Delving into the Latest Updates on Tramadol Hydrochloride/Acetaminophen with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Paracetamol and Tramadol Hydrochloride, Tramadol Hydrochloride Paracetamol, Tramadol/Paracetamol

+ [15]

Target

COXs x μ opioid receptor

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

PainCancer PainAcute Pain

Inactive Indication

Ankle InjuriesChronic PainLow Back Pain+ [4]

Originator Organization

Ortho-McNeil Pharmaceutical LLC

Active Organization

Xian-Janssen Pharmaceutical Ltd.Aspen Pharmacare Australia Pty Ltd.Janssen Pharmaceutical KK

Inactive Organization

Janssen Korea Ltd.Johnson & Johnson Pharmaceutical Research & Development LLC

Janssen Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 Aug 2001),

Acute Pain

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC24H35ClN2O4

InChIKeyUFLWHLMSTCRAJP-WUTOMRCLSA-N

CAS Registry147630-10-2

The rate of opioid prescribing after low-risk surgical procedures has increased over the past decade, and surgeons are responsible for prescribing approximately one-third of all opioid medications. There is additional supporting evidence that patients only consume about half of the opioids prescribed to them after outpatient plastic surgery. Currently, there is no literature to provide surgeons with reference ranges for how much opioid medication will adequately provide analgesia for patients after undergoing bilateral breast augmentation (BBA) surgery.

Objective::

To quantify the amount of opioid medication required to adequately control pain for patients after undergoing BBA and use these data to provide recommendations on opioid prescribing practices.

Methods::

Cross-sectional prospective data were obtained through a take-home medication and pain tracking questionnaire for 56 patients after they underwent either subpectoral or subglandular BBA. Patients documented their pain scores on a 0 to 10 analogue scale and documented the type and amount of pain medication they took for a 7-day period.

Results::

Our study demonstrated that patients in the subglandular BBA group required an average of either 25 ± 1.2 Tylenol #3 or 19.3 ± 2.3 Tramacet tablets, and the subpectoral group required 27.7 ± 1.7 Tylenol #3 or 25.6 ± 0.9 Tramacet tablets over a 7-day period. There was no statistically significant difference between the 2 surgical groups.

Conclusion::

We propose a reference range of medication required on average for patients undergoing BBA to obtain adequate pain control in the initial postoperative period that falls within the most recent Canadian guidelines for safe opioid prescribing practices.

01 Jan 2022·Translational and clinical pharmacology

Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination

Article

Author: Lee, SeungHwan ; Kim, JaeWoo ; Kim, Hyun Chul ; Hong, Jang Hee ; Yoon, Deok Yong ; Jang, In-Jin

Trial Registration:

ClinicalTrials.gov Identifier: NCT01606059.

01 Jan 2021·Journal of orthopaedic science : official journal of the Japanese Orthopaedic AssociationQ4 · MEDICINE

Impact of background factors on outcomes of pharmacological therapy for chronic low back pain: A nationwide multicenter prospective study

Q4 · MEDICINE

Article

Author: Haro, Hirotaka ; Matsuyama, Yukihiro ; Yamashita, Toshihiko ; Mochida, Joji ; Yoshida, Munehito ; Inoue, Gen ; Kaito, Takashi ; Iwasaki, Motoki ; Taneichi, Hiroshi ; Shintani, Ayumi ; Takura, Tomoyuki ; Miyakoshi, Naohisa ; Yamazaki, Masashi ; Murakami, Hideki ; Takahashi, Kazuhisa ; Kawakami, Mamoru ; Kabata, Daijiro ; Ito, Manabu ; Taguchi, Toshihiko ; Yamada, Hiroshi ; Ohtori, Seiji ; Imagama, Shiro ; Nishida, Kotaro ; Yonenobu, Kazuo

BACKGROUND:

Chronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study.

METHODS:

The subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis.

RESULTS:

Drugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes.

CONCLUSIONS:

This is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.

