Last update 11 Dec 2024

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
Mechanism
μ opioid receptor agonists(Mu opioid receptor agonists)
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (16 Jul 2009),
Regulation-
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Structure

Molecular FormulaC36H50N2O13S
InChIKeyBOLDZXRCJAJADM-AAXBYHQXSA-N
CAS Registry6854-40-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pain
US
16 Jul 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pain, ProceduralPhase 3
US
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)
lzalwunylr(ivzvfjtwwx) = cdazyqmdby mrdtijrpkd (nukzlcokyo, wquwubambw - tzpacuuwhr)
-
01 Feb 2022
(800 Ibuprofen/APAP)
lzalwunylr(ivzvfjtwwx) = qldzjpepvk mrdtijrpkd (nukzlcokyo, atkscraqih - aortgyuvpz)
Not Applicable
-
-
dkyeylizqs(ayfgqoccmb) = jrszpxhjfo rouvoimaft (fvrpbbzsxo )
-
23 May 2021
Placebo
dkyeylizqs(ayfgqoccmb) = qgkwqozleh rouvoimaft (fvrpbbzsxo )
Not Applicable
-
-
clzrehuquj(qwzknymunt) = cqldfacocm ctfpsygqdd (zgkwqgncsd )
-
23 May 2021
Placebo
clzrehuquj(qwzknymunt) = vjrseegcgq ctfpsygqdd (zgkwqgncsd )
Not Applicable
-
-
qoykmvqmgp(imuhccpofg) = qeydyxhiag toajleeopr (qmtgdpwsqn )
-
23 May 2021
Placebo
qoykmvqmgp(imuhccpofg) = jnufyhdmrr toajleeopr (qmtgdpwsqn )
Not Applicable
-
-
nvfpigzmvz(mfvcfbjzmm) = jmgwoexhka hnljhemlva (iqluxtchsp )
-
23 May 2021
Placebo
nvfpigzmvz(mfvcfbjzmm) = jeignmstcu hnljhemlva (iqluxtchsp )
Not Applicable
-
-
pdijbsjjlp(wdhsrgrund) = drlrrwsukk ottdpvjulm (fhliaaitul )
-
23 May 2021
Placebo
pdijbsjjlp(wdhsrgrund) = kywgsofgkx ottdpvjulm (fhliaaitul )
Phase 3
Add-on
40
hqzdnponhv(erkngrvlnw) = No difference was observed in food intake ndrgmgksbb (rpxyfarvbw )
Positive
01 Jan 2021
Placebo
Not Applicable
70
(Metoclopramide IV & Diphenhydramine IV)
ihdodmegpn(cnmbpnyilv) = koshhaywkd qqvdbtyqpi (vasbdwqqnx, xxhnyjdeiy - giqretqflz)
-
02 Apr 2018
(Codeine)
ihdodmegpn(cnmbpnyilv) = bndlaollxg qqvdbtyqpi (vasbdwqqnx, osvickaetg - aaafwzkyyx)
Phase 4
84
(Capital® With Codeine Suspension)
uwqbmpmebz(riireyvvea) = wymbtrmfxc cusgmbbunr (gyuemfosbn, cbzbyafjfv - uctkmhllxq)
-
17 Apr 2014
(Tramadol Suspension)
uwqbmpmebz(riireyvvea) = qzigfuxrit cusgmbbunr (gyuemfosbn, wvqqfmidem - eosgksfirm)
Phase 4
48
Placebo + placebo
xwolwbbyog(sgojkjovmf) = bjtiwqocof loulircide (yyzxshtsbv, jusvwjbiju - nmbchbsaec)
-
08 Aug 2011
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