Promethazine

Overview

Promethazine, originally known as 3,277 R.P., is an N-dimethylaminopropyl derivative of phenothiazine that was developed in France in 1946. Promethazine antagonizes a variety of receptors, allowing it to be used for a number of indications including allergic reactions, pain, sedation, nausea, and vomiting. Promethazine was granted FDA approval before 29 March 1951.

Indication

Promethazine tablets and suppositories are indicated to treat rhinitis, allergic conjunctivitis, allergic reactions to blood or plasma, dermographism, anaphylactic reactions, sedation, nausea, vomiting, pain, motion sickness, and allergic skin reactions. Promethazine cough syrup with phenylephrine and codeine is indicated to relieve cough and upper respiratory symptoms, and nasal congestion associated with allergy or the common cold.

Associated Conditions

Allergic Conjunctivitis (AC)
Allergic urticaria
Anaphylaxis
Cough
Dermographism
Motion Sickness
Nasal Congestion
Postoperative pain
Seasonal Allergic Rhinitis
Vasomotor Rhinitis
Acute Allergic Reactions
Dry cough
Perioperative nausea and vomiting
Upper respiratory symptoms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.	2022/10/19	NCT05586763	Phase 3	Recruiting	Oman Medical Speciality Board
Treatment of Pruritus With Intramuscular Promethazine	2021/03/18	NCT04805073	Phase 4	Completed	University of Florida
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease	2016/05/06	NCT02765256	Phase 2	Completed	University of Pennsylvania
Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis	2015/12/21	NCT02635828	Phase 4	Completed	Ohio State University
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	2015/12/09	NCT02625181	Not Applicable	Completed	Vanderbilt University
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)	2015/06/16	NCT02473042	Not Applicable	Completed	M.D. Anderson Cancer Center
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions	2015/06/09	NCT02465866	Phase 1	Completed	Charleston Laboratories, Inc
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels	2014/05/13	NCT02136420	Phase 4	Completed	Faisal_Karmali@MEEI.HARVARD.EDU
Study of Promethazine for Treatment of Diabetic Gastroparesis	2014/05/05	NCT02130622	Phase 2	Terminated	Dartmouth-Hitchcock Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
promethazine hydrochloride and codeine phosphate	Nostrum Laboratories, Inc.	70408-185	ORAL	6.25 mg in 5 mL	12/11/2018
PROMETHAZINE HYDROCHLORIDE	STAT Rx USA LLC	42549-543	ORAL	25 mg in 1 1	4/26/2012
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Wockhardt USA LLC.	64679-604	ORAL	6.25 mg in 5 mL	3/20/2023
Promethazine/Codeine	Direct_Rx	72189-486	ORAL	6.25 mg in 5 mL	6/2/2023
Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	0641-0955	INTRAMUSCULAR, INTRAVENOUS	25 mg in 1 mL	4/22/2022
Promethazine Hydrochloride	Rebel Distributors Corp	21695-885	ORAL	50 mg in 1 1	12/9/2010
PROMETHAZINE HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	39822-5550	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	1/9/2024
Promethazine with Codeine	Rebel Distributors Corp	21695-336	ORAL	6.25 mg in 5 mL	8/27/2009
PROMETHAZINE HYDROCHLORIDE	DIRECT RX	61919-630	ORAL	25 mg in 1 1	2/22/2016
Promethazine Hydrochloride	A-S Medication Solutions	50090-0879	INTRAMUSCULAR	50 mg in 1 mL	4/19/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
XEPAGAN ELIXIR 10 mg/5 ml	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN03294P	ELIXIR	10 mg/5 ml	6/7/1989
DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP 50 mg/2 ml	Siegfried Hameln GmbH	SIN02707P	INJECTION	50 mg	5/3/1989
PROZINE SYRUP 5 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02481P	SYRUP	5 mg/5 ml	3/6/1989
PROMETHAZINE 5 MG SYRUP 5 mg/5 ml	BEACONS PHARMACEUTICALS PTE LTD	SIN10327P	SYRUP	5 mg/5 ml	10/28/1998
PROMAGEN 10 ORAL MIXTURE 10 mg/5 ml	ICM PHARMA PTE. LTD.	SIN09073P	SYRUP	10 mg/5 ml	12/14/1996
PROZINE-10 SYRUP 10 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02482P	SYRUP	10 mg/5 ml	3/6/1989
AXCEL PROMETHAZINE-5 SYRUP 5 mg/5 ml	KOTRA PHARMA (M) SDN BHD	SIN10539P	SYRUP	5 mg/5 ml	12/11/1998
COPHADYL-E COUGH LINCTUS	ICM PHARMA PTE. LTD.	SIN09104P	ELIXIR	3.6 mg/5 ml	12/28/1996
VOTAZINE TABLET 25 mg	DUOPHARMA (M) SDN BHD	SIN03899P	TABLET	25 mg	2/22/1990
PROMEZINE SYRUP 1MG/ML	Y.S.P. Industries (M) Sdn. Bhd.	SIN16065P	SYRUP	1mg/ml	12/22/2020

