Acyclovir

Acyclovir Manufacturers

• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

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  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg:  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.
  Table 3. Dosage Modification for Renal Impairment 

  
  Normal Dosage Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval 200 mg every 4 hours
  
  > 10
  0-10
  200
   200 
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  > 10
  0-10
  400
   200 
  every 12 hours
  
  every 12 hours 800 mg every 4 hours
  > 25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  
  every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

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• Proficient Rx Lp
  

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  Acyclovir | Walgreens

  

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  find the right dose on the chart mL = milliliter measure only with dosing cup provided keep dosing cup with product take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours  age (yr)  dose (mL)  children 6 to 11 years 5 mL to 10 mL  children 2 to 5 years  do not use unless directed by a doctor  children under 2 years do not use

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• Quinn Pharmaceuticals, Llc
  

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  Acyclovir | Quinn Pharmaceuticals, Llc

  

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  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3.

  Table 3. Dosage Modifications for Renal Impairment Normal Dosage Regimen
  Creatinine Clearance (mL/min/1.73m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  0-10
  200
  200
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  >10
  0-10 400
  200
  every 12 hours
  every 12 hours
  800 mg every 4 hours
  >25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
  

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Acyclovir | Lake Erie Medical Dba Quality Care Products Llc

  

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  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Northwind Pharmaceuticals, Llc
  

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  Acyclovir | Northwind Pharmaceuticals, Llc

  

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  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage                  Regimen Creatinine Clearance                   Adjusted Dosage Regimen
                                              mL/min/1.73 m 2)                                       Dose (mg)      Dosing Interval

  200 mg every 4 hours             >10                                                            200               every 4 hours, 5x daily

                                                  0-10                                                          200                every 12 hours

  400  mg every 12 hours         >10                                                           400                 every 12 hours

                                                0-10                                                           200                  every 12 hours

  800 mg every 4 hours          >25                                                              800                  every 4 hours, 5x daily

                                              10-25                                                            800                  every 8 hours

                                               0-10                                                             800                  every 12 hours
  

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Mckesson Packaging Services A Business Unit Of Mckesson Corporation
  

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  Acyclovir | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

  

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  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage
  Regimen

  Creatinine Clearance
  mL/min/1.73 m 2)

  Adjusted Dosage Regimen

  Dose (mg)

  Dosing Interval

  200 mg every
  4 hours

  >10
  
  0-10

  200
  
  200

  every 4 hours,
  5x daily
  every 12 hours

  400 mg every
  
  12 hours

  >10
  
  0-10

  400
  
  200

  every 12 hours
  
  every 12 hours

  800 mg every
  4 hours

  >25
  
  10-25
  0-10

  800
  
  800
  800

  every 4 hours,
  5x daily
  every 8 hours
  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Blenheim Pharmacal, Inc.
  

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  Acyclovir | Blenheim Pharmacal, Inc.

  

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  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage
  Regimen

  Creatinine Clearance
  mL/min/1.73 m 2)

  Adjusted Dosage Regimen

  Dose (mg)

  Dosing Interval

  200 mg every
  4 hours

  >10
  
  0-10

  200
  
  200

  every 4 hours,
  5x daily
  every 12 hours

  400 mg every
  
  12 hours

  >10
  
  0-10

  400
  
  200

  every 12 hours
  
  every 12 hours

  800 mg every
  4 hours

  >25
  
  10-25
  0-10

  800
  
  800
  800

  every 4 hours,
  5x daily
  every 8 hours
  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

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  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

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• Avkare, Inc.
  

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  Acyclovir | Avkare, Inc.

  

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  Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment, USP 5% to prevent autoinoculation of other body sites and transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.

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• Direct Rx
  

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  Acyclovir | Direct Rx

  

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  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine Clearance
  mL/min/1.73 m 2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every
  4 hours >10
  
  0-10 200
  
  200 every 4 hours,
  5x daily
  every 12 hours 400 mg every
  
  12 hours >10
  
  0-10 400
  
  200 every 12 hours
  
  every 12 hours 800 mg every
  4 hours >25
  
  10-25
  0-10 800
  
  800
  800 every 4 hours,
  5x daily
  every 8 hours
  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Proficient Rx Lp
  

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  Acyclovir | Western Family Foods, Inc.

  

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  do not take more than 6 doses in a 24-hour period measure only with dosing cup provided Do not use any other dosing device. keep dosing cup with product mL=milliliter shake well before using adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use
  

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• Northwind Pharmaceuticals, Llc
  

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  Acyclovir | Northwind Pharmaceuticals, Llc

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Actavis Elizabeth Llc
  

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  Acyclovir | Actavis Elizabeth Llc

  

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  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, five times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes:200 mg every 4 hours, five times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg two times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from
  200 mg three times daily to 200 mg five times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy:200 mg every 4 hours, five times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older):20 mg/kg per dose orally four times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg:800 mg four times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules or tablets should be modified as shown in Table 3:

  Normal Dosage Regimen Creatinine Clearance (mL/min/1.73m2) Adjusted Dosage Regimen Dose (mg) Dosage Interval Table 3: Dosage Modification for Renal Impairment 200 mg every 4 hours >100-10 200200 every 4 hours,     5x dailyevery 12 hours 400 mg every 12 hours >100-10 400200 every 12 hoursevery 12 hours 800 mg every 4 hours >2510-250-10 800800800 every 4 hours,     5x dailyevery 8 hoursevery 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n=24).

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• Heritage Pharmaceuticals, Inc.
  

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  Acyclovir | Heritage Pharmaceuticals, Inc.

  

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  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3.

