Delving into the Latest Updates on Ibuprofen/Codeine Phosphate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

洛芬待因片, Boots Ibuprofen and Codeine, Burana

+ [3]

Target

COXs x Opioid receptors

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), Opioid receptors agonists(Opioid receptors agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Acute PainInflammationModerate pain

Inactive Indication-

Originator Organization

GlaxoSmithKline, Inc.

Active Organization

Reckitt Benckiser (Australia) Pty Ltd.

The Boots Co. Plc

Orion Oyj

+ [2]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Australia (17 Feb 2005),

Acute PainInflammationModerate pain

Regulation-

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Structure/Sequence

Molecular FormulaC18H26NO8P

InChIKeyJPGKFBXFEQWCAI-CCLYOLAMSA-N

CAS Registry41444-62-6

View All Structures (2)

以马应龙药业集团股份有限公司研制的洛芬待因缓释胶囊为受试制剂，以Reckitt Benckiser Healthcare (UK) Ltd生产的洛芬待因片为参比制剂，比较两者在空腹、餐后条件下单次给药的药代动力学特点，同时比较两者在空腹条件下多次给药的药代动力学特点，以验证洛芬待因缓释胶囊的缓释作用。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The fencodeine sustained-release capsules developed by Mayinglong Pharmaceutical Group Co., Ltd. were used as the test preparation, and the fencodeine tablets produced by Reckitt Benckiser Healthcare (UK) Ltd were used as the reference preparation. The pharmacokinetic characteristics of the two were compared after single administration under fasting and postprandial conditions, and the pharmacokinetic characteristics of the two were compared after multiple administration under fasting conditions to verify the sustained-release effect of the fencodeine sustained-release capsules. The safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date08 Jun 2022

Sponsor / Collaborator

Mayinglong Pharmaceutical Group Co., Ltd.

NCT01535001

/ CompletedNot ApplicableIIT

Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.
The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.

Start Date01 Feb 2012

Sponsor / Collaborator

Danish Rheumatism Association

NCT01410409

/ CompletedNot ApplicableIIT

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).
The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.

Start Date01 Sep 2011

Sponsor / Collaborator

Bevica Innovation A/S

[+5]

100 Clinical Results associated with Ibuprofen/Codeine Phosphate

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100 Translational Medicine associated with Ibuprofen/Codeine Phosphate

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100 Patents (Medical) associated with Ibuprofen/Codeine Phosphate

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11

Literatures (Medical) associated with Ibuprofen/Codeine Phosphate

01 Sep 2023·Exploratory Research in Clinical and Social Pharmacy

The quality of non-prescription medicine counselling in Finnish pharmacies – a simulated patient study

Article

Author: Alastalo, Niina ; Siitonen, Piia ; Hämeen-Anttila, Katri ; Jyrkkä, Johanna

BackgroundMedication counselling provided by pharmacists is important for ensuring the safe use of medicines.ObjectiveTo assess the quality of non-prescription medicines counselling in Finnish pharmacies.MethodsThree scenarios using simulated patient methodology were conducted: the patient requesting a specific brand name Burana® (ibuprofen, OTC medicine), Pronaxen® (naproxen, behind-the-counter (BTC) medicine) and a nasal spray. The visits were conducted in 146 pharmacies by trained simulated patients. Each pharmacy was visited twice. The quality of counselling was defined as poor (1-2 points), moderate (3-4 points), or high (5-6 points) based on developed scenario-based scoring criteria.ResultsThe total number of conducted visits was 292, of which only 29 received high quality counselling. The quality was high in 20% of the cases for Pronaxen® and in 7% of the cases for Nasal spray scenarios. In the Burana® scenario, counselling quality was high only in 2% of the cases. Patients who requested a nasal spray were often asked questions about their symptoms (93%). In the Pronaxen®-scenario, the most frequently asked questions were related to contraindications and drug interactions (56%). The most often given instructions varied between the scenarios, being follow-up in the Burana® and Nasal spray scenarios (17% and 70%, respectively) and how to use the medicine in the Pronaxen®-scenario (63%).ConclusionsNon-prescription medicine counselling is rarely performed with high quality. However, the quality of counselling depends on the medication in question. There is room to improve medication counselling and the assessment of the necessity and suitability of treatment, especially when a patient requests an OTC pain medicine by its brand name.

