Simplovir 1 gm/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
• Dependence on intracellular conversion of the drug to Acyclovir Triphosphate

Dosage

• 5 mg/kg every 8 hours for Herpes simplex infection in normal or immunocompromised immune status
• 5 mg/kg every 8 hours for very severe Herpes zoster infection (shingles) in normal immune status
• 10 mg/kg every 8 hours for Varicella zoster infection in immunocompromised immune status
• 10 mg/kg every 8 hours for Herpes simplex encephalitis in normal or immunocompromised immune status

Administration

• Recommended duration of administration: 5-7 days for most infections, at least 10 days for Herpes simplex encephalitis
• Should be administered by slow intravenous infusion over a one-hour period

Interaction

• Co-administration of probenecid with Simplovir increases mean Simplovir half-life
• Urinary excretion and renal clearance reduced with co-administration of probenecid
• Significant increase in plasma levels of Simplovir in patients over 60 years of age with concurrent use of diuretics

Contraindications

• Contraindicated in patients hypersensitive to Acyclovir or Valacyclovir

Side Effects

• Lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and 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
• Not well studied in pregnant women
• Should only be administered to nursing mothers if benefits to mother outweigh potential risks to the baby

Precautions & Warnings

• Intended for intravenous infusion only
• Reconstituted IV infusion with pH of approximately 11.0 should not be administered by mouth
• Must be given over a period of at least one hour to avoid renal tubular damage
• Concomitant use of other nephrotoxic drugs, pre-existing renal disease, and dehydration increase risk of renal impairment

Use in Special Populations

• Pediatric use: Dose calculation based on body surface area
• Geriatric use: Special attention to dosage reduction due to low creatinine clearance
• In patients with renal impairment: Dosage modification based on creatinine clearance

Overdose Effects

• Elevations of serum creatinine and blood urea nitrogen
• Renal failure
• Neurological effects - confusion, hallucinations, agitation, seizures, and coma
• Adequate hydration essential to reduce possibility of crystal formation in the urine

Therapeutic Class

• Herpes simplex & Varicella-zoster virus infections

Duration of Treatment

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

Reconstitution

• 250 mg vial reconstituted with 10 ml Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v)
• 500 mg vial reconstituted with 10 ml 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 the reach of children

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