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Zovirax Injection (Acyclovir Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Herpes Simplex Infections in Immunocompromised Patients: ZOVIRAX for 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: ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients.

Herpes Simplex Encephalitis: ZOVIRAX for Injection is indicated for the treatment of herpes simplex encephalitis.

Neonatal Herpes Simplex Virus Infection: ZOVIRAX for Injection is indicated for the treatment of neonatal herpes infections.

Varicella-Zoster Infections in Immunocompromised Patients: ZOVIRAX for 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 IMMUNOCOMPROMISED PATIENTS:

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

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

SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:

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

HERPES SIMPLEX ENCEPHALITIS:

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

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

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

VARICELLA ZOSTER INFECTIONS: ZOSTER IN IMMUNOCOMPROMISED PATIENTS:

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

Pediatrics (Under 12 years of age): 20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

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

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

Table 5. Dosage Adjustments for Patients with Renal Impairment
Creatinine Clearance
(mL/min per 1.73 m2)
Percent of
Recommended Dose
Dosing Interval
(hours)
>50 100% 8
25 - 50 100% 12
10 - 25 100% 24
0 - 10 50% 24

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

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

Method of Preparation: Each 10-mL vial contains acyclovir sodium equivalent to 500 mg of acyclovir. Each 20-mL vial contains acyclovir sodium equivalent to 1,000 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
1,000 mg 20 mL

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

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

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

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

HOW SUPPLIED

10-mL sterile vials, each containing acyclovir sodium equivalent to 500 mg of acyclovir. Tray of 10 (NDC 0173-0995-01).

20-mL sterile vials, each containing acyclovir sodium equivalent to 1,000 mg of acyclovir. Tray of 10 (NDC 0173-0952-01).

Store at 15 to 25C (59 to 77F).

Manufactured by DSM Pharmaceuticals, Inc.

Greenville, NC 27834

for GlaxoSmithKline, Research Triangle Park, NC 27709

2003, GlaxoSmithKline. All rights reserved.

November 2003/RL-2050

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