Can Buccolam (midazolam) be used in a patient with impaired renal function, specifically an estimated Glomerular Filtration Rate (eGFR) of 10?

From the Guidelines

Buccolam (midazolam) can be used with caution in patients with an eGFR of 10, but dose adjustment is recommended to minimize the risk of excessive sedation and respiratory depression. When considering the use of Buccolam in patients with severe renal impairment, it is essential to take into account the potential for accumulation of active metabolites, which can prolong the sedative effect 1.

Key Considerations

• For patients with severe renal impairment (eGFR <30 ml/min), consider reducing the dose by 25-50% and monitoring closely for signs of excessive sedation and respiratory depression.
• Midazolam is primarily metabolized by the liver, but its active metabolites can accumulate in renal failure, potentially prolonging the sedative effect.
• When administering Buccolam to a patient with this level of renal impairment, start with the lower end of the dosing range, ensure appropriate monitoring of vital signs, and have resuscitation equipment readily available.
• The patient should be observed for a longer period after administration due to the potential for delayed clearance.
• If the patient is on dialysis, note that midazolam is not significantly removed by hemodialysis, so timing relative to dialysis sessions is less critical than with some other medications 1.

Monitoring and Precautions

• Close monitoring of vital signs and respiratory function is crucial when using Buccolam in patients with severe renal impairment.
• Be aware of the potential for delayed clearance and prolonged sedative effects, and adjust the dosing regimen accordingly.
• Consider alternative sedation options if possible, and consult with a nephrologist or other specialist if unsure about the safe use of Buccolam in patients with severe renal impairment 1.

From the FDA Drug Label

Patients with renal impairment may have longer elimination half-lives for midazolam and its metabolites which may result in slower recovery. Midazolam and 1-hydroxy-midazolam pharmacokinetics in 6 ICU patients who developed acute renal failure (ARF) were compared with a normal renal function control group. Midazolam clearance was reduced (1. 9 vs 2.8 mL/min/kg) and the half-life was prolonged (7. 6 vs 13 hr) in the ARF patients.

The use of midazolam (BUCC) in patients with an eGFR of 10 is not explicitly addressed in the provided drug labels. However, it is mentioned that patients with renal impairment may have longer elimination half-lives for midazolam and its metabolites, which may result in slower recovery 2. Given the potential for accumulation and prolonged sedation in patients with renal impairment, it is recommended to exercise caution when using midazolam in patients with severe renal impairment. However, without explicit information on the use of midazolam in patients with an eGFR of 10, no conclusion can be drawn.

From the Research

Use of Buccolam with eGFR of 10

• There is no direct evidence in the provided studies regarding the use of Buccolam with an eGFR of 10.
• However, studies 3, 4 discuss the importance of dose adjustment for patients with impaired renal function, which may be relevant to the use of Buccolam in patients with low eGFR.
• Study 5 mentions that renal dosage adjustment and close monitoring are recommended for antiepileptic drugs (AEDs) in patients with impaired renal function, which could be applicable to Buccolam.
• Studies 6, 7 discuss the management of seizures in patients with kidney disease, including the challenges of determining the type and dosage of AEDs due to varying renal clearances.

Renal Impairment and Drug Dosing

• Study 3 found that 15% of renal risk drugs were not used or dosed in agreement with recommendations in patients with impaired renal function.
• Study 4 reported that adherence with dosing guidelines was present in only 53.9% of patients with impaired renal function at hospital discharge.
• Study 5 emphasizes the need for careful consideration of AEDs in patients with renal impairment, including potential nephrotoxic effects and renal adverse reactions.

Clinical Considerations

• The use of electronic prescribing and automated reporting of eGFR may help reduce medication errors, as suggested by study 3.
• Study 4 found that reporting the eGFR resulted in more adherence with dosing guidelines, highlighting the importance of considering renal function when prescribing medications.
• Close monitoring and renal dosage adjustment are crucial when using AEDs, including Buccolam, in patients with impaired renal function, as mentioned in study 5.