MedPath

Promethazine

Generic Name
Promethazine
Brand Names
Phenadoz, Phenergan, Promethazine DM, Promethegan
Drug Type
Small Molecule
Chemical Formula
C17H20N2S
CAS Number
60-87-7
Unique Ingredient Identifier
FF28EJQ494

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.

Background

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
2022/10/19
Phase 3
Recruiting
Oman Medical Speciality Board
2021/03/18
Phase 4
Completed
2016/05/06
Phase 2
Completed
2015/12/21
Phase 4
Completed
2015/12/09
Not Applicable
Completed
2015/06/16
Not Applicable
Completed
2015/06/09
Phase 1
Completed
2015/03/02
Phase 3
Terminated
2014/05/13
Phase 4
Completed
Faisal_Karmali@MEEI.HARVARD.EDU
2014/05/05
Phase 2
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Nostrum Laboratories, Inc.
70408-185
ORAL
6.25 mg in 5 mL
12/11/2018
STAT Rx USA LLC
42549-543
ORAL
25 mg in 1 1
4/26/2012
Wockhardt USA LLC.
64679-604
ORAL
6.25 mg in 5 mL
3/20/2023
Direct_Rx
72189-486
ORAL
6.25 mg in 5 mL
6/2/2023
Hikma Pharmaceuticals USA Inc.
0641-0955
INTRAMUSCULAR, INTRAVENOUS
25 mg in 1 mL
4/22/2022
Rebel Distributors Corp
21695-885
ORAL
50 mg in 1 1
12/9/2010
XGen Pharmaceuticals DJB, Inc.
39822-5550
INTRAMUSCULAR, INTRAVENOUS
50 mg in 1 mL
1/9/2024
Rebel Distributors Corp
21695-336
ORAL
6.25 mg in 5 mL
8/27/2009
DIRECT RX
61919-630
ORAL
25 mg in 1 1
2/22/2016
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
SIN03294P
ELIXIR
10 mg/5 ml
6/7/1989
DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP 50 mg/2 ml
SIN02707P
INJECTION
50 mg
5/3/1989
PROZINE SYRUP 5 mg/5 ml
SIN02481P
SYRUP
5 mg/5 ml
3/6/1989
PROMETHAZINE 5 MG SYRUP 5 mg/5 ml
SIN10327P
SYRUP
5 mg/5 ml
10/28/1998
PROMAGEN 10 ORAL MIXTURE 10 mg/5 ml
SIN09073P
SYRUP
10 mg/5 ml
12/14/1996
PROZINE-10 SYRUP 10 mg/5 ml
SIN02482P
SYRUP
10 mg/5 ml
3/6/1989
AXCEL PROMETHAZINE-5 SYRUP 5 mg/5 ml
SIN10539P
SYRUP
5 mg/5 ml
12/11/1998
COPHADYL-E COUGH LINCTUS
SIN09104P
ELIXIR
3.6 mg/5 ml
12/28/1996
VOTAZINE TABLET 25 mg
SIN03899P
TABLET
25 mg
2/22/1990
PROMEZINE SYRUP 1MG/ML
SIN16065P
SYRUP
1mg/ml
12/22/2020

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Promethazine Hydrochloride Injection
国药准字H32021438
化学药品
注射剂
8/11/2020
Promethazine Hydrochloride Injection
国药准字H42023002
化学药品
注射剂
6/10/2022
Promethazine Hydrochloride Injection
国药准字H44022111
化学药品
注射剂
4/7/2020
Promethazine Hydrochloride Injection
国药准字H41021097
化学药品
注射剂
9/11/2020
Promethazine Hydrochloride Injection
国药准字H44021728
化学药品
注射剂
8/24/2020
Promethazine Hydrochloride Injection
国药准字H44022110
化学药品
注射剂
4/7/2020
Promethazine Hydrochloride Injection
国药准字H21024243
化学药品
注射剂
7/29/2020
Promethazine Hydrochloride Injection
国药准字H12020969
化学药品
注射剂
7/27/2020
Promethazine Hydrochloride Injection
国药准字H50021802
化学药品
注射剂
8/24/2020
Promethazine Hydrochloride Injection
国药准字H31021490
化学药品
注射剂
12/23/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
PROSEDYL COUGH SYRUP
N/A
N/A
N/A
8/20/1985
MOTRACK COUGH SYRUP
N/A
N/A
N/A
9/14/2010
NEW MARSEDYL-DM ELIXIR
N/A
N/A
N/A
8/11/2015
MERSIDYL SYRUP
N/A
N/A
N/A
2/25/1986
COCLEAN SYRUP
N/A
N/A
N/A
6/15/2001
NICE PHENDYL-B LINCTUS
N/A
neochem pharmaceutical laboratories ltd.
N/A
N/A
7/15/1982
WASEDYL SYRUP
N/A
europharm lab co ltd
N/A
N/A
9/26/1997
COCURE COUGH SYRUP
N/A
neochem pharmaceutical laboratories ltd.
N/A
N/A
7/13/2001
SUPHENIN SYRUP
N/A
medipharma ltd
N/A
N/A
3/28/2001
MARSEDYL ELIXIR
N/A
N/A
N/A
2/25/1984
© Copyright 2025. All Rights Reserved by MedPath