  Table 3. Dosage Modifications for Renal Impairment Normal Dosage Regimen
  Creatinine Clearance (mL/min/1.73m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  0-10
  200
  200
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  >10
  0-10 400
  200
  every 12 hours
  every 12 hours
  800 mg every 4 hours
  >25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
  

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• Major Pharmaceuticals
  

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  Acyclovir | Major Pharmaceuticals

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:

   Table 3: Dosage Modification for Renal Impairment   Normal Dosage   Creatinine Clearance   Adjusted Dosage Regimen   Regimen   (mL/min/1.73 m2)   Dose(mg)   Dosing Interval   200 mg every   > 10   200   every 4 hours, 5 times daily   4 hours   0 to 10   200   every 12 hours   400 mg every   > 10   400   every 12 hours   12 hours   0 to 10   200   every 12 hours   800 mg every   > 25   800   every 4 hours, 5 times daily   4 hours   10 to 25   800   every 8 hours       0 to 10   800   every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).

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• Apotex Corp.
  

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  Acyclovir | Apotex Corp.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Boscogen, Inc.
  

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  Acyclovir | Boscogen, Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation.  Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.  The frequency and severity of episodes of untreated genital herpes may change over time.  After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assesst he need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days.  Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days.  Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox.  There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3.
  

                          Table 3. Dosage Modifications for Renal Impairment

  ------------------------------------------------------------------------------------------------------------------------------------------------------------

  Normal Dosage                        Creatinine Clearance               Adjusted Dosage                        Dosing Interval

  Regimen                                  (mL/min/1.73m2)                    Regimen Dose (mg)

  200 mg every 4 hours                >10                                       200                                          Every 4 hours, 5x daily

                                                  0-10                                      200                                          Every 12 hours

  400 mg every 12 hours              >10                                       400                                          Every 12 hours

                                                  0-10                                      200                                          Every 12 hours

                                                 >25                                        800                                          Every 4 hours, 5x daily

  800 mg every 4 hours                10-25                                     800                                          Every 8 hours

                                                  0-10                                      800                                           Every 12 hours

  -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period.  Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n=20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n=24).
  

                                               
  

  
  

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• Stat Rx Usa
  

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  Acyclovir | Stat Rx Usa

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance                                      Adjusted Dosage Regimen Regimen (mL/min/1.73 m2)                      Dose(mg) Dosing Interval 200 mg every      > 10                             200 every 4 hours, 5 times daily     4 hours  0 to 10                             200      every 12 hours 400 mg every      > 10                             400      every 12 hours     12 hours  0 to 10                             200      every 12 hours 800 mg every      > 25                             800 every 4 hours, 5 times daily     4 hours 10 to 25                             800      every 8 hours    0 to 10                             800      every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).

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• Blenheim Pharmacal, Inc.
  

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  Acyclovir | Blenheim Pharmacal, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Blenheim Pharmacal, Inc.
  

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  Acyclovir | Blenheim Pharmacal, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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  Acyclovir | Wal-mart Stores Inc

  

  ---

  do not take more than directed
  (see overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  DOSAGE AND ADMINISTRATION
  
  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 years of age and older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
  Table 3. Dosage Modification for Renal Impairment
  CreatinineAdjusted Dosage RegimenNormal Dosage RegimenClearanceDose (mg)Dosing Interval(mL/min/1.73 m2)200 mg every 4 hours>10200every 4 hours, 5x daily0-10200every 12 hours400 mg every 12 hours>10 0-10400 200every 12 hours every 12 hours800 mg every 4 hours>25800every 4 hours, 5x daily10-25800every 8 hours0-10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  DOSAGE AND ADMINISTRATION
  
  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 Years of age and Older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children Over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormalCreatinine ClearanceAdjusted Dosage RegimenDosage(mL/min/1.73 m2)DoseDosingRegimen(mg)Interval200 mg every> 10200every 4 hours,4 hours5x daily0 to 10200every 12 hours400 mg every> 10400every 12 hours12 hours0 to 10200every 12 hours800 mg every> 25800every 4 hours,4 hours5x daily10 to 25800every 8 hours0 to 10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 Years of age and Older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children Over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormal Dosage Creatinin CleranceAdjust Dosage RegimemRegiman(mL/min/1.73 m2)DoseDosing Interval(mg)200mg every>10200every 4 hours, 5x daily4 hours0 to 10200every 12 hours400mg every>10400every 12 hours12 hours0 to 10200every 12 hours800mg every>25800every 4 hours, 5x daily4 hours10 to 25800every 8 hours0 to 10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and children over 40 kg: 800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormal DosageCreatinine ClearanceAdjusted Dosage RegimenRegimen(mL/min/1.73 m2)Dose(mg)Dosing Interval200 mg every> 10200every 4 hours, 5 times daily4 hours0 to 10200every 12 hours400 mg every> 10400every 12 hours12 hours0 to 10200every 12 hours800 mg every> 25800every 4 hours, 5 times daily4 hours10 to 25800every 8 hours0 to 10800every 12 hoursHemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and children over 40 kg: 800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:
  Table 3: Dosage Modification for Renal ImpairmentNormal DosageCreatinine ClearanceAdjusted Dosage RegimenRegimen(mL/min/1.73 m2)Dose(mg)Dosing Interval200 mg every> 10200every 4 hours, 5 times daily4 hours0 to 10200every 12 hours400 mg every> 10400every 12 hours12 hours0 to 10200every 12 hours800 mg every> 25800every 4 hours, 5 times daily4 hours10 to 25800every 8 hours0 to 10800every 12 hoursHemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster:800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes:Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease:400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy:200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg:800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3.
  
