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Valacyclovir Dosage

Applies to the following strength(s): 500 mg ; 1 g

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Herpes Simplex Labialis

2 g orally every 12 hours for a total of 2 doses

HIV-infected adult (guideline dosing):
1 g orally twice a day for 5 to 10 days

Comments:
-Therapy should be started at the earliest sign of a cold sore, e.g. tingling, burning, or itching.
-Efficacy of treatment when initiated after the development of clinical signs of a cold sore have not been established.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of cold sores (herpes labialis).

Usual Adult Dose for Herpes Simplex - Mucocutaneous/Immunocompetent Host

Genital Herpes:

FIRST EPISODE: 1 g orally twice a day
Duration of therapy: 10 days (manufacturer): 7 to 10 days (CDC recommendation)

RECURRENT EPISODES: 500 mg orally twice a day for 3 days OR 1 g orally once a day for 5 days
-Therapy should be started at the first sign of a genital herpes episode

Comments:
-All patients with newly acquired genital herpes should receive antiviral therapy as first episodes can cause a prolonged clinical illness, even among persons with mild clinical manifestations initially.
-Therapy for the initial episode is most effective when administered within 48 hours of onset of signs and symptoms; the efficacy or initiating treatment more than 72 hours after onset of signs and symptoms has not been established.
-For recurrent episodes, the efficacy of starting more than 24 hours after onset of signs and symptoms has not been established.
-CDC STD treatment Guidelines may be consulted for additional guidance.

Use: For the treatment of the initial episode and recurrent episodes of genital herpes in adults.

Usual Adult Dose for Herpes Simplex - Suppression

Immunocompetent host: 1 g orally once a day
Immunocompetent host with 9 or fewer recurrences/year: 500 mg orally once a day

HIV-infected adults with a CD4 count of 100 cells/mm3 or greater: 500 mg twice a day

Reduction of Transmission: 500 mg orally once a day (source partner)

Comments:
-Suppressive therapy has been shown to decrease the rate of HSV-2 transmission in discordant, heterosexual couples when the source partner has a history of genital HSV-2 infection; in such cases, antiviral suppressive therapy should be part of a strategy to prevent transmission.
-In HIV-infected/HSV-2 seropositive persons not on antiretroviral therapy (ART) suppressive therapy did not prevent HSV-2 transmission to HSV-2 seronegative partners; suppressive anti-HSV therapy is not recommended to prevent HSV-2 transmission in HIV-infected persons not on ART.
-The frequency of recurrences has been shown to decrease over time and therefore continued therapy should be reevaluated at least annually.
-Safety and efficacy beyond 1 year in immunocompetent patient and beyond 6 months in HIV-infected patients has not been established; efficacy for suppression of genital herpes in discordant couples has not been established beyond 8 months.
-CDC STD treatment Guidelines may be consulted for additional guidance.

Use: As suppressive therapy of recurrent episodes of genital herpes and for the reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences/year.

Usual Adult Dose for Herpes Zoster

Immunocompetent host: 1 g orally every 8 hours for 7 days

HIV-infected adult (guideline dosing):
Acute Localized Dermatomal: 1 g orally every 8 hours for 7 to 10 days
-Longer duration should be considered if lesions are slow to resolve

Comments:
-Most effective if started within 48 hours of onset of rash; efficacy has not been established if started more than 72 hours after onset of rash.
-Safety and efficacy for treatment of disseminated herpes zoster has not been established.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of herpes zoster (shingles).

Usual Adult Dose for Herpes Simplex - Mucocutaneous/Immunocompromised Host

Genital Herpes with Concomitant HIV Infection

FIRST EPISODE: 1 g orally twice a day for 7 to 10 days (CDC recommendation)

RECURRENT EPISODES: 1 g orally twice a day for 5 to 10 days (CDC recommendation)
-Therapy should be started at the first sign of a genital herpes episode

Comments:
-All patients with newly acquired genital herpes should receive antiviral therapy as first episodes can cause a prolonged clinical illness, even among persons with mild clinical manifestations initially.
-Therapy for the initial episode is most effective when administered within 48 hours of onset of signs and symptoms; the efficacy or initiating treatment more than 72 hours after onset of signs and symptoms has not been established; for recurrent episodes, the efficacy of starting more than 24 hours after onset of signs and symptoms has not been established.
-The safety and efficacy of treating HSV infections in immunocompromised patients has not been established except for treating suppression of genital herpes in HIV-infected patients with a CD4 cell count of 100 cells/mm3 or greater.
-CDC STD Treatment Guidelines and Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of the initial episode and recurrent episodes of genital herpes in HIV-infected adults.

Usual Adult Dose for Varicella-Zoster

HIV-Infected Adults (guideline dosing):

-Primary Varicella Infection; Uncomplicated Course: 1 g orally 3 times a day for 5 to 7 days

Comments:
-This drug is considered preferred therapy for uncomplicated cases of primary varicella infection; treatment should be initiated at the earliest sign or symptom of chickenpox.
-This drug is preferred therapy in HIV-infected pregnant women with uncomplicated varicella during pregnancy.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of chickenpox (varicella).

