VALTREX TABLET 500 mg

TABLET, FILM COATED

**Dosage and Administration** Pharmaceutical form: Film-coated tablets - **Adults** **Treatment of herpes zoster (shingles)** The dosage is 1000 mg of _VALTREX_ to be taken three times daily for seven days. **Treatment of herpes simplex infections** The dosage is 500 mg of _VALTREX_ to be taken twice daily. For recurrent episodes, treatment should be for five days. For initial episodes, which can be more severe, treatment may have to be extended from five days to ten days. Dosing should begin as early as possible. For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately when the first signs or symptoms appear. _VALTREX_ can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence. **Prevention (suppression) of recurrences of herpes simplex infections** _**Immunocompetent adults**_ In immunocompetent patients, 500 mg of _VALTREX_ to be taken once daily. Some patients with very frequent recurrences (e.g. 10 or more per year) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily). _**Immunocompromised adults**_ For immunocompromised patients, the dose is 500 mg twice daily. **Reduction of transmission of genital herpes** In immunocompetent heterosexual adults with 9 or fewer recurrences per year and with the susceptible partner discordant for HSV-2 antibodies, 500 mg of _VALTREX_ to be taken once daily by the infected partner. The efficacy of reducing transmission beyond 8 months in discordant couples has not been established. There are no data on the reduction of transmission in other patient populations. - **Children** There are no data available on the use of _VALTREX_ in children. - **Elderly** The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly ( _see Renal impairment below_). Adequate hydration should be maintained. - **Renal impairment** Caution is advised when administering valaciclovir to patients with impaired renal function. Adequate hydration should be maintained. The dosage of _VALTREX_ should be reduced in patients with impaired renal function as shown in the table below:  In patients on intermittent haemodialysis, the _VALTREX_ dosage should be administered after the haemodialysis has been performed. The creatinine clearance should be monitored frequently, especially during periods when renal function is changing rapidly, the _VALTREX_ dosage should be adjusted accordingly. - **Hepatic impairment** Studies with a 1 g unit dose of _VALTREX_ show that dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained). Pharmacokinetic data in patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting), do not indicate the need for dosage adjustment; however, clinical experience is limited. For higher doses (4 g or more/day), ( _see Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).