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.

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

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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