Usual Adult Dose for Herpes Zoster - Prophylaxis

HIV-Infected Adults (guideline dosing):

-Post-Exposure Prophylaxis: 1 g orally 3 times a day for 5 to 7 days; begin 7 to 10 days after exposure

Comments:
-Varicella-zoster immune globulin is the preferred therapy for postexposure prophylaxis; oral antiviral therapy may be used when passive immunization is not possible; if antiviral therapy is used, varicella vaccines should not be given for at least 72 hours following last dose.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For HIV-infected person who has had close contact with a person who has active varicella or herpes zoster and is susceptible to the virus (e.g. no history of vaccination or either condition, or is known to be seronegative).

Usual Adult Dose for Varicella-Zoster - Prophylaxis

HIV-Infected Adults (guideline dosing):

-Post-Exposure Prophylaxis: 1 g orally 3 times a day for 5 to 7 days; begin 7 to 10 days after exposure

Comments:
-Varicella-zoster immune globulin is the preferred therapy for postexposure prophylaxis; oral antiviral therapy may be used when passive immunization is not possible; if antiviral therapy is used, varicella vaccines should not be given for at least 72 hours following last dose.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For HIV-infected person who has had close contact with a person who has active varicella or herpes zoster and is susceptible to the virus (e.g. no history of vaccination or either condition, or is known to be seronegative).

Usual Pediatric Dose for Herpes Simplex Labialis

12 years or older: 2 g orally every 12 hours for a total of 2 doses

HIV-infected (guideline dosing):
Adolescents: 1 g orally twice a day for 5 to 10 days

Comments:
-Therapy should be started at the earliest sign of a cold sore, e.g. tingling, burning, or itching.
-Efficacy of treatment when initiated after the development of clinical signs of a cold sore have not been established.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of cold sores (herpes labialis).

Usual Pediatric Dose for Varicella-Zoster

Immunocompetent host:
2 to less than 18 years: 20 mg/kg orally 3 times a day for 5 days
Maximum dosage: 1 g orally 3 times a day

HIV-Infected Adolescent (guideline dosing):
-Primary Varicella Infection; Uncomplicated Course: 1 g orally 3 times a day for 5 to 7 days

Comments:
-Therapy should be initiated at the earliest sign of chickenpox, no later than 24 hours after onset of rash.
-In HIV-infected, this drug is considered preferred therapy for uncomplicated cases of primary varicella infection; Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.
-See Administration Advice for extemporaneous preparation of oral suspension.

Use: For the treatment of varicella zoster (chicken pox).

Usual Pediatric Dose for Herpes Simplex - Suppression

HIV-infected adolescents: 500 mg orally twice a day

Comments:
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.
-The frequency of recurrences has been shown to decrease over time and therefore continued therapy should be reevaluated at least annually.

Use: As suppressive therapy of recurrent episodes of genital herpes in HIV-infected adolescents.

Usual Pediatric Dose for Herpes Simplex - Mucocutaneous/Immunocompromised Host

Genital Herpes and Concomitant HIV Infection in Adolescents

FIRST EPISODE: 1 g orally twice a day for 7 to 10 days (guideline recommendation)

RECURRENT EPISODES: 500 mg orally twice a day for 3 days OR 1 g orally once a day a day for 5 days (guideline recommendation)
-Therapy should be started at the first sign of a genital herpes episode.

Comments:
-All patients with newly acquired genital herpes should receive antiviral therapy as first episodes can cause a prolonged clinical illness, even among persons with mild clinical manifestations initially.
-Therapy for initial episode is most effective when administered within 48 hours of onset of signs and symptoms.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the treatment of the initial episode and recurrent episodes of genital herpes in HIV-infected adolescents.

Usual Pediatric Dose for Herpes Zoster - Prophylaxis

HIV-Infected Adolescents (guideline dosing):

-Post-Exposure Prophylaxis: 1 g orally 3 times a day for 5 to 7 days; begin 7 to 10 days after exposure

Comments:
-Varicella-zoster immune globulin is the preferred therapy for postexposure prophylaxis; oral antiviral therapy may be used when passive immunization is not possible; if antiviral therapy is used, varicella vaccines should not be given for at least 72 hours following last dose.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For HIV-infected person who has had close contact with a person who has active varicella or herpes zoster and is susceptible to the virus (e.g. no history of vaccination or either condition, or is known to be seronegative).

Usual Pediatric Dose for Varicella-Zoster - Prophylaxis

HIV-Infected Adolescents (guideline dosing):

-Post-Exposure Prophylaxis: 1 g orally 3 times a day for 5 to 7 days; begin 7 to 10 days after exposure

Comments:
-Varicella-zoster immune globulin is the preferred therapy for postexposure prophylaxis; oral antiviral therapy may be used when passive immunization is not possible; if antiviral therapy is used, varicella vaccines should not be given for at least 72 hours following last dose.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For HIV-infected person who has had close contact with a person who has active varicella or herpes zoster and is susceptible to the virus (e.g. no history of vaccination or either condition, or is known to be seronegative).

