Records from the Pharmacy Department and the Pathology and Laboratory Medicine Department identified 71 patients who had received domperidone therapy and who had undergone monitoring of serum prolactin levels between June 1, 2001, and October 1, 2005. Of these, 22 patients were excluded because they did not have a diagnosis of cystic fibrosis. A total of 49 pediatric patients with cystic fibrosis, 26 females and 23 males, were included in this chart review.
The median age at initiation of domperidone therapy was 8.5 years (range 1 month to 18 years). The median dose of domperidone was 1.42 mg/kg per day (range 0.45—3.41 mg/kg per day) (Figure 1). Dosing guidelines at this institution during the study period recommended a dosage of 1.2—2.4 mg/kg per day for children.
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A total of 219 samples for determination of prolactin levels were drawn from the 49 study patients during a total of 106 hospital admissions and 88 visits to the cystic fibrosis clinic. No prolactin levels had been measured before March 2003, when the previously described case of hyperprolactinemia resulting in amenorrhea and development of a prolactinoma had been reported.
Figure 1. Domperidone dosage in relation to age for 49 children with cystic fibrosis who underwent prolactin monitoring. Shaded area indicates recommended dosage at this institution at the time of the study.
Of the 49 study patients, 39 (80%), consisting of 20 males and 19 females, had a record of at least one elevated prolactin value. All of these patients had been receiving domperidone as outpatient therapy before admission, and baseline prolactin levels had not been measured before the start of therapy. Of the 219 prolactin values reported, 100 (45.7%) were above the normal range, 111 (50.7%) were within the normal range, and 8 (3.7%) were below the normal range. There appeared to be no relationship between the patients’ domperidone doses and the measured prolactin levels (Figure 2). The median domperidone dose associated with prolactin values in the normal range was 1.24 mg/kg per day (range 0.45—3.41 mg/kg per day), and the median dose associated with elevated prolactin values was 1.43 mg/kg per day (range 0.72—2.26 mg/kg per day). In fact, none of the elevated prolactin values resulted from supratherapeutic domperidone doses.
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