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209 results on '"Yamatani, Akimasa"'

4. Efficacy and Safety of Naldemedine for Opioid-Induced Constipation in Children.

Author

Miura, Rina, Utano, Tomoyuki, Miura, Yoriko, Chiba, Kyoko, Hasegawa, Ayaka, Takafuji, Yukiko, Takahashi, Hayato, Tanzawa, Ayano, Iwahashi, Kana, Yamatani, Akimasa, and Yotani, Nobuyuki

Subjects
DIARRHEA, PATIENT safety, LAXATIVES, RETROSPECTIVE studies, DESCRIPTIVE statistics, OPIOID analgesics, DRUG efficacy, DEFECATION, CONSTIPATION, OPIOID receptors, DISEASE risk factors, CHEMICAL inhibitors, CHILDREN
Abstract

Background: Naldemedine, a peripherally acting opioid μ receptor antagonist, is effective for prevention of opioid-induced constipation (OIC); however, evidence on its use in children is limited. Objective: To evaluate the efficacy and safety of naldemedine in pediatric patients with OIC. Design, Setting/Subjects: Retrospective analysis of 32 pediatric patients with OIC treated with naldemedine in a single institution in Japan from June 2017 to March 2021. Measurements: Efficacy was evaluated in 13 evaluable patients with bowel movement (BM) response, defined as those with at least three BMs in the first 7 days after naldemedine initiation and an increase of at least one BM from baseline. Safety was evaluated by examining adverse events (AEs) based on the Common Terminology Criteria for AEs (v5.0). Results: BM response was recorded in 11 of the 13 patients (85%), and the number BMs per day significantly increased from 0.43 before naldemedine to 1.00 after naldemedine (p = 0.025). The most common AE was diarrhea, observed in 16 of the 32 patients (50%), and all instances were grade 1 or 2. In three of the 16 patients, naldemedine was discontinued owing to worsening diarrhea. Conclusions: In pediatric patients, naldemedine resulted in a high rate of BM response and increased the BM frequency, indicating its efficacy. In some patients, grade 2 diarrhea required naldemedine discontinuation, suggesting that it should be used with caution in pediatric patients. Further studies are warranted to determine the optimal naldemedine dose in pediatric patients. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

Author

Saito, Jumpei, Nadatani, Naomi, Setoguchi, Makoto, Nakao, Masahiko, Kimura, Hitomi, Sameshima, Mayuri, Kobayashi, Keiko, Matsumoto, Hiroaki, Yoshikawa, Naoki, Yokoyama, Toshihiro, Takahashi, Hitomi, Suenaga, Mei, Watanabe, Ran, Imai, Kinuko, Obara, Mami, Hashimoto, Mari, Yamamoto, Kazuhiro, Fujiwara, Naoko, Sakata, Wakako, Nagai, Hiroaki, Enokihara, Takeshi, Katayama, Sayaka, Takahashi, Yuta, Araki, Mariko, Iino, Kanako, Akiyama, Naoko, Katsu, Hiroki, Fushimi, Kumiko, Takeda, Tomoya, Torimoto, Mayumi, Kishi, Rina, Mitsuya, Naoki, Kihara, Rie, Hasegawa, Yuki, Hamada, Yukihiro, Kimura, Toshimi, Wada, Masaki, Tanzawa, Ayano, and Yamatani, Akimasa

Published
2021
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15. Establishment of a measurement system to evaluate breast milk transfer of biological agents using dry filter paper: A multi‐institutional study.

Author

Saito, Jumpei, Yakuwa, Naho, Hosokawa, Yoshihiko, Hamada, Hiromi, Suzuki, Tomo, Sago, Haruhiko, Kaneko, Kayoko, Yamatani, Akimasa, and Murashima, Atsuko

Subjects
BREAST milk, FILTER paper, BREAST milk collection & preservation, DRYING agents, BREASTFEEDING, ENZYME-linked immunosorbent assay, GOLIMUMAB, ABATACEPT
Abstract

