Valacyclovir 500 mg Tablets, 90 Tablets/Bottle

NDC/Item Number: 69367026209
Manufacturer:
WESTMINSTER PHARMACEUTICALS, LLC
Form
TABLET
Unit size
90
Strength
500MG

Details

Details

Valacyclovir — 500MG, Tablet, bottle of 90 tablets

Valacyclovir is a tablet for oral use. Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) 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 ( 1.2 ) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3 ) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis).

  • Active ingredient or product type: VALACYCLOVIR HYDROCHLORIDE
  • Strength/concentration: 500MG
  • Dosage form and route: Tablet, Oral
  • Exact package presentation: bottle of 90 tablets
  • NDC/item number: 69367-262-09
  • Manufacturer: WESTMINSTER PHARMACEUTICALS, LLC
  • Storage/handling: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Status: Rx only

Important safety information: 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 valacyclovir tablets in clinical trials.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.