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 |