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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2007/02/01 | Phase 4 | Completed |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRAMUSCULAR | 50 mg in 1 mL | 2022/04/19 | 0641-6085 | ||
ORAL | 50 mg in 1 1 | 2024/02/26 | 76420-692 | ||
ORAL | 6.25 mg in 5 mL | 2022/11/11 | 50383-803 | ||
INTRAMUSCULAR | 50 mg in 1 mL | 2022/01/17 | 0404-9942 | ||
ORAL | 25 mg in 1 1 | 2021/02/16 | 68071-4424 | ||
INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 2024/01/09 | 39822-5550 | ||
RECTAL | 25 mg in 1 1 | 2023/09/19 | 43063-060 | ||
ORAL | 6.25 mg in 5 mL | 2021/01/01 | 67296-0516 | ||
ORAL | 6.25 mg in 5 mL | 2023/09/12 | 68788-8100 | ||
INTRAMUSCULAR, INTRAVENOUS | 25 mg in 1 mL | 2022/04/19 | 0641-6084 |
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
SYRUP | 0.05 g/100 ml | 1989/04/21 | SIN02613P | ||
SYRUP | 3.6 mg/5 ml | 1996/06/25 | SIN08748P | ||
SYRUP | 3.6 mg/5 ml | 1990/03/28 | SIN04075P | ||
ELIXIR | 3.6 mg/5 ml | 1989/06/26 | SIN03490P |
NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H21022245 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/07/13 | Domestic | ||
国药准字H41020482 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/09/04 | Domestic | ||
国药准字H61021138 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/11/20 | Domestic | ||
国药准字H21023652 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2015/09/10 | Domestic | ||
国药准字H62020337 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/09/11 | Domestic | ||
国药准字H42021178 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/07/13 | Domestic | ||
国药准字H20057420 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/08/12 | Domestic | ||
国药准字H20053946 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2023/10/18 | Domestic | ||
国药准字H35020157 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2014/09/15 | Domestic | ||
国药准字H50020140 | 注射剂 | N/A | 2ml:50mg | Chemical Drug | Approved | 2020/11/09 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-25374 | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 1985/08/20 | ||
HK-60038 | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 2010/09/14 | ||
HK-63899 | Part 1 & Schedule 1 Poison | Pharmacy only Medicines | 2015/08/11 | ||
HK-26329 | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 1986/02/25 | ||
HK-48017 | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 2001/06/15 | ||
HK-17896 | neochem pharmaceutical laboratories ltd. | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 1982/07/15 | |
HK-42448 | europharm lab co ltd | Part 1 & Schedule 1 Poison | Pharmacy only Medicines | 1997/09/26 | |
HK-48211 | neochem pharmaceutical laboratories ltd. | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 2001/07/13 | |
HK-47601 | medipharma ltd | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 2001/03/28 | |
HK-21197 | Part 1 & Schedule 1 Poison & Part II & III Dangerous Drug | Pharmacy only Medicines | 1984/02/25 |
TGA Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
317344 | Active | 2019/05/08 | promethazine hydrochloride | ||
16255 | Active | 1991/10/08 | promethazine hydrochloride | ||
322630 | Active | 2019/09/03 | promethazine hydrochloride | ||
342520 | Active | 2020/08/27 | promethazine hydrochloride | ||
342521 | Active | 2020/08/27 | promethazine hydrochloride | ||
342518 | Active | 2020/08/27 | promethazine hydrochloride | ||
407901 | Active | 2023/04/19 | promethazine hydrochloride | ||
317343 | Active | 2019/05/08 | promethazine hydrochloride | ||
407930 | Active | 2023/04/20 | promethazine hydrochloride | ||
355611 | Active | 2021/02/25 | promethazine hydrochloride |