Valacyclovir Hydrochloride

VALACYCLOVIR HYDROCHLORIDE- valacyclovir hydrochloride tablet, film coated
Actavis Inc.

1 INDICATIONS & USAGE

1.1 Adult Patients

Cold Sores (Herpes Labialis):
Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets 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 tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established.

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

Suppressive Therapy: Valacyclovir tablets 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 tablets 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 tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets 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 tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established.

1.2 Pediatric Patients

Cold Sores (Herpes Labialis):
Information for pediatric patients is approved for GlaxoSmithKline’s valacyclovir tablets. However, due to GlaxoSmithKline’s marketing exclusivity rights, this drug product is not labeled with pediatric patient information.

Labeling describing use of valacyclovir hydrochloride 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 tablet product.

1.3 Limitations of Use

The efficacy and safety of Valacyclovir tablets 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 hydrochloride 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 tablet product

2 DOSAGE & ADMINISTRATION

  • Valacyclovir tablets may be given without regard to meals.

Labeling describing use of valacyclovir hydrochloride 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 tablet product.

2.1 Adult Dosing Recommendations

Cold Sores (Herpes Labialis):
The recommended dosage of valacyclovir hydrochloride 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 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 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 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 for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of valacyclovir hydrochloride 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 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 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 hydrochloride 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 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 in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment
Normal Creatinine Clearance (mL/min)
Dosage Regimen
(Creatinine
Clearance ≥50
Indications (mL/min) 30-49 10-29 <10
Cold sores (Herpes labialis) Two 2 gram Two 1 gram Two 500 mg 500 mg single
doses taken doses taken doses taken dose
12 hours apart 12 hours apart 12 hours apart
Do not exceed 1 day of treatment
Genital herpes: 1 gram every no reduction 1 gram every 500 mg every
Initial episode 12 hours 24 hours 24 hours
Genital herpes: 500 mg every no reduction 500 mg every 500 mg every
Recurrent episode 12 hours 24 hours 24 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 every 1 gram every 1 gram every 500 mg every
8 hours 12 hours 24 hours 24 hours

Hemodialysis:
Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride 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 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 should not be required following CAPD or CAVHD.

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