Ritodrine 10mg tablets

Abstract Background Some studies have compared the efficacy of nifedipine with that of other tocolytic drugs in the treatment of preterm labor, but the reported results are conflicting. Objective To compare the efficacy of nifedipine with that of ritodrine, nitroglycerine and magnesium sulfate for the management of preterm labor. Methods In this systematic review and meta-analysis, PubMed/MEDLINE, Scopus, Clarivate Analytics Web of Science, and Google Scholar were searched until April 3,2024 using predefined keywords. Randomized controlled trials (RCTs) and clinical trials that compared the efficacy of nifedipine with that of ritodrine, nitroglycerine and magnesium sulfate for the management of preterm labor were included. Two authors independently reviewed the articles, assessed their quality and extracted the data. The quality of the included RCTs based on the Cochrane Risk of Bias Tool 1 for clinical trial studies. The risk difference (RD) with the associated 95% confidence interval (CI) was calculated. A forest plot diagram was used to show the comparative point estimates of nifedipine and other tocolytic drugs on the prevention of preterm labor and their associated 95% confidence intervals based on the duration of pregnancy prolongation. Study heterogeneity was evaluated by the I 2 index, and publication bias was evaluated by Egger’s test. Results Forty studies enrolling 4336 women were included. According to our meta-analysis, there was a significant difference in the prolongation of preterm labor within the first 48 h between the nifedipine group and the nitroglycerine group (RD, -0.04; 95% CI, -0.08 to -0.00; I 2 : 32.3%). Additionally, there were significant differences between nifedipine and ritodrine (RD, 0.11; 95% CI, 0.02 to 0.21; I 2 , 51.2%) for more than one week RD, 0.10; 95% CI, 0.03 to 0.19; I 2 , 33.2%) and for 34 weeks and more. The difference between nifedipine and magnesium sulfate was not significant in any of the four time points. Conclusions Considering the superiority of nifedipine over ritodrine and nitroglycerine and its similar efficacy to magnesium sulfate for tocolysis, it seems that the side effects of these options determine the first drug line.

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Background: Cesarean section is frequently performed for breech presentation; however, external cephalic version (ECV) is recommended as an alternative strategy to increase the likelihood of vaginal birth. Tocolytic agents are commonly administrated to improve ECV success, yet the comparative effectiveness of different regimens remains inadequately characterized. Aims: To systematically evaluate and compare the efficacy and safety of various tocolytic agents in facilitating successful ECV through a Bayesian network meta-analysis. Study Design: Bayesian network meta-analysis. Methods: Bayesian network meta-analysis was performed using the "gemtc" package in R 4.1.1. Treatment effects were quantified by calculating odds ratios (ORs) with corresponding 95% credible intervals (CrIs). Surface under the cumulative ranking curve values were used to rank tocolytic agents according to ECV success rates, maternal outcomes, and adverse events. Results: A total of sixteen RCTs encompassing 2,817 participants and six distinct tocolytic agents met the inclusion criteria. Compared with placebo, terbutaline (OR: 2.7, 95% CrI: 1.1-6.4) and ritodrine (OR: 2.2, 95% CrI: 1.4-3.9) were associated with significantly higher ECV success rates. Additionally, terbutaline was linked to an increased likelihood of vaginal delivery (OR: 2.0, 95% CrI: 1.0-2.9). Maternal adverse effects, including tachycardia, palpitations, hypotension, nausea, dizziness, and flushing, were more frequently reported with terbutaline, nifedipine, and nitroglycerin than with placebo. No statistically significant differences in fetal heart rate abnormalities were detected among the elevated interventions. Conclusion: Terbutaline and ritodrine appear to offer superior efficacy in improving ECV success compared with alternative tocolytic agents, albeit with a higher incidence of maternal side effects. Consequently, clinical decision-making regarding tocolytic use should be informed by a comprehensive assessment of the associated benefits and potential risks.