  Table 3. Dosage Modifications for Renal Impairment
  Normal Dosage RegimenCreatinine Clearance (mL/min/1.73m2)Adjusted Dosage Regimen Dose (mg)Dosing Interval200 mg every 4 hours>10 0-10200 200every 4 hours, 5x daily every 12 hours400 mg every 12 hours>10 0-10400 200every 12 hours every 12 hours800 mg every 4 hours>25 10-25 0-10800 800 800every 4 hours, 5x daily every 8 hours every 12 hours Hemodialysis:For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis:No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms:acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
  
  

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• Pd-rx Pharmaceuticals, Inc.
  

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  Acyclovir | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After one year of therapy, the frequency and severity of the patient’s genital herpes infection should be reevaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine
  Clearance
  (mL/min/1.72m2 ) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every
  4 hours > 10
  0 to 10 200
  200 every 4 hours, 5x daily
  every 12 hours 400 mg every
  12 hours > 10
  0 to 10 400
  200 every 12 hours
  every 12 hours 800 mg every
  4 hours
  > 25
  10 to 25
  0 to 10 800
  800
  800 every 4 hours, 5x daily
  every 8 hours
  every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four 200 mg capsules (n = 24).

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster:800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes:Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease:400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  Intermittent Therapy:200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older):20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and children over 40 kg:800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients with Acute or Chronic Renal Impairment:In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:
  Table 3: Dosage Modification for Renal ImpairmentNormal DosageCreatinine ClearanceAdjusted Dosage RegimenRegimen(mL/min/1.73 m2)Dose(mg)Dosing Interval200 mg every> 10200every 4 hours, 5 times daily4 hours0 to 10200every 12 hours400 mg every> 10400every 12 hours12 hours0 to 10200every 12 hours800 mg every> 25800every 4 hours, 5 times daily4 hours10 to 25800every 8 hours0 to 10800every 12 hours Hemodialysis:For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis:No supplemental dose appears to be necessary after adjustment of the dosing interval.
  Bioequivalence of Dosage Forms:Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).
  
  

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 Years of age and Older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children Over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormal Dosage RegimenCreatinine Clearance (mL/min/1.73 m2)Adjusted Dosage RegimenDose (mg)Dosing Interval200 mg every 4 hours> 10200every 4 hours, 5x daily0 to 10200every 12 hours400 mg every 12 hours> 10400every 12 hours0 to 10200every 12 hours800 mg every 4 hours> 25800every 4 hours, 5x daily10 to 25800every 8 hours0 to 10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
  
  

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• Redpharm Drug Inc.
  

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  Acyclovir | Redpharm Drug Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 Years of age and Older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children Over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormal Dosage RegimenCreatinine Clearance (mL/min/1.73 m2)Adjusted Dosage RegimenDose (mg)Dosing Interval200 mg every 4 hours> 10200every 4 hours, 5x daily0 to 10200every 12 hours400 mg every 12 hours> 10400every 12 hours0 to 10200every 12 hours800 mg every 4 hours> 25800every 4 hours, 5x daily10 to 25800every 8 hours0 to 10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
  
  

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• H.j. Harkins Company, Inc.
  

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  Acyclovir | H.j. Harkins Company, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy
  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 Years of age and Older)
  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children Over 40 kg
  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:
  
  Table 3: Dosage Modification for Renal ImpairmentNormal Dosage RegimenCreatinine Clearance (mL/min/1.73 m2)Adjusted Dosage RegimenDose (mg)Dosing Interval200 mg every 4 hours> 10200every 4 hours, 5x daily0 to 10200every 12 hours400 mg every 12 hours> 10400every 12 hours0 to 10200every 12 hours800 mg every 4 hours> 25800every 4 hours, 5x daily10 to 25800every 8 hours0 to 10800every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
  
  

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• Golden State Medical Supply, Inc.
  

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  Acyclovir | Golden State Medical Supply, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• App Pharmaceuticals, Llc
  

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  Acyclovir | Proactive Solutions Usa, Llc

  

  ---

  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Acyclovir | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Apotex Corp.
  

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  Acyclovir | Apotex Corp.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Golden State Medical Supply, Inc.
  

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  Acyclovir | Golden State Medical Supply, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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  Acyclovir | Carlsbad Technology, Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen mL/min/1.73 m2) Dose (mg) Dosing Interval 200 mg every >10 200 every 4 hours, 4 hours 5x daily 0-10 200 every 12 hours 400 mg every >10 400 every 12 hours 12 hours 0-10 200 every 12 hours 800 mg every >25 800 every 4 hours, 4 hours 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Golden State Medical Supply, Inc.
  

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  Acyclovir | Golden State Medical Supply, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3 (below):

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• App Pharmaceuticals, Llc
  

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  Acyclovir | App Pharmaceuticals, Llc

  

  ---

  CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS).

  INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS).

  Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections.

  A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2) INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

  HERPES SIMPLEX ENCEPHALITIS:

  Adults and Adolescents (12 years of age and older):

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

  Pediatrics (3 months to 12 years of age): 

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

   

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older):

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age):

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients: 

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

   

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT

  Refer to DOSAGE AND ADMINISTRATION for recommended doses, and adjust the dosing interval as indicated in Table 5.

   

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73m2)

  Percent of Recommended Dose

  Dosing Interval

  (hours)

  >50

  25-50

  10-25

  0-10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis:

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis:

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Method of Preparation:

  Each 10 mL vial contains acyclovir sodium equivalent to 500 mg of acyclovir.  The contents of the vial should be dissolved with 10 mL Sterile Water for Injection.

  The resulting solution contains 50 mg acyclovir per mL.  The pH of the solution is approximately 11.  Shake the vial well to assure complete dissolution before measuring and transferring each individual dose.  The reconstituted solution should be used within 12 hours.  Refrigeration of reconstituted solution may result in the formation of a precipitate which will redissolve at room temperature. 

  DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL OR PARABENS.

  Administration:

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2) INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

  HERPES SIMPLEX ENCEPHALITIS:

  Adults and Adolescents (12 years of age and older):

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

  Pediatrics (3 months to 12 years of age): 

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

   

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older):

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age):

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients: 

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

   

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT

  Refer to DOSAGE AND ADMINISTRATION for recommended doses, and adjust the dosing interval as indicated in Table 5.

   

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73m2)

  Percent of Recommended Dose

  Dosing Interval

  (hours)

  >50

  25-50

  10-25

  0-10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis:

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis:

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Method of Preparation:

  Each 10 mL vial contains acyclovir sodium equivalent to 500 mg of acyclovir.  The contents of the vial should be dissolved with 10 mL Sterile Water for Injection.

  The resulting solution contains 50 mg acyclovir per mL.  The pH of the solution is approximately 11.  Shake the vial well to assure complete dissolution before measuring and transferring each individual dose.  The reconstituted solution should be used within 12 hours.  Refrigeration of reconstituted solution may result in the formation of a precipitate which will redissolve at room temperature. 

  DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL OR PARABENS.

  Administration:

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Bryant Ranch Prepack
  

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  Acyclovir | Bryant Ranch Prepack

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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  Acyclovir | Kanebo Cosmetics Inc.

  

  ---

  Apply liberally and evenly before sun exposure and as needed.

  Use helps prevent sunburn.

  Apply and reapply as directed to avoid lowering protection.

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  Acyclovir | Remedyrepack Inc.

  

  ---

  Acute Treatment of Herpes Zoster
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes
  
  Treatment of Initial Genital Herpes:200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease:
  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy:200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox
  
  Children (2 years of age and older):20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children over 40 kg:800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment
  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:
  
  Table 3. Dosage Modification for Renal Impairment
  Normal Dosage
  RegimenCreatinine Clearance
  mL/min/1.73 m2)Adjusted Dosage RegimenDose (mg)Dosing Interval200 mg every
  4 hours>10
  
  0-10200
  
  200every 4 hours,
  5x daily
  every 12 hours400 mg every
  
  12 hours>10
  
  0-10400
  
  200every 12 hours
  
  every 12 hours800 mg every
  4 hours>25
  
  10-25
  0-10800
  
  800
  800every 4 hours,
  5x daily
  every 8 hours
  every 12 hours
  Hemodialysis
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms
  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
  

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• Bryant Ranch Prepack
  

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  Acyclovir | Bryant Ranch Prepack

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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  ---

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

   

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine Clearance
  mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every
  4 hours >10
  
  0-10 200
  
  200 every 4 hours,
  5x daily
  every 12 hours 400 mg every
  
  12 hours >10
  
  0-10 400
  
  200 every 12 hours
  
  every 12 hours 800 mg every
  4 hours >25
  
  10-25
  0-10 800
  
  800
  800 every 4 hours,
  5x daily
  every 8 hours
  every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

   

   

   

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

   

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• Preferred Pharmaceuticals, Inc.
  

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  Acyclovir | Preferred Pharmaceuticals, Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen mL/min/1.73 m2) Dose (mg) Dosing Interval 200 mg every >10 200 every 4 hours, 4 hours 5x daily 0-10 200 every 12 hours 400 mg every >10 400 every 12 hours 12 hours 0-10 200 every 12 hours 800 mg every >25 800 every 4 hours, 4 hours 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Rebel Distributors Corp
  

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  Acyclovir | Rebel Distributors Corp

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen (mL/min/1.73 m2) Dose(mg) Dosing Interval 200 mg every > 10 200 every 4 hours, 5 times daily 4 hours 0 to 10 200 every 12 hours 400 mg every > 10 400 every 12 hours 12 hours 0 to 10 200 every 12 hours 800 mg every > 25 800 every 4 hours, 5 times daily 4 hours 10 to 25 800 every 8 hours   0 to 10 800 every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n = 24).

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

   

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

   

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• Pd-rx Pharmaceuticals, Inc.
  

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  Acyclovir | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Medvantx, Inc.
  

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  Acyclovir | Medvantx, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Avkare, Inc.
  

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  Acyclovir | Avkare, Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes:Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen mL/min/1.73 m2) Dose (mg) Dosing Interval 200 mg every >10 200 every 4 hours, 4 hours 5x daily 0-10 200 every 12 hours 400 mg every >10 400 every 12 hours 12 hours 0-10 200 every 12 hours 800 mg every >25 800 every 4 hours, 4 hours 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Golden State Medical Supply, Inc.
  

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  Acyclovir | Golden State Medical Supply, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Acyclovir | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Major Pharmaceuticals
  

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  Acyclovir | Major Pharmaceuticals

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment    

  Creatinine

   

  Adjusted Dosage Regimen

   

  Normal Dosage

  Regimen

   

  Clearance

  (mL/min/1.73 m2)

   

  Dose

  (mg)

   

  Dosing Interval

   

  200 mg every 4 hours

   

  >10

   

  200

   

  every 4 hours, 5x daily

     

  0-10

   

  200

   

  every 12 hours

   

  400 mg every 12 hours

   

  >10

  0-10

   

  400

  200

   

  every 12 hours

  every 12 hours

   

  800 mg every 4 hours

   

  >25

   

  800

   

  every 4 hours, 5x daily

     

  10-25

   

  800

   

  every 8 hours

     

  0-10

   

  800

   

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Major Pharmaceuticals
  

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  Acyclovir | Major Pharmaceuticals

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment    

  Creatinine

   

  Adjusted Dosage Regimen

   

  Normal Dosage

  Regimen

   

  Clearance

  (mL/min/1.73 m2)

   

  Dose

  (mg)

   

  Dosing Interval

   

  200 mg every 4 hours

   

  >10

   

  200

   

  every 4 hours, 5x daily

     

  0-10

   

  200

   

  every 12 hours

   

  400 mg every 12 hours

   

  >10

  0-10

   

  400

  200

   

  every 12 hours

  every 12 hours

   

  800 mg every 4 hours

   

  >25

   

  800

   

  every 4 hours, 5x daily

     

  10-25

   

  800

   

  every 8 hours

     

  0-10

   

  800

   

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

   

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• Golden State Medical Supply, Inc.
  

