Valacyclovir Hydrochloride

VALACYCLOVIR HYDROCHLORIDE- valacyclovir hydrochloride tablet, film coated
Watson Laboratories, Inc.

1 INDICATIONS AND USAGE

1.1 Adult Patients

Cold Sores (Herpes Labialis): Valacyclovir hydrochloride tablets USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride tablets USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.

Genital Herpes:Initial Episode: Valacyclovir hydrochloride tablets USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride tablets USP when initiated more than 72 hours after the onset of signs and symptoms has not been established.

Recurrent Episodes: Valacyclovir hydrochloride tablets USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride tablets USP when initiated more than 24 hours after the onset of signs and symptoms has not been established.

Suppressive Therapy: Valacyclovir hydrochloride tablets USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults. The efficacy and safety of valacyclovir hydrochloride tablets USP for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-infected patients have not been established.

Reduction of Transmission: Valacyclovir hydrochloride tablets USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir hydrochloride tablets USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir hydrochloride tablets USP for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines).

Herpes Zoster: Valacyclovir hydrochloride tablets USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir hydrochloride tablets USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir hydrochloride tablets USP for treatment of disseminated herpes zoster have not been established.

1.2 Pediatric Patients

Cold Sores (Herpes Labialis): Valacyclovir hydrochloride tablets USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. The efficacy of valacyclovir hydrochloride tablets USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.

Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages 2 to ≤ 18 years) is approved for GlaxoSmithKline’s Valtrex®* Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that pediatric use is not approved for this valacyclovir HCL tablet product.

1.3 Limitations of Use

The efficacy and safety of valacyclovir hydrochloride tablets USP have not been established in:

  • Immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients with a CD4+ cell count ≥100 cells/mm3.
  • Patients <12 years of age with cold sores (herpes labialis).
  • Patients <18 years of age with genital herpes.
  • Patients <18 years of age with herpes zoster.
  • Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages of 2 to ≤ 18 years) is approved for GlaxoSmithKline’s Valtrex® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that pediatric use is not approved for this valacyclovir HCL tablet product.

2 DOSAGE AND ADMINISTRATION

  • Valacyclovir hydrochloride tablets may be given without regard to meals.

Labeling describing use of valacyclovir HCL in pediatric patients for whom a solid dosage form is not appropriate is approved for GlaxoSmithKline’s Valtrex® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that information is not approved for this valacyclovir HCL tablet product.

2.1 Adult Dosing Recommendations

Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

Genital Herpes:Initial Episode: The recommended dosage of valacyclovir hydrochloride tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.

Recurrent Episodes: The recommended dosage of valacyclovir hydrochloride tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.

Suppressive Therapy: The recommended dosage of valacyclovir hydrochloride tablets for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.

In HIV-infected patients with a CD4+ cell count ≥100 cells/mm3 , the recommended dosage of valacyclovir hydrochloride tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of valacyclovir hydrochloride tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.

Herpes Zoster: The recommended dosage of valacyclovir hydrochloride tablets for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.

2.2 Pediatric Dosing Recommendations

Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride tablets for the treatment of cold sores in pediatric patients ≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

Labeling describing additional dosing of valacyclovir HCL for pediatric patients with chickenpox is approved for GlaxoSmithKline’s Valtrex®* Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that additional dosing information is not approved for this valacyclovir HCL tablet product.

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)]. Data are not available for the use of valacyclovir hydrochloride tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

Table 1. Valacyclovir Hydrochloride Tablets Dosage Recommendations for Adults With Renal Impairment
Normal Dosage Regimen Creatinine Clearance (mL/min)
Indications (Creatinine Clearance ≥ 50 mL/min) 30 to 49 10 to 29 <10
Cold sores (Herpes labialis) Do not exceed 1 day of treatment. Two 2 gramdoses taken12 hours apart Two 1 gramdoses taken12 hours apart Two 500 mg doses taken 12 hours apart 500 mg singledose
Genital herpes: Initial E pisode 1 gram every12 hours no reduction 1 gram every24 hours 500 mg every24 hours
Genital herpes: Recurrent episode 500 mg every12 hours no reduction 500 mg every24 hours 500 mg every24 hours
Genital herpes: Suppressive therapy
Immunocompetent 1 gram every no reduction 500 mg every 500 mg every
patients 24 hours 24 hours 24 hours
Alternate dose for 500 mg every no reduction 500 mg every 500 mg every
immunocompetent 24 hours 48 hours 48 hours
patients with ≤ 9
recurrences/year
HIV-Infected patients 500 mg every no reduction 500 mg every 500 mg every
12 hours 24 hours 24 hours
Herpes zoster 1 gram every8 hours 1 gram every12 hours 1 gram every24 hours 500 mg every24 hours

Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.

Peritoneal Dialysis: There is no information specific to administration of valacyclovir hydrochloride tablets in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir hydrochloride tablets should not be required following CAPD or CAVHD.

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