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3PC-059 Use of extemporaneous oral suspensions of oxybutinin and prazosine in neonates
  1. R Claramunt García,
  2. CL Muñoz Cid,
  3. I Caba Porras,
  4. AM López-López,
  5. M Merino Almazán,
  6. Y Jimenez López,
  7. E Perez Cano,
  8. JF Marín Pozo
  1. Complejo Hospitalario de Jaén, Servicio de Farmacia, Jaén, Spain


Background Primary bladder neck obstruction (PBNO) is a failure in which the bladder neck does not open appropriately or completely during voiding. α-Blocker together with anticholinergics are the pharmacological therapy that has shown some benefit in children. Off-label therapy with prazosin and oxybutynin was proposed in two neonates with PBNO.

Purpose To compound oxybutynin and prazosin correctly for dosing and administration in these patients and monitoring them.

Material and methods A bibliographic search of indication, dosage and formulation was made in Pubmed, Micromedex and other compounding pharmaceutical sources. Keywords: prazosin, oxybutynin, neonate, PBNO.

Clinical monitoring and interviews were carried out with the parents of two neonates (5 and 12 months’ old) in treatment from the first month of life to the present.

Results We did not find any bibliographic reference describing its use in neonates.

Initially, we formulated sachets with their specific dose. Later, we formulated in suspension, 100 mcg/ml prazosin and 1 mg/ml (minurin) and oxybutynin (raw material), using simple syrup without preservatives as a vehicle.

The initial doses collected were the minimum referenced in children: 10 mcg/kg/12 hour for prazosin and 0.1 mg/kg/12 hour for oxybutynin. The dose of prazosin was increased weekly, in both neonates, because of the improvement in uro-dynamics tests and no significant adverse effects detected. It was increased until 25 mcg/kg/8 hour (maximum collected in paediatrics 25 mcg/Kg/6 hour).

The dose of oxybutynin was maintained in one patient with the initial dose and, in another, rose to 0.1 mg/kg/8 hour (the maximum 0.2 mg/kg/8 hour).

Pharmaceutical care was performed by the explanation of the doses in milliliters adjusted to the weight and monitoring of possible adverse effects. Strawberry essence was incorporated into the suspension to improve flavour.

Since birth, the number of catheters has decreased, with an improvement in the patient’s symptoms. Regarding safety, no adverse reactions attributable to the drugs have been observed.

Conclusion Both oral suspensions were appropriated for the pathology of our patients, which continue in treatment. They are well tolerated, for an age range not included in the bibliography, with good response. Pharmaceutical care was given from the beginning to the family and the paediatric service.

References and/or acknowledgements To Rosa Millán García for the review of the work and her contribution to it.

No conflict of interest.

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