Mutagenicity, Carcinogenicity and Teratogenicity
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits and mice. In a non-standard test in rats, fetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain. Experience in humans is limited, so use of Aciclovir Cream should be considered only when the potential benefits outweigh the possibility of unknown risks. Limited human data show that the drug does pass into breast milk following systemic administration.

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that Aciclovir does not pose a genetic risk to man. Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.

CONTACT INFORMATION

Tel: (905) 264 2641 / (905) 882-7036
Fax: (905) 264 2825 / (905) 882-7063

General Inquiries info@health-2000.com
Director of Sales dsales@health-2000.com
Director of Marketing dmarketing@health-2000.com
Product Information products@health-2000.com
Custom Manufacturing cmanufacturing@health-2000.com

Health 2000 Inc.
70 East Beaver Creek Road
Richmond Hill, Ont.
Canada, L4B 3B2