Delving into the Latest Updates on Ranitidine Bismuth Citrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pylorid, Ranitidine Bismuth, Ranitidine bismuth citrate (USAN)

+ [5]

Target

H2 receptor

Mechanism

H2 receptor antagonists(Histamine H2 receptor antagonists)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Helicobacter InfectionsStomach UlcerDuodenal Ulcer

Inactive Indication

Erosive esophagitisGastroesophageal RefluxHeartburn+ [1]

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

GB (13 Sep 1995),

Duodenal Ulcer

Regulation-

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Structure/Sequence

Molecular FormulaC19H30BiN4O10S

InChIKeyKMNPCCNMXHDTHJ-UHFFFAOYSA-N

CAS Registry128345-62-0

Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded based on it's severity and has been known to cause various problems like patient's discomfort, hypoxia, change in hemodynamic variables of the patient and poor wound healing. This problem has been managed via pharmacologic and non-pharmacologic means. Non-pharmacologic modalities involve options aimed at warming the patient. Pharmacologically, opioids are used more commonly to prevent and treat this condition. This then introduces the side effect of nausea/vomiting and sedation which may reduce overall patient's satisfaction on the perception of the Subarachnoid block. It is for this reason that Nefopam - a centrally acting non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic, relatively new drug in the Nigerian market with significant anti-shivering effect is compared with a well established opioid like Tramadol. Having similar cost profile, the option of replacing Tramadol with Nefopam especially in conditions where the patient is more hemodynamically unstable is considered in this project.

Start Date12 Oct 2018

Sponsor / Collaborator-

100 Clinical Results associated with Ranitidine Bismuth Citrate

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100 Translational Medicine associated with Ranitidine Bismuth Citrate

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100 Patents (Medical) associated with Ranitidine Bismuth Citrate

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330

Literatures (Medical) associated with Ranitidine Bismuth Citrate

01 Nov 2024·Nature Medicine

Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized controlled trial

Article

Author: Liu, Wei-Dong ; Liu, Zong-Chao ; Wang, Jian-Xi ; Gerhard, Markus ; Xu, Heng-Min ; Li, Wen-Qing ; Pan, Kai-Feng ; Bajbouj, Monther ; Quante, Michael ; Li, Ming ; Ulm, Kurt ; Schmid, Roland M ; Zhang, Lan-Fu ; Fan, Xiao-Han ; Wang, Le-Hua ; Classen, Meinhard ; Ma, Jun-Ling ; Zhang, Lei ; Zhang, Yang ; Zhou, Tong ; Guan, Wei-Xiang ; You, Wei-Cheng ; Vieth, Michael ; Mejías-Luque, Raquel ; Zhang, Lian ; Suchanek, Stepan ; Han, Xuan

Gastric cancer is a leading cause of cancer-related deaths in China. Affecting more than 40% of the world's population, Helicobacter pylori is a major risk factor for gastric cancer. While previous clinical trials indicated that eradication of H. pylori could reduce gastric cancer risk, this remains to be shown using a population-based approach. We conducted a community-based, cluster-randomized, controlled, superiority intervention trial in Linqu County, China, with individuals who tested positive for H. pylori using a ¹³C-urea breath test randomly assigned to receiving either (1) a 10-day, quadruple anti-H. pylori treatment (comprising 20 mg of omeprazole, 750 mg of tetracycline, 400 mg of metronidazole and 300 mg of bismuth citrate) or (2) symptom alleviation treatment with a single daily dosage of omeprazole and bismuth citrate. H. pylori-negative individuals did not receive any treatment. We examined the incidence of gastric cancer as the primary outcome. A total of 180,284 eligible participants from 980 villages were enrolled over 11.8 years of follow-up, and a total of 1,035 cases of incident gastric cancer were documented. Individuals receiving anti-H. pylori therapy showed a modest reduction in gastric cancer incidence in intention-to-treat analyses (hazard ratio 0.86, 95% confidence interval 0.74-0.99), with a stronger effect observed for those having successful H. pylori eradication (hazard ratio 0.81, 95% confidence interval 0.69-0.96) than for those who failed treatment. Moderate adverse effects were reported in 1,345 participants during the 10-day treatment. We observed no severe intolerable adverse events during either treatment or follow-up. The findings suggest the potential for H. pylori mass screening and eradication as a public health policy for gastric cancer prevention. Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10000979 .

01 Mar 2024·Drugs in R&D

Pharmacokinetic and Safety Study of Bismuth Potassium Citrate Formulations in Healthy Subjects

Article

Author: Cheng, Yan ; Su, Yu ; Zhou, Zi-Wei ; Long, Hui-Zhi ; Hu, Jin-Da ; Luo, Hong-Yu ; Li, Feng-Jiao ; Xu, Shuo-Guo ; Dai, Shang-Ming ; Gao, Li-Chen

