Valacyclovir

DRUG INFORMATION

  ADULT
    - Recurrent Episodes: The recommended dosage of valacyclovir tablets for treatment
      of recurrent genital herpes is 500 mg twice daily for 3 days.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - In patients with a history of 9 or fewer recurrences per year, an alternative dose
      is 500 mg once daily.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - In HIV-infected patients with a CD4+ cell count ≥100 cells/mm 3 , the recommended
      dosage of valacyclovir tablets for chronic suppressive therapy of recurrent
      genital herpes is 500 mg twice daily.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Valacyclovir hydrochloride is indicated for treatment of cold sores in pediatric
      patients ≥12 years of age and for treatment of chickenpox in pediatric patients 2
      to <18 years of age [see Indications and Usage (1.2) , Dosage and Administration
      (2.2) ].
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'pediatric use', retrieved 2026-08-29
    - • Valacyclovir tablets may be given without regard to meals. Valacyclovir oral
      suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg
      valacyclovir tablets for use in pediatric patients for whom a solid dosage form is
      not appropriate [see Dosage and Administration (2.3) ] .
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - Fifty-seven subjects were enrolled and received a single dose of 25 mg/kg
      valacyclovir oral suspension.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Discard after 28 days.” *The amount of cherry flavor added is as instructed by the
      suppliers of the cherry flavor. 2.4 Patients With Renal Impairment Dosage
      recommendations for adult patients with reduced renal function are provided in
      Table 1 [see Use in Specific Populations (8.5 , 8.6) , Clinical Pharmacology
      (12.3) ] .
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for valacyclovir
      (Valacyclovir Hydrochloride), section 'dosage and administration', retrieved
      2026-08-29
    - Data are not available for the use of valacyclovir tablets in pediatric patients
      with a creatinine clearance <50 mL/min/1.73 m 2 .
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment
      Indications Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min) Creatinine
      Clearance (mL/min) 30-49 10-29 <10 Cold sores (Herpes labialis) Do not exceed 1
      day of treatment.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'dosage and administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for valacyclovir (Valacyclovir
      Hydrochloride), retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - There are no adequate and well-controlled studies of valacyclovir hydrochloride or
      acyclovir in pregnant women.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Based on prospective pregnancy registry data on 749 pregnancies, the overall rate
      of birth defects in infants exposed to acyclovir in-utero appears similar to the
      rate for infants in the general population.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Valacyclovir hydrochloride should be used during pregnancy only if the potential
      benefit justifies the potential risk to the fetus.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Following oral administration of a 500 mg dose of valacyclovir hydrochloride to 5
      nursing mothers, peak acyclovir concentrations (C max ) in breast milk ranged from
      0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum
      concentrations.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'nursing mothers', retrieved 2026-08-29
    - The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal
      serum AUC.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'nursing mothers', retrieved 2026-08-29
    - A 500 mg maternal dosage of valacyclovir hydrochloride twice daily would provide a
      nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day.
      Source: US FDA label for valacyclovir (Valacyclovir Hydrochloride), section
      'nursing mothers', retrieved 2026-08-29