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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/02/17 | Phase 1 | Completed | |||
2017/01/11 | Phase 4 | UNKNOWN | |||
2016/12/05 | Not Applicable | Terminated | Xijing Hospital | ||
2016/12/01 | Phase 3 | UNKNOWN | Dr Atul Sharma | ||
2016/11/23 | Phase 4 | Terminated | |||
2016/11/17 | Not Applicable | Active, not recruiting | |||
2016/11/09 | Phase 4 | Completed | |||
2016/09/23 | Phase 4 | UNKNOWN | General Hospital of Chinese Armed Police Forces | ||
2016/09/20 | Phase 4 | Completed | Nathalie Charpak | ||
2016/07/28 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-240 | INTRAMUSCULAR, INTRAVENOUS | 5 mg in 1 mL | 1/25/2022 | |
| PAI Holdings, LLC | 0121-1576 | ORAL | 5 mg in 5 mL | 1/25/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7698 | ORAL | 5 mg in 1 1 | 2/27/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4326 | ORAL | 10 mg in 1 1 | 3/3/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4551 | ORAL | 5 mg in 1 1 | 2/19/2021 | |
| ANI Pharmaceuticals, Inc. | 62559-296 | ORAL | 10 mg in 1 1 | 7/1/2021 | |
| Teva Parenteral Medicines, Inc. | 0703-4502 | INTRAMUSCULAR, INTRAVENOUS | 5 mg in 1 mL | 1/31/2022 | |
| Chartwell RX, LLC | 62135-526 | ORAL | 5 mg in 5 mL | 3/29/2023 | |
| AvKARE | 42291-595 | ORAL | 5 mg in 1 1 | 1/10/2024 | |
| DIRECT RX | 61919-150 | ORAL | 5 mg in 1 1 | 1/20/2020 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metoclopramide Tablets | 国药准字H14020936 | 化学药品 | 片剂 | 4/20/2020 | |
| Metoclopramide Tablets | 国药准字H15020661 | 化学药品 | 片剂 | 5/14/2020 | |
| Metoclopramide Tablets | 国药准字H34022969 | 化学药品 | 片剂 | 6/18/2020 | |
| Metoclopramide Tablets | 国药准字H41020478 | 化学药品 | 片剂 | 11/25/2019 | |
| Metoclopramide Tablets | 国药准字H34020218 | 化学药品 | 片剂 | 5/28/2020 | |
| Metoclopramide Tablets | 国药准字H34022805 | 化学药品 | 片剂 | 4/24/2020 | |
| Metoclopramide Tablets | 国药准字H13020681 | 化学药品 | 片剂 | 1/15/2021 | |
| Metoclopramide Tablets | 国药准字H12020722 | 化学药品 | 片剂 | 7/7/2020 | |
| Metoclopramide Tablets | 国药准字H61022924 | 化学药品 | 片剂 | 8/3/2020 | |
| Metoclopramide Tablets | 国药准字H21021721 | 化学药品 | 片剂 | 8/26/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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