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Acyclovir (Acyclovir) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Herpes Simplex Infections in lmmunocompromised Patients

Acyclovir Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients.

Initial Episodes of Herpes Genitalis

Acyclovir Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients.

Herpes Simplex Encephalitis

Acyclovir Injection is indicated for the treatment of herpes simplex encephalitis.

Neonatal Herpes Simplex Virus Infection

Acyclovir Injection is indicated for the treatment of neonatal herpes infections.

Varicella-Zoster Infections in lmmunocompromised Patients

Acyclovir Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.

DOSAGE AND ADMINISTRATION

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

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

Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.

Dosage

Herpes Simplex Infections: Mucosal and Cutaneous Herpes Simplex (HSV-1 and HSV-2) Infections in lmmunocompromised Patients :

  •   Adults and Adolescents (12 years of age and older): 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
  •   Pediatrics (Under 12 years of age): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

Severe Initial Clinical Episodes of Herpes Genitalis:

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

Herpes Simplex Encephalitis:

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

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

Varicella Zoster Infections: Zoster in Immunocompromised Patients:

  •   Adults and Adolescents (12 years of age and older): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.
  •   Pediatrics (under 12 years of age): 20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

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

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

Table 5: Dosage Adjustments for Patients with Renal Impairment
Creatine Clearance
(mL/min/1.73 m2)
Percent of
Recommended Dose
Dosing Interval
(hours)
>50100%8
25 - 50100%12
10 - 25100%24
0 - 1050%24

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

Method of Preparation: Each 20 mL vial contains acyclovir sodium equivalent to 500 mg of acyclovir as a sterile aqueous solution. Each 40 mL vial contains acyclovir sodium equivalent to 1000 mg or 1 g of acyclovir as a sterile aqueous solution. The solution in the vial is ready for further dilution prior to infusion.

Administration

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

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

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

HOW SUPPLIED

Acyclovir Injection is supplied as sterile vials, each containing acyclovir sodium equivalent to 500 mg of acyclovir for intravenous administration in 20 mL of water for injection, tray of 10 (NDC 61703-311-21). Each mL contains acyclovir 25 mg/mL.

Acyclovir Injection is supplied as sterile vials, each containing acyclovir sodium equivalent to 1000 mg of acyclovir for intravenous administration in 40 mL of water for injection, tray of 10 (NDC 61703-311-43). Each mL contains acyclovir 25 mg/mL.

Store between 15° to 25°C (59° and 77°F).

Manufactured for:

Mayne Pharma (USA) Inc.

Paramus, NJ  07652

By: Mayne Pharma Pty Ltd

Mulgrave VIC 3170

Australia

Rev. February 2004

480162

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