Background Alprostadil is a drug widely used, among other indications, for the symptomatic treatment of arteriosclerotic occlusive disease of the lower limbs. Most marketed presentations of this drug for parenteral administration contain alfaciclodextrin as an excipient. In renal failure, this excipient can accumulate and cause nephrotoxicity.
Purpose To describe a clinical case of individualised drug selection based on the patient’s condition and establish strategies to optimise the treatment through dose fractionation.
Material and methods Inpatient admitted with a diagnosis of spontaneous atheroembolism cholesterol and renal failure that required parenteral alprostadil. The responsible physician prescribed alprostadil 50 µg/24 h intravenously and prednisone 1 mg/kg/day orally.
Our patient had a creatinine clearance of approximately 10 mL/min so the pharmacy service had to look for an alternative treatment or marketed presentation.
The protocol created by the pharmacy service for this pharmacotherapy problem had the following steps:
To search for a marketed alprostadil presentation without alfacyclodextrin as an excipient.
To search handling stability information: specialty sheet and Stabilis 4.0.
To develop a standard operating protocol (SOP) to carry out conditioning of the prescribed dose.
Preparation of the daily dose in a horizontal laminar flow hood.
Results Only one of the alprostadil specialities marketed has no alfacyclodextrin in our country (Alprostadil Pfizer 0.5 mg/mL,1 mL ampoules). The pharmacy service decided to prepare a daily dose prescribed to employ the entire volume of the ampoule.
According to the SOP, the total content of the ampoule is transferred into a glass vial under aseptic conditions in a horizontal laminar flow hood. Stability for 9 days at 2–8°C was assigned based on the available evidence.
The pharmacy staff prepared the daily dose prescribe (0.1 mL for our patient) and incorporated it into a physiological saline solution of 100 mL.
The solution for infusion in 0.9% sodium chloride is stable for only 24 h.
The patient was treated with 4 ampoules of the selected specialty. This handling procedure had a real cost saving of 756€ (17 ampoules) compared with Sugiran 20 mg, included normally at our hospital.
Conclusion In special situations, such as kidney failure, individual selection of marketed drug presentations is important. Moreover, handling fractionation maintains the safety and quality of the pharmacotherapy and sometimes can achieve cost savings.
No conflict of interest.
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