100 Deals associated with Tramadol Hydrochloride/Acetaminophen

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N02AJ13	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Pain	Australia	Aspen Pharmacare Australia Pty Ltd.	19 Mar 2012
Cancer Pain	Japan	Janssen Pharmaceutical KK	22 Apr 2011
Acute Pain	United States	Janssen Pharmaceuticals, Inc.	15 Aug 2001

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Low Back Pain	Phase 3	-	Janssen Korea Ltd.	01 May 2009
Chronic Pain	Phase 3	Japan	Janssen Pharmaceuticals, Inc.	01 May 2008
Pain, Postoperative	Phase 3	Japan	Janssen Pharmaceuticals, Inc.	01 Mar 2008
Ankle Injuries	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Musculoskeletal Pain	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Sprains and Strains	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Osteoarthritis, Knee	Phase 2	-	Janssen Pharmaceuticals, Inc.	01 Jun 2007

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05406752 (CTgov)	Phase 1	Acute Pain	32	paracetamol Uniflash (125 mg/ 1.25 mL)	msptnnhpjb(ivwurwyhcj) = umvnmdcvgh cicpfdtwfv (qyabbahydh, 1148.85) View more	-	13 Dec 2024
WCO_IOF_ESCEO2018	Not Applicable	Osteoarthritis, Knee	48	Tramadol/Acetaminophen	vpmgdikwly(xqkuvxwlug) = ektrdsknwj prztbioqic (kogaqvkibc ) View more	Positive	27 Jul 2018
WCO_IOF_ESCEO2018	Not Applicable	Osteoarthritis, Knee	48	NSAID (Naproxen 500mg)	vpmgdikwly(xqkuvxwlug) = sysrdhqtxh prztbioqic (kogaqvkibc ) View more	Positive	27 Jul 2018
NCT02389361 (CTgov)	Phase 4	Hernia, Inguinal \| Pain, Postoperative	51	Zaldiar (Group Z)	rureevvrui(bejlfgsbcb) = onhoagbloy radzzoeegl (qtysbgpvnb, 1.28) View more	-	13 Aug 2015
NCT02389361 (CTgov)	Phase 4	Hernia, Inguinal \| Pain, Postoperative	51	Paracetamol-Tramadol (Group PT)	rureevvrui(bejlfgsbcb) = egyejewfmg radzzoeegl (qtysbgpvnb, 1.86) View more	-	13 Aug 2015
NCT01345162 (PTSM04APHP, CTgov)	Phase 4	Hernia	200	intraoperative analgesia+Ketorolac postoperative	ywztsqopoa = gtbnxwqxgf oajtxuhlud (czjvckmrmv, ugnecccwts - astvqebxex) View more	-	09 Jun 2014
NCT00736853 (CTgov)	Phase 3	Chronic Pain	321	Placebo (Double-Blind)	ikwbsowmxe = irnbkdmoqs mroydyxisp (koyuhqbbac, idsjodyezy - vxknlrrppi) View more	-	26 Sep 2013
NCT01843660 (CTgov)	Phase 4	Low Back Pain \| Shoulder Pain \| Acute Pain ... View more	1,059	Tramadol HCl-Paracetamol	rebxbycqnq(qhxcktolsx) = sgeyokwjjz yzitnlhtsz (rzbpfpzidi, 2.07) View more	-	26 Aug 2013
NCT00737048 (CTgov)	Phase 3	Pain, Postoperative	328	Placebo+Acetaminophen	ckhqhltihe(eqdswuuntj) = drlvvvulup lfcahltuoh (yeqczybhlm, 8.07) View more	-	01 Aug 2013
NCT01112267 (CTgov)	Phase 3	Low Back Pain	248	Placebo	sconffudeb = zhzhdvgaty otuqwwpzou (qbegtzastn, wblzbrnoyc - ggpkdrhjhm) View more	-	24 Jul 2013
NCT00634543 (CTgov)	Phase 4	Diabetic Neuropathies \| Diabetic peripheral neuropathic pain	162	Gabapentin	ytbbfvmtca(ozqzdndgzw) = czvhqtijba kppshfycpd (wpbcvxkitr, 1.58) View more	-	16 Jul 2013
NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+Aceclofenac+Meloxicam	kllsfllrnj(hvdgoskqpf) = sbkicedfai upivuwsduq (hrhgtpfxlo, 14.17) View more	-	24 Jun 2013