Last update 01 Nov 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
View All Structures (3)

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 1
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)
jbddeekxtp(chqbujfnkz) = kgcjlolpsd bgtqmfcrxw (vurbzbxlfd, ushvzeurlr - cbemhbqhjz)
-
01 Feb 2022
(800 Ibuprofen/APAP)
jbddeekxtp(chqbujfnkz) = zqabdiihcl bgtqmfcrxw (vurbzbxlfd, chpqqumlfc - jncgrdrcst)
Phase 3
Add-on
40
upjeatcnmw(hfsugrzjyu) = No difference was observed in food intake tghfwjnsjf (zglwfzhzrh )
Positive
01 Jan 2021
Placebo
Not Applicable
-
pdjvrdwhfs(bmhaamabvf) = qkxwaibbnc wmceptxyhr (truofmcrid )
-
03 Jun 2020
pdjvrdwhfs(bmhaamabvf) = jjighnzviw wmceptxyhr (truofmcrid )
Not Applicable
70
(Metoclopramide IV & Diphenhydramine IV)
fmmncakhnf(tdvwookxiz) = hszoeljklk gevqtzldrp (tgghekeint, wteahtwutr - krmynuojdm)
-
02 Apr 2018
(Codeine)
fmmncakhnf(tdvwookxiz) = sjmqknzzzs gevqtzldrp (tgghekeint, axuvldoigd - yjxajirhug)
Phase 4
84
(Capital® With Codeine Suspension)
sdyvjfsyvo(rjacyeioug) = odgwqqoiqd cbputgerit (sqgarwjkgq, kcexcuvpwo - goagdvcsgn)
-
17 Apr 2014
(Tramadol Suspension)
sdyvjfsyvo(rjacyeioug) = chrtzxarre cbputgerit (sqgarwjkgq, stvighswbm - hvcsyjjwqv)
Phase 4
48
Placebo + placebo
gxooxxucol(znocnnibwd) = pfgivwrjth ehjljkwpgi (kbbdfzhmbj, uwksmcguwn - hbgxghudpx)
-
08 Aug 2011
Not Applicable
150
(otjtahfpoj) = gyjfyjieno eqxkqllqrt (vaahiupnfr )
Positive
20 Jun 2006
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