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  Acyclovir | Golden State Medical Supply, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Creatinine Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg) Dosing Interval 200 mg every 4 hours >10 200 every 4 hours, 5x daily 0-10 200 every 12 hours 400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours 800 mg every 4 hours >25 800 every 4 hours, 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Heritage Pharmaceuticals Inc.
  

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  Acyclovir | Heritage Pharmaceuticals Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes:

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days. Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox:

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment:

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine
  Clearance
  (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours >10
  0-10 200
  200 every 4 hours, 5x daily
  every 12 hours 400 mg every 12 hours >10
  0-10 400
  200 every 12 hours
  every 12 hours 800 mg every 4 hours >25
  10-25
  0-10 800
  800
  800 every 4 hours, 5x daily
  every 8 hours
  every 12 hours Hemodialysis:

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis:

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms:

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Clinical Solutions Wholesale
  

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  Acyclovir | Ascend Laboratories, Llc

  

  ---

  Swallow Duloxetine Delayed-Release Capsules USP whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine Delayed-Release Capsules USP can be given without regard to meals. If a dose of Duloxetine Delayed-Release Capsules USP is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Duloxetine Delayed-Release Capsules USP at the same time.

  2.1 Dosage for Treatment of Major Depressive Disorder
  
  

  Administer duloxetine at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].

  2.2 Dosage for Treatment of Generalized Anxiety Disorder
  

  Adults
  For most patients, initiate duloxetine 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
  
  Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.’s duloxetine delayed-release capsules. However, due to Eli Lilly and Company, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain
  

  Administer duloxetine 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.
  
  Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see Dosage and Administration (2.6), Use in Specific Populations (8.10), and Clinical Pharmacology (12.3)].

  2.5 Dosage for Treatment of Chronic Musculoskeletal Pain

  Administer duloxetine 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].

  2.6 Dosing in Special Populations
  

  Hepatic Impairment — Avoid use in patients with chronic liver disease or cirrhosis [see Warnings and Precautions  (5.14)and Use in Specific Populations (8.9)].
  Severe Renal Impairment — Avoid use in patients with severe renal impairment, GFR <30 mL/min [see Warnings and Precautions (5.14) and Use in Specific Populations (8.10)].

  2.7 Discontinuing Duloxetine
  

  Adverse reactions after discontinuation of duloxetine, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].

  2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
  

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine. Conversely, at least 5 days should be allowed after stopping duloxetine before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4)].

  2.9 Use of Duloxetine with Other MAOIs such as Linezolid or Methylene Blue
  

  Do not start duloxetine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4)].
  
  In some cases, a patient already receiving duloxetine therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine A may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)].
  
  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].

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• Avkare, Inc.
  

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  Acyclovir | Avkare, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Camber Pharmaceuticals, Inc.
  

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  Acyclovir | Camber Pharmaceuticals, Inc.

  

  ---

  
  

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg:  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.
  Table 3. Dosage Modification for Renal Impairment 

  
  
  Normal Dosage Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval 200 mg every 4 hours
  
  > 10
  0-10
  200
   200 
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  > 10
  0-10
  400
   200 
  every 12 hours
  
  every 12 hours 800 mg every 4 hours
  > 25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Unit Dose Services
  

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  Acyclovir | Unit Dose Services

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older)

  20 mg/kg orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox. per dose

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m ) 2

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Cadila Pharmaceuticals Limited
  

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  Acyclovir | Cadila Pharmaceuticals Limited

  

  ---

  
  

  Acute Treatment of Herpes Zoster:
  
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes:
  
  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox:
  
  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
  
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment:
  
  In patients with renal impairment, the dose of Acyclovir Tablets should be modified as shown in Table 3.

  
  
  
  Table 3. Dosage Modification for Renal Impairment
  Normal Dosage
  Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  0-10
  200
  200
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  >10
  0-10
  400
  200
  every 12 hours
  every 12 hours
  800 mg every 4 hours
  >25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  every 12 hours
  
  

  Hemodialysis:
   
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis:
  
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms:
   One Acyclovir 800-mg tablet was shown to be bioequivalent to four Acyclovir 200-mg capsules (n = 24).

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• Blenheim Pharmacal, Inc.
  

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  Acyclovir | Wal-mart Stores Inc.

  

  ---

  Directions

  Wet hands with product and allow to dry without wiping. Not recommended for infants.

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• American Health Packaging
  

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  Acyclovir | American Health Packaging

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• American Health Packaging
  

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  Acyclovir | American Health Packaging

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Cadila Pharmaceuticals Limited
  

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  Acyclovir | Cadila Pharmaceuticals Limited

  

  ---

  
  

  Acute Treatment of Herpes Zoster:
  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  
  Genital Herpes: 
  
  Treatment of Initial Genital Herpes:
  200 mg every 4 hours, 5 times daily for 10 days.
  
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
  
  
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  
  Treatment of Chickenpox:
  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
  
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  
  Patients With Acute or Chronic Renal Impairment:
  In patients with renal impairment, the dose of Acyclovir Capsules should be modified as shown in Table 3.
  
