Valacyclovir Hydrochloride

Valacyclovir Hydrochloride Manufacturers

• Remedyrepack Inc.
  

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  Valacyclovir Hydrochloride | Remedyrepack Inc.

  

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      Adult Dosage 
  (2.1) Cold Sores
  2 grams every 12 hours for 1 day
  Genital Herpes
  
  Initial episode
  1 gram twice daily for 10 days
  Recurrent episodes
  500 mg twice daily for 3 days
  Suppressive therapy        
  
           Immunocompetent patients
  1 gram once daily
               Alternate dose in patients
  500 mg once daily
               with ≤9 recurrences/yr
  
           HIV-infected patients
  500 mg twice daily
  Reduction of transmission
  500 mg once daily
  Herpes Zoster
  1 gram 3 times daily for 7 days
                            Pediatric Dosage 
  (2.2) Cold Sores (≥12 years of age)
  2 grams every 12 hours for 1 day
  Chickenpox (2 to <18 years of
  age)
  20 mg/kg 3 times daily for 5 days; 
  not to exceed 1 gram 3 times daily
  

  Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from 500 mg Valacyclovir tablets, USP. (2.3)

   

  Valacyclovir tablets, USP 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, USP for use in pediatric patients for whom a solid dosage form is not appropriate[see Dosage and Administration (2.3)] .

   

  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.

   

  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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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)].

   

  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.

  Prepare Suspension at Time of Dispensing as Follows:

    Prepare SSV according to the USP-NF.   Using a pestle and mortar, grind the required number of Valacyclovir tablets 500 mg 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°C to 8°C (36°F 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.

   

  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 Dosage Recommendations for Adults With Renal Impairment Indications
  Normal
  Dosage
  Regimen
  
  Creatinine Clearance 
  (mL/min)
  
  (Creatinine
  Clearance
  ≥50 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 
  
  1 gram every
  24 hours
  
  no reduction
  
  500 mg every
  24 hours
  
  500 mg every
  24 hours
  
  Alternate dose for 
  immunocompetent 
  patients with ≤9 
  recurrences/year 
  
  500 mg every
  24 hours
  
  no reduction
  
  500 mg every
  48 hours
  
  
  500 mg every 48 hours
  
  HIV-infected patients
  500 mg every 12 hours
  no reduction
  500 mg every 24 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 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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• Preferred Pharmaceuticals, Inc.
  

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  Valacyclovir Hydrochloride | Preferred Pharmaceuticals, Inc.

  

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    Valacyclovir tablets, USP may be given without regard to meals.   Valacyclovir oral suspension (25 mg/mLor 50 mg/mL) may be prepared extemporaneously from valacyclovir tablets, USP 500 mg for use in pediatric patients for whoma 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 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).
  
  Chickenpox:The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 hydrochloride 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.  
  
  Prepare Suspension at Time of Dispensing as Follows:

    Prepare SSV accordingto the USP-NF.   Using a pestle and mortar, grind the required number of valacyclovir tablets, USP 500 mg until a fine powder is produced (5 valacyclovir tablets, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 50mg/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°C to 8°C (36°F 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 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

                              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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

  Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

  HIV‑infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 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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• Proficient Rx Lp
  

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  Valacyclovir Hydrochloride | Proficient Rx Lp

  

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  • 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 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 greater than or equal to 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 greater than or equal to 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to less than18 years of age 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.

  Prepare Suspension at Time of Dispensing as Follows:

  • 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 hydrochloride in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment    Normal Dosage  Creatinine Clearance (mL/min)    Regimen          (Creatinine          Clearance      

    Indications

   ≥50 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

   Do not exceed 1 day of treatment.

