Metoclopramide

Metoclopramide is an FDA-registered drug product whose active ingredient is METOCLOPRAMIDE. It is labelled by Aphena Pharma Solutions - Tennessee, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 53401-027, application ANDA070184, label effective 20260818. It is one of 24 FDA drug label records sharing the active ingredient METOCLOPRAMIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METOCLOPRAMIDE are most often described in connection with: metoclopramide tablets, gastroesophageal reflux, symptomatic documented, fail respond, conventional therapy, relief symptoms, recurrent diabetic, gastroparesis limitations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Metoclopramide 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 : Metoclopramide tablets have not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ( 5.1 )]. Metoclopramide 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 [see Use in Specific Populations ( 8.4 )] . Metoclopramide 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. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. ( 1 , 5.1 ) Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 )

2 DOSAGE AND ADMINISTRATION Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy ( 2.1 ) Administer metoclopramide continuously or intermittently: Continuous: The recommended dosage is 10 to 15 mg orally, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks, as determined by endoscopic response. Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis in Adults ( 2.2 ) The recommended dosage is 10 mg orally, 30 minutes before each meal and at bedtime (maximum of 40 mg per day). Dosage Adjustment in Specific Populations ( 2.1 , 2.2 ) For symptomatic, documented gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Information for recommended dosage reductions for elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers. 2.1 Recommended Dosage for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy: Continuous Dosing The recommended dosage of metoclopramide tablets is 10 to 15 mg orally four times daily. The maximum recommended daily oral dosage is 60 mg. Administer each dose thirty minutes before a meal and at bedtime. The recommended treatment duration is 4 to 12 weeks, as determined by endoscopic response. Use metoclopramide tablets for the shortest duration of treatment and periodically reassess the need for continued treatment. The maximum recommended duration of treatment is 12 weeks [see Warnings and Precautions (5.1)] . Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. Intermittent Dosing If symptoms only occur intermittently or at specific times of the day, administer metoclopramide as a single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1. Table 1. Recommended Dosage of Metoclopramide Tablet for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Recommended Dosage Maximum Recommended Daily Dosage Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations ( 8.5 )] 5 mg 1 four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability. 2.2 Recommended Dosage for Acute and Recurrent Diabetic Gastroparesis in Adults The recommended oral dosage of metoclopramide tablets for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis is 10 mg four times daily. The maximum recommended daily dosage is 40 mg. Administer each dose thirty minutes before each meal and at bedtime. Use metoclopramide for the shortest duration of treatment and periodically reassess the need for continued treatment. Avoid treatment with metoclopramide, including metoclopramide tablets, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral metoclopramide tablets, consider starting therapy with metoclopramide injection given intramuscularly or intravenously for up to 10 days (see the prescribing information for metoclopramide injection). After patients are able to take oral therapy, switch to metoclopramide tablets. Table 2. Recommended Metoclopramide Tablet Dosage in Adult Patients with Acute and Recurrent Diabetic Gastroparesis Recommended Dosage Maximum Recommended Daily Dosage Adult Patients 10 mg four times daily (30 minutes before each meal and at bedtime) 40 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations ( 8.5 )] 5 mg 1 four times daily (30 minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (30 minutes before each meal and at bedtime) 20 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg twice daily 10 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based upon response and tolerability.

4 CONTRAINDICATIONS Metoclopramide is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions ( 5.1 , 5.2 )] . 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. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions ( 5.5 )] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions ( 6 )] . In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions ( 6 )] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hypersensitivity to metoclopramide ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal symptoms [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression [see Warnings and Precautions ( 5.4 )] Hypertension [see Warnings and Precautions ( 5.5 )] Fluid retention [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Effects on the ability to drive and operate machinery [see Warnings and Precautions ( 5.8 )] 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 Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 24 drug label records with METOCLOPRAMIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Metoclopramide used for?
1 INDICATIONS AND USAGE Metoclopramide 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 : Metoclopramide tablets have not been shown to be safe and effective for the treatment of …

Who makes Metoclopramide?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for Metoclopramide. 24 FDA label records share the active ingredient METOCLOPRAMIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Metoclopramide come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Metoclopramide prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METOCLOPRAMIDE?
Yes. 24 FDA drug label records list METOCLOPRAMIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Metoclopramide been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.