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BACKGROUND: The Targeted Learning roadmap provides a systematic guide for generating and evaluating real-world evidence (RWE). From a regulatory perspective, RWE arises from diverse sources such as randomized controlled trials that make use of real-world data, observational studies, and other study designs. This paper illustrates a principled approach to assessing the validity and interpretability of RWE. METHODS: We applied the roadmap to a published observational study of the dose-response association between ritodrine hydrochloride and pulmonary edema among women pregnant with twins in Japan. The goal was to identify barriers to causal effect estimation beyond unmeasured confounding reported by the study's authors, and to explore potential options for overcoming the barriers that robustify results. RESULTS: Following the roadmap raised issues that led us to formulate alternative causal questions that produced more reliable, interpretable RWE. The process revealed a lack of information in the available data to identify a causal dose-response curve. However, under explicit assumptions the effect of treatment with any amount of ritodrine versus none, albeit a less ambitious parameter, can be estimated from data. CONCLUSIONS: Before RWE can be used in support of clinical and regulatory decision-making, its quality and reliability must be systematically evaluated. The TL roadmap prescribes how to carry out a thorough, transparent, and realistic assessment of RWE. We recommend this approach be a routine part of any decision-making process.

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BACKGROUND: External Cephalic Version (ECV) is an effective procedure for modifying fetal position to achieve a cephalic presentation. ECV is usually performed with tocolysis and spinal anesthesia. Recently, propofol has been proposed as a sedative agent for ECV, showing promising results in observational studies. This clinical trial aims to compare the outcomes of ECV performed under tocolysis with either propofol or spinal anesthesia. METHODS: The PropoSpinECV randomized clinical trial is designed as a single-center, randomized, open-label trial. Participation will be offered to every pregnant woman with a non-cephalic presentation undergoing external cephalic version. Sedation with propofol and spinal analgesia with bupivacaine and fentanyl will be compared for ECV with a 1:1 allocation ratio. All procedures will be performed under tocolysis with ritodrine. The breech progression angle before ECV will be measured for all participants. The main outcome will be the ECV success rate. ECV complication rates and post-procedure pain will also be evaluated. DISCUSSION: The PropoSpinECV trial will thoroughly evaluate the efficacy of propofol in ECV. Additionally, this trial will investigate the role of the breech progression angle prior to ECV as a predictive variable for the success of the procedure. TRIAL REGISTRATION: The PropoSpinECV clinical trial is registered in the European Union Clinical Trial Database (EU CT number: 2024-510701-29-00) and in the ClinicalTrials.gov Database (NCT06449430) with the Clinical Trial Registry (2024-06-03).

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Abstract Background Ritodrine hydrochloride, a β2-adrenergic agonist, has been widely used in Asia and Europe to treat preterm labor in pregnant women. It has some typical side effects, such as palpitations, pulmonary edema, and hypokalemia. Here, we report a case of rhabdomyolysis and psychiatric symptoms might be associated with intravenous ritodrine. Case presentation A 32-year-old Chinese primigravida woman who was pregnant with twins by in vitro fertilization-embryo transfer was diagnosed with placenta previa and threatened abortion at 21 gestational weeks (GW). The patient was then treated with ritodrine hydrochloride. The initial dose of ritodrine was 150 μg/min, gradually increasing to 360 μg/min at 23 5/7 GW and 400 μg/min at 27 1/7 GW. Magnesium sulfate was added to the ritodrine regimen at 21 5/7 GW in dosage of 1-2 g/h. Psychiatric symptoms appeared at 24 5/7 , 26 5/7 , and 27 3/7 GW, manifesting as depression, anxiety, and suicidal tendencies. Severe muscle pain in her limbs and general weakness appeared after six weeks of ritodrine administration, which might have been a sign of rhabdomyolysis resulting from ritodrine administration. After ceasing the administration of ritodrine, the muscle pain and relevant data from laboratory tests on the patient were significantly improved, and her mood was stable. It is worth noting that this is the first time to report psychiatric symptoms may associated with the administration of ritodrine. In addition, we reviewed and analyzed six reported cases of rhabdomyolysis caused by ritodrine. Conclusion Our results suggest that we should pay more attention to the risk of rhabdomyolysis and psychiatric symptoms induced by intravenous ritodrine hydrochloride, especially in patients with a history of neuromuscular disorder, or concomitant use of magnesium sulfate.