   12 hours apart

   12 hours apart

   12 hours apart

   

   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 patients

   1 gram every

   no reduction

   500 mg every

   500 mg every

   

   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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• Cardinal Health
  

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  Valacyclovir Hydrochloride | Cardinal Health

  

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

  Labeling describing use of valacyclovir hydrochloride tablets 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 hydrochloride 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 hydrochloride tablets 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 hydrochloride 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

  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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 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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• Dr. Reddys Laboratories Limited
  

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  Valacyclovir Hydrochloride | Dr. Reddys Laboratories Limited

  

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  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 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

  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 in pediatric patients with a creatinine clearance < 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment   

  Indications Normal Dosage Regimen (Creatinine Clearance50 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 taken12 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 every12 hours no reduction 1 gram every 24 hours 500 mg every 24 hours Genital herpes: Recurrent episode 500 mg every12 hours no reduction 500 mg every 24 hours 500 mg every 24 hours Genital herpes: Suppressive therapy
  Immunocompetent patients 
  
  Alternate dose for immunocompetentpatients with≤9 recurrences/year
   
  HIV-infected patients
  
  1 gram every24 hours 
  
  500 mg every24 hours   
  
  500 mg every12 hours
  
  no reduction   
  
  
  no reduction    
  
  no reduction
  
  500 mg every 24 hours 
  500 mg every 48 hours   
  500 mg every24 hours
  
  500 mg every
  24 hours 
  500 mg every
  48 hours   
  500 mg every
  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  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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  Valacyclovir Hydrochloride | Bryant Ranch Prepack

  

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  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 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  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
  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 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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• Pd-rx Pharmaceuticals, Inc.
  

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  Valacyclovir Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  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).

  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 Indications Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30 to 49 10 to 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: Initialepisode 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   1 gram every 24 hours   no reduction   500 mg every 24 hours   500 mg every 24 hours Alternate dose for immunocompetent patients with ≤ 9 recurrences/year 500 mg every 24 hours no reduction 500 mg every 48 hours 500 mg every 48 hours HIV-infected patients 500 mg every 12 hours no reduction 500 mg every 24 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 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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• Rebel Distributors Corp
  

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  Valacyclovir Hydrochloride | Rebel Distributors Corp

  

  ---

  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 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  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
  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 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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• Physicians Total Care, Inc.
  

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  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 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  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
  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 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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• Rebel Distributors Corp
  

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  Valacyclovir Hydrochloride | Rebel Distributors Corp

  

  ---

  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 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  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
  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 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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  Valacyclovir hydrochloride tablets may be given without regard to meals.

  Labeling describing use of valacyclovir hydrochloride tablets 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 hydrochloride 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 hydrochloride tablets 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 hydrochloride 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 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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 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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  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 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  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
  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 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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  Valacyclovir hydrochloride tablets may be given without regard to meals.
  

  Labeling describing use of valacyclovir hydrochloride tablets 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 hydrochloride 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/mm

  3

  , 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 hydrochloride tablets 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 hydrochloride 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 m

  2

  .  

  
  Table 1. Valacyclovir Hydrochloride 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. 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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 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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  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 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  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
  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 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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  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 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 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 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 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/mm 3, the recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
  
  Reduction of Transmission:  The recommended dosage of valacyclovir 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 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 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).
  
  

  Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.
   
  Prepare Suspension at Time of Dispensing as Follows:
    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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m 2.  
  Table 1. Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment Indications
  Normal Dosage
  Regimen
  (Creatinine
  Clearance ≥50)
  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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  Valacyclovir tablets, USP may be given without regard to meals.

  Valacyclovir oral suspension (25 mg/mLor 50 mg/mL) may be prepared extemporaneously from valacyclovir tablets, USP 500 mg for use in pediatric patients for whoma 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 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).
  
  Chickenpox:The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 hydrochloride 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.  
  
  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV accordingto the USP-NF.

  Using a pestle and mortar, grind the required number of valacyclovir tablets, USP 500 mg until a fine powder is produced (5 valacyclovir tablets, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 50mg/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°C to 8°C (36°F 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 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

                              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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

  Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

  HIV‑infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 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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  Hypertension

  The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.

  The usual initial dosage of metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one week of therapy. The effective dosage range is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of metoprolol is increased.

  Angina Pectoris

  The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.

