Dosage form: Topical cream

Ingredients: A 5g cream tube contains:

Aciclovir                                          250mg

Excipients: stearyl alcohol, Vaseline, propylene glycol, sodium lauryl sulfate, propylparaben, methylparaben, distilled water…… enough for 5g.

Pharmacodynamics:

Acyclovir is a substance similar to nucleoside (acycloguanosine) that exhibits selective effect on cells infected with Herpes virus. To produce this effect, acyclovir has to be phosphorylated into the active form acyclovir triphosphate. In the initial phase, acyclovir is converted to acyclovir monophosphate by the enzyme thymidine kinase on the virus, then other cell resident enzymes subsequently convert this product into acyclovir diphosphate and eventually triphosphate. Acyclovir triphosphate inhibits DNA synthesis processes of the virus, thus preventing virus replication without affecting normal metabolic processes in the cell.

Acyclovir is the most efficacious in treating Herpes simplex type 1 (HSV – 1), less potent in treatment of Herpes simplex type 2 (HSV – 2), Varicella zoster virus (VZV) and the least efficacious on cytomegalovirus (CMV). Acyclovir shows no clinical effect on patients infected with CMV. Effects against Epstein Barr virus are not yet known. During treatment, drug-resistant types have emerged and Herpes simplex virus hidden within ganglions was not eliminated.

Pharmacokinetics

Acyclovir is widely distributed in bodily fluids and organs such as: brain, kidneys, lungs, intestine, liver, spleen, muscles, uterus, vaginal mucosa and discharge, tears, aqueous humour, sperm and cerebrospinal fluid.

A small amount of the product is metabolized in the liver while the majority (30 – 90% of the dose) is excreted unchanged by the kidneys.

Indications:

Use in initial treatment and in preventing reinfection of Herpes simplex type 1 and 2 virus on the skin, including initial genital infection and reinfection, herpes infection of the lips, smallpox.

Treatment of herpes zoster infection.

Contraindications:

Patients allergic to product ingredients.

Cautions

Acyclovir cream is not recommended for use on mucous membranes such as the oral mucosa, on the eyes or in the vagina. Use extra caution to avoid direct contact with the eyes.

Dosage – Usage:

Apply on the infected area once every 4 hours (5-6 times a day) in 5-7 days since symptoms first appear or use as directed by doctors.

Adverse effects:

The area in contact with the product may have a sharp tingling or burning sensation along with red rash once dried.

“Inform doctors of adverse effects upon using the product.”

Drug interactions:

No information reported on drug interactions of acyclovir in topical administration.

Effects on drivers and machine operators:

The product can be used in patients who drive or operate machines.

Use during pregnancy and lactation:

Do not use this product in pregnant or nursing women.

Overdosage:

Overdosing can increase the chance of adverse effects.

Expiry date: 36 months since manufacture.

Storage: Store in a clean dry area from 15⁰C – 25⁰C, avoid direct light sources.

Quality standard: primary specifications.

Packaging: A box containing a 5g cream tube, enclosed with directions for use.

Notes:    – Read directions for use before applying the product.

                – Keep out of the reach of children. Consult doctors for more information.