- Approval Id
- b3a458e5f5b32b38
- Drug Name
- ZOVIRAX SUSPENSION 200 MG/5 ML
- Product Name
- ZOVIRAX SUSPENSION 200 MG/5 ML
- Approval Number
- SIN01192P
- Approval Date
- 1988-05-14
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SUSPENSION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><em>Pharmaceutical Form</em></p>
<p>Tablets.<br>
Dispersible tablets.<br>
Oral suspension.</p>
<p><em>Dosage for treatment of herpes simplex in adults</em></p>
<p>For the treatment of herpes simplex infections, 200 mg 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.</p>
<p>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 400 mg or, alternatively, intravenous dosing could be considered.</p>
<p>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.</p>
<p><em>Dosage for suppression of herpes simplex in adults</em></p>
<p>For suppression of herpes simplex infections in immune-competent patients, 200 mg Zovirax should be taken four times daily at approximately six-hourly intervals.</p>
<p>Many patients may be conveniently managed on a regimen of 400 mg Zovirax taken twice daily at approximately twelve-hourly intervals.</p>
<p>Dosage titration down to 200 mg Zovirax taken three times daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective.</p>
<p>Some patients may experience breakthrough infections on total daily doses of 800 mg Zovirax.</p>
<p>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.</p>
<p><em>Dosage for prophylaxis of herpes simplex in adults</em></p>
<p>For prophylaxis of herpes simplex infections in immunocompromised patients, 200 mg Zovirax should be taken four times daily at approximately six-hourly intervals.</p>
<p>In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 400 mg 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.</p>
<p><em>Dosage for treatment of varicella and herpes zoster in adults</em></p>
<p>For treatment of varicella and herpes zoster infections, 800 mg Zovirax should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.</p>
<p>In severely immune-compromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.</p>
<p>Dosing should begin as early as possible after the start of an infection. Treatment yields better results if initiated as soon as possible after onset of the rash.</p>
<p><em>Dosage in infants and children</em></p>
<p>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.</p>
<p>For treatment of varicella infections in children:</p>
<table class="borderless-100">
<tbody>
<tr>
<td>6 years and over:</td>
<td>800 mg Zovirax four times daily</td>
</tr>
<tr>
<td>2 – <6 years:</td>
<td>400 mg Zovirax four times daily</td>
</tr>
<tr>
<td>Under 2 years:</td>
<td>200 mg Zovirax four times daily</td>
</tr>
</tbody>
</table>
<p>Dosing may be more accurately calculated as 20 mg Zovirax/kg body weight (not to exceed 800 mg) four times daily.</p>
<p>Treatment should continue for five days.</p>
<p>No specific data are available on the suppression of herpes simplex infections or the treatment of herpes zoster infections in immune-competent children.</p>
<p><em>Dosage in elderly</em></p>
<p>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 <em>Renal impairment</em>).</p>
<p><em>Dosage in renal impairment</em></p>
<p>Caution is advised when administering Zovirax oral formulations to patients with impaired renal function. Adequate hydration should be maintained.</p>
<p>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 10 ml/minute) an adjustment of dosage to 200 mg twice daily at approximately twelve-hourly intervals is recommended.</p>
<p>In the treatment of varicella and herpes zoster infections, it is recommended to adjust the dosage to 800 mg twice daily at approximately twelve-hourly intervals, for patients with severe renal impairment (creatinine clearance less than 10 ml/minute), and to 800 mg three times daily, at intervals of approximately 8 hours, for patients with moderate renal impairment (creatinine clearance in the range 10 to 25 ml/minute).</p>
<p><strong>Administration</strong></p>
<p>Zovirax Dispersible Tablets 800 mg may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p>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.</p>
<p>Zovirax Oral Formulations are indicated for the suppression (prevention of recurrence) of recurrent herpes simplex infections in immune-competent patients.</p>
<p>Zovirax Oral Formulations are indicated for the prophylaxis of herpes simplex infections in immune-compromised patients.</p>
<p>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).</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Zovirax Tablets and Zovirax Suspension are contraindicated in patients known to be hypersensitive to aciclovir or valaciclovir.</p>
- Atc Code
- J05AB01
- Atc Item Name
- aciclovir
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
