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HSA Approval

ZOVIRAX SUSPENSION 200 mg/5 ml

SIN01192P

ZOVIRAX SUSPENSION 200 mg/5 ml

ZOVIRAX SUSPENSION 200 mg/5 ml

May 14, 1988

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SUSPENSION

**Dosage and Administration** _Pharmaceutical Form:_ Tablets. Dispersible tablets. Oral suspension. _Dosage for treatment of Herpes simplex in adults_ For the treatment of Herpes simplex infections, 200mg Zovirax should be taken five times daily at approximately four-hourly intervals omitting the night time dose. Treatment should continue for five days but in severe initial infections may have to be extended. In severely immune-compromised patients (e.g., after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400mg or, alternatively, intravenous dosing could be considered. Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear. _Dosage for suppression of Herpes simplex in adults_ For suppression of Herpes simplex infections in immune-competent patients, 200mg Zovirax should be taken four times daily at approximately six-hourly intervals. Many patients may be conveniently managed on a regimen of 400mg Zovirax taken twice daily at approximately twelve-hourly intervals. Dosage titration down to 200mg Zovirax taken three times daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective. Some patients may experience breakthrough infections on total daily doses of 800mg Zovirax. Therapy should be interrupted periodically at intervals of six to twelve months in order to observe possible changes in the natural history of the disease. _Dosage for prophylaxis of Herpes simplex in adults_ For prophylaxis of Herpes simplex infections in immunocompromised patients, 200mg Zovirax should be taken four times daily at approximately six-hourly intervals. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400mg Zovirax four times daily at approximately six hourly intervals or, alternatively, intravenous dosing could be considered. The duration of prophylactic administration is determined by the duration of the period at risk. _Dosage for treatment of Varicella and Herpes zoster in adults_ For treatment of Varicella and Herpes zoster infections, 800mg Zovirax should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days. In severely immune-compromised patients (e.g. marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing ( _see Administration_). Dosing should begin as early as possible after the start of an infection; treatment yields better result if initiated as soon as possible after onset of the rash. _Dosage in infants and children_ For the treatment of Herpes simplex infections and for prophylaxis of Herpes simplex infections in the immune-compromised, children aged two years and older should be given adult dosage and infants and children below the age of two years should be given half the adult dose. Do not dilute the oral suspension formulation. For treatment of Varicella infections in children: 6 years and over:800mg Zovirax four times daily2 – <6 years:400mg Zovirax four times dailyUnder 2 years:200mg Zovirax four times daily Dosing may be more accurately calculated as 20mg Zovirax/kg body weight (not to exceed 800mg) four times daily. Treatment should continue for five days ( _see Administration_). No specific data are available on the suppression of Herpes simplex infections or the treatment of Herpes zoster infections in immune-competent children. _Dosage in elderly_ In the elderly, total aciclovir body clearance declines in parallel with creatinine clearance. Adequate hydration of elderly patients taking high oral doses of Zovirax should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function ( _see Renal impairment_). _Dosage in renal impairment_ Caution is advised when administering Zovirax oral formulations to patients with impaired renal function. Adequate hydration should be maintained. In the management of Herpes simplex infections in patients with impaired renal function, the recommended oral doses will not lead to accumulation of aciclovir above levels that have been established safe by intravenous infusion. However for patients with severe renal impairment (creatinine clearance less than 10mL/minute) an adjustment of dosage to 200mg twice daily at approximately twelve-hourly intervals is recommended. In the treatment of Varicella and Herpes zoster infections, it is recommended to adjust the dosage to 800mg twice daily at approximately twelve-hourly intervals, for patients with severe renal impairment (creatinine clearance less than 10mL/minute), and to 800mg three times daily, at intervals of approximately eight hours, for patients with moderate renal impairment (creatinine clearance in the range 10 to 25mL/minute) ( _see Administration_). **Administration** Zovirax Dispersible Tablets 800mg may be dispersed in a minimum of 50ml of water or swallowed whole with a little water.

ORAL

Medical Information

**Indications** Zovirax Oral Formulations are indicated for the treatment of Herpes simplex virus infections of the skin and mucous membranes, including initial and recurrent genital herpes. Zovirax Oral Formulations are indicated for the suppression (prevention of recurrence) of recurrent Herpes simplex infections in immune-competent patients. Zovirax Oral Formulations are indicated for the prophylaxis of Herpes simplex infections in immune-compromised patients. Zovirax Oral Formulations are indicated for treatment of Varicella (Chickenpox) and Herpes zoster (Shingles) infections. Studies have shown that early treatment of shingles with Zovirax has a beneficial effect on pain and can reduce the incidence of post-herpetic neuralgia (zoster- associated pain).

**Contraindications** Zovirax Tablets and Zovirax Suspensions are contraindicated in patients known to be hypersensitive to aciclovir or valaciclovir.

J05AB01

aciclovir

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

ASPEN BAD OLDESLOE GMBH

Active Ingredients

ACYCLOVIR

200 mg/5 ml

Acyclovir

Documents

Package Inserts

Zovirax PI.pdf

Approved: November 13, 2020

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