  The usual initial dosage of metoprolol tartrate tablets is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of metoprolol tartrate tablets is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1 to 2 weeks. (See WARNINGS.)

  Myocardial Infarction Early Treatment

  During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate tablets can be initiated as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.

  Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2 minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate, and electrocardiogram should be carefully monitored.

  In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below).

  Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol should be discontinued (see WARNINGS).

  Late Treatment

  Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.

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  • 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 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 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 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 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 nine 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission

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

  Herpes Zoster

  The recommended dosage of valacyclovir 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 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).

  Chickenpox

  The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age is 20 mg/kg administered three 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.

  Prepare Suspension at Time of Dispensing as Follows • 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 (five valacyclovir tablets for 25 mg/mL suspension; ten 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 three 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 tablets in pediatric patients with a creatinine clearance < 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Dosage Recommendations for Adults with Renal Impairment

  Indications

  Normal Dosage Regimen
  (Creatinine Clearance ≥ 50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every
  24 hours

  no reduction

  500 mg every
  24 hours

  500 mg every
  24 hours

        Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every
  24 hours

  no reduction

  500 mg every
  48 hours

  500 mg every
  48 hours

        HIV-infected patients

  500 mg every
  12 hours

  no reduction

  500 mg every
  24 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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  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 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/mm 3, 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 use of valacyclovir HCL in pediatric patients with chickenpox 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.

  2.4 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 Indications Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30 to 49 10 to 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   1 gram every 24 hours   no reduction   500 mg every 24 hours   500 mg every 24 hours Alternate dose for immunocompetent patients with ≤ 9 recurrences/year 500 mg every 24 hours no reduction 500 mg every 48 hours 500 mg every 48 hours HIV-infected patients 500 mg every 12 hours no reduction 500 mg every 24 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 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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  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 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  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
  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 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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  • Valacyclovir tablets, USP 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, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission

  The recommended dosage of valacyclovir tablets, USP 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 tablets, USP 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 tablets,USP 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).

  Chickenpox

  The recommended dosage of valacyclovir tablets, USP for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 [seeUSE 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, USP 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.

  Prepare Suspension at Time of Dispensing as Follows

  • 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, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 2º to 8ºC (36º to 46ºF) 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 tablets, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

  Table 1.Valacyclovir Tablets, USP Dosage Recommendations for Adults With Renal Impairment

  Indications

  Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

    Alternate dose for immunocompetent patients with ≤9 recurrences/ year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

    HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 tablets, USP after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets, USP 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 tablets, USP 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 tablets, USP should not be required following CAPD or CAVHD.

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  Valacyclovir hydrochloride tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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)
  30-49
  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
  1 gram every
  24 hours
  no reduction
  500 mg every
  24 hours
  500 mg every
  24 hours
  Alternate dose for immunocompetent patients with ≤9 recurrences/year
  500 mg every
  24 hours
  no reduction
  500 mg every
  48 hours
  500 mg every
  48 hours
  HIV-infected patients
  500 mg every
  12 hours
  no reduction
  500 mg every
  24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  Valacyclovir hydrochloride tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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)
  30-49
  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
  1 gram every
  24 hours
  no reduction
  500 mg every
  24 hours
  500 mg every
  24 hours
  Alternate dose for immunocompetent patients with ≤9 recurrences/year
  500 mg every
  24 hours
  no reduction
  500 mg every
  48 hours
  500 mg every
  48 hours
  HIV-infected patients
  500 mg every
  12 hours
  no reduction
  500 mg every
  24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  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.

   

  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.

   

  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.

   

  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.

  Normal Dosage Creatinine Clearance (mL/min) Regimen (Creatinine Clearance Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment                  Indications ≥50 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 Do not exceed 1 day of treatment. 12 hours apart 12 hours apart 12 hours apart 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 patients 1 gram every no reduction 500 mg every 500 mg every 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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  Valacyclovir tablets, USP 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, USP for use in pediatric patients for whom a solid dosage form is not appropriate [seeDOSAGE AND ADMINISTRATION ( 2.3) ]. 2.1 Adult Dosing Recommendations

  Cold Sores (Herpes Labialis)

  The recommended dosage of valacyclovir tablets, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP 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/mm 3, the recommended dosage of valacyclovir tablets, USP for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission

  The recommended dosage of valacyclovir tablets, USP 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 tablets, USP 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 tablets,USP 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).

