From the FDA Drug Label
When high dose therapy is desired, the recommended dose of methylprednisolone sodium succinate for injection is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.
The protocol for ordering methylprednisolone pulse therapy in severe leptospirosis involves administering 30 mg/kg of methylprednisolone sodium succinate intravenously over at least 30 minutes, which can be repeated every 4 to 6 hours for 48 hours 1.
- Key points:
- Dose: 30 mg/kg
- Administration: intravenously over at least 30 minutes
- Frequency: every 4 to 6 hours
- Duration: for 48 hours It is essential to individualize the dosage based on the patient's response and clinical status.
From the Research
For severe leptospirosis with pulmonary involvement or other severe manifestations, methylprednisolone pulse therapy should be administered at a dose of 1 gram intravenously daily for 3 consecutive days, as this approach may reduce mortality in critically ill patients by mitigating the cytokine storm and subsequent organ damage, as suggested by the study published in 2011 2.
Key Considerations
- The therapy should be initiated early in the course of severe disease, ideally within the first 12-24 hours of diagnosis or when severe manifestations appear.
- Methylprednisolone should be administered as a slow intravenous infusion over 30-60 minutes to minimize adverse effects.
- Before starting therapy, patients should be screened for contraindications including active untreated infections, uncontrolled diabetes, or active gastrointestinal bleeding.
- Concurrent antibiotic therapy with intravenous penicillin G (1.5 million units every 6 hours) or ceftriaxone (1 gram daily) remains essential and should not be delayed, as supported by the study published in 2006 3.
Rationale
- The rationale for corticosteroid pulse therapy is to suppress the severe inflammatory response and immune-mediated tissue damage that occurs in severe leptospirosis, particularly in pulmonary hemorrhage syndrome and other immunologically mediated complications.
- The use of high-dose corticosteroids in severe leptospirosis has been shown to be beneficial in some studies, including the one published in 2006 4, which demonstrated a significant reduction in mortality in patients with pulmonary involvement.
- However, a systematic review published in 2014 5 highlighted the need for a well-designed randomized clinical trial to resolve the uncertainty surrounding the effectiveness of high-dose corticosteroids in severe leptospirosis.
Protocol
- The protocol for ordering methylprednisolone pulse therapy should include:
- Administration of 1 gram of methylprednisolone intravenously daily for 3 consecutive days.
- Followed by oral prednisolone at 1 mg/kg/day, which is then gradually tapered over 4-6 weeks.
- Close monitoring of patients for adverse effects and contraindications.
- Concurrent antibiotic therapy with intravenous penicillin G or ceftriaxone.