Clovir IV Infusion

500 mg/vial
Ibn-Sina Pharmaceuticals Ltd.

Pack Size & Price:

500 mg vial : Price Unavailable

Indications

Acyclovir IV for Infusion is indicated for the treatment of-
  • Herpes Simplex infections in immunocompromised patients 
  • Initial and recurrent mucosal and cutaneous Herpes Simplex (HSV-1 and HSV-2) infections in immunocompromised patients 
  • Severe initial clinical episodes of herpes genitalis in immunocompetent patients 
  • Herpes Simplex encephalitis 
  • Neonatal herpes simplex virus infections and varicella-zoster (shingles) infections in immunocompromised patients.

Therapeutic Class

Herpes simplex & Varicella-zoster virus infections

Pharmacology

Acyclovir is a synthetic purine nucleoside analogue which is active against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. Acyclovir triphosphate stops replication of herpes viral DNA.

This is accomplished in three ways
  1. Competitive inhibition of viral DNA polymerase
  2. Incorporation into and termination of the growing viral DNA chain
  3. Inactivation of the viral DNA polymerase

Dosage & Administration

Intravenous-

Prophylaxis of herpes simplex in immunocompromised patients:
  • Adult: 5 mg/kg 8 hrly for 5-7 days. Dose to be given as IV infusion over 1 hr.
  • Child: >3 mth to 12 yr 250 mg/m2 8 hrly for 5-10 days. Dose to be given as IV infusion over 1 hr.
Herpes simplex encephalitis:
  • Adult: 10 mg/kg 8 hrly for 10 days. Dose to be given as IV infusion over 1 hr.
  • Child: >3 mth to 12 yr 500 mg/m2 8 hrly for 5-10 days. Dose to be given as IV infusion over 1 hr.
First episodes of genital herpes:
  • Adult: 5 mg/kg 8 hrly for 5-7 days. Dose to be given as IV infusion over 1 hr.
Varicella zoster:
  • Adult: 5 mg/kg 8 hrly. Immunocompromised patients: 10 mg/kg 8 hrly. Dose to be given as IV infusion over 1 hr.
  • Child: >3 mth to 12 yr 250 mg/m2 8 hrly for 5-10 days. Immunocompromised patients: 500 mg/m2 8 hrly for 5-10 days. Dose to be given as IV infusion over 1 hr.
Neonatal herpes simplex virus infections:
  • Child: 0-3 mth 10 mg/kg every 8 hr for 10 days. Dose to be given as IV infusion over 1 hr.

Interaction

Coadministration of probenecid with acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.

Contraindications

Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.

Side Effects

Most common side effects are headache, nausea, diarrhea, rash and phlebitis.

Pregnancy & Lactation

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 

Use in nursing mothers: Acyclovir should be administered to a nursing mother with caution and only when indicated. Geriatric Use: No overall differences in safety are observed between older and younger subjects.

Precautions

Precipitation of acyclovir crystals in renal tubules can occur if the maximum solubility of free acyclovir is exceeded or if the drug is administered by bolus injection. When dosage adjustments are required they should be based on estimated creatinine clearance.

Overdose Effects

Symptoms: Elevations in BUN and serum creatinine, subsequent renal failure, anuria, agitation, coma, lethargy, seizures.

Management: Consider use of haemodialysis until renal function is restored.

Use in Special Population

The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir Infusion in doses of 250 mg per square metre of body surface area (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg per square metre of body surface area (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.

Duration of Treatment

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Reconstitutions

Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.

Storage Conditions

Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.