Metoclopramide 10 mg Tablet, 8-count
Other active recalls for Metoclopramide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Dopamine-2 Receptor Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Metoclopramide is used to treat gastroesophageal reflux disease (GERD; condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus) and gastroparesis (slow stomach emptying) . Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.
Read the full MedlinePlus article ↗- It helps your digestive system move food along faster. If you have acid reflux, it tightens the valve between your esophagus and stomach so acid is less likely to back up. If you h...
- What exactly is metoclopramide supposed to do for me?
- This medication is meant to be short-term. For acid reflux, treatment is generally 4 to 12 weeks. For diabetic gastroparesis, it's usually 2 to 8 weeks. Using it longer than recomm...
- The most common ones — restlessness, drowsiness, and fatigue — affect roughly 1 in 10 people and are usually manageable. The ones that need urgent attention are any unusual or repe...
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0766 | $0.61 / 8 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metoclopramide 10 mg 00093-2203-01 | Teva | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 50228-0233-01 | ScieGen | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 51079-0888-20 | Mylan | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 60687-0631-01 | American | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 62559-0296-01 | ANI | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 83980-0011-01 | Ipca | 100 tablets | $0.044 | AB | Availability likely | — |
| Metoclopramide 10 mg 00615-8285-30 | NCS | 30 tablets | — | AB | Discontinued | — |
| Metoclopramide 10 mg 42291-0596-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 48433-0067-20 | Safecor | 100 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 50090-0132-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 51655-0240-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Reglan 10 mg 62559-0166-01 | ANI | 100 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 63187-0235-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 63629-8745-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 66267-0286-20 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mgthis 66267-0827-08 | NuCare | 8 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 67046-0581-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 68788-7930-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 70518-0669-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 70518-1193-00 | REMEDYREPACK | 60 tablets | — | AB | Discontinued | — |
| Metoclopramide 10 mg 70518-4541-00 | REMEDYREPACK | 40 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 71335-0362-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 67296-2309-02 | Redpharm | 15 tablets | — | AB | FDA listed | — |
| Metoclopramide 10 mg 53401-0027-01 | Aphena | 1 tablet | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 66267-0827-04 | 4 TABLET in 1 BOTTLE (66267-827-04) | 2017-11-08 | Active |
| 66267-0827-06 | 6 TABLET in 1 BOTTLE (66267-827-06) | 2017-11-08 | Active |
| 66267-0827-08 You're viewing this | 8 TABLET in 1 BOTTLE (66267-827-08) | 2017-11-08 | Active |
You're viewing the largest of 3 pack sizes for this product.
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [ see Warnings and Precautions ( 5.1 ) ].
Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [ see Warnings and Precautions ( 5.1 ) ]. Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [ see Warnings and Precautions ( 5.1 ) and Dosage and Administration ( 2.2 , 2.3 ) ].
WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning. Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD.
The risk of developing TD increases with duration of treatment and total cumulative dosage ( 5.1 ) Discontinue metoclopramide in patients who develop signs or symptoms of TD ( 5.1 ) Avoid treatment with metoclopramide for longer than 12 weeks because of the risk of developing TD with longer-term use ( 5.1 , 2.1 , 2.2 , 2.3 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Metoclopramide tablets are indicated for the: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 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 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Gastroesophageal Reflux ( 2.2 ) Administer metoclopramide continuously or intermittently: Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks. Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis ( 2.3 ) Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks Dosage Adjustment in Specific Populations ( 2.2 , 2.3 ) For 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.
2.1Important Administration Instructions Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [ see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 ) ].
2.2Dosage for Gastroesophageal Reflux Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy:Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy: Continuous Dosing The recommended adult dosage of metoclopramide is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response.
Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.The recommended adult dosage of metoclopramide is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response.
Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg. 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 in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1.If symptoms only occur intermittently or at specific times of the day, administer metoclopramide in 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 Metoclopramide Tablet Dosage in Patients with Gastroesophageal Reflux Recommended Dosage Maximum Recommended Daily Dosage Adult patientsAdult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime)10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg60 mg Mild hepatic impairment (Child-Pugh A)Mild hepatic impairment (Child-Pugh A) Elderly patients [ ] Elderly patients [ see Use in Specific Populations ( 8.5 ) ] 5 mg four times daily (thirty minutes before each meal and at bedtime) 5 mg 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. four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [ ] 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)…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg metoclopramide: white, round, unscored, debossed “TV” on one side and “2204” on the other side. 10 mg metoclopramide: white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side. Tablets: 5 mg and 10 mg metoclopramide ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Metoclopramide is contraindicated: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 ) ].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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue metoclopramide and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 )
5.1Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage.
