Delving into the Latest Updates on Orphenadrine Citrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Orphenadrine citrate (USP), Norflex

Target

H1 receptor x NMDA receptor

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists), NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Musculoskeletal Pain

Originator Organization

Bausch Health Cos., Inc.

Active Organization-

Inactive Organization

Bausch Health US LLC

Drug Highest PhaseWithdrawn

First Approval Date

US (04 Nov 1959),

Musculoskeletal Pain

Regulation-

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Structure

Molecular FormulaC18H23NO

InChIKeyQVYRGXJJSLMXQH-UHFFFAOYSA-N

CAS Registry83-98-7

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This study consisted of a randomized controlled trial designed to evaluate a Multimodal Analgesia (MMA) Protocol on patients undergoing Posterior Spinal Fusion. The purpose is to describe the narcotic requirements and usage during the perioperative period of posterior spinal fusion and instrumentation surgery with the implementation of multimodal anesthesia protocol. The study will consist of two parallel arms, with Group 1 receiving our MMA protocol and Group 2 receiving a traditional opioid-based regime. The primary outcome of this study will be the reported Visual Analog Scale (VAS) for pain at 12, 24, and 48 hours after surgery. We considered that our findings could contribute to the fight against the opioid crisis proving alternatives to opioids as feasible alternatives for pain management even in significant surgery, as is posterior spinal fusion with instrumentation.

Start Date05 Apr 2021

Sponsor / Collaborator

University of Puerto Rico

NCT02985671 / Unknown statusPhase 3

National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.

The purpose of this study is to determine whether the fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute episode of mechanical postural low back pain than Voltaren®. Will be randomized 110 participants of both sexes, aged 18 years or older and less than 65 years of age with an acute episode of mechanical postural low back pain and they will be allocated to one of two treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium; or Group 2: Voltaren®

Start Date01 Jan 2021

Sponsor / Collaborator

Aché Laboratórios Farmacêuticos SA

NCT04509336 / TerminatedNot ApplicableIIT

Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

Start Date20 Aug 2020

Sponsor / Collaborator

Mansoura University

100 Clinical Results associated with Orphenadrine Citrate

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100 Translational Medicine associated with Orphenadrine Citrate

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100 Patents (Medical) associated with Orphenadrine Citrate

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440

Literatures (Medical) associated with Orphenadrine Citrate

01 Nov 2024·Marine Environmental Research

Temporal variability and ecological risks of pharmaceuticals and cocaine during the Christmas and New Year holidays in a beach area of North Coast of São Paulo, Brazil

Article

Author: Assis Junior, Wellington Rui Andrade de ; Metropolo, Ana Paula ; Pereira, Camilo Dias Seabra ; Kiyotani, Rafael Barreiros ; Santos, Gilmar Aparecido Dos ; Santos, Gilmar Aparecido dos ; Roveri, Vinicius ; Guimarães, Luciana Lopes ; Rodrigues, Aírton Zogaib ; Correia, Alberto Teodorico

This study assessed the occurrence and ecological potential risk of nine selected pharmaceuticals in water samples from the Juquehy River. The river flows continuously to Juquehy Beach, known as "the jewel of the north coast" of São Paulo, Brazil. Samples were collected during Christmas and the New Year (period of December 2023-January 2024), in addition to a previous baseline weekend, to compare the loads during "celebratory parties" versus "normal operational conditions." The findings indicated that the "mass gathering" during Christmas and New Year holidays contributed significantly to an increase of the mass load of the nine pharmaceuticals flowing along to the Juquehy River, i.e., caffeine (14.40-633.00 ng/L) > losartan ( furosemide (< LOQ to 9.16 ng/L) > diclofenac (0.61-4.55 ng/L) > carbamazepine (< LOQ to 0.73 ng/L) > orphenadrine (< LOQ to 0.11 ng/L) showed higher concentrations during the New Year holiday. Conversely, atenolol (< LOQ to 13.10 ng/L) > benzoylecgonine (0.33-7.23 ng/L) > cocaine (0.12-6.59 ng/L) showed higher concentrations during the Christmas day. The individual ecological risk assessment in the Juquehy River revealed a clear environmental concern for the aquatic ecosystem. The threat to the aquatic biota is significant, with caffeine and losartan presenting a moderate level of risk. Moreover, the mixture ecological risk assessment of nine compounds indicates acute moderate risks to algae, crustaceans, and fishes, as well as chronic low risks to fishes.

01 Sep 2024·Pakistan journal of pharmaceutical sciences

Prevalence and comparative analysis of potential drug-drug interactions among hospitalized patients at a tertiary care cardiac institute in Pakistan: Findings from a single centre.

