Generic Reglan ( Metoclopramide )

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Reglan (Metoclopramide 10 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Reglan is a medication that helps the stomach empty faster and prevents nausea and vomiting. It works by blocking the effects of a natural substance called dopamine in the gut and in the brain's vomiting centre. By doing this, it speeds up the movement of food through the stomach and upper intestine, and it stops the signals that trigger the urge to vomit. It is also used to help pass a tube into the small intestine during certain medical procedures.

For specialists: Metoclopramide is a dopamine-2 (D2) receptor antagonist. It stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its exact mechanism of action in the treatment of gastroesophageal reflux and gastroparesis has not been fully established, but it appears to sensitize tissues to the action of acetylcholine. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum, resulting in accelerated gastric emptying and intestinal transit. It also increases the resting tone of the lower esophageal sphincter. It inhibits the central and peripheral effects of apomorphine, induces release of prolactin, and produces a transient increase in circulating aldosterone levels. The antiemetic effect is due to antagonism of dopamine D2 receptors in the chemoreceptor trigger zone.

Pharmacokinetics

• Absorption: The absolute bioavailability of oral metoclopramide is approximately 80% ± 15.5%. Peak plasma concentrations occur about 1 to 2 hours after a single oral dose. Food may delay the time to peak concentration but does not significantly affect the extent of absorption.
• Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. The major oxidative metabolite is monodethylmetoclopramide, formed primarily by CYP2D6.
• Elimination: The average elimination half-life in subjects with normal renal function is 5 to 6 hours. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hours. After oral administration of 10 mg, a mean of 18% of the dose was recovered as free metoclopramide in urine within 36 hours. Metoclopramide is not extensively bound to plasma proteins (about 30%).
• Onset of Action: Following oral administration, metoclopramide begins to take effect within approximately 30 to 60 minutes. For intravenous use, the antiemetic effect begins within minutes.
• Duration of Action: The antiemetic and prokinetic effects typically last for approximately 1 to 2 hours following a single dose.

Uses in Daily Life and Best Practice Advice

Metoclopramide is prescribed in Canada for the treatment of nausea and vomiting and for conditions involving delayed stomach emptying. Your physician will determine the appropriate use and dose based on your specific medical situation.

• Typical Uses: Treatment of symptoms of slowed stomach emptying (gastroparesis) seen in people with some gastrointestinal disorders; prevention of nausea and vomiting caused by some drugs used to treat Parkinson's disease; prevention of postoperative nausea and vomiting; prevention of nausea and vomiting associated with radiation therapy; and facilitation of small bowel intubation.
• Administration: Tablets are taken orally, usually 30 minutes before meals and at bedtime. The recommended adult dose is 5 to 10 mg, repeated 3 to 4 times per day. The maximum daily dose is 30 mg or 0.5 mg/kg body weight, whichever is lower.
• Monitoring: If symptoms do not improve within a reasonable period, or if they worsen, consult your physician. The maximum recommended treatment duration is 5 days for most indications. Treatment should not exceed 12 weeks because of the increased risk of tardive dyskinesia.
• Do Not Exceed Recommended Dose: Do not take more than the prescribed dose. The maximum recommended daily dose is 30 mg.

Morning vs. Evening Dosing

Metoclopramide is typically taken three to four times daily, with doses spaced at least 6 hours apart. For best results, take it 30 minutes before meals and at bedtime if needed for nausea. There is no specific clinical recommendation for morning versus evening dosing beyond the meal-related timing. Always follow the schedule recommended by your physician.

• Before Meals: Taking metoclopramide 30 minutes before meals helps with delayed stomach emptying and prevents nausea associated with eating.
• Consistency: Take metoclopramide at the same times each day to ensure consistent effects.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
• Minimum Interval: Wait at least 6 hours between each dose, even if you vomit or do not retain the dose, to avoid overdose.

Administration With or Without Food

Metoclopramide should be taken 30 minutes before meals. This timing allows the medication to be absorbed and reach the gastrointestinal tract before food enters, maximizing its prokinetic and antiemetic effects.

