Regulatory Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET
**Dosage and Administration:** **I. Adult dose:** _Treatment of Herpes Simplex Infection:_ 200mg (400mg in the immunocompromised patient) 5 times daily, usually for 5 days. _Prevention of recurrent Herpes Simplex Infection:_ 200mg to be taken 4 times daily, or 400mg twice daily, possibly reduced to 200mg 2 or 3 times daily. Therapy should be interrupted periodically at interval 6 – 12 months in order to observe possible changes in the nature history of the disease. _Prophylaxis of Herpes Simplex Infection in immunocompromised patients:_ 200mg to be taken 4 times daily at approximately 6 hours interval. In situation of severe immunocompromised, eg., after bone marrow transplantation, or in patients with impaired gastrointestinal absorption, the dose may be doubled to 400mg. _Treatment of Varicella and Herpes Zoster infection:_ 800mg, 5 times daily for 7 days. **II. Pediatric Dose:** For treatment of Herpes Simplex Infection and for _Prophylaxis of Herpes Simplex Infection_ in immunocompromised, children 2 years and over should be given adult dosage, and children < 2 years should be given half the adult dose. For treatment of Varicella Infection, children > 6 years: 800mg 4 times a day.2 – 6 years: 400mg 4 times a day.below 2 years: 200mg 4 times a day. Dosing may be calculated as 20mg/kg body weight (not to exceed 800mg), 4 times daily. Treatment should be continued for 5 days. No specific data are available on the treatment of Herpes Simplex Infection in immune-competent children. **III. Dosage in Elderly** Elderly patients are more likely to have an age-related decrease in renal function, which may required an adjustment of dosage or dosing interval. **IV. Dosage in Renal Impairment** For patient with renal impairment (creatinine clearance < 10ml/min), the dosage should be decreased to 200mg every 12 hours for treatment of _Herpes Simplex Infection_, and 800mg twice daily for treatment of _Varicella and Zoster Infection_.
ORAL
Medical Information
**Indication(s):** 1. Infections caused by Varicella-Zoster Virus. 2. Skin and mucous membrane infections due to Herpes Simplex Virus. 3. Prophylaxis of Herpes Simplex infection in patients who are immunocompromised including those with bone marrow transplant and leukemia. 4. Suppression of recurrent Herpes Simplex Virus infections.
**Contraindication(s):** Contraindicated in patients who develop hypersensitivity or intolerance to any of the components of the formulation.
J05AB01
aciclovir
Manufacturer Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Y S P INDUSTRIES (M) SDN BHD