  Chickenpox

  The recommended dosage of valacyclovir tablets, USP for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 [seeUSE 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, USP 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.

  Prepare Suspension at Time of Dispensing as Follows

  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, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 2º to 8ºC (36º to 46ºF) 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 tablets, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m 2.

  Table 1.Valacyclovir Tablets, USP Dosage Recommendations for Adults With Renal Impairment

  Indications

  Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

  Alternate dose for immunocompetent patients with ≤9 recurrences/ year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

  HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 tablets, USP after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets, USP 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 tablets, USP 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 tablets, USP should not be required following CAPD or CAVHD.

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  Valacyclovir hydrochloride tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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 Indications Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30 to 49 10 to 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 1 gram every 24 hours no reduction 500 mg every 24 hours 500 mg every 24 hours    Alternate dose for immunocompetent patients with ≤ 9 recurrences/year 500 mg every 24 hours no reduction 500 mg every 48 hours 500 mg every 48 hours    HIV-infected patients 500 mg every 12 hours no reduction 500 mg every 24 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 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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  • Valacyclovir hydrochloride tablets may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  • Prepare SSV according to the USP-NF. • Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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

  Indications

  Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

     Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

     HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 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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  2.1 General Dosing Information Valganciclovir tablets USP should be taken with food [see Clinical Pharmacology (12.3)]. The bioavailability of ganciclovir from valganciclovir is significantly higher than from ganciclovir capsules. Therefore, valganciclovir tablets USP cannot be substituted for ganciclovir capsules on a one-to-one basis [see Clinical Pharmacology (12.3)]. Adult patients should use valganciclovir tablets, not valganciclovir for oral solution. 2.2 Adult Patients With Normal Renal Function

  For dosage recommendations in adult patients with renal impairment [see Dosage and Administration (2.5)].

  Treatment of CMV Retinitis: Induction:

  The recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days. Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once a day.

  Prevention of CMV Disease:

  For adult patients who have received a heart or kidney-pancreas transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days post-transplantation. For adult patients who have received a kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post-transplantation. 2.3 Pediatric Patients

  Prevention of CMV Disease: For pediatric patients 4 months to 16 years of age who have received a kidney or heart transplant, the recommended once daily dose of valganciclovir tablets USP starting within 10 days of transplantation until 100 days post-transplantation is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the equation below:

  Pediatric Dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73m2, then a maximum value of 150 mL/min/1.73m2 should be used in the equation.

  where k =

  0.45 for patients aged 4 months to < 1 year,

  0.45 for patients aged 1 to < 2 years (note k value is 0.45 instead of the typical value of 0.55),

  0.55 for boys aged 2 to < 13 years and girls aged 2 to 16 years, and

  0.7 for boys aged 13 to 16 years.

  All calculated doses should be rounded to the nearest 25 mg increment for the actual deliverable dose. If the calculated dose exceeds 900 mg, a maximum dose of 900 mg should be administered. Valganciclovir for oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, valganciclovir tablets USP may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, if the calculated dose is between 405 mg and 495 mg, one 450 mg tablet may be taken.

  2.5 Renal Impairment

  Dosage recommendations for adult patients with reduced renal function are provided in Table 1. For adult patients on hemodialysis (CrCl <10 mL/min), a dose recommendation for valganciclovir tablets cannot be given [see Use in Specific Populations (8.5, 8.6 ), Clinical Pharmacology (12.3)].