Renal Dose Adjustments

Adults:
Mild renal impairment (CrCl 50 mL/min or greater): No adjustment recommended

Moderate renal impairment (CrCl 30 to 49 mL/min):
-Herpes labialis: 1 g orally every 12 hours for a total of 2 doses
-Herpes zoster: 1 g orally every 12 hours
-Genital herpes: No adjustment recommended

Severe renal impairment (CrCl 10 to 29 mL/min):
-Herpes labialis: 500 mg orally every 12 hours for a total of 2 doses
-Genital herpes; Initial episode: 1 g orally every 24 hours
-Genital herpes; Recurrent episodes: 500 mg orally every 24 hours
-Genital herpes; Suppressive therapy in immunocompetent host: 500 mg orally every 24 hours OR in those with 9 or fewer recurrences per year: 500 mg orally every 48 hours
-Genital herpes; Suppression in HIV-infected host: 500 mg orally every 24 hours
-Herpes zoster: 1 g orally every 24 hours

Severe renal impairment (CrCl less than 10 mL/min):
-Herpes labialis: 500 mg orally as a single dose
-Genital herpes; Initial episode: 500 mg orally every 24 hours
-Genital herpes; Recurrent episodes: 500 mg orally every 24 hours
-Genital herpes; Suppressive therapy in immunocompetent host: 500 mg orally every 24 hours OR in those with 9 or fewer recurrences per year: 500 mg orally every 48 hours
-Genital herpes; Suppression in HIV-infected host: 500 mg orally every 24 hours
-Herpes zoster: 500 mg orally every 24 hours

Pediatric patients: Specific data not available, adult adjustment should be considered.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Elderly: Dose adjustments may be required depending on renal status

Precautions

-Safety and efficacy have not been established in immunocompromised patients except for the suppression of genital herpes in HIV-infected adult patients with CD4 cell counts of 100 cells/mm3 or greater
-Safety and efficacy have not been established in pediatric patients less than 18 years of age with genital herpes or herpes zoster, in patients less than 12 years of age with cold sores, in patients less than 2 years of age with chickenpox, or in pediatric patients requiring suppressive treatment after neonatal herpes simplex virus infection.
-Safety and efficacy have not been established in patients 18 years of age or older with chickenpox.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Patients should receive the recommended dose after hemodialysis
Chronic ambulatory peritoneal dialysis and continuous arteriovenous hemofiltration/dialysis: Use with caution, supplemental doses do not appear to be needed

Other Comments

Administration advice:
-Take orally with or without food
-Maintain adequate hydration during therapy
-Shake suspension well prior to use

Preparation Instructions for Extemporaneous Oral Suspension:
1. Prepare Suspension Structured Vehicle USP-NF (SSV) according to USP-NF.
2. Using a pestle and mortar, grind 5 valacyclovir caplets for 25 mg/mL suspension or 10 valacyclovir caplets for 50 mg/mL suspension until a fine powder is produced.
3. Gradually add approximately 5 mL aliquots of SSV to mortar and triturate powder until paste has been produced ensuring the powder has been adequately wetted.
4. Continue to add approximately 5 mL aliquots of SSV to mortar 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.
5. Transfer mixture to suitable 100 mL measuring flask.
6. Transfer cherry flavor (add amount as instructed by suppliers of cherry flavor) to mortar and dissolve in approximately 5 mL SSV. Once dissolved, add to measuring flask.
7. Rinse mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to measuring flask between additions.
8. Add SSV until suspension volume is 100 mL and shake thoroughly to mix.
9. Transfer suspension to an amber glass bottle with a child-resistant closure.

Storage requirements: Suspension should be stored in refrigerator; discard after 28 days.

General:
-Patients should be counseled on safe sex practices as genital herpes may be transmitted in the absence of symptoms through asymptomatic viral shedding
-This drug has not been shown to decrease transmission of sexually transmitted infections other than HSV-2; type-specific serologic testing can determine whether risk for HSV-2 acquisition exits.
-Efficacy of initiating therapy more than 72 hours after onset of the zoster rash, 72 hours after onset of signs and symptoms of a first episode of genital herpes, or 24 hours after onset of signs and symptoms of a recurrent episode are unknown.

Monitoring:
-Asses renal function prior to initiating therapy, especially in the elderly, in patients with preexisting renal disease, or patients receiving concomitant nephrotoxic drugs

Patient advice:
-Patients should be advised to maintain adequate hydration during therapy.
-Patients should understand this drug is not a cure for genital herpes; proper precautions should be discussed and practiced to prevent transmission.
-Patients will need to initiate treatment promptly for recurrences; they should discuss with their healthcare provider whether they need to keep a supply of medication on hand for this purpose.

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