VALTREX TABLET 500 MG

GLAXO WELLCOME SA (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Jun 29, 1995
Approval ID: a1d56f406deb9369
Company: GLAXO WELLCOME SA (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: a1d56f406deb9369
Drug Name: VALTREX TABLET 500 MG
Product Name: VALTREX TABLET 500 MG
Approval Number: SIN08229P
Approval Date: 1995-06-29
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration Pharmaceutical form: Film-coated tablets <ul> <li>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.</li> <li>Children There are no data available on the use of VALTREX in children.</li> <li>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.</li> <li>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: <img src="/TGIF/Valtrex-Table1_071222.png" alt="Valtrex Dosage Table 1" /> 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.</li> <li>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.</li> </ul>
Route Of Administration: ORAL
Indication Info: Indications VALTREX is indicated for the treatment of herpes zoster (shingles). VALTREX accelerates the resolution of pain: it reduces the duration of and the proportion of patients with zoster-associated pain, which includes acute and post-herpetic neuralgia. VALTREX is indicated for the treatment of herpes simplex infections of the skin and mucous membranes, including initial and recurrent genital herpes. VALTREX is indicated for the prevention (suppression) of recurrent herpes simplex infections of the skin and mucous membranes, including genital herpes. VALTREX is indicated for reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with VALTREX, it is recommended that patients use safer sex practices.
Contraindications: Contraindications VALTREX is contraindicated in patients known to be hypersensitive to valaciclovir, aciclovir or any components of formulations of VALTREX.
Atc Code: J05AB11
Atc Item Name: valaciclovir
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

VALACICLOVIR HCl EQV VALACICLOVIR

500 mg

VALACICLOVIR HCl EQV VALACICLOVIR

500 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 29, 1995

Approval ID

a1d56f406deb9369

Type

Therapeutic

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