Aims: Information on breastfeeding and safety of biologics in infants is lacking due to difficulties in case collection. We evaluated methods for determining the concentration of biologics in breast milk using a dry filter method that can simplify the collection, storage and transport of breast milk. Methods: To generate dried filter paper (DFP) samples, approximately 30 μL of breast milk was placed onto a Whatman 903 card and punched out. After extraction, the supernatant was measured using an enzyme‐linked immunosorbent assay. Three concentrations of each drug were prepared in liquid breast milk (LBM) and DFP samples to determine their stability up to 28 days after storage at 2–8°C or −20°C for LBM and 25 ± 5°C for DFP. LBM and DFP samples were also provided by nursing mothers using biologics during lactation, and drug concentrations in both samples were compared. The agreement between the two measurement methods was confirmed by Bland–Altman analysis. Results: Breast milk was provided by 12 mothers who used biologics (tocilizumab, abatacept, etanercept, golimumab, sarilumab and belimumab). The coefficients of variation for within‐run and between‐run precision for the six drugs were within 15% for both LBM and DFP, and accuracy was within 90%–110% of the quality controls. After 28 days, concentrations remained at more than 90%. The difference between the values obtained by each method was within the acceptable range of error (−12.1 to +16.6 ng/mL). Conclusions: A method for determining the concentration of biologics using DFP is expected to help improve pharmacotherapy for lactating women. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Transfer of Zolpidem to Cord Blood and Breast Milk: A Case Series Evaluating Zolpidem Serum Levels and Outcomes in Birth and Suckling Infants

Author

Saito, Jumpei, primary, Tachibana, Yoshiyuki, additional, Kawasaki, Hiroyo, additional, Tamon, Hiroki, additional, Ishii, Mariko, additional, Wada, Yuka Sano, additional, Oho, Motoko, additional, Yakuwa, Naho, additional, Suzuki, Tomo, additional, Sago, Haruhiko, additional, Yamatani, Akimasa, additional, and Murashima, Atsuko, additional

Published
2022
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20. Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study.

Author

Saito, Jumpei, Suzuki, Eiji, Nakamura, Yosuke, Otsuji, Takashi, Yamamoto, Hiroshi, Yamamoto, Hideki, Kai, Yuiko, Totsu, Maiko, Hashimoto, Sayuki, Nakamura, Hidefumi, Akabane, Miki, and Yamatani, Akimasa

Subjects
RESEARCH, DRUG packaging, QUALITY assurance, BACLOFEN, DRUG stability, RESEARCH funding, PHARMACEUTICAL chemistry, CLONIDINE, DRUG storage, DOSAGE forms of drugs, HYDROCORTISONE, POWDERS
Abstract

The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, a multicenter study was conducted to validate the preparation method for the quality assurance of baclofen powder, clonidine powder, and hydrocortisone powder prepared from tablets according to a previously established method. In-hospital preparations were prepared at five medical facilities under different crushing and mixing conditions. After storage in closed bottles, in-use bottles, and laminated paper for 120 days, ingredients stability, drug elution, and content uniformity after packaging were evaluated. All three ingredients were maintained at between 90% and 110% of their initial content for 120 days under packaging conditions of 25 ± 2 °C and 60 ± 5% relative humidity, with no change in dissolution in all formulations made at all five facilities. The content uniformity was also acceptable. The established method may contribute to quality-assured pediatric dosage form modification. [ABSTRACT FROM AUTHOR]

Published
2023
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25. Presence of Hypnotics in the Cord Blood and Breast Milk, with No Adverse Effects in the Infant: A Case Report

Author

Saito, Jumpei, primary, Tachibana, Yoshiyuki, additional, Sano Wada, Yuka, additional, Kawasaki, Hiroyo, additional, Miura, Yoriko, additional, Oho, Motoko, additional, Aoyagi, Kaori, additional, Yakuwa, Naho, additional, Suzuki, Tomo, additional, Yamatani, Akimasa, additional, Sago, Haruhiko, additional, and Murashima, Atsuko, additional

Published
2022
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27. The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

Author

Saito, Jumpei, primary, Agrawal, Anjali, additional, Patravale, Vandana, additional, Pandya, Anjali, additional, Orubu, Samuel, additional, Zhao, Min, additional, Andrews, Gavin P., additional, Petit-Turcotte, Caroline, additional, Landry, Hannah, additional, Croker, Alysha, additional, Nakamura, Hidefumi, additional, Yamatani, Akimasa, additional, and Salunke, Smita, additional

Published
2022
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29. Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

Author

Mitsui, Nao, primary, Hida, Noriko, additional, Kamiya, Taro, additional, Yamazaki, Taigi, additional, Miyazaki, Kazuki, additional, Saito, Kiyomi, additional, Saito, Jumpei, additional, Yamatani, Akimasa, additional, Ishikawa, Yoichi, additional, Nakamura, Hidefumi, additional, Nakamura, Akihiro, additional, and Harada, Tsutomu, additional

Published
2022
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31. Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