  Table 3. Dosage Modification for Renal Impairment

  
  Normal Dosage
  Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  0-10
  200
  200
  every 4 hours, 5x daily
  every 12 hours
  400 mg every 12 hours
  >10
  0-10
  400
  200
  every 12 hours
  every 12 hours
  800 mg every 4 hours
  >25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours
  every 12 hours
  
  
  

  Hemodialysis:
  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  
  Peritoneal Dialysis:
  No supplemental dose appears to be necessary after adjustment of the dosing interval.
  
  Bioequivalence of Dosage Forms:
  Acyclovir Suspension was shown to be bioequivalent to Acyclovir Capsules (n = 20) and 1 Acyclovir 800-mg tablet was shown to be bioequivalent to 4 Acyclovir 200-mg capsules (n = 24).

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• State Of Florida Doh Central Pharmacy
  

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  Acyclovir | State Of Florida Doh Central Pharmacy

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine Clearance
  mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every
  4 hours >10
  
  0-10 200
  
  200 every 4 hours,
  5x daily
  every 12 hours 400 mg every
  
  12 hours >10
  
  0-10 400
  
  200 every 12 hours
  
  every 12 hours 800 mg every
  4 hours >25
  
  10-25
  0-10 800
  
  800
  800 every 4 hours,
  5x daily
  every 8 hours
  every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• State Of Florida Doh Central Pharmacy
  

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  Acyclovir | State Of Florida Doh Central Pharmacy

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After one year of therapy, the frequency and severity of the patient’s genital herpes infection should be reevaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of Age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment

  Normal Dosage
  Regimen

  Creatinine
  Clearance
  (mL/min/1.73m2 )

  Adjusted Dosage Regimen

  Dose (mg)

  Dosing Interval

  200 mg every
  4 hours

  > 10
  0 to 10

  200
  200

  every 4 hours, 5x daily
  every 12 hours

  400 mg every
  12 hours

  > 10
  0 to 10

  400
  200

  every 12 hours
  every 12 hours

  800 mg every
  4 hours
  

  > 25
  10 to 25
  0 to 10

  800
  800
  800

  every 4 hours, 5x daily
  every 8 hours
  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four 200 mg capsules (n = 24).

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• Direct Rx
  

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  Acyclovir | Direct Rx

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital HerpesTreatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of ChickenpoxChildren (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Bedford Laboratories
  

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  Acyclovir | Bedford Laboratories

  

  ---

  CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS).

  INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (seeWARNINGS).

  Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections.

  A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.

  DOSAGE

  HERPES SIMPLEX INFECTIONS: MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 AND HSV-2) INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older): 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age): 10 mg/kg infused at a constant rate over

  1 hour, every 8 hours for 7 days.

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:

  Adults and Adolescents (12 years of age and older): 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

  HERPES SIMPLEX ENCEPHALITIS:

  Adults and Adolescents (12 years of age and older): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

  Pediatrics (3 months to 12 years of age): 20 mg/kg infused at a constant rate over at least 1 hour, every 8 hours for 10 days.

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days. In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

  VARICELLA ZOSTER INFECTIONS: ZOSTER IN IMMUNOCOMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Pediatrics (Under 12 years of age): 20 mg/kg infused at a constant rate over

  1 hour, every 8 hours for 7 days.

  Obese Patients: Obese patients should be dosed at recommended adult dose using Ideal Body Weight.

  Patients with Acute or Chronic Renal Impairment: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in Table 5.

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73 m2)

  Percent of Recommended Dose

  Dosing Interval

  (hours)

  > 50
  25 – 50
  10 – 25
  0 – 10

  100%
  100%
  100%
  50%

  8
  12
  24
  24

  Hemodialysis

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Method of Preparation

   Each 10 mL vial contains acyclovir sodium equivalent to 500 mg of acyclovir. Each 20 mL vial contains acyclovir sodium equivalent to 1000 mg of acyclovir. The contents of the vial should be dissolved in Sterile Water for Injection as follows:

  Contents of Vial

  Amount of Diluent

  500 mg

  10 mL

  1000 mg

  20 mL

  The resulting solution in each case contains 50 mg acyclovir per mL (pH approximately 11). Shake the vial well to assure complete dissolution before measuring and transferring each individual dose. The reconstituted solution should be used within 12 hours. Refrigeration of reconstituted solution may result in the formation of a precipitate which will redissolve at room temperature.

  DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL OR PARABENS.

  ADMINISTRATION

  The calculated dose should then be removed and added to any appropriate intravenous solution at a volume selected for administration during each 1 hour infusion. Infusion concentrations of approximately 7 mg/mL or lower are recommended. In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose. Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation. Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Fresenius Kabi Usa, Llc
  

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  Acyclovir | Fresenius Kabi Usa, Llc

  

  ---

  CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS).

  INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS).

  Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. 

  A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2)

  INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

   

  HERPES SIMPLEX ENCEPHALITIS:
  

  Adults and Adolescents (12 years of age and older): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Pediatrics (3 months to 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

  
  

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNO­COMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older: 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in Table 5.

   

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73 m2)

  Percent of

  Recommended Dose

  Dosing Interval

  (hours)

  >50

  25 to 50

  10 to 25

  0 to 10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis
  

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Administration

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2)

  INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

   

  HERPES SIMPLEX ENCEPHALITIS:
  

  Adults and Adolescents (12 years of age and older): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Pediatrics (3 months to 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

  
  

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNO­COMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older: 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in Table 5.