  Table 1 Dosage Recommendations for Adult Patients with Impaired Renal Function

  Valganciclovir 450 mg Tablets CrCl*(mL/min) Induction Dose Maintenance/ Prevention Dose ≥ 60 900 mg twice daily 900 mg once daily 40 to 59 450 mg twice daily 450 mg once daily 25 to 39 450 mg once daily 450 mg every 2 days 10 to 24 450 mg every 2 days 450 mg twice weekly < 10 (on hemodialysis) not recommended not recommended

  *An estimated creatinine clearance is calculated from serum creatinine by the following formulas:

  For males=  (140 – age [years]) x (body weight [kg])

                       _______________________________

                          (72) x (serum creatinine [mg/dL])

  For females= 0.85 x male value

  Dosing in pediatric patients with renal impairment can be done using the recommended equations because CrCl is a component in the calculation [see Dosage and Administration (2.3)].

  2.6 Handling and Disposal

  Caution should be exercised in the handling of valganciclovir tablets USP. Tablets should not be broken or crushed. Because valganciclovir is considered a potential teratogen and carcinogen in humans, caution should be observed in handling broken tablets, [see Warnings and Precautions (5.3, 5.4)]. Avoid direct contact with broken or crushed tablets with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with plain water.

  Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. Several guidelines on this subject have been published. However, there is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate [see References (15)].

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  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.

   

  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.

   

  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.

   

  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 Dosage   Creatinine Clearance (mL/min)     Regimen           (Creatinine           Clearance                         Indications  ≥50 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  Do not exceed 1 day of treatment.  12 hours apart  12 hours apart  12 hours apart    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 patients  1 gram every  no reduction  500 mg every  500 mg every    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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  Valacyclovir Hydrochloride | Mylan Pharmaceuticals Inc.

  

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  • 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 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 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 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 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 nine 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission

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

  Herpes Zoster

  The recommended dosage of valacyclovir 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 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).

  Chickenpox

  The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age is 20 mg/kg administered three 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.

  Prepare Suspension at Time of Dispensing as Follows • 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 (five valacyclovir tablets for 25 mg/mL suspension; ten 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 three 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 tablets in pediatric patients with a creatinine clearance < 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Dosage Recommendations for Adults with Renal Impairment

  Indications

  Normal Dosage Regimen
  (Creatinine Clearance ≥ 50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every
  24 hours

  no reduction

  500 mg every
  24 hours

  500 mg every
  24 hours

        Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every
  24 hours

  no reduction

  500 mg every
  48 hours

  500 mg every
  48 hours

        HIV-infected patients

  500 mg every
  12 hours

  no reduction

  500 mg every
  24 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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  Valacyclovir Hydrochloride | American Health Packaging

  

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  • Valacyclovir hydrochloride 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 hydrochloride 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 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 hydrochloride 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

  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

    1 gram every 24 hours

    no reduction

    500 mg every 24 hours

    500 mg every 24 hours

      Alternate dose for
      immunocompetent
      patients with ≤ 9
      recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

      HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  Valacyclovir Hydrochloride | Remedyrepack Inc.

  

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  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.

   

  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.

   

  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.

   

  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 Dosage   Creatinine Clearance (mL/min)     Regimen           (Creatinine           Clearance                         Indications  ≥50 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  Do not exceed 1 day of treatment.  12 hours apart  12 hours apart  12 hours apart    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 patients  1 gram every  no reduction  500 mg every  500 mg every    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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  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 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 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 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 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
  
  Reduction of Transmission:  The recommended dosage of valacyclovir 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 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 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).

  
  
  

  Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.
  
  Prepare Suspension at Time of Dispensing as Follows:

  
  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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.  

  
  Table 1. 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. 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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  Valacyclovir Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium delayed-release, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).

  For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).

  For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.

