Prescription Drug Information: Valacyclovir Hydrochloride

VALACYCLOVIR HYDROCHLORIDE — valacyclovir hydrochloride tablet
TIME CAP LABORATORIES, INC.

1 INDICATIONS AND USAGE

1.1 Adult Patients

Cold Sores (Herpes Labialis)

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

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

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

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

1.2 Pediatric Patients

Cold Sores (Herpes Labialis)

Valacyclovir is indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of valacyclovir initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.


Chickenpox

Valacyclovir is indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir should be initiated within 24 hours after the onset of rash [see Clinical Studies (14.4)].

1.3 Limitations of Use

The efficacy and safety of valacyclovir have not been established in:
• Immunocompromised patients other than for the suppression of genital herpes HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3.
• Patients aged less than 12 years with cold sores (herpes labialis).
• Patients aged less than 2 years or greater than or equal to 18 years with chickenpox.
• Patients aged less than 18 years with genital herpes.
• Patients aged less than 18 years with herpes zoster.
• Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

2 DOSAGE AND ADMINISTRATION

• 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)].

2.1 Adult Dosing Recommendations

Cold Sores (Herpes Labialis)

The recommended dosage of valacyclovir 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 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 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 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-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 , the recommended dosage of valacyclovir for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of valacyclovir 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 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 for the treatment of cold sores in pediatric patients aged greater than or equal to 12 years 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).


Chickenpox
The recommended dosage of valacyclovir for treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4),Clinical Pharmacology (12.3), Clinical Studies (14.4)].

2.3 Extemporaneous Preparation of Oral Suspension

Ingredients and Preparation per USP-NF
Valacyclovir tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV).
Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.
Instructions for Preparing Suspension at Time of Dispensing
• Prepare SSV according to the USP-NF.
• Using a pestle and mortar, grind the required number of Valacyclovir 500-mg tablets until a fine powder is produced (5 Valacyclovir tablets for 25-mg/mL suspension; 10 Valacyclovir tablets for 50-mg/mL suspension).
• Gradually add approximately 5-mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted.
• Continue to add approximately 5-mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25-mg/mL and 50-mg/mL suspensions.
• Transfer the mixture to a suitable 100-mL measuring flask.
• Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask.
• Rinse the mortar at least 3 times with approximately 5-mL aliquots of SSV, transferring the rinsing to the measuring flask between additions.
• Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix.
• Transfer the suspension to an amber glass medicine bottle with a child-resistant closure.
• The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2° to 8°C (36° to 46°F) in a refrigerator. 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)].Data are not available for the use of valacyclovir in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m 2.

Table 1. Valacyclovir 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. Two 2-gram doses taken 12 hours apart Two 1-gram doses taken 12 hours apart Two 500-mg doses taken 12 hours apart 500-mg single dose
Genital herpes: Initial episode 1 gram every 12 hours no reduction 1 gram every 24 hours 500 mg every 24 hours
Genital herpes: Recurrent episode 500 mg every 12 hours no reduction 500 mg every 24 hours 500 mg every 24 hours
Genital herpes: Suppressive therapy Immunocompetent patients Alternate dose for immunocompetent patients with less than or equal to 9 recurrences/year HIV-1-infected patients 1 gram every 24 hours 500 mg every 24 hours 500 mg every 12 hours no reduction no reduction no reduction 500 mg every 24 hours 500 mg every 48 hours 500 mg every 24 hours 500 mg every 24 hours 500 mg every 48 hours 500 mg every 24 hours
Herpes zoster 1 gram every 8 hours 1 gram every 12 hours 1 gram every 24 hours 500 mg every 24 hours

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

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