Simplovir 250 mg/vial (IV Infusion)

Indications

• Treatment of acute clinical manifestations of Herpes simplex virus in immunocompromised patients
• Treatment of severe primary or non-primary genital herpes in immune competent patients
• Treatment of Varicella zoster virus infection in immunocompromised patients
• Treatment of Herpes zoster (shingles) in immune competent patients with severe acute local or systemic manifestations
• Treatment of Herpes simplex encephalitis

Pharmacology

• Interferes with DNA synthesis of Herpes simplex virus and Varicella zoster virus
• Inhibits viral replication
• Dependent on intracellular conversion to Acyclovir Triphosphate

Dosage

• Dose for Herpes simplex infection in normal or immunocompromised patients: 5 mg/kg every 8 hours
• Dose for very severe Herpes zoster infection (shingles) in normal immune status: 5 mg/kg every 8 hours
• Dose for Varicella zoster infection in immunocompromised patients: 10 mg/kg every 8 hours
• Dose for Herpes simplex encephalitis in normal or immunocompromised patients: 10 mg/kg every 8 hours
• Each dose should be administered by slow intravenous infusion over a one-hour period

Administration

• Recommended duration of administration for most infections: 5-7 days
• Recommended duration of administration for Herpes simplex encephalitis: at least 10 days
• Administered by intravenous infusion only
• Must be given over a period of at least one hour to avoid renal tubular damage
• Maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively
• Compatible with various infusion fluids
• No preservatives

Interaction

• Co-administration of probenecid increases Simplovir half-life
• Concurrent use of diuretics in patients over 60 years increases plasma levels significantly

Contraindications

• Hypersensitivity to Acyclovir or Valacyclovir

Side effects

• Lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions, coma
• Phlebitis, nausea, vomiting
• Reversible increases in liver-related enzymes
• Pruritus, urticaria, rashes
• Increases in blood urea and creatinine
• Local inflammatory reactions if infused into extracellular tissues

Pregnancy lactation

• Pregnancy category B
• No adequate and well-controlled studies
• Should only be administered to nursing mothers if benefits outweigh potential risks
• No experience of the effect on human fertility

Precautions warnings

• Reconstituted solution has a pH of approximately 11.0 and should not be administered by mouth
• Must be accompanied by adequate hydration
• Contraindicated with other nephrotoxic drugs
• Associated with reversible encephalopathic changes
• Use with caution in patients with neurological abnormalities, significant hypoxia, serious renal, hepatic, or electrolyte abnormalities

Pediatric uses

• Dose calculation based on body surface area for children aged 1-12 years
• Immunocompromised children may require higher doses
• Dose modification required for children with impaired renal function

Overdose effects

• Elevations of serum creatinine, blood urea nitrogen, and subsequent renal failure
• Neurological effects including confusion, hallucinations, agitation, seizures, coma
• Adequate hydration essential to reduce possibility of crystal formation in urine
• Hemodialysis enhances removal from blood

Therapeutic class

• Herpes simplex & Varicella-zoster virus infections

Duration of treatment

• Recommended duration for most infections: 5-7 days
• Recommended duration for Herpes simplex encephalitis: at least 10 days

Reconstitution

• 250 mg vial: reconstituted by addition of 10 ml of Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v)
• 500 mg vial: reconstituted by addition of 10 ml of Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v)

Storage conditions

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

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