Article

Author: Khan, Khalid ; Humza, Ahmad Ullah ; Ammar, Ali ; Bilal Awan, Muhammad Asad ; Akbar, Muhammad Asad ; Yousuf, Jibran Bin

Hospitalized post-operative cardiovascular disease (CVD) patients are often subject to polypharmacy, increasing the risk of potential drug-drug interactions (pDDIs). This observational study assessed 384 post-operative CVD patients for pDDIs using Micromedex Drug-Int® and Lexicomp Interact®. Prevalence, severity, onset and documentation of pDDIs were analyzed using SPSS 23.0, with logistic regression identifying factors associated with at least two major pDDIs or two pDDIs categorized as X, D, or C. Micromedex Drug-Int® revealed a median of 6.23 pDDIs per patient, with 98.7% of patients having ≥1 pDDIs. Of 2,389 pDDIs, 64.1% were major. Lexicomp Interact® data showed a median of 7.15 pDDIs per patient, with 99.2% of patients having ≥1 pDDIs. Class C interactions were the most frequent (62.1%), followed by Classes B, D and X. Additionally, the study identified unique pDDIs from Lexicomp, including Ipratropium-Orphenadrine and Furosemide-Levosulpiride, not listed in Micromedex. The findings highlight the high prevalence of pDDIs in this population, emphasizing the need for regular monitoring. Using pDDI screening tools, clinical pharmacists can be crucial in mitigating these risks, particularly in high-risk patients.

03 Mar 2024·Clinical Toxicology

Clinical outcomes associated with orphenadrine deliberate self-poisoning: a retrospective poisons centre study

Article

Author: Roberts, Darren M. ; Dhaliwal, Nina

INTRODUCTIONOrphenadrine overdoses can cause antimuscarinic toxicity, respiratory failure, refractory seizures and cardiotoxicity. The dose-toxicity relationship is poorly defined. Orphenadrine is marketed as immediate and sustained release formulations, and it is not known how the formulation impacts on toxicity. We determined the clinical toxicity of orphenadrine in patients referred to a regional poisons centre.METHODSRetrospective case series of patients in New South Wales with orphenadrine deliberate self-poisoning from January 2016 to April 2022 referred to the New South Wales Poisons Information Centre. Demographics, history of exposure, treatment and outcomes were extracted from clinical databases. Receiver-operating characteristic curves were constructed to determine thresholds predicting toxicity.RESULTSForty-eight patients were identified, with information on clinical outcomes in 46 patients and doses in 41 patients. All patients were older than 12 years. The median orphenadrine dose was 770 mg (range 210-10,000 mg), 59 per cent as the immediate release formulation, and 67 per cent reported coingestants. Doses of sustained release formulations were significantly greater than immediate release formulations, median 2,750 mg versus 595 mg. Common clinical features were drowsiness (59 per cent), sinus tachycardia (37 per cent) and confusion (33 per cent). Three patients had mild hypotension, three were intubated for coma, and two had seizures; no patients suffered ventricular dysrhythmias. All patients survived, with 75 per cent being medically cleared within 24 hours of presentation. A dose-toxicity relationship was observed, but conclusions are limited by the small number of cases with moderate or severe toxicity.DISCUSSIONAll patients survived, and severe cardiac and neurological toxicity were not observed. This contrasts to published case reports noting severe poisoning at similar or lower doses. Formulation may have an impact on outcomes, with lesser toxicity from sustained release products.CONCLUSIONSOrphenadrine doses up to 10 g were associated with antimuscarinic toxicity and sedation, but not severe cardiotoxicity. More research exploring the effect of dose and formulation on outcomes is required.

100 Deals associated with Orphenadrine Citrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D00774	Orphenadrine Citrate	M03BC01	DB01173

R&D Status

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2018	Not Applicable	Liver Cirrhosis	-	Orphenadrine 100 mg	fazpeavmkf(fzniwfljwm) = few such as dry mouth, drowsiness, and nausea, with no significant difference between their occurrences in the 2 groups nrionyvuvc (puiexsodpi )	-	01 Oct 2018
				Placebo
NCT02665286 (CTgov)	Phase 4	Acute low back pain	240	Placebo+Naproxen (Placebo)	iiiiehfgfj(fwmkfijccs) = hljxnrzmfj vyxqckarxo (fnglmmfpqv, iahnjgpbbd - hladsphant) View more	-	26 Jun 2018
				Naproxen+Orphenadrine (Orphenadrine)	iiiiehfgfj(fwmkfijccs) = mkfsufriim vyxqckarxo (fnglmmfpqv, yigkfbmyxp - sxqilnedxz) View more
NCT02665286 (Pubmed \| Ann Emerg Med)	Phase 4	Acute low back pain	240	Naproxen+Placebo	(eltvxnznzp) = zeuedasyki yriemvpgpl (wfditngefe, 8.9 - 12.9)	Negative	01 Mar 2018
				Naproxen+Orphenadrine	(eltvxnznzp) = tietzswyea yriemvpgpl (wfditngefe, 7.4 - 11.5)