  Different formulations of diclofenac (diclofenac sodium delayed-release tablets; diclofenac sodium extended-release tablets, USP; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

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  Valacyclovir Hydrochloride | Cardinal Health

  

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  Valacyclovir hydrochloride 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 hydrochloride 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 nine 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 nine 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 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 hydrochloride 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 Dosage Recommendations for Adults with Renal Impairment Indications Normal Dosage Regimen
  (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30 to 49 10 to 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

  1 gram every

  24 hours no reduction

  500 mg every

  24 hours

  500 mg every

  24 hours      Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every

  24 hours no reduction

  500 mg every

  48 hours

  500 mg every

  48 hours      HIV-infected patients

  500 mg every

  12 hours no reduction

  500 mg every

  24 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 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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  Valacyclovir hydrochloride tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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)
   30-49
   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
   1 gram every
  24 hours
   no reduction
   500 mg every
  24 hours
   500 mg every
  24 hours
   Alternate dose for immunocompetent patients with ≤9 recurrences/year
   500 mg every
  24 hours
   no reduction
   500 mg every
  48 hours
   500 mg every
  48 hours
   HIV-infected patients
   500 mg every
  12 hours
   no reduction
   500 mg every
  24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  Valacyclovir Hydrochloride | Preferred Pharmaceuticals, Inc.

  

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  • Valacyclovir hydrochloride tablets may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  • Prepare SSV according to the USP-NF. • Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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)
  

  30-49
  

  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
  

  1 gram every
  24 hours
  

  no reduction
  

  500 mg every
  24 hours
  

  500 mg every
  24 hours
  

  Alternate dose for immunocompetent patients with ≤9 recurrences/year
  

  500 mg every
  24 hours
  

  no reduction
  

  500 mg every
  48 hours
  

  500 mg every
  48 hours
  

  HIV-infected patients
  

  500 mg every
  12 hours
  

  no reduction
  

  500 mg every
  24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  Valacyclovir Hydrochloride | American Health Packaging

  

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  • 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 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 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 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 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
  
  Reduction of Transmission:  The recommended dosage of valacyclovir 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 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 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).
  
  

  Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.
   
  Prepare Suspension at Time of Dispensing as Follows:
   

  • 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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.  
  

  Table 1. Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment

  Indications
  

  Normal Dosage
  Regimen
  (Creatinine
  Clearance ≥50)
  

  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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  Valacyclovir Hydrochloride | Greenstone Llc

  

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  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 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 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 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 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

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  • •Valacyclovir hydrochloride 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 hydrochloride 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 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 hydrochloride 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

  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

    1 gram every 24 hours

    no reduction

    500 mg every 24 hours

    500 mg every 24 hours

      Alternate dose for
      immunocompetent
      patients with ≤ 9
      recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

      HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are 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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  Valacyclovir Hydrochloride | State Of Florida Doh Central Pharmacy

  

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  Valacyclovir hydrochloride tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age 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 hydrochloride 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.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride 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 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 Indications Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30 to 49 10 to 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 1 gram every 24 hours no reduction 500 mg every 24 hours 500 mg every 24 hours    Alternate dose for immunocompetent patients with ≤ 9 recurrences/year 500 mg every 24 hours no reduction 500 mg every 48 hours 500 mg every 48 hours    HIV-infected patients 500 mg every 12 hours no reduction 500 mg every 24 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 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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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Valacyclovir Hydrochloride | Cipla Usa Inc.

  

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  Valacyclovir tablets, USP 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, USP 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 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.

  Prepare Suspension at Time of Dispensing as Follows:

    Prepare SSV according to the USP-NF.   Using a pestle and mortar, grind the required number of Valacyclovir tablets 500 mg 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°C to 8°C (36°F 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 hydrochloride tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

  Table 1. Valacyclovir hydrochloride Dosage Recommendations for Adults With Renal Impairment Indications
  Normal
  Dosage
  Regimen
  
  Creatinine Clearance 
  (mL/min)
  
  (Creatinine
  Clearance
  ≥50 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 
  
  1 gram every
  24 hours
  
  no reduction
  
  500 mg every
  24 hours
  
  500 mg every
  24 hours
  
  Alternate dose for 
  immunocompetent 
  patients with ≤9 
  recurrences/year 
  
  500 mg every
  24 hours
  
  no reduction
  
  500 mg every
  48 hours
  
  
  500 mg every 48 hours
  
  HIV-infected patients
  500 mg every 12 hours
  no reduction
  500 mg every 24 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 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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  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 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 greater than or equal to 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 greater than or equal to 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).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to less than18 years of age 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.

