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Inflammatory Bowel Disease
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Prednisone and budesonide are commonly used to treat flares. Due to pregnancy risks and long-term health risks, corticosteroids are not appropriate for maintenance therapy [3, 30]. First trimester exposure is associated with an increased risk of orofacial clefting, and use during this time period should be avoided or limited to the lowest effective dose. Corticosteroid use is also associated with an increased risk of low birthweight, gestational diabetes, and preterm birth [33, 46, 47]. Budesonide is generally safe in pregnancy and with breastfeeding. Prednisone is generally safe with breastfeeding, but women on high doses should avoid breastfeeding within 4 hours of taking their dose to minimize possible neonatal effects. High-dose prednisone confers risk of diabetes (early glucola is warranted) and PPROM. A steroid taper is recommended when used for more than 1 week. Stress dose steroids are indicated only in special circumstances.
Gastrointestinal diseases and pregnancy
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Murtaza Arif, Anjana Sathyamurthy, Jessica Winn, Jamal A. Ibdah
Evidence suggests that steroids should be used with caution in the first trimester because of an association with an increased risk of oral clefts (93). A number of studies showed no adverse effects on fetal outcome in women who took corticosteroids during pregnancy (94,95). A meta-analysis of five studies of oral corticosteroid use did not reveal a major teratogenic risk of major malformations in the offspring of exposed patients at therapeutic doses (95). A significant increase was noted in risk of oral clefts (OR 3.69; 95% CI, 2.15–6.32); however, the increased risk appeared to be in women taking steroids for non-IBD diseases such as asthma. A case series of eight patients receiving budesonide during pregnancy demonstrated no increase in maternal adverse events (96). Corticosteroids also appear to be safe during breast-feeding (97). As in their nonpregnant counterparts, pregnant patients should be taken off steroids if at all possible, yet treatment during pregnancy can be safely initiated or continued as needed to control disease activity.
Respiratory, endocrine, cardiac, and renal topics
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
After 1 month, the doctor can evaluate if asthma is under control. There are two possibilities: Asthma is under control. Treatment should continue, but the dose will be decreased in steps of 100 μg/day budesonide or equivalent.Asthma is not under control, therefore two possibilities exist. Patients on intermittent short-acting beta-agonists will be switched to daily inhaled corticosteroids (max. budesonide 500 μg/day or equivalent). If the patient is already taking budesonide 500 μg/day or equivalent, long acting beta agonists or leukotriene antagonists will be associated.
Exacerbations of asthma following step-up and step-down inhaled corticosteroid and long acting beta agonist therapy in the managing asthma in pregnancy study
Published in Journal of Asthma, 2022
Vanessa E. Murphy, Megan E. Jensen, Peter G. Gibson
During pregnancy, guidelines recommend that asthma be managed as for other adults, with the goal of maintaining asthma control and avoiding exacerbations, with 4-weekly review of symptoms and lung function recommended (18,19). For pregnant women, preventer medication should be prescribed (and not withheld), if indicated, just as for other adults. Budesonide has the best safety rating of ICS medications for use in pregnancy, while other ICS and ICS/long acting beta agonist (LABA) combination treatments are not contraindicated in pregnancy (18). However, step-down of ICS is not recommended in pregnancy; the National Asthma Council’s Australian Asthma Handbook states that step down of ICS should only be considered if a woman is taking “an inappropriately high dose of a medicine,” and indicates that stepping down is not a priority due to the risk of exacerbations (18). These recommendations are based on expert consensus, not evidence. There are currently no studies which investigate the risk of exacerbation following changes to ICS dose in pregnancy.
Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients with ulcerative colitis: interim analysis of post-marketing surveillance
Published in Expert Opinion on Pharmacotherapy, 2021
Teppei Omori, Masayuki Saruta, Akira Nagaki, Yuki Arai, Akira Ohta, Kiyotoshi Kuramoto, Yasuo Suzuki
For patients with distal colitis, topical drugs are generally considered more useful than oral drugs [2], as they yield quicker responses through direct actions of the drug with high concentrations at local inflammatory sites and fewer systemic adverse events (AEs), owing to its lower systemic bioavailability [8]. Currently, topical 5-aminosalicylic acid (5-ASA) is recommended as a first-line therapy for mild-to-moderate proctitis and left-sided colitis, and topical steroids are recommended as a second-line therapy for 5-ASA-refractory or -intolerant patients [9–11]. Topical steroids are effective in controlling acute colonic inflammation; however, their use is limited to short-term treatment, owing to the occurrence of systemic AEs after absorption through the rectal mucosa. Budesonide is a synthetic second-generation corticosteroid that has been used for the treatment of inflammatory bowel disease [12]. Moreover, budesonide is an antedrug characterized by low bioavailability with high first-pass degradation in the liver, thereby minimizing the occurrence of systemic AEs. The foam formulation of budesonide can be efficiently delivered from the rectum to the sigmoid colon by one-push dosing, covering the area for several hours [13]. This drug has been developed by Dr. Falk Pharma GmbH and was first approved in Europe in 2006, followed by the USA in 2014 [14,15]. As of July 2020, the drug was approved in 37 countries worldwide.
A sensitive and high-throughput LC-ESI-MS/MS method to detect budesonide in human plasma: application to an evaluation of pharmacokinetics of budesonide intranasal formulations with and without charcoal-block in healthy volunteers
Published in Drug Development and Industrial Pharmacy, 2021
Xin Li, Huan Tong, Bing Xu, Yang Deng, Yuan Li, Junchen Huang, Yong Mao, Mengqin Liu, Ping Zhang, Siwei Guo
Budesonide is a second-generation INC [9], with intermediate lipophilicity and relatively moderate affinity for GR, which enables better absorption and longer retention in the nasal mucosa than other INCs [10]. Therefore, budesonide is administered in low doses for 256 μg once-daily. The systemic bioavailability (BA) of budesonide is considered low after oral (∼10%) and intranasal (34%) administration, and it is rapidly and extensively metabolized by the liver to two main metabolites, 16a-hydroxy prednisolone and 6b-hydroxy budesonide [11]. The GR affinity of these metabolites is less than 1% of parent compound budesonide [11]. Hence, the exposure level of parent budesonide in human plasma is the basis for pharmacokinetic (PK) research. However, the plasma concentrations of budesonide are in picogram levels as a result of small daily doses and low BA, and thus a sensitive and specific method for detecting the plasma concentrations of budesonide is required.