   

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73 m2)

  Percent of

  Recommended Dose

  Dosing Interval

  (hours)

  >50

  25 to 50

  10 to 25

  0 to 10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis
  

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Administration

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  Acyclovir | Sun Pharmaceutical Industries, Inc.

  

  ---

  For Control of Hypertension

  The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

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• Blenheim Pharmacal, Inc.
  

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  Acyclovir | Blenheim Pharmacal, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours, orally, 5 times daily for 7 to 10 days

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days-therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients with Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Aphena Pharma Solutions – Tennessee, Llc
  

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  Acyclovir | Aphena Pharma Solutions - Tennessee, Llc

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 years of age and older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Northwind Pharmaceuticals
  

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  Acyclovir | Northwind Pharmaceuticals

  

  ---

  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Carlsbad Technology, Inc.
  

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  Acyclovir | Carlsbad Technology, Inc.

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes

  Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox

  Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen Creatinine Clearance
  mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every
  4 hours >10
  
  0-10 200
  
  200 every 4 hours,
  5x daily
  every 12 hours 400 mg every
  
  12 hours >10
  
  0-10 400
  
  200 every 12 hours
  
  every 12 hours 800 mg every
  4 hours >25
  
  10-25
  0-10 800
  
  800
  800 every 4 hours,
  5x daily
  every 8 hours
  every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Cardinal Health
  

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  Acyclovir | Cardinal Health

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes:Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage

  Creatinine Clearance

  Adjusted Dosage Regimen

  Regimen

  mL/min/1.73 m2)

  Dose (mg)

  Dosing Interval

  200 mg every

  >10

  200

  every 4 hours,

  4 hours

  5x daily

  0-10

  200

  every 12 hours

  400 mg every

  >10

  400

  every 12 hours

  12 hours

  0-10

  200

  every 12 hours

  800 mg every

  >25

  800

  every 4 hours,

  4 hours

  5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Bryant Ranch Prepack
  

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  Acyclovir | Bryant Ranch Prepack

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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  Acyclovir | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 Usual Dosage and Administration

  The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.

  Adults

  The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For Pediatric Patients Above 8 Years of Age

  The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline-class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].

  If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12)].

  When used in streptococcal infections, therapy should be continued for 10 days.

  Uncomplicated Urethral, Endocervical, or Rectal Infection Caused by Chlamydia Trachomatis

  100 mg by mouth twice a day for 7 days. As an alternate dosing regimen for uncomplicated urethral or endocervical infection caused by Chlamydia trachomatis, administer 200 mg by mouth once a day for 7 days.

  Uncomplicated Gonococcal Infections in Adults (Except Anorectal Infections in Men)

  100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

  Nongonococcal Urethritis (NGU) Caused by U. Urealyticum

  100 mg by mouth twice-a-day for 7 days.

  Syphilis–Early

  Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.

  Syphilis of More Than One Year’s Duration

  Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.

  Acute Epididymo-Orchitis Caused by C. Trachomatis

  100 mg, by mouth, twice-a-day for at least 10 days.

  2.2 For Prophylaxis of Malaria

  For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

  2.3 Inhalational Anthrax (Post-Exposure) Adults

  100 mg, of doxycycline, by mouth, twice-a-day for 60 days.

  Children

  weighing less than 45 kg, 2.2 mg/kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.

  2.4 Sprinkling the Tablet over Applesauce

  Doxycycline hyclate delayed-release tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release beads) on a spoonful of applesauce. The delayed-release beads must not be crushed or damaged when breaking up the tablet. Any loss of beads in the transfer would prevent using the dose. The applesauce/doxycycline mixture should be swallowed immediately without chewing and may be followed by a glass of water if desired. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/doxycycline cannot be taken immediately, the mixture should be discarded and not stored for later use.

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• Cardinal Health
  

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  Acyclovir | Cardinal Health

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment

  Normal Dosage Regimen

  Creatinine Clearance (mL/min/1.73 m2)

  Adjusted Dosage Regimen

  Dose (mg)

  Dosing Interval

  200 mg every 4 hours

  > 10

  200

  every 4 hours, 5x daily

  0 to 10

  200

  every 12 hours

  400 mg every 12 hours

  > 10

  400

  every 12 hours

  0 to 10

  200

  every 12 hours

  800 mg every 4 hours

  > 25

  800

  every 4 hours, 5x daily

  10 to 25

  800

  every 8 hours

  0 to 10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Zydus Pharmaceuticals (Usa) Inc.
  

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  Acyclovir | Zydus Pharmaceuticals (usa) Inc.

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir Tablets should be modified as shown in Table 3.

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  
  
  
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  200
  every 4 hours, 5x daily
  
  0 to 10
  200
  every 12 hours
  400 mg every 12 hours
  >10
  400
  every 12 hours
  
  0 to 10
  200
  every 12 hours
  800 mg every 4 hours
  >25
  800
  every 4 hours, 5x daily
  
  10 to 25
  800
  every 8 hours
  
  0 to 10
  800
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Cadila Healthcare Limited
  

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  Acyclovir | Cadila Healthcare Limited

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir Tablets should be modified as shown in Table 3.