Additionally, the risk of developing TD is increased among the elderly, especially elderly women [ ], and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks and reduce the dosage in elderly patients [ ]. Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities.
Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [ see Use in Specific Populations ( 8.5 ) ], and in patients with diabetes mellitus.
Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks and reduce the dosage in elderly patients [ see Dosage and Administration ( 2.2 , 2.3 ) ]. Discontinue metoclopramide immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn.Discontinue metoclopramide immediately in patients who develop signs and symptoms of TD.
There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown.
Metoclopramide is contraindicated in patients with a history of TD [ ]. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown.
Metoclopramide is contraindicated in patients with a history of TD [ see Contraindications ( 4 ) ]. Avoid metoclopramide in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).
5.2Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue metoclopramide.In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue metoclopramide.
Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (metoc…
🤒 Adverse Reactions ▾
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 effects [ 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 USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antipsychotics : Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use. ( 7.1 ) CNS depressants : Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions.
( 7.1 ) Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) : See Full Prescribing Information for recommended dosage reductions. ( 2.2 , 2.3 , 7.1 ) MAO inhibitors : Increased risk of hypertension; avoid concomitant use. ( 5.5 , 7.1 ) Additional drug interactions : See Full Prescribing Information.
( 7.1 , 7.2 )
7.1Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3. Effects of Other Drugs on Metoclopramide Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).
Intervention Avoid concomitant use [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ]. Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [ see Clinical Pharmacology ( 12.3 ) ]. Intervention Reduce the metoclopramide dosage [ see Dosage and Administration ( 2.2 , 2.3 ) ].
Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [ see Warnings and Precautions ( 5.5 ) ]. Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [ see Warnings and Precautions ( 5.8 ) ].
Intervention Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates and anxiolytics Drugs that Impair Gastrointestinal Motility Clinical Impact Decreased systemic absorption of metoclopramide. Intervention Monitor for reduced therapeutic effect.
Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine
7.2Effects of Metoclopramide on Other Drugs Table 4 displays the effects of metoclopramide on other drugs. Table 4. Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine.
Potential exacerbation of symptoms (e.g., parkinsonian symptoms). Intervention Avoid concomitant use [ see Warnings and Precautions ( 5.2 ) ]. Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.
Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade Drugs with Absorption Altered due to Increased Gastrointestinal Motility Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablets , fosfomycin) : Monitor for reduced therapeutic effect of the interacting drug.
For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine) : Monitor therapeutic dr…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [ see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [ see Data ].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [ see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 ) ]. Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area.
No evidence of adverse developmental effects due to metoclopramide were observed.
8.2Lactation Risk Summary Limited published data report the presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [ see Data ]. Metoclopramide elevates prolactin levels [ see Warnings and Precautions ( 5.7 ) ]; however, the published data are not adequate to support drug effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoclopramide and any potential adverse effects on the breastfed child from metoclopramide or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [ see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 ) ]. Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose.
In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.
8.4Pediatric Use Metoclopramide is 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. The safety and effectiveness of metoclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [ see Warnings and Precautions ( 5.1 , 5.2 ) ].
In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [ see Use in Specific Populations ( 8.8 ) ].
8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [ see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [ see Data ].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [ see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 ) ]. Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area.
No evidence of adverse developmental effects due to metoclopramide were observed.
🧒 Pediatric Use ▾
8.4Pediatric Use Metoclopramide is 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. The safety and effectiveness of metoclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [ see Warnings and Precautions ( 5.1 , 5.2 ) ].
In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [ see Use in Specific Populations ( 8.8 ) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [ see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 ) ]. Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [ see Boxed Warning , Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 ) ].
🆘 Overdosage ▾
10 OVERDOSAGE 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 [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ]. There are no specific antidotes for metoclopramide 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.
The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. 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 increases the resting tone of the lower esophageal sphincter.
It has little, if any, effect on the motility of the colon or gallbladder.
12.2Pharmacodynamics Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of metoclopramide produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours.
Increased rate of stomach emptying was observed with single oral doses of 10 mg.
12.3Pharmacokinetics Absorption Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state.
In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours.
Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Distribution Metoclopramide is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about
3.5L/kg), which suggests extensive distribution of drug to the tissues. Elimination Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [ see Dosage and Administration ( 2.2 , 2.3 ), Use in Specific Populations ( 8.9 ) ].
Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free metoclopramide in urine within 36 hours. Specific Populations Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function.
The AUC of metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [ see Dosage and Administration ( 2.2 , 2.3 ) and Use in Specific Populations ( 8.6 ) ]. Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function [ see Dosage and Adminis…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.
The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. 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 increases the resting tone of the lower esophageal sphincter.
It has little, if any, effect on the motility of the colon or gallbladder.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. NDC 66267-827-04 Bottles of 4 NDC 66267-827-06 Bottles of 6 NDC 66267-827-08 Bottles of 8 Dispense in a tight, light-resistant container. Store tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
📋 Description ▾
11 DESCRIPTION Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether.
Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows: C 14 H 22 ClN 3 O 2 •HCl•H 2 O M.W. 354.3 Metoclopramide tablets are for oral administration.
Metoclopramide tablets are available in 5 mg and 10 mg tablets. Each metoclopramide tablet, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP). Each metoclopramide tablet, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).
Inactive Ingredients Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. \\Client\X$\Products\Metoclopramide Tablets USP, 10 mg (ANDA 070184)\Submissions\2017-08-30 CBE-0 - AJK\Working\INSERT\Images\metoclopramide-sf1.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients or their caregivers that metoclopramide can cause serious adverse reactions. Instruct patients to discontinue metoclopramide and contact a healthcare provider immediately if the following serious reactions occur: Tardive dyskinesia and other extrapyramidal reactions [ see Warnings and Precautions ( 5.1 , 5.2 ) ] Neuroleptic malignant syndrome [ see Warnings and Precautions ( 5.3 ) ] Depression and/or possible suicidal ideation [ see Warnings and Precautions ( 5.4 ) ] 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 [ see Drug Interactions ( 7.1 , 7.2 ) ].
Explain that the prescriber of any other medication must be made aware that the patient is taking metoclopramide. Inform patients or their caregivers that metoclopramide 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 [ see Warnings and Precautions ( 5.8 ) ]. Manufactured In Croatia By: Pliva Hrvatska d.o.o.
Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. Q 8/2017
💬 Medication Guide ▾
MEDICATION GUIDE METOCLOPRAMIDE TABLETS, USP (MET-oh-KLOE-pra-mide), oral use Read this Medication Guide before you start taking metoclopramide tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product.
Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about metoclopramide tablets?
Metoclopramide tablets can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You cannot control these movements.
They may not go away even after stopping metoclopramide tablets. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking metoclopramide tablets. Your chances for getting tardive dyskinesia increase: the longer you take metoclopramide tablets and the more metoclopramide tablets you take.
You should not take metoclopramide tablets for more than 12 weeks. if you are older, especially if you are an older woman. if you have diabetes. It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take metoclopramide tablets. Call your healthcare provider right away if you get movements you cannot stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section “ What are the possible side effects of metoclopramide tablets? ” for more information about side effects.
What are metoclopramide tablets? Metoclopramide tablets are a prescription medicine used in adults: for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work. to relieve the symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablets are not recommended for use in children.
Do not take metoclopramide tablets if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking metoclopramide tablets or a medicine that works like metoclopramide tablets. have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage or a tear in the stomach or bowel wall. have a type of tumor that can cause high blood pressure such as pheochromocytoma. have epilepsy (seizures). Metoclopramide tablets can increase your chance for seizures and make them worse. are allergic to metoclopramide.
Metoclopramide tablets can cause serious allergic reactions. Stop taking metoclopramide tablets right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face. trouble swallowing or breathing. skin rash, hives, sores in your mouth, or skin blisters. Before taking metoclopramide tablets, tell your healthcare provider about all of your medical conditions, including if you: have diabetes.
Your dose of insulin may need to be changed. had problems controlling your muscle movements after taking any medicine. have Parkinson’s disease. have a type of tumor that can cause high blood pressure (pheochromoctyoma). have kidney or liver disease. have or had depression or mental illness. have high blood pressure. have heart failure or heart rhythm problems. have breast cancer. drink alcohol. have seizures are pregnant or plan to become pregnant. Metoclopramide tablets may harm your unborn baby if taken during the end of pregnancy.
Talk to your healthcare provider if you become pregnant while taking metoclopramide tablets. are breastfeeding or plan to breastfeed. Metoclopramid…