Antiviral

ganciclovir

Active Ingredient. Ganciclovir 0.15%.

Eye gel

Treatment of acute herpetic keratitis (dendritic and geographic ulcers).

Instil one drop of gel in the inferior conjunctival sac of the eye to be treated, 5 times a day until complete corneal re-epithelialisation. Then 3 instillations a day for 7 days after healing. The treatment does not usually exceed 21 days.

VIRGAN eye gel is not recommended for use in children.

Only limited clinical trial data are available (7 children, range 2-14 years).

The dosage in the elderly is the same as in adults (see above). There is no need to adjust the dosage in the elderly as in clinical trials patients up to the age of 85 years have been treated and no specific health concerns were observed.

Hypersensitivity to ganciclovir or acyclovir or to any other ingredients of the product.

The following special warnings and precautions for use should be borne in mind, although systemic effects after ocular instillation are very unlikely. In preclinical testing ganciclovir given systemically caused aspermatogenesis, mutagenicity, teratogenicity, carcinogenicity and suppression of female fertility. These effects in animal studies have been observed at plasma concentrations far exceeding those being seen in humans after therapeutic use of Virgan Eye Gel. However, ganciclovir should be considered a potential carcinogen and teratogen in humans.

In case of any additional local ocular treatment there should be an application interval of at least 5 minutes between the two medications. VIRGAN Eye Gel should be the last medication instilled.

Although the quantities of ganciclovir passing into the general circulation after ophthalmic use are small, the risk of drug interactions cannot be ruled out.

Interactions with ganciclovir administered systemically have been observed:

Binding of ganciclovir to plasma proteins is only about 1-2% and drug interactions involving binding site displacement are not anticipated.

It is possible that drugs which inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa might have combined additive toxic effects when used concomitantly with, before or after ganciclovir. Because of the possibility of additive toxicity with co-administration of drugs such as dapsone, pentamidine, flucystosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulpha combinations or other nucleoside analogues, combination with ganciclovir therapy should be used only if the potential benefits outweigh the risks.

Since both zidovudine and ganciclovir can result in neutropenia, it is recommended that these two drugs should not be given concomitantly during induction treatment with ganciclovir. Maintenance ganciclovir treatment plus zidovudine at the recommended dose resulted in severe neutropenia in most patients studied to date.

Generalised seizures have been reported in patients taking ganciclovir and imipenem-cilastatin concomitantly.

It is also possible that probenecid, as well as other drugs which inhibit renal tubular secretion or resorption, may reduce renal clearance of ganciclovir and could increase the plasma half-life of ganciclovir.

In some cases, adverse events which did not result in a treatment interruption were observed in relation to the use of VIRGAN eye gel: burning sensations or brief tingling sensations, superficial punctate keratitis, visual disturbance on application.

Spectrum Thea Pharmaceuticals Limited

(POM)

16 February 2012