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Side Effects & Adverse Reactions
Acyclovir tablets are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
History
There is currently no drug history available for this drug.
Other Information
Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration.
Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively.
Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C8H11N5O3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25.
The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:
Sources
Acyclovir Manufacturers
- Remedyrepack Inc.
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 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 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. - Proficient Rx Lp
Acyclovir | Walgreens
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 - Quinn Pharmaceuticals, Llc
Acyclovir | Quinn Pharmaceuticals, Llc
Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Table 3. Dosage Modifications for Renal Impairment Normal Dosage Regimen
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.
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24). - Lake Erie Medical Dba Quality Care Products Llc
Acyclovir | Lake Erie Medical Dba Quality Care Products Llc
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Northwind Pharmaceuticals, Llc
Acyclovir | Northwind Pharmaceuticals, 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 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 Interval200 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).
- Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Acyclovir | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Acute Treatment of Herpes Zoster800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentNormal Dosage
RegimenCreatinine Clearance
mL/min/1.73 m 2)Adjusted Dosage Regimen
Dose (mg)
Dosing Interval
200 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,
Hemodialysis
5x daily
every 8 hours
every 12 hoursFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Blenheim Pharmacal, Inc.
Acyclovir | Blenheim Pharmacal, Inc.
Acute Treatment of Herpes Zoster800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentNormal Dosage
RegimenCreatinine Clearance
mL/min/1.73 m 2)Adjusted Dosage Regimen
Dose (mg)
Dosing Interval
200 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,
Hemodialysis
5x daily
every 8 hours
every 12 hoursFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Remedyrepack Inc.
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 ImpairmentCreatinine
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.
- Avkare, Inc.
Acyclovir | Avkare, Inc.
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.
- Direct Rx
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.
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 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 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
- Proficient Rx Lp
Acyclovir | Western Family Foods, Inc.
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 - Northwind Pharmaceuticals, Llc
- Actavis Elizabeth Llc
Acyclovir | Actavis Elizabeth Llc
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 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).
- Heritage Pharmaceuticals, Inc.
Acyclovir | Heritage Pharmaceuticals, Inc.
Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Table 3. Dosage Modifications for Renal Impairment Normal Dosage Regimen
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.
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24). - Major Pharmaceuticals
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 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).
- Apotex Corp.
Acyclovir | Apotex Corp.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Boscogen, Inc.
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).
- Stat Rx Usa
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 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).
- Blenheim Pharmacal, Inc.
Acyclovir | Blenheim Pharmacal, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Blenheim Pharmacal, Inc.
Acyclovir | Blenheim Pharmacal, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Blenheim Pharmacal, Inc.
- Remedyrepack Inc.
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. - Remedyrepack Inc.
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). - Remedyrepack Inc.
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). - Remedyrepack Inc.
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). - Remedyrepack Inc.
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). - Remedyrepack Inc.
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). - Pd-rx Pharmaceuticals, Inc.
Acyclovir | Pd-rx Pharmaceuticals, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Remedyrepack Inc.
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). - Remedyrepack Inc.
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). - Redpharm Drug Inc.
Acyclovir | Redpharm Drug Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Remedyrepack Inc.
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). - H.j. Harkins Company, Inc.
Acyclovir | H.j. Harkins Company, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Remedyrepack Inc.
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). - Golden State Medical Supply, Inc.
Acyclovir | Golden State Medical Supply, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- App Pharmaceuticals, Llc
- Pd-rx Pharmaceuticals, Inc.
Acyclovir | Pd-rx Pharmaceuticals, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Apotex Corp.
Acyclovir | Apotex Corp.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Golden State Medical Supply, Inc.
Acyclovir | Golden State Medical Supply, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Carlsbad Technology, Inc.
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
- Golden State Medical Supply, Inc.
Acyclovir | Golden State Medical Supply, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- App Pharmaceuticals, Llc
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.
DosageHERPES 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.
DosageHERPES 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.
- Bryant Ranch Prepack
Acyclovir | Bryant Ranch Prepack
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Pd-rx Pharmaceuticals, Inc.
- Remedyrepack Inc.
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). - Bryant Ranch Prepack
Acyclovir | Bryant Ranch Prepack
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Remedyrepack Inc.
Acyclovir | Remedyrepack Inc.
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 hoursFor 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).
- Remedyrepack Inc.
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 hoursFor 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).
- Preferred Pharmaceuticals, Inc.
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
- Rebel Distributors Corp
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 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).
- Remedyrepack Inc.
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 hoursFor 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).
- Remedyrepack Inc.
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 hoursFor 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).
- Pd-rx Pharmaceuticals, Inc.
Acyclovir | Pd-rx Pharmaceuticals, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Medvantx, Inc.
Acyclovir | Medvantx, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Avkare, Inc.
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
- Golden State Medical Supply, Inc.
Acyclovir | Golden State Medical Supply, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Lake Erie Medical Dba Quality Care Products Llc
Acyclovir | Lake Erie Medical Dba Quality Care Products Llc
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Major Pharmaceuticals
Acyclovir | Major Pharmaceuticals
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Major Pharmaceuticals
Acyclovir | Major Pharmaceuticals
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Remedyrepack Inc.
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 hoursFor 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).
- Golden State Medical Supply, Inc.
Acyclovir | Golden State Medical Supply, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 RegimenNormal Dosage
RegimenClearance
(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
0-10400
200every 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Heritage Pharmaceuticals Inc.
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).
- Clinical Solutions Wholesale
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 DisorderAdminister 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 DisorderAdults
2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain
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.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.
