Valaciclovir

Valtrex

Zugelassene Anwendungsgebiete

• VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients
• Cold Sores (Herpes Labialis)
• Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)
• Suppression in immunocompetent or HIV-1−infected patients Reduction of transmission Herpes Zoster Pediatric Patients
• The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients.

Darreichungsformen und Stärken

• Tablets: 1-gram: Each blue, film‑coated, capsule‑shaped tablet, with a partial scorebar on both sides, printed with "VALTREX 1 gram" contains 1.112 grams of valacyclovir hydrochloride equivalent to 1...
• Tablets: 1 gram (partially scored)

Einnahme

• VALTREX may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid dosage form is not appropriate. Adult Dosage
• Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with less than or equal to 9 recurrences/year 500 mg once daily HIV-1−infected patients 500 mg twice daily Reduction of transmission 500 mg once daily...
• Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg VALTREX tablets.

Darf nicht angewendet werden bei

• VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation.
• Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation.

Wechselwirkungen

• No clinically significant drug-drug or drug-food interactions with VALTREX are known.

Warnhinweise und Vorsichtsmaßnahmen

• Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of VALTREX in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur.
• Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of VALTREX for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment.
• Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher-than-recommended doses of VALTREX for their level of renal function.
• Severe cutaneous adverse reactions (SCARs): Including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome (SJS) have been reported during the postmarketing experience with valacyclovir.

Häufige Nebenwirkungen

• most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with VALTREX and observed more frequently with VALTREX compared with placebo are headache, nausea, and abdominal pain.

Schwangerschaft

Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, have not identified a drug associated risk of major birth defects. There are insufficient data on the use of valacyclovir regarding miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the fetus associated with untreated herpes simplex during pregnancy (see Clinical Considerations).

Wirkmechanismus

Valacyclovir is an antiviral drug active against α-herpes viruses.

Zulassungsinhaber:

REMEDYREPACK INC.

Stand der Fachinformation:

16. Juli 2026

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