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen
  
  
  
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  200
  every 4 hours, 5x daily
  
  0 to 10
  200
  every 12 hours
  400 mg every 12 hours
  >10
  400
  every 12 hours
  
  0 to 10
  200
  every 12 hours
  800 mg every 4 hours
  >25
  800
  every 4 hours, 5x daily
  
  10 to 25
  800
  every 8 hours
  
  0 to 10
  800
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Proficient Rx Lp
  

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  Acyclovir | Proficient Rx Lp

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment

  Normal Dosage Regimen

  Creatinine Clearance (mL/min/1.73 m2)

  Adjusted Dosage Regimen

  Dose (mg)

  Dosing Interval

  200 mg every 4 hours

  > 10

  200

  every 4 hours, 5x daily

  0 to 10

  200

  every 12 hours

  400 mg every 12 hours

  > 10

  400

  every 12 hours

  0 to 10

  200

  every 12 hours

  800 mg every 4 hours

  > 25

  800

  every 4 hours, 5x daily

  10 to 25

  800

  every 8 hours

  0 to 10

  800

  every 12 hours

  Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Avpak
  

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  Acyclovir | Avpak

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Avpak
  

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  Acyclovir | Avpak

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes:Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen mL/min/1.73 m2) Dose (mg) Dosing Interval 200 mg every >10 200 every 4 hours, 4 hours 5x daily 0-10 200 every 12 hours 400 mg every >10 400 every 12 hours 12 hours 0-10 200 every 12 hours 800 mg every >25 800 every 4 hours, 4 hours 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Preferred Pharmaceuticals, Inc.
  

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  Acyclovir | Walgreen Co.

  

  ---

  drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

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• State Of Florida Doh Central Pharmacy
  

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  Acyclovir | State Of Florida Doh Central Pharmacy

  

  ---

  Acute Treatment of Herpes Zoster

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes Treatment of Initial Genital Herpes

  200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox Children (2 Years of age and Older)

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children Over 40 kg

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment

  In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

  Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours > 10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours > 10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours > 25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6 hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms

  Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

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• Proficient Rx Lp
  

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  Acyclovir | Proficient Rx Lp

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease:

  400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage

  Creatinine Clearance

  Adjusted Dosage Regimen

  Regimen

  mL/min/1.73 m2)

  Dose (mg)

  Dosing Interval

  200 mg every

  >10

  200

  every 4 hours,

  4 hours

  5x daily

  0-10

  200

  every 12 hours

  400 mg every

  >10

  400

  every 12 hours

  12 hours

  0-10

  200

  every 12 hours

  800 mg every

  >25

  800

  every 4 hours,

  4 hours

  5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

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• Medsource Pharmaceuticals
  

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  Acyclovir | Medsource Pharmaceuticals

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir Tablets should be modified as shown in Table 3.

  Table 3. Dosage Modification for Renal Impairment Normal Dosage
  Regimen
  Creatinine Clearance
  (mL/min/1.73 m 2)
  Adjusted Dosage Regimen
  
  
  
  Dose (mg)
  Dosing Interval
  200 mg every 4 hours
  >10
  200
  every 4 hours, 5x daily
  
  0 to 10
  200
  every 12 hours
  400 mg every 12 hours
  >10
  400
  every 12 hours
  
  0 to 10
  200
  every 12 hours
  800 mg every 4 hours
  >25
  800
  every 4 hours, 5x daily
  
  10 to 25
  800
  every 8 hours
  
  0 to 10
  800
  every 12 hours
  

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Remedyrepack Inc.
  

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  Acyclovir | Remedyrepack Inc.

  

  ---

   

  800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

   

   

  200 mg every 4 hours, 5 times daily for 10 days.

   

  400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

   

  200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

   

   

  20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

   

  800 mg 4 times daily for 5 days.

  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

   

  In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

  Table 3. Dosage Modification for Renal Impairment

  Creatinine

  Adjusted Dosage Regimen

  Normal Dosage

  Regimen

  Clearance

  (mL/min/1.73 m2)

  Dose

  (mg)

  Dosing Interval

  200 mg every 4 hours

  >10

  200

  every 4 hours, 5x daily

  0-10

  200

  every 12 hours

  400 mg every 12 hours

  >10

  0-10

  400

  200

  every 12 hours

  every 12 hours

  800 mg every 4 hours

  >25

  800

  every 4 hours, 5x daily

  10-25

  800

  every 8 hours

  0-10

  800

  every 12 hours

   

  For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

   

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

   

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• Direct Rx
  

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  Acyclovir | Direct Rx

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.

  Table 3. Dosage Modification for Renal Impairment

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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• Proficient Rx Lp
  

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  Acyclovir | Proficient Rx Lp

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg:  800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.
  Table 3. Dosage Modification for Renal Impairment 

  
  Normal Dosage Regimen

  
  Creatinine Clearance
  (mL/min/1.73 m2)

  
  Adjusted Dosage Regimen

  
  Dose (mg)

  
  Dosing Interval

  200 mg every 4 hours
  

  
  > 10
  0-10

  
  200
   200 

  
  every 4 hours, 5x daily
  every 12 hours

  
  400 mg every 12 hours

  
  > 10
  0-10

  
  400
   200 

  
  every 12 hours
  
  every 12 hours

  800 mg every 4 hours

  
  > 25
  10-25
  0-10

  
  800
  800
  800

  
  every 4 hours, 5x daily
  every 8 hours
  
  every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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  Acyclovir | Proficient Rx Lp

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].  

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

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• Directrx
  

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  Acyclovir | Directrx

  

  ---

  Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
  Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
  Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
  The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
  Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
  Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
  Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
  Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
  When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
  Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.
  Table 3. Dosage Modification for Renal Impairment

  Normal Dosage Regimen
  Creatinine Clearance
  (mL/min/1.73 m2)
  Adjusted Dosage Regimen

  Dose (mg)
  Dosing Interval
  200 mg every 4 hours

  > 10
  0-10
  200
  200
  every 4 hours, 5x daily
  every 12 hours

  400 mg every 12 hours
  > 10
  0-10
  400
  200
  every 12 hours

  every 12 hours
  800 mg every 4 hours
  > 25
  10-25
  0-10
  800
  800
  800
  every 4 hours, 5x daily
  every 8 hours

  every 12 hours

  Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
  Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

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