pediatric

To determine if the measured prolactin level influenced domperidone therapy, data reflecting whether the domperi- done dose had been changed as a result of the prolactin level were recorded from the charts. Of the 100 values above the nor­mal range, 86 (86%) resulted in no dosage adjustments, 9 (9%) resulted in a dosage decrease, and 5 (5%) resulted in discontin­uation of domperidone therapy (Figure 3). The prolactin levels resulting in a decrease in domperidone dose ranged from 42.2 to 91.1 Hg/L (Table 1), and those resulting in discontinuation of therapy ranged from 59.8 to 131.9 Hg/L (Table 2). The patients had been receiving domperidone doses ranging from 0.74 to 2.26 mg/kg per day and from 0.88 to 1.40 mg/kg per day, respectively. For the 9 instances in which an elevated prolactin value resulted in a decrease in domperidone dose, prolactin levels were also measured subsequent to the dosage decrease. The prolactin level rose in 3 cases and declined in 6 cases, but in 5 of the 6 latter cases, prolactin was still above the laboratory reference range. For the 86 cases in which elevated prolactin level resulted in no dosage adjustment, the prolactin values ranged from 13.2 to 72.2 Hg/L in association with domperidone doses ranging from 0.72 to 2.25 mg/kg per day. cialis soft tabs

Table 1. Individual Domperidone Doses and Prolactin Levels that Led to a Decrease in Domperidone Dose




Patient




Sex




Domperidone Dose* (mg/kg per day)




Prolactin Levelt (ng/L)


1


F


1.48


47.0


2


F


1.56


82.8


3


F


1.72


64.7


4


F


1.80


50.1


5


M


0.74


55.7


6


M


1.74


43.9


7


M


1.95


42.2


8


M


1.99


61.1


9


M


2.26


91.1

Prolactin levels are known to fluctuate during the day, with peak production during sleep and lowest production occurring at mid-afternoon. The time at which samples were drawn for prolactin determination varied greatly both between patients and within the same patient, with 137 (62.6%) of the 219 samples being drawn in the morning (median prolactin level 19.6 Hg/L, range 0.9-99.8 Hg/L) and 82 (37.4%) being drawn in the evening (median prolactin level 15.0 Hg/L, range 0.7-131.9 Hg/L). Given this variability and the diurnal pattern of prolactin production, domperidone dose might not have been the only factor influencing the measured values of prolactin.
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Table 2. Individual Domperidone Doses and Prolactin Levels that Resulted in Discontinuation of Domperidone Therapy

Patient Sex

Domperidone Dose* (mg/kg per day)

Prolactin Levelt (ng/L)


4 F


1.35


63.7


10 F


0.88


131.9


11 F


0.90


83.6


12 F


1.40


59.8


8 M


1.00


99.8

The cystic fibrosis team considered prolactin levels below or at the lower limit of the normal reference range to be suggestive of noncompliance with therapy. In 15 (31 %) of the 49 patients, a total of 17 prolactin values (median 5.9 Hg/L, range 2.3-16.1 Hg/L) were deemed suggestive of noncompli­ance. Of the 106 hospital admissions, 25 (23.6%) had records of 2 measurements of prolactin level, one at admission and one before anticipated discharge (after a 2-week hospital stay). For 23 of these patient admissions, the domperidone dosage remained the same throughout the hospital stay. In 20 (87%) of these 23 cases, the prolactin level increased from a median of 10.9 Hg/L at admission (range 3.3-35.5 Hg/L) to a median of 29.5 Hg/L before discharge (range 8.3-82.8 Hg/L); in the other 3 (13%) cases, the prolactin level decreased from a median of 39.4 Hg/L at admission (range 16.3-41.4 Hg/L) to a median of 24.9 Hg/L before discharge (range 7.0-34.2 Hg/L). For 1 of the other 2 admissions with dual prolactin measurements (at admission and before discharge), the domperidone dosage was decreased because the initial prolactin level was elevated, at 50.1 Hg/L; however, even with the lower dosage, the subsequent prolactin level was higher, at 63.7 Hg/L. In the other case (the patient with amenorrhea and prolactinoma, described above), the domperidone was discontinued and the prolactin level declined. tadacip

Figure 2. Prolactin levels

Figure 2. Prolactin levels in relation to domperidone dose in the 49 study patients. Shaded area indicates recommended dosage at this institution at the time of the study.

Among these 25 admissions, 4 female patients were questioned about compliance because the admission prolactin value was within the normal range (median 7.0 Hg/L, range 4.4-12.4 Hg/L). For all 4 of these patients, prolactin level increased by the time of discharge, although it remained within the normal range (median 13.0 Hg/L, range 11.9­26.3 Hg/L). There were 16 other admissions for which poor compliance may have been considered, given that prolactin levels were checked on admission and before discharge, although the patients were not specifically questioned. In these 16 cases, prolactin level increased during the hospital stay, from a median of 13.6 Hg/L (range 3.3-35.5 Hg/L) at admission to a median of 37.8 Hg/L (range 8.3-82.8 Hg/L).

With the exception of the previously described patient with amenorrhea and prolactinoma, who was treated in 2003 and whose experience precipitated the routine measurement of prolactin levels, no reports of hyperprolactinemia-related side effects directly attributable to domperidone therapy were noted in the study population.
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This chart review revealed 2 cases of amenorrhea in female patients 16 and 17 years of age. The 16-year-old patient was receiving medroxyprogesterone acetate by injection concurrently with domperidone therapy, and the 17-year-old patient was recovering from gastrointestinal bleeding. The prolactin level for these patients when amenorrhea was reported was 38.9 Hg/L and 3.9 Hg/L, respectively. Both cases of amenorrhea were deemed unrelated to domperidone therapy.

The chart review also revealed 2 reports of delayed puberty. Domperidone therapy was discontinued for a 13-year-old girl whose measured serum prolactin level was elevated, at 131.9 Hg/L, while she was receiving domperidone 0.88 mg/kg per day. It was unclear whether the elevated prolactin had contributed to this patient’s delayed puberty. The second patient was a 14-year-old girl whose serum prolactin level was 27.3 Hg/L while she was receiving a low dose of domperidone; in this patient, delayed puberty was attributed to a family history of late menarche.