  Prepare Suspension at Time of Dispensing as Follows:

  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 hydrochloride in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment    Normal Dosage  Creatinine Clearance (mL/min)    Regimen          (Creatinine          Clearance         Indications  ≥50 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  Do not exceed 1 day of treatment.  12 hours apart  12 hours apart  12 hours apart    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 patients  1 gram every  no reduction  500 mg every  500 mg every    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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  • Valacyclovir tablets, USP 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, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP 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 tablets, USP for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission

  The recommended dosage of valacyclovir tablets, USP 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 tablets, USP 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 tablets,USP 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).

  Chickenpox

  The recommended dosage of valacyclovir tablets, USP for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 [seeUSE 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, USP 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.

  Prepare Suspension at Time of Dispensing as Follows

  • 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, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 2º to 8ºC (36º to 46ºF) 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 tablets, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

  Table 1.Valacyclovir Tablets, USP Dosage Recommendations for Adults With Renal Impairment

  Indications

  Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min)

  Creatinine Clearance (mL/min)

  30 to 49

  10 to 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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

    Alternate dose for immunocompetent patients with ≤9 recurrences/ year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

    HIV-infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 tablets, USP after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets, USP 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 tablets, USP 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 tablets, USP should not be required following CAPD or CAVHD.

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  (See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).

  Adults * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)

  Infection*

  Recommended Dose/Duration of Therapy

  Community-acquired pneumonia

  (mild severity)

  Pharyngitis/tonsillitis (second

  line therapy)

  Skin/skin structure (uncomplicated)

  500 mg as a single dose on

  Day 1, followed by 250 mg

  once daily on Days 2 through 5.

  Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)

  500 mg QD x 3 days

  OR

  500 mg as a single dose on

  Day 1, followed by 250 mg

  once daily on Days 2 through 5.

  Acute bacterial sinusitis

  500 mg QD x 3 days

  Genital ulcer disease (chancroid)

  One single 1 gram dose

  Non-gonoccocal urethritis and cervicitis

  One single 1 gram dose

  Gonococcal urethritis and cervicitis

  One single 2 gram dose

  Azithromycin tablets can be taken with or without food.

  Renal Insufficiency

  No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).

  Hepatic Insufficiency

  The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).

  No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).

  Pediatric Patients

  Azithromycin for oral suspension can be taken with or without food.

  Acute Otitis Media

  The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

  Acute Bacterial Sinusitis

  The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)

  Community-Acquired Pneumonia

  The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

  PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
  Per
  Treatment
  Course Total mg
  Per
  Treatment
  Course
  Kg
  Lbs. Day
  1 Days
  2-5 Day
  1 Days
  2-5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

  5

  11

  2.5 mL

  (1/2 tsp)

  1.25 mL

  (1/4 tsp)

  7.5 mL

  150 mg

  10

  22

  5 mL

  (1 tsp)

  2.5 mL

  (1/2 tsp)

  15 mL

  300 mg

  20

  44

  5 mL

  (1 tsp)

  2.5 mL

  (1/2 tsp)

  15 mL

  600 mg

  30

  66

  7.5 mL

  (1-1/2 tsp)

  3.75 mL

  (3/4 tsp)

  22.5 mL

  900 mg

  40

  88

  10 mL

  (2 tsp)

  5 mL

  (1 tsp)

  30 mL

  1200 mg

  50

  and

  above

  110

  and

  above

  12.5 mL

  (2-1/2 tsp)

  6.25 mL

  (1-1/4 tsp)

  37.5 mL

  1500 mg

  OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
  Treatment
  Course Total mg per
  Treatment
  Course Kg Lbs. Day 1-3 Day 1-3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.