• Take the tablet with a full glass of water.
• Take metoclopramide 30 minutes before each meal and at bedtime if prescribed.
• Swallow the tablet whole. Do not crush or chew unless directed by your pharmacist.
• For the oral solution, use the provided measuring device for accurate dosing.
• Avoid taking metoclopramide at the same time as food, as this may reduce its effectiveness for delayed gastric emptying.

Interaction Warnings

Indications for Metoclopramide

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition. Metoclopramide is contraindicated in children less than 1 year of age due to the risk of extrapyramidal symptoms. The maximum recommended treatment duration is 5 days for most indications; treatment beyond 12 weeks should be avoided in all but rare cases due to the risk of tardive dyskinesia.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take metoclopramide exactly as prescribed by your physician. Do not change your dose without medical advice.
• Take the tablet with a full glass of water, 30 minutes before meals and at bedtime if prescribed.
• Do not exceed the maximum daily dose of 30 mg or 0.5 mg/kg body weight.
• Do not use for more than 5 days for most indications unless directed by your physician.
• Avoid treatment longer than 12 weeks because of the increased risk of developing tardive dyskinesia.
• Wait at least 6 hours between each dose, even if you vomit or do not retain the dose.
• Do not drink alcohol while taking metoclopramide, as it increases the sedative effect.
• Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking metoclopramide.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician before use. Metoclopramide is not recommended during breastfeeding.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at room temperature in a dry place. Keep out of reach of children.

Alternative Treatment Options

• Ondansetron (Zofran): A 5-HT3 receptor antagonist commonly used for nausea and vomiting, particularly chemotherapy-induced and postoperative. Available in oral, orally disintegrating, and injectable forms.
• Prochlorperazine (Stemetil): A phenothiazine antiemetic used for various causes of nausea and vomiting. Available in oral, rectal, and injectable forms.
• Dimenhydrinate (Gravol): An antihistamine antiemetic available over the counter for motion sickness and general nausea.
• Domperidone (Motilium): A peripherally acting dopamine antagonist used as a prokinetic agent and antiemetic. Available in Canada as a prescription medication. The AGA 2025 guideline issued a conditional recommendation against routine first-line use of domperidone due to limited efficacy and cardiac risk.
• Erythromycin: A macrolide antibiotic with prokinetic properties. The AGA 2025 guideline conditionally recommends erythromycin as a first-line option for gastroparesis, alongside metoclopramide.

Comparison: Metoclopramide remains the primary pharmacologic option for treating gastroparesis, according to the 2025 American Gastroenterological Association guideline. The panel recommended short-term therapy of up to 12 weeks. Seven trials demonstrated improvements in nausea, vomiting, and composite symptom scores. Metoclopramide is the only FDA-approved prokinetic for gastroparesis. Adverse effects, including neurologic side effects (confusion and restlessness) and gastrointestinal (nausea and diarrhea), limit long-term use. Recent research has shown that tardive dyskinesia occurs in less than 1% of patients, including those using the drug for a median of 490 days. Erythromycin is conditionally recommended but develops tachyphylaxis quickly. Domperidone is not recommended as first-line due to limited efficacy and cardiac risk. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Metoclopramide is authorized for sale in Canada by Health Canada as a prescription drug. The brand-name Reglan (DIN 02043521) was cancelled post-market on 2002-02-06. The brand-name Maxeran has also been cancelled. Generic formulations are available in 5 mg and 10 mg tablets from Marcan Pharmaceuticals (MAR-Metoclopramide, DIN 02517809), Pharmascience (PMS-Metoclopramide), Pharmaris Canada (PRZ-Metoclopramide, DIN 02548747), Pro Doc Limitée, and others.
• Prescription Status: Prescription only in Canada.
• Coverage: Coverage varies by province and territory. In Ontario, PRZ-Metoclopramide, PMS-Metoclopramide, and Mar-Metoclopramide are listed as General Benefits on the Ontario Drug Benefit (ODB) formulary at a unit price of $0.0257. In Quebec, metoclopramide is covered under the RAMQ formulary. Generic formulations are generally more affordable than brand-name products.
• Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program.

