Metoclopramide (oral)

Metoclopramide (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

WARNING: TARDIVE DYSKINESIA See full prescribing information for complete Boxed Warning. * Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Overview

Metoclopramide (oral) is a {{{drugClass}}} that is FDA approved for the treatment of symptoms due to gastroesophageal reflux and diabetic gastroparesis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, nausea, vomiting, fatigue, and somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Symptomatic Gastroesophageal Reflux Disease

• Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

• Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.

Important Limitations

• Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established.

Dosage

Symptomatic Gastroesophageal Reflux Disease

• For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks in duration.

• Take 10 mg to 15 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Doses may vary depending upon the symptoms being treated and the clinical response. If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment.

• Since there is a poor correlation between symptomatic relief and healing of esophageal lesions, any therapy directed at esophageal lesions is best confirmed by endoscopic evaluation. Although experience with the effects of metoclopramide on esophageal erosions and ulcerations is limited, healing was documented in a controlled trial using four times daily therapy at 15 mg/dose. Prolonged treatment (>12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

• For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

• Take a 10 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times a day (e.g., at least 30 minutes before each meal and at bedtime).

• The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Metoclopramide Hydrochloride Orally Disintegrating Tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection.

• Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, Metoclopramide Hydrochloride Orally Disintegrating Tablets therapy should be reinstituted at the earliest manifestation.

Renal Impairment

• Some patients, such as the elderly or those with impaired kidney function (creatinine clearance below 40 mL/min) may be more sensitive to the therapeutic dose or the adverse effects of metoclopramide. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.

DOSAGE FORMS & STRENGTHS

• 5 mg Tablets: Metoclopramide Hydrochloride Orally Disintegrating Tablets are round, white to off-white, flat faced beveled edge tablet, debossed with ‘N’ on one side and “581” on the other side.

• 10 mg Tablets: Metoclopramide Hydrochloride Orally Disintegrating Tablets are round, white to off-white, flat faced beveled edge tablet, debossed with ‘N’ on one side and “580” on the other side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Metoclopramide (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Metoclopramide (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Metoclopramide (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Metoclopramide (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Metoclopramide (oral) in pediatric patients.

Contraindications

Intestinal Obstruction, Hemorrhage, or Perforation

• Do not use metoclopramide whenever stimulation of gastrointestinal motility may be dangerous such as in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Pheochromocytoma

Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may precipitate a hypertensive crisis, most likely due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine.

Known Sensitivity or Intolerance

• Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug.

Epilepsy

• Do not use metoclopramide in patients with epilepsy since the frequency and severity of seizures may be increased.

Concomitant Medications with Extrapyramidal Reactions

• Do not use metoclopramide in patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased.

Warnings

WARNING: TARDIVE DYSKINESIA See full prescribing information for complete Boxed Warning. * Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Tardive Dyskinesia

• Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20% of patients who used metoclopramide took it for longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.

• Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.

• Metoclopramide should be discontinued in patients who develop signs or 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. Therefore, metoclopramide should not be used for the symptomatic control of TD.

Acute Dystonic Reactions, Drug-induced Parkinsonism, and Other Extrapyramidal Symptoms

• Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms occur, inject 50 mg diphenhydramine hydrochloride intramuscularly. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions.

• Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment, but also after longer periods. Parkinsonian symptoms generally subside within 2 to 3 months following discontinuation of metoclopramide. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.

Neuroleptic Malignant Syndrome

• There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy; intensive symptomatic treatment and medical monitoring; and, treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness has not been established.

Depression

• Depression associated with metoclopramide use has occurred in patients with and without a history of depression. Symptoms ranged from mild to severe and included suicidal ideation and suicide. For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.

Hypertension

• In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. There are also clinical reports of hypertensive crises in some patients with undiagnosed pheochromocytoma, thus any rapid rise in blood pressure associated with Metoclopramide Hydrochloride Orally Disintegrating Tablets use should result in immediate cessation of metoclopramide use in those patients.

Congestive Heart Failure and Ventricular Arrhythmia

• Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.

Withdrawal from Metoclopramide

• Adverse reactions, especially those involving the nervous system, may occur after stopping the use of Metoclopramide Hydrochloride Orally Disintegrating Tablets. A small number of patients may experience withdrawal symptoms after stopping that could include dizziness, nervousness, and/or headaches.

Phenylketonurics:

• Phenylalanine is a component of aspartame. Each 5 mg and 10 mg Metoclopramide Hydrochloride Orally Disintegrating Tablets contains 4.7 mg of phenylalanine.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Metoclopramide (oral) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Metoclopramide (oral) in the drug label.

Drug Interactions

There is limited information regarding Metoclopramide (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Metoclopramide (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Metoclopramide (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Metoclopramide (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Metoclopramide (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Metoclopramide (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Metoclopramide (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Metoclopramide (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Metoclopramide (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Metoclopramide (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Metoclopramide (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Metoclopramide (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Metoclopramide (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Metoclopramide (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Metoclopramide (oral) in the drug label.

Pharmacology

There is limited information regarding Metoclopramide (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Metoclopramide (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Metoclopramide (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Metoclopramide (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Metoclopramide (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Metoclopramide (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Metoclopramide (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Metoclopramide (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Metoclopramide (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• METOCLOPRAMIDE HYDROCHLORIDE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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