01 Nov 2019·BMJ Case Reports

Impaired consciousness, hypokalaemia and renal tubular acidosis in sustained Nurofen Plus abuse

Article

Author: Li, Rebecca ; Armstrong, Luke ; Hasan, Neda ; Cockings, Jerome

Ibuprofen-induced renal tubular acidosis is a rare but important diagnosis which should be considered in patients presenting with hypokalaemia and metabolic acidosis. This case report details the case of a 33-year-old woman presenting with reduced conscious state, metabolic acidosis and profound hypokalaemia without an obvious cause. With correction of the patient’s electrolyte and acid-base disturbance, her conscious state improved allowing disclosure of her use of Nurofen Plus for its euphoric opiate effects. The diagnosis of renal tubular acidosis had been considered and subsequent disclosure of excessive chronic ingestion of ibuprofen suggested this to be the underlying cause. The striking feature of our patient was the insidious development of the problem and delayed accurate drug history. An important safety message arising from our case is the composite risk of dependence on the opiate component of over the counter analgesics, such as Nurofen Plus, and adverse events related to the ibuprofen component.

01 Jan 2012·Case Reports in Critical Care

Hypokalaemia and Renal Tubular Acidosis due to Abuse of Nurofen Plus

Article

Author: Blackstock, M. J. ; Lee, A.

Nurofen Plus is a common analgesic containing ibuprofen and codeine. We present a case of a 38-year-old lady who developed renal tubular acidosis with severe hypokalaemia, after chronic abuse of Nurofen Plus tablets. She presented with confusion and profound biochemical abnormalities requiring critical care admission for electrolyte replacement. Ibuprofen causes renal tubular acidosis due to its effects on carbonic anhydrase activity.

100 Deals associated with Ibuprofen/Codeine Phosphate

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Pain	Australia	Reckitt Benckiser (Australia) Pty Ltd.	17 Feb 2005
Inflammation	Australia	Reckitt Benckiser (Australia) Pty Ltd.	17 Feb 2005
Moderate pain	Australia	Reckitt Benckiser (Australia) Pty Ltd.	17 Feb 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01229449 (CTgov)	Phase 3	Toothache \| Pain, Postoperative	678	Nurofen Plus® (Nurofen Plus®)	bebhrjlfxi(dvljyjlqkc) = afdztmexuc djmaqyotgt (ikzcucwxoc, qdbguvaekb - imqydydzha) View more	-	17 Sep 2018
				Panadeine® Extra (Panadeine® Extra)	bebhrjlfxi(dvljyjlqkc) = vxsdioipiw djmaqyotgt (ikzcucwxoc, jutrhxasxl - gqqzsofjld) View more
NCT01410409 (MEDIC, CTgov)	Not Applicable	Pain \| Osteoarthritis, Knee	100	Insoles+Paracetamol+Burana+Pantoprazol (MEDIC)	gsbslkmgxm(vbpoltnimq) = ozutezwqee rhslyesgvi (slwmkhnlir, wxqyrejeeq - sklssaiazk) View more	-	27 Jan 2016
				Insoles+Paracetamol+Burana+Pantoprazol (MEDIC + TKR)	gsbslkmgxm(vbpoltnimq) = xagghyidda rhslyesgvi (slwmkhnlir, ifcmecyfyr - uuzoigzknr) View more
NCT01535001 (CTgov)	Not Applicable	Pain \| Osteoarthritis, Knee	100	Insoles+paracetamol+Burana+Pantoprazole (MEDIC)	fwegtrzrsf(xxgaqiofsb) = qdljozfsxi lnqcxawfdd (bhuxndlahk, psyyojtcvc - tkdthomskc) View more	-	27 Jan 2016
				Information (Standard Treatment)	fwegtrzrsf(xxgaqiofsb) = qhcmackxlt lnqcxawfdd (bhuxndlahk, eoyaboumrp - dvwmjyotxk) View more