Zimilast Dosage/Direction for Use

Adults: The dosage recommendations for Zimilast represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.
The total daily dosage for Zimilast should be based on the type or severity of infection, and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function and body weight. Adult patients with impaired renal function, as judged by creatinine clearance=70 mL/min/1.73 m², require adjustment of dosage.
Fully Susceptible Organisms Including Gram-Positive and Gram-Negative Aerobes and Anaerobes: Mild: 250 mg every 6 hrs. Total Daily Dose: 1 g. Moderate: 500 mg every 8 hrs; 500 mg every 6 hrs. Total Daily Dose: 1.5 g; 2 g. Severe Life-Threatening Only: 500 mg every 6 hrs. Total Daily Dose: 2 g. Uncomplicated Urinary Tract Infection: 250 mg every 6 hrs. Total Daily Dose: 1 g. Complicated Urinary Tract Infection: 500 mg every 6 hrs. Total Daily Dose: 2 g.
Moderately Susceptible Organisms, Primarily Some Strains of P. Aeruginosa: Mild: 500 mg every 6 hrs. Total Daily Dose: 2 g. Moderate: 500 mg every 6 hrs; 1 g every 8 hrs. Total Daily Dose: 2 g; 3 g. Severe Life-Threatening Only: 1 g every 8 hrs; 1 g every 6 hrs. Total Daily Dose: 3 g; 4 g. Uncomplicated Urinary Tract Infection: 250 mg every 6 hrs. Total Daily Dose: 1 g. Complicated Urinary Tract Infection: 500 mg every 6 hrs. Total Daily Dose: 2 g.
Due to the high antimicrobial activity of Zimilast, it is recommended that the maximum total daily dosage not exceed 59 mg/kg/day or 4 g daily, whichever is lower.
Children: Children 3 months: The recommended dose for non-central nervous system (CNS) infections is 15-25 mg/kg/dose administered every 6 hrs.
Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2 g daily and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4 g daily. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.
Children ≤3 months (Weighing 1500 g): The following dosage schedule is recommended for non-CNS infections: 4 weeks to 3 months: 25 mg/kg every 6 hrs; 1-4 weeks: 25 mg/kg every 8 hrs; <1 week: 25 mg/kg every 12 hrs.
Doses ≤500 mg should be given by IV infusion over 15-30 min.
Doses >500 mg should be given by IV infusion over 40-60 min.
Zimilast is not recommended in pediatric patients with CNS infections because of risk of seizures. Zimilast is not recommended in pediatric patients <30 kg with impaired renal function.
Administration: Each 125-, 250- or 500-mg dose should be given by IV administration over 20-30 min. Each 750- or 1000-mg dose should be infused over 40-60 min. In patients who develop nausea during the infusion, the rate of infusion may be slowed.