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PROSEDYL COUGH SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/20/1985
MOTRACK COUGH SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/14/2010
NEW MARSEDYL-DM ELIXIR	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/11/2015
MERSIDYL SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/25/1986
COCLEAN SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	6/15/2001
NICE PHENDYL-B LINCTUS	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	7/15/1982
WASEDYL SYRUP	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	9/26/1997
COCURE COUGH SYRUP	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	7/13/2001
SUPHENIN SYRUP	N/A	MEDIPHARMA	N/A	N/A	3/28/2001
MARSEDYL ELIXIR	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/25/1984

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
METINA promethazine hydrochloride 1 mg/mL oral liquid bottle	402716	Metina Australia Pty Ltd	Medicine	A	1/20/2023
APOHEALTH PROMETHAZINE 25 ANTIHISTAMINE FOR ALLERGY RELIEF promethazine hydrochloride 25 mg tablet blister pack	337353	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/2/2020
Allersoothe Elixir promethazine 5 mg/5 mL oral liquid bottle	202453	AFT Pharmaceuticals Pty Ltd	Medicine	A	10/29/2012
ALLERSOOTHE 25 promethazine hydrochloride 25mg tablet blister pack	160734	AFT Pharmaceuticals Pty Ltd	Medicine	A	4/1/2009
NOUMED PROMETHAZINE 10 promethazine hydrochloride 10 mg film coated tablet blister pack	385713	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	3/16/2022
FENERSOOTHE 10 promethazine hydrochloride 10 mg tablet blister pack	375982	Neo Health (OTC) Pty Ltd	Medicine	A	10/8/2021
CHEMISTS' OWN ANTIHISTAMINE FOR ALLERGY RELIEF promethazine hydrochloride 10 mg tablet blister pack	322629	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/3/2019
FENEZINE 10 promethazine hydrochloride 10 mg tablet blister pack	351892	Sandoz Pty Ltd	Medicine	A	12/17/2020
FENEZINE 25 promethazine hydrochloride 25 mg tablet blister pack	351891	Sandoz Pty Ltd	Medicine	A	12/17/2020
METINA promethazine hydrochloride 25 mg tablet blister pack	403198	Metina Australia Pty Ltd	Medicine	A	1/24/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PHENERGAN TABLET 10MG	rhone-poulenc rorer consumer inc.	01937723	Tablet - Oral	10 MG / TAB	12/31/1993
PHENERGAN TABLET 25MG	rhone-poulenc rorer consumer inc.	01937715	Tablet - Oral	25 MG / TAB	12/31/1993
HISTANTIL TAB 50MG	Pharmascience Inc	00575186	Tablet - Oral	50 MG	12/31/1983
HISTANTIL TAB 25MG	Pharmascience Inc	00575178	Tablet - Oral	25 MG	12/31/1983
PHENERGAN 50	columbia laboratories canada inc	02162237	Tablet - Oral	50 MG	12/31/1996
PHENERGAN TABLET 25MG	novartis consumer health canada inc.	02162229	Tablet - Oral	25 MG / TAB	12/31/1996
PMS-PROMETHAZINE SYR 10MG/5ML	Pharmascience Inc	00583979	Syrup - Oral	10 MG / 5 ML	12/31/1984
PHENERGAN CREAM 2%	rhone-poulenc rorer consumer inc.	01937685	Cream - Topical	2 %	12/31/1993
PHENERGAN EXPECTORANT WITH CODEINE LIQUID	columbia laboratories canada inc	02162180	Liquid - Oral	5.65 MG / 5 ML	12/31/1996
PHENERGAN SYRUP 10MG/5ML	rhone-poulenc rorer consumer inc.	01937693	Syrup - Oral	10 MG / 5 ML	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FENERGAN CREMA	Teofarma S.R.L.	17471	CREMA	Sin Receta	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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