- Approval Id
- 1380daa1e94f1ddb
- Drug Name
- VACICLOR TABLET 500 MG
- Product Name
- VACICLOR TABLET 500 MG
- Approval Number
- SIN14207P
- Approval Date
- 2012-08-10
- Registrant
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Licence Holder
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<em>Route of administration</em><br>
Oral use<br>
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.</p>
<p><em><strong>Adults</strong></em><br>
<strong>Herpes zoster infections</strong><br>
<em>Treatment of zoster-associated pain:</em></p>
<ul>
<li>1000 mg of valaciclovir 3 times daily for 7 days.</li>
</ul>
<p>Treatment should be initiated as soon as possible after the beginning of the infection, within 72 hours of the appearance of skin lesions.</p>
<p><strong>Herpes simplex infections</strong><br>
<em>Treatment of genital herpes simplex infections in immunocompetent patients:</em></p>
<ul>
<li>500 mg twice daily for 10 days for the initial episode.</li>
<li>1000 mg per day in one or two divided doses for 5 days for recurrent episodes.</li>
</ul>
<p>Treatment should be initiated as soon as possible in the course of infection, preferably at the prodromal stage or when lesions begin to appear.</p>
<p><em>Suppression of recurrent genital herpes simplex infections:</em></p>
<ul>
<li>500 mg per day in one or two divided doses<br>
(Better results have been obtained by dividing the daily dose into two, i.e. by administering 250 mg twice daily, when the administration of a single 500 mg dose per day failed, or if the recurrences were frequent or very symptomatic).</li>
</ul>
<p>For this indication, the need for treatment must be re-evaluated after 6 to 12 months.</p>
<p><em><strong>Adults and adolescents aged 12 years and above</strong></em><br>
<em><strong>Elderly</strong></em><br>
Dosage modification is not required unless renal function is significantly impaired (see Renal impairment, below). Adequate hydration must be maintained.</p>
<img src="/TGIF/Vaciclor-Table1_071125.png" alt="Vaciclor Dosage Table 1" /><br><br>
<p>Patients on haemodialysis should receive the same dose as patients with creatinine clearance <10 ml/min. On dialysis days, the dose should be given after dialysis.<br>
In patients on haemodialysis, the dose must be administered after the haemodialysis has been performed.</p>
<p><em><strong>Hepatic impairment</strong></em><br>
Dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained).<br>
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.</p>
<p><em><strong>Children below the age of 12 years</strong></em><br>
Valaciclovir is not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Vaciclor is indicated for the treatment of herpes zoster (shingles). Vaciclor 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.<br>
Vaciclor is indicated for the treatment of herpes simplex infection of the skin and mucous membranes, including initial and recurrent genital herpes.<br>
Vaciclor can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.<br>
Vaciclor is indicated for the prevention (suppression) of recurrent herpes simplex infections of the skin and mucous membranes, including genital herpes.<br>
Consideration should be given to official guidance on the appropriate use of antiviral agents.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Hypersensitivity to valaciclovir, aciclovir or to any of the excipients.</p>
- Atc Code
- J05AB11
- Atc Item Name
- valaciclovir
- Pharma Manufacturer Name
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
