Generic Name
Metoclopramide
Brand Names
Reglan, Gimoti
FDA approval date: September 30, 1990
Classification: Dopamine-2 Receptor Antagonist
Form: Injection, Spray, Tablet, Solution
What is Reglan (Metoclopramide)?
Diabetic Gastroparesis Metoclopramide injection is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Metoclopramide injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting Metoclopramide injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation Metoclopramide injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination Metoclopramide injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
Approved To Treat
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Brand Information
Reglan (Metoclopramide Hydrochloride)
WARNING: TARDIVE DYSKINESIA
- Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of treatment and total cumulative dosage
- Reglan is contraindicated in patients with a history of TD.
- Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment.
- Immediately discontinue Reglan in patients who develop signs or symptoms of TD
- In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of Reglan treatment is 12 weeks
- In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including Reglan tablets, for longer than 12 weeks. If longer term use is unavoidable, routinely monitor for signs and symptoms of TD
1INDICATIONS AND USAGE
Reglan tablets are indicated for the:
- Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
- Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use:
- Reglan has not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks
- Reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 5 mg metoclopramide: green, elliptical-shaped, debossed “REGLAN” over “5” on one side and “ANI” on the opposite side
- 10 mg metoclopramide: white, double edge scored, capsule-shaped, debossed “REGLAN” on one side and “ANI 10” on the opposite side
3CONTRAINDICATIONS
Reglan is contraindicated:
- In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide
- When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
- In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor
- In patients with epilepsy. Reglan may increase the frequency and severity of seizures
- In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm
4ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
- Tardive dyskinesia
- Other extrapyramidal symptoms
- Neuroleptic malignant syndrome
- Depression
- Hypertension
- Fluid retention
- Hyperprolactinemia
- Effects on the ability to drive and operate machinery
The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.
Central Nervous System Disorders
- Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms
- Convulsive seizures
- Hallucinations
- Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently.
- Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents).
Endocrine Disorders: Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia
Cardiovascular Disorders: Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention
Gastrointestinal Disorders: Nausea, bowel disturbances (primarily diarrhea)
Hepatic Disorders: Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential
Renal and Urinary Disorders: Urinary frequency, urinary incontinence
Hematologic Disorders: Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia
Hypersensitivity Reactions: Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema
Eye Disorders: Visual disturbances
Metabolism Disorders: Porphyria
5OVERDOSAGE
Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS
There are no specific antidotes for Reglan overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage
Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.
Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.
6DESCRIPTION
Metoclopramide hydrochloride, the active ingredient of Reglan, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.
The molecular formula is C
Reglan tablets are for oral administration. Reglan is available in 5 mg and 10 mg tablets.
- Each Reglan 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride USP). Inactive ingredients consist of corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, lactose, microcrystalline cellulose, silicon dioxide, and stearic acid.
- Each Reglan 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.82 mg metoclopramide hydrochloride USP). Inactive ingredients consist of magnesium stearate, mannitol, microcrystalline cellulose, and stearic acid.
7HOW SUPPLIED/STORAGE AND HANDLING
Each green, elliptical-shaped Reglan tablet contains 5 mg metoclopramide. The tablet is debossed “REGLAN” over “5” on one side and “ANI” on the opposite side. Available in bottles of 100 tablets (NDC 62559-165-01)
Each white, double edge scored, capsule-shaped Reglan tablet contains 10 mg metoclopramide. The tablet is debossed “REGLAN” on one side and “ANI 10” on the opposite side. Available in bottles of 100 tablets (NDC 62559-166-01)
Dispense tablets in tight, light-resistant container. Store tablets at controlled room temperature between 20°C and 25°C (68°F and 77°F).
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Tardive Dyskinesia and/or other Extrapyramidal Reactions
Inform patients that Reglan may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately discontinue Reglan and contact their healthcare provider if symptoms occur
Neuroleptic Malignant Syndrome
Inform patients that serious neuroleptic malignant syndrome (NMS) has been reported in association with concomitant treatment with another drug associated with NMS. Advise patients to report all prescription and over-the-counter medications to the healthcare provider. Instruct patients to immediately discontinue Reglan and seek medical attention if symptoms occur
Depression and/or Possible Suicidal Ideation
Inform patients that symptoms of new onset or worsening depression as well as suicidal ideation have been reported in patients taking metoclopramide. Instruct patients to immediately discontinue Reglan and contact their healthcare provider if any of these symptoms occur
Drug Interactions
Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression
Effects on the Ability to Drive and Operate Machinery
Inform patients or their caregivers that Reglan can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle
Manufactured by:
9Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Reglan
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Reglan