Recent Research and Clinical Guidelines (2022–2026)

• The 2025 American Gastroenterological Association (AGA) guideline on the management of gastroparesis conditionally recommends metoclopramide and erythromycin as first-line pharmacologic treatment. The panel recommended short-term metoclopramide therapy of up to 12 weeks. Seven trials demonstrated improvements in nausea, vomiting, and composite symptom scores, although most were small and decades old. The panel noted that adverse effects limit long-term use, but recent research has shown that tardive dyskinesia occurs in less than 1% of patients, including those using the drug for a median of 490 days.
• The AGA guideline recommended a starting dose of 5 mg pre-prandial for metoclopramide, which can be increased to 10 mg up to 3 times daily. The panel noted that akathisia and depression are among the side effects that may limit use.
• The AGA guideline conditionally recommended against routine first-line use of domperidone, prucalopride, and aprepitant for gastroparesis due to limited efficacy or safety concerns.
• Health Canada has issued multiple safety communications regarding metoclopramide, including stricter warnings on the risk of tardive dyskinesia. The risk increases with the duration of treatment and is higher in older adults, particularly older women. Treatment longer than 12 weeks should be avoided unless the benefits outweigh the risks.
• Health Canada has advised that metoclopramide be contraindicated in children less than 1 year of age and that the maximum daily dosage not exceed 0.5 mg/kg/24 hr, due to the risk of extrapyramidal symptoms.
• A drug shortage of metoclopramide 10 mg tablets from Pro Doc Limitée was reported in July 2025, with the product subsequently cancelled post-market.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. Generic metoclopramide formulations are widely available in Canada and are generally more affordable than brand-name products. A shortage of metoclopramide 10 mg tablets from Pro Doc Limitée was reported in 2025, with the product subsequently cancelled post-market. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. What is Reglan used for?
   Reglan (metoclopramide) is used to treat nausea and vomiting, including nausea caused by migraine, and to prevent nausea and vomiting after surgery or radiation therapy. It is also used to treat delayed stomach emptying (diabetic gastroparesis) and to help pass a tube into the small intestine during certain medical procedures.
2. How long can I take metoclopramide?
   The maximum recommended treatment duration is 5 days for most indications. Treatment should not exceed 12 weeks because of the increased risk of developing tardive dyskinesia, a serious movement disorder that is often irreversible.
3. What is the correct dose of metoclopramide 10 mg?
   The recommended adult single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight, whichever is lower. For diabetic gastroparesis, the dose may be 10 mg four times daily.
4. Can I take metoclopramide with food?
   Metoclopramide should be taken 30 minutes before meals. This timing allows the medication to be absorbed and reach the gastrointestinal tract before food enters, maximizing its prokinetic and antiemetic effects.
5. What should I do if I miss a dose?
   If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time. Wait at least 6 hours between each dose, even if you vomit.
6. Can I drink alcohol while taking metoclopramide?
   No. Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of the medication.
7. What are the serious side effects of metoclopramide?
   Serious side effects include tardive dyskinesia (involuntary, repetitive movements of the face, tongue, or limbs), acute dystonic reactions (involuntary muscle contractions), neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status), and methemoglobinemia. Seek immediate medical attention if you experience any of these symptoms.
8. Is metoclopramide safe during pregnancy?
   Metoclopramide can be used during pregnancy if clinically necessary, based on a large amount of data showing no increased risk of fetal malformations. Consult your physician if you are pregnant or planning to become pregnant.
9. Is metoclopramide safe during breastfeeding?
   Metoclopramide is not recommended during breastfeeding because it passes into breast milk and may cause adverse reactions in the infant, including gastrointestinal discomfort and extrapyramidal signs.
10. What should I do if I experience involuntary movements while taking metoclopramide?
    Seek immediate medical attention if you experience involuntary movements of your face, tongue, limbs, or body. These may be signs of tardive dyskinesia or an acute dystonic reaction. Do not wait for symptoms to resolve on their own.

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