Acyclovir Suspension

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 oral suspension.

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 per 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 oral suspension is indicated for the treatment of varicellazoster 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 oral suspension 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.

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 oral suspension.

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 per 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 oral suspension is indicated for the treatment of varicellazoster 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 oral suspension 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.

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 Oral Suspension 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) Dosage
Interval

200 mg every
4 hours

>10


0-10

200


200

every
4 hours,
5 x 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,
5 x 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 oral 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).

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 oral suspension should be modified as shown in Table 3:

Table 3: Dosage Modification for Renal Impairment Creatinine Adjusted Dosage Regimen Normal Clearance Dose Dosage Regimen (mL/min/1.73m2) (mg) Dosage Interval 200 mg every 4 hours >10 200 every 4 hours, 5 x 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, 5 x 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 oral 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).

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 oral suspension.

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 per 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 oral suspension is indicated for the treatment of varicellazoster 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 oral suspension 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.

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 oral suspension.

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 per 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 oral suspension is indicated for the treatment of varicellazoster 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 oral suspension 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.

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, Tablets, or Suspension 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  0-10 200  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).