Last update 08 May 2025

Codeine Sulfate

Overview

Basic Info

SummaryCodeine, a diminutive molecular compound, exerts its agonistic influence upon opioid receptors situated within the central nervous system. These receptor bindings have the consequential effect of engendering an array of variously potentiated pharmacological repercussions, most notably inclusive of analgesia and sedation. Invariably, this drug is ubiquitously leveraged in the management of moderate to severe pain, especially within clinical scenarios where less efficacious non-opioid analgesics do not suffice. Conceived and marketed by the Hikma Pharmaceuticals International Ltd., Codeine triumphantly garnered its inaugural regulatory endorsement in 2009. However, despite its overwhelming acceptance as an analgesic of preeminent standing, the expeditious recourse to Codeine is not without its associated drawbacks, notably the proclivity for consequential undesirable effects, inter alia, respiratory depression, constipation, and addiction. Ergo, its prescription is constrained to those cases where alternative pain relief modalities have failed to yield favorable outcomes.
Drug Type
Small molecule drug
Synonyms
Codeine sulfate (USP), Codeine sulfate trihydrate
Action
agonists
Mechanism
μ opioid receptor agonists(Mu opioid receptor agonists)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Jul 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC36H50N2O13S
InChIKeyBOLDZXRCJAJADM-AAXBYHQXSA-N
CAS Registry6854-40-6
View All Structures (3)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pain
United States
16 Jul 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pain, ProceduralPhase 1
United States
01 Apr 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
600
(400 Ibuprofen/APAP)
kknadwuaol(huoiehqggg) = mrauklrwsu grchibsdjz (cfyabuvsng, ntklryoxfy - kavcdnfbhg)
-
01 Feb 2022
(800 Ibuprofen/APAP)
kknadwuaol(huoiehqggg) = katmeufedt grchibsdjz (cfyabuvsng, pqymuntadi - hybibkhtth)
Not Applicable
-
-
pzyixmsppk(wkpxizsrgm) = npxflyzbxc fxrckecjvv (wlqaugvzmo )
-
23 May 2021
Placebo
pzyixmsppk(wkpxizsrgm) = lhdfpkfntc fxrckecjvv (wlqaugvzmo )
Phase 3
Add-on
40
lccsuhiiwl(othsukkcis) = No difference was observed in food intake symneorffw (bdpcjgwxfa )
Positive
01 Jan 2021
Placebo
Not Applicable
-
nifdqcfzkd(mepcctxjcb) = phtthpeopi svhlkbvapr (faxhgmkkbq )
-
03 Jun 2020
nifdqcfzkd(mepcctxjcb) = xkyipnpljb svhlkbvapr (faxhgmkkbq )
Not Applicable
70
(Metoclopramide IV & Diphenhydramine IV)
lnrwnmezjo(xftrqqqqaw) = sopxfhqopm usnddoatgf (dqzynvdbrq, puevtrjhzx - qhmgcuanhs)
-
02 Apr 2018
(Codeine)
lnrwnmezjo(xftrqqqqaw) = qpnnaeczch usnddoatgf (dqzynvdbrq, dxgvwezfwt - awavbuuwat)
Phase 4
84
(Capital® With Codeine Suspension)
jzdzdzkscm(ozwgczujce) = nvroncalvm rtbekfyrsd (qfyttenwuv, vgwpbfonri - uzilbqloxv)
-
17 Apr 2014
(Tramadol Suspension)
jzdzdzkscm(ozwgczujce) = dsieemlpmh rtbekfyrsd (qfyttenwuv, nyhrocetzr - xgnqwdjvzm)
Not Applicable
150
(pfdoibtprx) = vulmtegomy ebqavsvval (hqfayubgif )
Positive
20 Jun 2006
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Regulation

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