Clonidine use while Breastfeeding
Drugs containing Clonidine: Catapres, Kapvay, Clonidine ER, Catapres-TTS, Nexiclon XR, Duraclon, Jenloga, Clorpres
Clonidine Levels and Effects while Breastfeeding
Summary of Use during Lactation
Because of the high serum levels found in breastfed infants, possible infant side effects, and the possible negative effects on lactation, other agents may be preferred, especially while nursing a newborn or preterm infant.
Maternal Levels. In 9 women taking oral clonidine, milk levels were measured on 3 occasions: 1 to 5 days, 10 to 14 days and 45 to 60 days postpartum. Average daily dosages and approximate milk levels on the for the 3 measurements were 392 mcg/day and 1.8 mcg/L, 309 mcg/day and 2.9 mcg/L, and 242 mcg/day and 1.9 mcg/L. Using the average milk level data from this study, an exclusively breastfed infant would receive an estimated 4.1 to 8.4% of the maternal weight-adjusted dosage.
In a 4-week-postpartum mother, a milk level of 0.6 mcg/L was found in milk 2.5 hours after a dose while taking a clonidine dosage of 37.5 mcg orally twice daily. Based on this single milk level, the authors estimated that an exclusively breastfed infant would receive a maximum 6.8% of the maternal weight-adjusted dosage with this maternal dosage regimen.
In 3 women who received clonidine 150 mcg twice daily during pregnancy and postpartum, milk levels were measured 12 hours after their previous dose for the first 3 days postpartum. Milk clonidine levels ranged from 0.8 to 2.8 mcg/L.
Infant Levels. A 4-week-old breastfed infant whose mother was taking clonidine 37.5 mcg orally twice daily had an undetectable (<96 ng/L) serum clonidine level 1 hour after nursing.
In the infants of 9 women taking clonidine, infant serum levels were measured on three occasions: 1 to 5 days, 10 to 14 days and 45 to 60 days postpartum. Average daily maternal dosages on the three measurements were 392 mcg/day, 309 mcg/day, and 242 mcg/day, respectively. At these times, the infants had serum clonidine concentrations of 0.69, 0.53 and 0.35 mcg/L, respectively. These values represent an average of about 66% of the simultaneous maternal serum levels.
Effects in Breastfed Infants
No typical clonidine side effects (e.g., dry mouth, sedation) were seen in 9 infants whose mothers were taking clonidine, despite the infants' serum levels being about two-thirds that of their mothers'.
Three infants whose mothers were taking clonidine 150 mcg twice daily were breastfed. During the first 3 days postpartum, no adverse effects on blood glucose, electrocardiogram or blood pressure. The infants had normal growth and psychomotor development at 1 year of age, although the duration of breastfeeding and clonidine use was not stated.
An infant was born to a mother taking clonidine 0.15 mg daily during pregnancy and postpartum. At 2 days of life, the infant presented with drowsiness, hypotonia, and suspected generalized seizures. At day 5, episodes of apnea were noted. On day 9 postpartum, breastfeeding was stopped and all symptoms resolved within 24 hours. Clonidine was probably the cause of the reaction, but the relative contributions of exposure during pregnancy and breastfeeding cannot be determined.
Effects on Lactation and Breastmilk
Clonidine has complex, dose-related actions on both oxytocin and prolactin secretion. The net effect of the drug on nursing mothers has not been well studied. A case of hyperprolactinemia and gynecomastia occurred in a 6-year-old boy taking clonidine for hyperactivity and valproic acid for a seizure disorder. Galactorrhea ceased within 3 weeks of discontinuing clonidine. A case of clonidine-induced postpartum galactorrhea has also been reported.
The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Alternate Drugs to Consider
1. Hartikainen-Sorri AL, Heikkinen JE, Koivisto M. Pharmacokinetics of clonidine during pregnancy and nursing. Obstet Gynecol. 1987;69:598-600. PMID: 3822302
2. Bunjes R, Schaefer C, Holzinger D. Clonidine and breast-feeding. Clin Pharm. 1993;12:178-9. Letter. PMID: 8491075
3. Boutroy MJ, Gisonna CR, Legagneur M. Clonidine: placental transfer and neonatal adaption. Early Hum Dev. 1988;17:275-86. PMID: 3208682
4. Sevrez C, Lavocat MP, Mounier G et al. [Transplacental or breast milk intoxication to clonidine: A case of neonatal hypotonia and drowsiness.]. Arch Pediatr. 2014;21:198-200. PMID: 24411570
5. Mendhekar DN. Clonidine-induced gynecomastia and hyperprolactinemia in a 6-year-old child. J Clin Psychiatry. 2005;66:1616-7. Letter. PMID: 16401171
6. Heim J, Massart C, Auvray E et al. [Post-partum galactorrhea with persistent hyperprolactinaemia during a clonidine treatment]. Sem Hop. 1979;55:933-4. PMID: 231318
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