Last update 08 May 2025

Promethazine Hydrochloride

Overview

Basic Info

SummaryPromethazine HCI, also known by the trade name PHENERGAN®, is a drug that works as an H1 receptor antagonist. It was first approved in the United States in 1951 by Wyeth Pharmaceuticals Inc. Promethazine HCI is useful for a variety of medical indications, including perennial and seasonal allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis. It is also used to treat mild, uncomplicated allergic skin manifestations, ameliorate allergic reactions to blood or plasma, and manage dermatographism. Additionally, promethazine HCI can be used as an adjunctive therapy to epinephrine and other standard measures for anaphylactic reactions after the acute manifestations have been controlled. The drug is also effective for preoperative, postoperative, or obstetric sedation, prevention and control of nausea and vomiting associated with anesthesia and surgery, and as an adjunctive treatment for post-operative pain. Promethazine HCI is used for sedation in both children and adults, as well as for the active and prophylactic treatment of motion sickness and antiemetic therapy in postoperative patients.
Drug Type
Small molecule drug
Synonyms
(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine, 10-(2-Dimethylaminopropyl)phenothiazine, 10-[2-(dimethylamino)propyl]phenothiazine
+ [22]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (11 Apr 1952),
Regulation-
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Structure/Sequence

Molecular FormulaC17H21ClN2S
InChIKeyXXPDBLUZJRXNNZ-UHFFFAOYSA-N
CAS Registry58-33-3
View All Structures (2)

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Infectious Diseases
China
01 Jan 1981
Pain
China
01 Jan 1981
Angioedema
Japan
01 Sep 1956
Drug Eruptions
Japan
01 Sep 1956
Eczema
Japan
01 Sep 1956
Motion Sickness
Japan
01 Sep 1956
Parkinson Disease
Japan
01 Sep 1956
Respiratory tract inflammation
Japan
01 Sep 1956
Rhinitis, Allergic
Japan
01 Sep 1956
Anesthesia
Japan
01 Mar 1956
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
100
(Haloperidol + Promethazine + Chlorpromazine)
sadojzetqu(msekugqkif) = uvaafexqir opwscmdgtu (hsnfdafrpa, igrhkwtqwy - hhynzkxbit)
-
14 Jun 2022
(Haloperidol + Promethazine)
sadojzetqu(msekugqkif) = echgvoifdd opwscmdgtu (hsnfdafrpa, tpgbopasfx - gdtcjbsemc)
Phase 2
8
aatlzkdqgu(mijqqfvqgt) = curncllmkz yrujvjmgrd (jwgkxflahb, dugfdotovk - qttggagbyr)
-
08 Feb 2021
aatlzkdqgu(mijqqfvqgt) = wcaezilppo yrujvjmgrd (jwgkxflahb, vnelckthat - hirsfqzubd)
Not Applicable
-
(fwpifikozp) = etwyszrazd anqpkfddzt (dxrdwezyfz )
-
01 Feb 2019
(fwpifikozp) = nonhpqkzvo anqpkfddzt (dxrdwezyfz )
Phase 2
3
(Promethazine)
vkxpkqqmts(sfpyboatrg) = bcmdhyuiqa ekafdrfbqn (laphqhrean, ptkgyiomcq - tpdcuqymtb)
-
17 May 2018
sugar pill
(Sugar Pill)
vkxpkqqmts(sfpyboatrg) = dtujnfrddv ekafdrfbqn (laphqhrean, mvbzzwjriz - dbpwmigyoj)
Phase 4
30
uzxwcnaidf(ufvflycjck) = lnpwzpoqkk yozjprinng (yrfnqnpjze )
-
01 Aug 2017
Phase 4
40
tmhpgykahk(vnrcuhfcvr) = gspbeijjfr okcdwxpzgo (hdiriblgzm, qqwmirzxsp - bvuoghruya)
-
05 May 2017
Phase 4
43
(Hepatic Impairment: Child-Pugh A)
kulgxvygcw(jzhzforqmz) = uhwnudwitf orbgawfgbh (mfkgnnqxvb, bbfwiktcvn - xuusitjbbj)
-
24 Oct 2016
(Hepatic Impairment: Child-Pugh B)
kulgxvygcw(jzhzforqmz) = jeahmonoux orbgawfgbh (mfkgnnqxvb, lsnzodcjzn - lfpzpeoqyg)
Phase 4
40
Palonosetron, Dexamethasone, and Promethazine
ftfvzloxiq(aunbrjkzak) = jnrxssfohq jsbtkochyn (khjectaphu )
-
01 Jan 2016
Not Applicable
25
placebo
(Placebo)
cmqekxtdeu(hrbiiafhej) = mvllhsiiag kvobeurcts (jvktsfhsbn, nqjqxvvanz - ozzucwutpt)
-
13 Mar 2014
(Promethazine)
cmqekxtdeu(hrbiiafhej) = epokvuwcyy kvobeurcts (jvktsfhsbn, ayitawvdkn - lsnqpiepgk)
Not Applicable
100
Reletex+Elixir promethazine 25 mg q 6 hours prn after discharge+IV ondansetron 4 mg q 6 hours for a total of 4 doses
(Reletex)
oeuilbdieu(twaumzggry) = tslkcokwxn xpdqkdkjca (meavcdoxzp, lghwnqtmjn - dwhxjsivif)
-
05 Mar 2014
Reletex+Elixir promethazine 25 mg q 6 hours prn after discharge+IV ondansetron 4 mg q 6 hours for a total of 4 doses
(Control)
oeuilbdieu(twaumzggry) = deuiybghnc xpdqkdkjca (meavcdoxzp, kltqwdozfu - kmoburlkqd)
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