  5

  11

  2.5 mL

  (1/2 tsp)

  7.5 mL

  150 mg

  10

  22

  5 mL

  (1 tsp)

  15 mL

  300 mg

  20

  44

  5 mL

  (1 tsp)

  15 mL

  600 mg

  30

  66

  7.5 mL

  (1-1/2 tsp)

  22.5 mL

  900 mg

  40

  88

  10 mL

  (2 tsp)

  30 mL

  1200 mg

  50

  and

  above

  110

  and

  above

  12.5 mL

  (2-1/2 tsp)

  37.5 mL

  1500 mg

  OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
  Treatment
  Course Total mg per
  Treatment
  Course Kg Lbs.
  Day 1
  

  5

  11

  3.75 mL

  (3/4 tsp)

  3.75 mL

  150 mg

  10

  22

  7.5 mL

  (1-1/2 tsp)

  7.5 mL

  300 mg

  20

  44

  15 mL

  (3 tsp)

  15 mL

  600 mg

  30

  66

  22.5 mL

  (4-1/2 tsp)

  22.5 mL

  900 mg

  40

  88

  30 mL

  (6 tsp)

  30 mL

  1200 mg

  50 and

  above

  110 and

  above

  37.5 mL

  (7-1/2 tsp)

  37.5 mL

  1500 mg

  The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

  Pharyngitis/Tonsillitis

  The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

  PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
  Treatment Course Total mg per
  Treatment Course Kg Lbs. Day 1-5

  8

  18

  2.5 mL

  (1/2 tsp)

  12.5 mL

  500 mg

  17

  37

  5 mL

  (1 tsp)

  25 mL

  1000 mg

  25

  55

  7.5 mL

  (1-1/2 tsp)

  37.5 mL

  1500 mg

  33

  73

  10 mL

  (2 tsp)

  50 mL

  2000 mg

  40

  88

  12.5 mL

  (2-1/2 tsp)

  62.5 mL

  2500 mg

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  Valacyclovir Hydrochloride | Avpak

  

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  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 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 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 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 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
  
  Reduction of Transmission:  The recommended dosage of valacyclovir 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 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 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).
  
  

  Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.
   
  Prepare Suspension at Time of Dispensing as Follows:
   

  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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.  
  

  Table 1. Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment Indications
  Normal Dosage
  Regimen
  (Creatinine
  Clearance ≥50)
  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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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  Valacyclovir tablets, USP may be given without regard to meals.

  Valacyclovir oral suspension (25 mg/mLor 50 mg/mL) may be prepared extemporaneously from valacyclovir tablets, USP 500 mg for use in pediatric patients for whoma 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 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/mm 3, 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).
  
  Chickenpox:The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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 hydrochloride 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.  
  
  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV accordingto the USP-NF.

  Using a pestle and mortar, grind the required number of valacyclovir tablets, USP 500 mg until a fine powder is produced (5 valacyclovir tablets, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP 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 50mg/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°C to 8°C (36°F 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 hydrochloride in pediatric patients with a creatinine clearance <50 mL/min/1.73 m 2.  
  
  Table 1.Valacyclovir Hydrochloride 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

  1 gram every 24 hours

  no reduction

  500 mg every 24 hours

  500 mg every 24 hours

  Alternate dose for immunocompetent patients with ≤ 9 recurrences/year

  500 mg every 24 hours

  no reduction

  500 mg every 48 hours

  500 mg every 48 hours

  HIV‑infected patients

  500 mg every 12 hours

  no reduction

  500 mg every 24 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 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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  Valacyclovir Hydrochloride | Alcon Laboratories, Inc.

  

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  Directions

  Shake well before using. Instill 1 or 2 drops in the affected eye(s) as needed.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Valacyclovir Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

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  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 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 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 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 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 tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
  
  Reduction of Transmission:  The recommended dosage of valacyclovir 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 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 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).
  

  Chickenpox: The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age 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.
  
  Prepare Suspension at Time of Dispensing as Follows:

  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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.  

  Table 1. Valacyclovir Tablets Dosage Recommendations for Adults With Renal Impairment Indications Normal Dosage
  Regimen
  (Creatinine
  Clearance ≥50) 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 
        patient with 
        ≤9 recurrences/year 
  
        HIV-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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir 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 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 tablets should not be required following CAPD or CAVHD.

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