Overview
Diabetic gastroparesis is a condition that causes frequent nausea and vomiting, which has a negative impact on quality of life and poses a significant burden on the healthcare system. Metoclopramide is a dopamine antagonist used to treat nausea and vomiting that may be associated with diabetic gastroparesis in addition to gastroesophageal reflux disease (GERD). It can also be used to prevent nausea or vomiting associated with chemotherapy or certain surgical or diagnostic procedures. One unique property of this drug is that it does not increase gastric acid secretion. It is available in the oral tablet form or in solution, and can also be administered through the intravenous route. Metoclopramide was initially approved by the FDA in 1980.
Indication
Metoclopramide in the oral tablet form is used for symptomatic treatment of both acute and recurrent diabetic gastroparesis, in addition to the treatment of gastroesophageal reflux disease (GERD) in patients who have failed to respond to traditional therapy. A nasal spray formulation is also indicated to treat adults with acute, recurrent diabetic gastroparesis. In the intravenous injection form, it is indicated for the above conditions as well as for the prevention of vomiting that may follow emetogenic chemotherapy or nausea and vomiting after surgery. Intravenous metoclopramide facilitates intubation of the small bowel and stimulates gastric emptying and barium flow in patients who require radiological examination of the stomach or small intestine. In some cases, the delay of gastrointestinal emptying interferes with the radiographic visualization of the gastrointestinal tract, and metoclopramide is used to facilitate emptying in these cases, allowing for adequate diagnostic visualization. Some off-label uses of metoclopramide include the management of radiation-induced nausea and vomiting, gastric bezoars, intractable hiccups, and migraine pain.
Associated Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Diabetic Gastroparesis
- Dyspepsia
- Flatulence
- Gastroesophageal Reflux
- Gastroparesis
- Hiccups
- Hyperacidity
- Migraine
- Nausea and vomiting
- Post Operative Nausea and Vomiting (PONV)
- Radiation-Induced Nausea and Vomiting
- Acute, recurrent Diabetic Gastroparesis
- Gastric bezoar
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/22 | Phase 4 | Not yet recruiting | |||
2025/03/27 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2025/02/14 | Phase 3 | Not yet recruiting | |||
2025/01/27 | Phase 3 | Not yet recruiting | |||
2024/12/18 | Phase 2 | Not yet recruiting | |||
2024/04/30 | Phase 2 | Completed | |||
2024/04/23 | Phase 1 | Recruiting | |||
2024/03/07 | Phase 3 | Completed | Universidad Autonoma de Nuevo Leon | ||
2023/12/13 | Phase 4 | Recruiting | |||
2023/08/09 | Not Applicable | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RedPharm Drug, Inc. | 67296-1738 | ORAL | 10 mg in 1 1 | 11/3/2020 | |
| AvKARE | 42291-596 | ORAL | 10 mg in 1 1 | 1/10/2024 | |
| Cardinal Health 107, LLC | 55154-4383 | ORAL | 5 mg in 1 1 | 12/23/2022 | |
| State of Florida DOH Central Pharmacy | 53808-0723 | ORAL | 5 mg in 1 1 | 6/7/2010 | |
| American Health Packaging | 60687-631 | ORAL | 10 mg in 1 1 | 10/21/2022 | |
| Mylan Institutional Inc. | 51079-886 | ORAL | 5 mg in 1 1 | 12/29/2021 | |
| American Health Packaging | 60687-620 | ORAL | 5 mg in 1 1 | 10/21/2022 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8285 | ORAL | 10 mg in 1 1 | 2/27/2023 | |
| ANI Pharmaceuticals, Inc. | 62559-165 | ORAL | 5 mg in 1 1 | 8/1/2017 | |
| Medical Purchasing Solutions, LLC | 71872-7076 | INTRAMUSCULAR, INTRAVENOUS | 5 mg in 1 mL | 5/23/2023 |
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 |
|---|---|---|---|---|---|
| METOCLOPRAMIDE TABLET 10 mg | SIN02804P | TABLET | 10 mg | 5/12/1989 | |
| EMELIV TABLET 10 mg | SIN03435P | TABLET | 10 mg | 6/17/1989 | |
| METOCLOPRAMIDE SYRUP 5 mg/5 ml | SIN03349P | SYRUP | 5 mg/5 ml | 6/16/1989 | |
| METOCLOPRAMIDE INJECTION BP 5 mg/ml | SIN05202P | INJECTION | 5 mg/ml | 11/14/1990 | |
| PULIN FILM-COATED TABLET 10 mg | SIN10581P | TABLET, FILM COATED | 10 mg | 12/22/1998 | |
| SW METOCLOPRAMIDE TABLET 10 mg | SIN03350P | TABLET | 10 mg | 6/16/1989 | |
| PULIN INJECTION 10 mg/2 ml | SIN06638P | INJECTION | 10 mg/2 ml | 10/14/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metoclopramide Dihydrochloride Injection | 国药准字H20253061 | 化学药品 | 注射剂 | 1/2/2025 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H41025483 | 化学药品 | 注射剂 | 4/7/2020 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H20253536 | 化学药品 | 注射剂 | 3/4/2025 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H20247080 | 化学药品 | 注射剂 | 4/19/2024 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H32026442 | 化学药品 | 注射剂 | 8/31/2020 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H11020524 | 化学药品 | 注射剂（小容量注射剂） | 3/10/2023 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H41021198 | 化学药品 | 注射剂 | 8/31/2020 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H20023103 | 化学药品 | 注射剂 | 12/6/2019 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H11021623 | 化学药品 | 注射剂(小容量注射剂) | 7/23/2021 | |
| Metoclopramide Dihydrochloride Injection | 国药准字H20163268 | 化学药品 | 注射剂 | 7/27/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TABS MA-5 TAB 5MG | N/A | N/A | N/A | 3/24/1984 | |
| METOCLOPRAMIDE TAB 5MG | N/A | N/A | N/A | 7/15/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| EMEXLON metoclopramide hydrochloride 10 mg film coated tablets blister pack | 229659 | Medicine | A | 12/17/2015 | |
| CIPLA MIGRAINE HEADACHE AND NAUSEA RELIEF tablet blister pack | 186861 | Medicine | A | 7/25/2011 | |
| CHEMISTS’ OWN MIGRAINE AND NAUSEA RELIEF tablet blister pack | 296885 | Medicine | A | 11/29/2017 | |
| PIP-METOCLOPRAMIDE metoclopramide hydrochloride monohydate 5 mg film coated tablets blister pack | 196477 | Medicine | A | 6/3/2013 | |
| IPCA-METOCLOPRAMIDE metoclopramide hydrochloride 5 mg film coated tablets blister pack | 196495 | Medicine | A | 6/3/2013 | |
| CLOVOMET metoclopramide hydrochloride 10 mg film coated tablets bottle | 268303 | Medicine | A | 5/4/2016 | |
| METPRAM metoclopramide hydrochloride 10 mg film coated tablets bottle | 268297 | Medicine | A | 5/4/2016 | |
| Maxolon Tablets | 11153 | Medicine | A | 8/14/1991 | |
| Anagraine Tablet Blister Pack | 13547 | Medicine | A | 9/20/1991 | |
| IPCA-METOCLOPRAMIDE metoclopramide hydrochloride 10 mg film coated tablets blister pack | 196462 | Medicine | A | 6/3/2013 |
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