BACKGROUNDPotassium bismuth citrate is a gastric mucosal protector and a key drug for treating peptic ulcers.OBJECTIVETo evaluate the pharmacokinetic characteristics and safety of 120-mg bismuth potassium citrate formulations administered orally under fasting conditions in healthy Chinese subjects.METHODA single-center open two-cycle trial was conducted on 12 healthy subjects who received a single oral dose of 120 mg of bismuth potassium citrate. The plasma concentration of bismuth was determined using a validated inductively coupled plasma mass spectrometry (ICP‒MS) method. The pharmacokinetic parameters, including maximum serum concentration (C_max) and area under the curve concentration-time curve (AUC_0-t and AUC_0-∞), and safety were evaluated via noncompartment analysis.RESULTSThe ratios of the least square geometric mean ratio between the test (T) and reference (R) formulations for C_max, AUC_0-t, and AUC_0-∞ were 44.8%, 55.5%, and 64.4%, respectively; the bilateral 95% confidence intervals (Cis) for these parameters were 20.2-99.6%, 24.1-127.5%, and 23.7-175.0%, respectively, and the non-inferior limits for these parameters were 169.4%, 198.8%, and 200.5%, respectively. The upper limits of the one-sided 97.5% confidence interval for the least squares geometric mean ratio (T/R) were lower than the non-inferior limits. No serious adverse reactions or adverse reactions leading to detachment were observed among the subjects.CONCLUSIONThe concentration of bismuth in the blood of healthy subjects in the T formulation was not greater than that in the R formulation. Similarly, the safety of oral administration of 120 mg of bismuth potassium citrate formulations to healthy subjects was good. The trial registration number (TRN) was [2018] 013, 6 December 2018.

01 Jan 2024·Therapeutic Advances in Gastroenterology

Clarithromycin sustained-release tablet may be an improper therapy for the eradication of Helicobacter pylori

Article

Author: Luo, Jing ; Zuo, Xingsheng ; Zhao, Chenglong ; Shen, Qingli ; Wang, Yaqin

Background: Clarithromycin plays an important role in eradicating Helicobacter pylori ( H. pylori) through quadruple therapy. However, there is limited research on whether different forms of clarithromycin dosage have similar efficacies against H. pylori. Objective: We aimed to evaluate the efficacy of different forms of clarithromycin dosage in bismuth-containing quadruple therapy for eradicating H. pylori. Design: A single-center retrospective analysis comparing the efficacy of different forms of clarithromycin dosage in eradicating H. pylori. Methods: An analysis was conducted on patients diagnosed with H. pylori infection through the 13C-urea breath test (13C-UBT) at Henan Provincial People’s Hospital, China from 2020 to 2022 who were treated with either a dispersible or sustained-release clarithromycin tablet (500 mg each), alongside amoxicillin (1000 mg), a standard dose of proton pump inhibitors (PPIs), and bismuth citrate (220 mg), administered twice daily as part of bismuth-containing quadruple therapy. Treatment efficacy was assessed using 13C-UBT at least 4 weeks after treatment completion. The H. pylori eradication rate was the primary outcome of this study, and factors influencing it were analyzed. Results: Among 2094 screened patients, 307 with H. pylori infection (mean age, 41.8 ± 0.7 years; 43% men) received bismuth-containing quadruple therapy. Univariate analysis of the dispersible and sustained-release tablet groups revealed a lower eradication rate with the sustained-release tablet compared with the dispersible clarithromycin tablet regimen (75.26% (73/97) vs 95.26% (200/210), respectively; p < 0.05). Other factors, such as smoking, age, and PPI type, were not significantly associated with the cure rate. Multivariate analysis identified the form of clarithromycin dosage (dispersible vs sustained-release) to be an independent risk factor for eradication failure using the bismuth-containing quadruple therapy (odds ratio = 0.145, 95% confidence interval: (0.065–0.323); p < 0.05). Conclusion: The clarithromycin dispersible tablet demonstrated a higher H. pylori eradication rate, and the sustained-release clarithromycin tablet may be inappropriate for H. pylori eradication.

100 Deals associated with Ranitidine Bismuth Citrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D05699	Ranitidine Bismuth Citrate	A02BA02	DBSALT001128

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Helicobacter Infections	GB	GSK Plc	23 Sep 1995
Stomach Ulcer	GB	GSK Plc	18 Sep 1995
Duodenal Ulcer	GB	GSK Plc	13 Sep 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heartburn	Phase 2	AU	GSK Plc	01 May 2006
Gastroesophageal Reflux	Discovery	US	GSK Plc	23 Mar 1998

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01896557 (Pubmed \| Am J Cardiovasc Drugs)	Phase 4	Coronary Artery Disease	92	Clopidogrel + Omeprazole	(clbvsyppzz) = ghopjwcjym dnnwsfvjru (lrgbsqnxrz )	-	01 Aug 2016
				Clopidogrel + Ranitidine	(clbvsyppzz) = mybfntoloe dnnwsfvjru (lrgbsqnxrz )
NCT01896557 (CTgov)	Phase 4	Coronary Artery Disease \| Medication interactions	92	clopidogrel+omeprazole (Omeprazole)	voclchofou(tcjoulerwv) = eptmtwxxlz ubjulhkejt (alkxqwgxhi, luimaoxttd - ghaqejodlv) View more	-	23 May 2016
				clopidogrel+Ranitidine (Ranitidine)	voclchofou(tcjoulerwv) = qmjdlmqtes ubjulhkejt (alkxqwgxhi, wbgarerixz - rczawkknnr) View more