VILERM TABLET 400 MG

SIAM BHEASACH CO LTD (THAILAND)🇸🇬 Health Sciences Authority

Approval Date: Apr 16, 1997
Approval ID: d457b2056b17b5ed
Company: SIAM BHEASACH CO LTD (THAILAND)
Type: Therapeutic

Approval Details

Approval Id: d457b2056b17b5ed
Drug Name: VILERM TABLET 400 MG
Product Name: VILERM TABLET 400 MG
Approval Number: SIN09298P
Approval Date: 1997-04-16
Registrant: JOYSON PTE. LTD.
Licence Holder: JOYSON PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET
Dosage: Dosage and administration:- Dosage for treatment of Herpes simplex Adults VILERM® 200 mg 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 400 mg 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. Infants and children Children aged two years and older should be given adult dosage. Infants and children below the age of two years should be given half the adult dosage. Dosage for suppression of Herpes simplex in immune-competent patients Adults VILERM® 200mg should be taken four times daily at approximately six-hourly intervals. Many patients may be conveniently managed on a regimen of 400 mg VILERM® taken twice daily at approximately twelve-hourly intervals. Dosage titration down to 200 mg VILERM® 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 800 mg VILERM®. 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. Children No specific data are available on the suppression of Herpes simplex infections or the treatment of Herpes zoster infections in immune-competent children. Dosage for prophylaxis of Herpes simplex in immune-compromised patients Adult VILERM® 200 mg 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 400 mg VILERM® 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. Infants and children Children aged two years and older should be given adult dosage. Infants and children below the age of two years should be given half the adult dosage. Dosage for treatment of Varicella and Herpes zoster Adult VILERM® 800 mg should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days. In severely immunocompromised patients (e.g. marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. 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. Children <table class="borderless-100"> <tbody> <tr> <td>6 years and over</td> <td>:</td> <td>800 mg VILERM® four times daily</td> </tr> <tr> <td>2 – < 6 years</td> <td>:</td> <td>400 mg VILERM® four times daily</td> </tr> <tr> <td>Under 2 years</td> <td>:</td> <td>200 mg VILERM® four times daily</td> </tr> </tbody> </table> Dosing may be more accurately calculated as 20 mg VILERM®/kg bodyweight (not to exceed 800 mg) four times daily. Treatment should continue for five days. Dosage in elderly In the elderly, total acyclovir body clearance declines in parallel with creatinine clearance. Adequate hydration of elderly patients taking high oral doses of VILERM® should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function. Dosage in renal impairment Caution is advised when administering VILERM® 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 acyclovir above levels that have been established safe by intravenous infusion. However forpatients with severe renal impairment (creatinine clearance less than 10mL/minute) an adjustment of dosage to 200 mg 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 800 mg twice daily at approximately twelve-hourly intervals, for patients with severe renal impairment (creatinine clearance less than 10mL/minute), and to 800 mg three times daily, at intervals of approximately eight hours, for patients with moderate renal impairment (creatinine clearance in the range 10 to 25mL/minute).
Route Of Administration: ORAL
Indication Info: Indications :- <ul class="dash"> <li>For the treatment of Herpes simplex virus infections of the skin and mucous membranes, including initial and recurrent genital herpes.</li> <li>For treatment of Varicella (Chickenpox) and Herpes zoster (Shingles) infections.</li> <li>For the suppression (prevention of recurrence) of recurrent Herpes simplex infections in immune-competent patients.</li> <li>For the prophylaxis of Herpes simplex infections in immune-compromised patients.</li> </ul>
Contraindications: Contraindication:- VILERM® tablets is contraindicated in patients known to be hypersensitive to acyclovir or valacyclovir.
Atc Code: J05AB01
Atc Item Name: aciclovir
Pharma Manufacturer Name: JOYSON PTE. LTD.

Active Ingredients

ACYCLOVIR

400 mg

ACYCLOVIR

400 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 16, 1997

Approval ID

d457b2056b17b5ed

Type

Therapeutic

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