Overview
A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.
Background
A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.
Indication
Used to control moderate to severe pain.
Associated Conditions
- Severe Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/15 | Phase 3 | Recruiting | |||
2024/12/17 | Phase 4 | Not yet recruiting | Fondazione Andrea Cesalpino Arezzo ONLUS | ||
2024/08/19 | Phase 4 | Completed | Ismail Tekin | ||
2024/07/22 | Phase 4 | Not yet recruiting | |||
2024/03/22 | Phase 2 | Recruiting | Kasr El Aini Hospital | ||
2023/11/01 | Phase 2 | Completed | National University of Malaysia | ||
2023/10/13 | Phase 2 | Not yet recruiting | |||
2023/01/25 | Not Applicable | Completed | |||
2022/08/12 | Not Applicable | Completed | Medipol University | ||
2022/05/23 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5808 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 50 mg in 1 mL | 12/28/2011 | |
| Hospira, Inc. | 0409-1179 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 75 mg in 1 mL | 4/2/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6054 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 mL | 1/30/2024 | |
| Physicians Total Care, Inc. | 54868-3559 | INTRAMUSCULAR | 50 mg in 1 mL | 5/6/2010 | |
| Hospira, Inc. | 0409-1362 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 25 mg in 1 mL | 4/2/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0054-4595 | ORAL | 50 mg in 1 1 | 4/18/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6052 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 25 mg in 1 mL | 1/30/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6053 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 50 mg in 1 mL | 1/30/2024 | |
| Hospira, Inc. | 0409-1180 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 mL | 4/2/2024 | |
| Validus Pharmaceuticals LLC | 30698-337 | ORAL | 100 mg in 1 1 | 1/24/2024 |
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 |
|---|---|---|---|---|---|
| Pethidine-hameln Solution for Injection 50mg/ml | SIN14662P | INJECTION, SOLUTION | 50mg | 11/14/2014 | |
| DBL PETHIDINE HYDROCHLORIDE INJECTION BP 50mg/ml | SIN00753P | INJECTION | 50 mg/ml | 5/4/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pethidine Hydrochloride Injection | 国药准字H21022413 | 化学药品 | 注射剂 | 6/15/2020 | |
| Pethidine Hydrochloride Injection | 国药准字H63020021 | 化学药品 | 注射剂 | 5/13/2020 | |
| Pethidine Hydrochloride Injection | 国药准字H63020022 | 化学药品 | 注射剂 | 5/13/2020 | |
| Pethidine Hydrochloride Injection | 国药准字H21023058 | 化学药品 | 注射剂 | 6/15/2020 | |
| Pethidine Hydrochloride Injection | 国药准字H42022074 | 化学药品 | 注射剂 | 7/16/2020 | |
| Pethidine Hydrochloride Tablets | 国药准字H63020017 | 化学药品 | 片剂 | 5/13/2020 | |
| Pethidine Hydrochloride Tablets | 国药准字H63020016 | 化学药品 | 片剂 | 5/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DEMOTHINE SOLUTION FOR INJECTION 100MG/2ML | N/A | N/A | N/A | 1/25/2024 | |
| DEMOTHINE SOLUTION FOR INJECTION 50MG/1ML | N/A | N/A | N/A | 1/25/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DBL PETHIDINE HYDROCHLORIDE 100mg/2mL Injection | 107387 | Medicine | A | 12/15/2004 | |
| NOUMED PETHIDINE TABLETS pethidine hydrochloride 50 mg uncoated tablet bottle | 397893 | Medicine | A | 10/17/2022 | |
| PETHIDINE JUNO pethidine injection BP 100mg/2mL ampoule | 340377 | Medicine | A | 9/28/2020 | |
| DBL PETHIDINE HYDROCHLORIDE 50mg/1mL Injection | 107386 | Medicine | A | 12/15/2004 |