2.5 Dosage for Treatment of Chronic Musculoskeletal Pain
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)].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 PopulationsHepatic Impairment — Avoid use in patients with chronic liver disease or cirrhosis [see Warnings and Precautions (5.14)and Use in Specific Populations (8.9)].
2.7 Discontinuing Duloxetine
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)].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 DisordersAt 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 BlueDo 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)]. - Avkare, Inc.
Acyclovir | Avkare, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Camber Pharmaceuticals, Inc.
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 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. - Unit Dose Services
Acyclovir | Unit Dose Services
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Cadila Pharmaceuticals Limited
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 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:
One Acyclovir 800-mg tablet was shown to be bioequivalent to four Acyclovir 200-mg capsules (n = 24). - Blenheim Pharmacal, Inc.
- American Health Packaging
Acyclovir | American Health Packaging
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- American Health Packaging
Acyclovir | American Health Packaging
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 Herpes200 mg every 4 hours, 5 times daily for 10 days.
Adults and Children over 40 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Cadila Pharmaceuticals Limited
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). - State Of Florida Doh Central Pharmacy
Acyclovir | State Of Florida Doh Central Pharmacy
Acute Treatment of Herpes Zoster800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- State Of Florida Doh Central Pharmacy
Acyclovir | State Of Florida Doh Central Pharmacy
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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/1.73m2 )Adjusted Dosage Regimen
Dose (mg)
Dosing Interval
200 mg every
4 hours> 10
0 to 10200
200every 4 hours, 5x daily
every 12 hours400 mg every
12 hours> 10
0 to 10400
200every 12 hours
every 12 hours800 mg every
4 hours> 25
10 to 25
0 to 10800
800
800every 4 hours, 5x daily
Hemodialysis
every 8 hours
every 12 hoursFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Direct Rx
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 ImpairmentCreatinine
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.
- Bedford Laboratories
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.
DOSAGEHERPES 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 ImpairmentCreatinine Clearance
(mL/min/1.73 m2)
Percent of Recommended Dose
Dosing Interval
(hours)
> 50
25 – 50
10 – 25
0 – 10100%
100%
100%
50%8
Hemodialysis
12
24
24For 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Method of PreparationEach 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.
ADMINISTRATIONThe 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.
- Fresenius Kabi Usa, Llc
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.
DosageHERPES 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.
10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
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.
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.
20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.
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.
20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
Obese PatientsObese 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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
AdministrationThe 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.
DosageHERPES 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.
10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
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.
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.
20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.
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.
20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
Obese PatientsObese 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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
AdministrationThe 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.
- Blenheim Pharmacal, Inc.
- Blenheim Pharmacal, Inc.
Acyclovir | Blenheim Pharmacal, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours, orally, 5 times daily for 7 to 10 days
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Aphena Pharma Solutions – Tennessee, Llc
Acyclovir | Aphena Pharma Solutions - Tennessee, Llc
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
- Northwind Pharmaceuticals
- Carlsbad Technology, Inc.
Acyclovir | Carlsbad Technology, Inc.
Acute Treatment of Herpes Zoster800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Cardinal Health
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 ImpairmentNormal 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).
- Bryant Ranch Prepack
Acyclovir | Bryant Ranch Prepack
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Pd-rx Pharmaceuticals, Inc.
Acyclovir | Mylan Pharmaceuticals Inc.
2.1 Usual Dosage and AdministrationThe 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.
AdultsThe 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 AgeThe 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 Trachomatis100 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. Urealyticum100 mg by mouth twice-a-day for 7 days.
Syphilis–EarlyPatients 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 DurationPatients 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. Trachomatis100 mg, by mouth, twice-a-day for at least 10 days.
2.2 For Prophylaxis of MalariaFor 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) Adults100 mg, of doxycycline, by mouth, twice-a-day for 60 days.
Childrenweighing 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 ApplesauceDoxycycline 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.
- Cardinal Health
Acyclovir | Cardinal Health
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Zydus Pharmaceuticals (Usa) Inc.
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 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.
- Cadila Healthcare Limited
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 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.
- Proficient Rx Lp
Acyclovir | Proficient Rx Lp
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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
HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Avpak
Acyclovir | Avpak
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Avpak
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 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 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
- Preferred Pharmaceuticals, Inc.
- State Of Florida Doh Central Pharmacy
Acyclovir | State Of Florida Doh Central Pharmacy
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 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 Therapy200 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 kg800 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 ImpairmentIn 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 HemodialysisFor 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 DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage FormsAcyclovir 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).
- Proficient Rx Lp
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 ImpairmentNormal 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).
- Medsource Pharmaceuticals
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 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.
- Remedyrepack Inc.
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 ImpairmentCreatinine
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.
- Direct Rx
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. - Proficient Rx Lp
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 Interval200 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 hours800 mg every 4 hours
> 25
10-25
0-10
800
800
800
every 4 hours, 5x daily
every 8 hours
every 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. - Remedyrepack Inc.
Acyclovir | Proficient Rx Lp
2.1 Dosage in AdultsUse 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 PopulationsElderly 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 DepressantsDosage 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 AdministrationThe effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
- Directrx
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 ImpairmentNormal Dosage Regimen
Creatinine Clearance
(mL/min/1.73 m2)
Adjusted Dosage RegimenDose (mg)
Dosing Interval
200 mg every 4 hours> 10
0-10
200
200
every 4 hours, 5x daily
every 12 hours400 mg every 12 hours
> 10
0-10
400
200
every 12 hoursevery 12 hours
800 mg every 4 hours
> 25
10-25
0-10
800
800
800
every 4 hours, 5x daily
every 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.
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