Ebastine during pregnancy and lactation in a patient with chronic urticaria: ebastine and carebastine levels in maternal serum, cord blood, breast milk and the infant’s serum

Saito, Jumpei; Yakuwa, Naho; Sandaiji, Noriko; Yagishita, S.; Kawasaki, Hiroyo; Suzuki, Tomo; Ozawa, Keiya; Kamura, Shunsuke; Yamatani, Akimasa; Wada, Seiji; Sago, Haruhiko; Murashima, Atsuko

doi:10.1111/jdv.16415

Cited by 3 publications

(4 citation statements)

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“…Thus, a total of nine studies were finally included. Seven of these (with a total of 25 mother–infant pairs) included the following antihistamines: cetirizine, 31 clemastine, 32 ebastine, 33 epinastine, 34 loratadine, 35 terfenadine 36 and triprolidine 37 (Table 3). One study including 17 women investigated the impact of chlorpheniramine or promethazine on prolactin levels 38 .…”

Section: Resultsmentioning

confidence: 99%

“…Given the maternal doses listed in Table 3, absolute infant doses via breast milk per kilogram body weight per day are presented in Table 4. Based on these numbers, an exclusively breastfed infant weighing 5 kg would have been exposed to an absolute infant dose of 15.5 μg cetirizine, 7.5 μg clemastine, 8.8 μg ebastine, 23.0 μg of epinastine, 34.0 μg loratadine, 30.0 μg, terfenadine or 1.8 μg triprolidine 32–37 every 24 h.…”

Section: Resultsmentioning

confidence: 99%

“…Only three of the studies were published after 2019. 31,33,34 The remaining studies were published between 1982 and 1995, that is, almost more than three decades ago where use of antihistamines and allergy treatment among breastfed women may not have been as common as today, particularly for secondgeneration antihistamines. Notably, few studies systematically monitored the breastfed infants for possible ADRs.…”

Section: Discussionmentioning

confidence: 99%

“…However, it is important to include the half‐life of the antihistamines in the assessment, as antihistamines with longer half‐life will have a higher risk of accumulation in the breastfed infant during continuous use. Only three of the studies were published after 2019 31,33,34 . The remaining studies were published between 1982 and 1995, that is, almost more than three decades ago where use of antihistamines and allergy treatment among breastfed women may not have been as common as today, particularly for second‐generation antihistamines.…”

Section: Discussionmentioning

confidence: 99%

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Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review

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Lupattelli

et al. 2021

Basic Clin Pharma Tox

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Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an overview of studies measuring the levels of antihistamines in human breast milk, estimating the exposure for breastfed infants and/or reporting possible adverse effects on the breastfed infant. An additional aim was to review the antihistamine product labels available in the European Union (EU) and the United States. We searched seven online databases and identified seven human lactation studies that included 25 mother–infant pairs covering cetirizine, clemastine, ebastine, epinastine, loratadine, terfenadine and triprolidine. In addition, one study investigated the impact of chlorpheniramine or promethazine on prolactin levels among 17 women, and one study investigated possible adverse drug reactions in 85 breastfed infants exposed to various antihistamines. The relative infant dose was below 5% for all antihistamines, ranging from 0.3% for terfenadine to 4.5% for clemastine. Most product labels of the 10 antihistamines with available information in both the EU and the United States reported lack of evidence and recommended to avoid use during breastfeeding. The knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review

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Lupattelli

et al. 2021

Basic Clin Pharma Tox

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Chronic Urticaria: Advances in Understanding of the Disease and Clinical Management

Huang

et al. 2021

Clinic Rev Allerg Immunol

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A bioequivalence study of Allergostin compared to administration of Kestin in healthy volunteers

Таликова¹

2023

Russian Journal of Allergy

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Relevance. International non-proprietary name (INN) Ebastin is widely used in medical practice in the treatment of urticaria and allergic rhinitis. It is an antiallergic drug, which belongs to the second generation of H1-histamine receptor blocker, it is necessary to emphasize that Ebastin is effective when taken orally. As part of the registration of trade name Allergostin, a clinical study of its bioequivalence with Kestin was conducted with the participation of 26 healthy volunteers. Aim. The aim of this publication is summarize results of the clinical study of the comparative pharmacokinetics and bioequivalence, safety and tolerability of Allergostin, film-coated tablets, 20 mg (NTFF POLYSAN LLC, Russia), and Kestin, film-coated tablets, 20 mg (Almiral S.A., Spain), in healthy volunteers after a single oral dose on an empty stomach. Materials and methods. To confirm bioequivalence, an open, randomized, two-period, cross-over study of comparative pharmacokinetics and bioequivalence of drugs with a single oral intake on an empty stomach in adult healthy male and female volunteers was conducted. During the study, blood plasma samples were taken from volunteers. Each sample was tested by using a validated high performance liquid chromatography with tandem mass spectrometry method, the concentrations of ebastine and the active metabolite carabastin were determined. Based on obtained data , pharmacokinetic and statistical analysis was carried out, 90% confidence intervals (CI) were calculated for the ratio of the geometric mean values of the pharmacokinetic parameters Cmax and AUC0-72 for carabastin. Results. Based on results of statistical analysis, it was shown that the pharmacokinetic parameters of the test (Allergostin) and reference (Kestin) drug are characterized by high similarity. For the estimated pharmacokinetic parameters of carabastin, 90% CI ranged from 80-125% for AUC0-t and Cmax. Conclusion. Thus, according to the applied criteria, the drugs are recognized as bioequivalent.

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Ebastine during pregnancy and lactation in a patient with chronic urticaria: ebastine and carebastine levels in maternal serum, cord blood, breast milk and the infant’s serum

Cited by 3 publications

References 5 publications

Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review

Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review

Chronic Urticaria: Advances in Understanding of the Disease and Clinical Management

A bioequivalence study of Allergostin compared to administration of Kestin in healthy volunteers

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