Clovir 500 mg/vial (IV Infusion)

Title

• Clovir IV Injection for Intravenous Infusion

Category

• Medicine
• Pharmaceutical

Description

• Acyclovir exerts its antiviral effects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication.

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 who show very severe acute local or systemic manifestations of the disease
• Treatment of Herpes simplex encephalitis

Pharmacology

• Interferes with DNA synthesis and inhibits viral replication

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 to 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
• Should be administered by slow intravenous infusion over a one-hour period
• Compatible with Sodium Chloride Intravenous Infusion BP and other specified infusion fluids
• Contains no preservative and should not be refrigerated

Interaction

• Co-administration of probenecid with Clovir has been shown to increase the mean Clovir half-life and the area under the concentration time curve

Contraindications

• Contraindicated in patients known to be hypersensitive 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

Pregnancy & Lactation

• Pregnancy Category B - should not be used during pregnancy unless benefits clearly outweigh potential risks to the fetus
• Should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby
• No experience of the effect of Acyclovir on human fertility

Precautions & Warnings

• Intended for intravenous infusion only and should not be used through any other route
• Should not be administered by mouth and must be given over a period of at least one hour
• Maximum urine concentration occurs within the first few hours following infusion, so attention should be given to establish sufficient urine flow during that period
• Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Clovir

Use in Special Populations

• Pediatric use - dose calculated based on body surface area
• Geriatric use - special attention should be given to dosage reduction due to low creatinine clearance
• In patients with renal impairment - dose modification based on creatinine clearance level

Overdose Effects

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

Therapeutic Class

• Herpes simplex & Varicella-zoster virus infections

Duration of Treatment

• Recommended for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis

Reconstitution

• Reconstituted with Water for Injection or Sodium Chloride Intravenous Infusion to specific concentrations

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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