Author

Vallet, Thibault, primary, Bensouda, Yahya, additional, Saito, Jumpei, additional, Mathiesen, Liv, additional, Pokharkar, Varsha, additional, Klingmann, Viviane, additional, Peak, Matthew, additional, Elhamdaoui, Omar, additional, Yamatani, Akimasa, additional, Ivanovic, Ivana, additional, Sajith, Manjusha, additional, Münch, Juliane, additional, Bracken, Louise, additional, Duncan, Jennifer Claire, additional, Salunke, Smita, additional, Wang, Siri, additional, and Ruiz, Fabrice, additional

Published
2021
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36. Additional file 2 of Stability of clonidine hydrochloride in an oral powder form compounded for pediatric patients in Japan

Author

Saito, Jumpei, Hanawa, Takehisa, Matsumoto, Takahiro, Yoshikawa, Nozomi, Harada, Tsutomu, Iwahashi, Kana, Nakamura, Hidefumi, and Yamatani, Akimasa

Abstract

Additional file 2: Figure S2 Chromatograms of compounded clonidine in the bottle “closed” condition on day 0 (a) and day 120 (b), in the “bottle (in use)” condition on day 0 (c) and day 120 (d), and in the “laminated paper” condition on day 0 (e) and day 120 (f).

Published
2021
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42. Reply to Béranger et al., “Integration of Continuous Renal Replacement Therapy in a Meropenem Population Pharmacokinetics Model in Critically Ill Children”

Author

Saito, Jumpei, primary, Shoji, Kensuke, additional, Oho, Yusuke, additional, Kato, Hiroki, additional, Matsumoto, Shotaro, additional, Aoki, Satoshi, additional, Nakamura, Hidefumi, additional, Ogawa, Takanori, additional, Hasegawa, Mayumi, additional, Yamatani, Akimasa, additional, and Miyairi, Isao, additional

Published
2021
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46. Pravastatin concentrations in maternal serum, umbilical cord serum, breast milk and neonatal serum during pregnancy and lactation: A case study.

Author

Saito, Jumpei, Kaneko, Kayoko, Abe, Sawako, Yakuwa, Naho, Kawasaki, Hiroyo, Suzuki, Tomo, Yamatani, Akimasa, Sago, Haruhiko, and Murashima, Atsuko

Subjects
PREECLAMPSIA prevention, PRAVASTATIN, LACTATION, ANTIPHOSPHOLIPID syndrome, BREAST milk, LIQUID chromatography, UMBILICAL cord, HEALTH outcome assessment, CORD blood, MASS spectrometry, PREGNANCY
Abstract

What is known and objective: Statins are associated with improved pregnancy outcomes in patients with preeclamptic antiphospholipid syndrome (APS) and intrauterine foetal death. Several studies showed that statins are not teratogenic. However, data characterizing placental transfer and excretion of pravastatin into breast milk are limited. Case summary: We experienced two patients diagnosed with APS received 10 mg of pravastatin from the first trimester until delivery to prevent pre‐eclampsia. Pravastatin concentrations in maternal serum, infant serum and cord blood were evaluated. The estimated maternal‐foetal transfer ratios of pravastatin in the two patients were 25.5% and 23.8% respectively. Pravastatin was eliminated from neonatal serum within 2 days. Both infants developed normally with no drug‐related adverse effects. Pravastatin was not detected in either patient's breast milk at 3 days after the last dose. What is new and conclusion: The infants delivered from the mothers who were treated with pravastatin during pregnancy had no apparent adverse effects. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Omalizumab concentrations in pregnancy and lactation: A case study

Author

Saito, Jumpei, primary, Yakuwa, Naho, additional, Sandaiji, Noriko, additional, Uno, Chiaki, additional, Yagishita, Sachiko, additional, Suzuki, Tomo, additional, Ozawa, Katsusuke, additional, Kamura, Shunsuke, additional, Yamatani, Akimasa, additional, Wada, Seiji, additional, Sago, Haruhiko, additional, and Murashima, Atsuko, additional

Published
2020
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49. Tocilizumab drug levels during pregnancy and lactation: A woman who discontinued tocilizumab therapy until the end of the first trimester and resumed it after birth

Author

Saito, Jumpei, primary, Yakuwa, Naho, additional, Kaneko, Kayoko, additional, Goto, Mikako, additional, Kawasaki, Hiroyo, additional, Hamamachi, Yurie, additional, Suzuki, Tomo, additional, Sago, Haruhiko, additional, Yamatani, Akimasa, additional, and Murashima, Atsuko, additional

Published
2020
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