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Abstract Background Pregnancy in women with chronic kidney disease (CKD) is associated with an increased risk of adverse maternal and fetal outcomes, including worsening renal function, hypertension, proteinuria, preeclampsia, preterm delivery, stillbirth, and intrauterine growth restriction. Some pregnant women with CKD may require dialysis after conception. Clinical guidelines provide recommendations for optimal hemodialysis prescription in pregnant women undergoing maintenance hemodialysis for end-stage kidney disease. However, the timing of initiation and optimal doses of hemodialysis for pregnant women with non-dialysis advanced CKD remain uncertain. Case presentation We describe the case of a 29-year-old woman with a history of CKD for at least 2 years. She was referred to our department with a serum creatinine level of 2.48 mg/dL and an estimated glomerular filtration rate of 20 mL/min/1.73 m 2 . Because she was found to be pregnant at the initial visit, she was referred to the Department of Obstetrics. At 23 weeks’ gestation, she was admitted due to threatened premature delivery and urinary tract infection, which were managed with ritodrine hydrochloride and antibiotics. Owing to maternal weight loss and asymmetrical fetal growth restriction, daily protein intake was increased from 40 g/day to 60–80 g/day. Additionally, supportive hemodialysis (three times per week) was initiated at 26 weeks’ gestation, and the pre-dialysis blood urea nitrogen (BUN) level was consistently maintained < 40 mg/dL. Consequently, the patient’s weight increased, and fetal growth recovered. Because her blood pressure increased particularly during and after dialysis sessions, dialysis was discontinued at 32 weeks’ gestation. Urinary protein increased to a nephrotic level, and blood pressure was poorly controlled by medication, suggesting the onset of preeclampsia. Thus, a cesarean section was performed at 33 weeks’ gestation, and she delivered a male baby weighing 1449 g. Following childbirth, the patient did not require hemodialysis. Conclusions Supportive hemodialysis during pregnancy in women with advanced CKD can increase maternal protein intake without elevating BUN levels, leading to improved fetal growth.

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Preterm birth (PTB) remains a leading cause of infant mortality and morbidity, significantly affecting the long-term health, welfare, and development of newborns. Tocolytics, such as ritodrine, a β 2 -adrenergic receptor agonist, are widely used in developing countries due to their affordability for preventing PTB by inhibiting uterine contractions. However, ritodrine's short half-life necessitates frequent administration, and prolonged high-dose usage often leads to serious maternal side effects, prompting discontinuation. The uterine first-pass effect, where vaginally administered drugs preferentially target the uterus, can enhance drug concentration in uterine tissue while minimizing systemic absorption and side effects. This study designed a kind of ritodrine-loaded thermosensitive gel (Gel@Rit) to intervene in PTB by exploiting the uterine first-pass effect and investigate its underlying mechanisms. The gel, formulated with poloxamer, demonstrated excellent temperature sensitivity and viscosity, ensuring sustained ritodrine release in vitro . Plasma pharmacokinetic and tissue distribution studies in pregnant mice confirmed the uterine first-pass effect, showing significantly higher drug concentrations in the uterus and markedly lower plasma levels following Gel@Rit administration. The distinctive drug-time curve in Gel@Rit-treated mice, along with uterine tissue fluorescence profiles, elucidated four mechanisms of uterine localization: diffusion through reproductive tract cavities, penetration via vaginal and uterine structures, diffusion through systemic circulation, and retrograde transvaginal veno-uterine artery exchange. This study provides valuable insights into vaginal drug delivery research methodologies, advancing therapeutic strategies for uterine-related conditions and benefiting clinical outcomes in PTB prevention. A schematic diagram depicting the preparation procedure of ritodrine-loaded thermosensitive gel and elucidating the underlying mechanisms facilitating uterine drug delivery via the uterine first-pass effect.

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BACKGROUND: Ritodrine hydrochloride is a widely used beta-adrenergic agonist used to stop preterm labor in Taiwan. Many side effects causing maternal morbidity and mortality have been reported. We report a case complicated with ritodrine-induced side effects and mirror syndrome that was associated with placental chorioangioma. CASE PRESENTATION: A 36-year-old singleton pregnant woman at 25 6/7 weeks of gestation, with an undiagnosed placental chorioangioma, underwent tocolysis due to preterm uterine contractions. Her clinical condition deteriorated, attributed to mirror syndrome and adverse events induced by ritodrine. An emergency cesarean section was performed at 27 1/7 weeks of gestation, delivering an infant with generalized subcutaneous edema. A placental tumor measuring 8.5 cm was discovered during the operation, and pathology confirmed chorioangioma. Gradual improvement in her symptoms and laboratory data was observed during the postpartum period. Identifying mirror syndrome and ritodrine-induced side effects poses challenges. Therefore, this case is educational and warrants discussion. CONCLUSION: Our case demonstrates mirror syndrome induced by chorioangioma, which is rare, and ritodrine-induced side effects. The cessation of intravenous ritodrine and delivery are the best methods to treat maternal critical status due to fluid overload.

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