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Cautions

Contraindications

• Mechanical obstruction or perforation or other situations in which stimulation of GI motility might be dangerous.
• GI hemorrhage (however, has been used to empty the stomach of blood prior to endoscopy in patients with acute upper GI hemorrhage).
• Pheochromocytoma (due to potential for hypertensive crisis).
• History of seizure disorders.
• Concomitant therapy with drugs likely to cause extrapyramidal reactions (e.g., phenothiazines, butyrophenones).
• Known intolerance to metoclopramide.
• Known hypersensitivity to metoclopramide or any ingredient in the formulation.

Warnings/Precautions

Warnings

Depression

Mild to severe depression (including suicidal ideation and suicide) has occurred in patients with or without prior history of depression.

Use with extreme caution and only when anticipated benefits outweigh possible risks in patients with a history of mental depression, especially those with suicidal tendencies.

Extrapyramidal Symptoms

Potential for extrapyramidal reactions, especially in children or young adults (<30 years of age) or when high doses (e.g., IV doses for prophylaxis of cancer chemotherapy-induced nausea and vomiting) are administered.

Principally manifested as acute dystonic reactions; stridor and dyspnea (possibly due to laryngospasm) reported rarely.

Generally occur within 24–48 hours after starting therapy and usually subside within 24 hours following drug discontinuance.

Most patients respond rapidly to treatment with diazepam or an agent with central anticholinergic activity (e.g., diphenhydramine hydrochloride 50 mg IM, benztropine 1–2 mg IM).

Parkinsonian Symptoms

Parkinsonian symptoms (e.g., tremor, rigidity, bradykinesia, akinesia) occur rarely; may be associated with usual or excessive metoclopramide doses or decreased renal function.

Possible exacerbation of parkinsonian symptoms; use with caution, if at all, in patients with parkinsonian syndrome.

More common during first 6 months of therapy but occur occasionally after longer periods.

Symptoms generally subside within 2–3 months following drug discontinuance.

Tardive Dyskinesia

Tardive dyskinesia occurs most commonly in geriatric patients (particularly geriatric women), usually following discontinuance of the drug.

Manifested by orobuccolingual dyskinetic movements and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance.

Risk of occurrence and irreversibility potential are believed to increase with increasing duration of therapy and total cumulative dose. Can occur after relatively brief therapy at low doses but appears to be more readily reversible under such circumstances.

Neuroleptic Malignant Syndrome (NMS)

NMS (characterized by hyperthermia, varying levels of consciousness, muscular rigidity, and autonomic dysfunction) reported rarely.

Important to determine whether untreated or inadequately treated extrapyramidal reactions and serious medical illness (e.g., pneumonia, septicemia) may coexist. Also consider the possibility of central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, and primary CNS pathology.

Immediately discontinue metoclopramide and other drugs not considered essential, provide supportive and symptomatic treatment, monitor patient, and treat any concomitant serious medical condition for which specific therapies are available. Dantrolene and bromocriptine have been used in the treatment of NMS, but their efficacy has not been established and there currently is no specific drug therapy.

Sensitivity Reactions

Procainamide Cross-sensitivity

Theoretical potential for patients who are allergic to procainamide to exhibit cross-sensitivity to metoclopramide (since the drugs are structurally similar).

General Precautions

GI Anastomosis or Closure

When deciding whether to use metoclopramide or NG suction to prevent postoperative nausea and vomiting, consider the possibility that metoclopramide theoretically could produce increased pressure on suture lines following GI anastomosis or closure.

Fluid and Electrolyte Effects

Possible transient increases in plasma aldosterone concentrations and sodium retention; closely monitor patients (e.g., those with CHF or cirrhosis) at risk of developing fluid retention and volume overload or hypokalemia.

Discontinue metoclopramide if fluid retention or volume overload occurs during the first few weeks of therapy.

Hypertension

Possible increase in circulating catecholamines in hypertensive patients; use with caution in these patients.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk. Use caution in nursing women.

Pediatric Use

Manufacturers currently recommend use in children only to facilitate intubation of the small intestine; however, has been effective for the management of gastric stasis† and gastroesophageal reflux† in infants and children.

Use with caution; incidence of extrapyramidal reactions is increased in children.

Use with caution in neonates. Neonatal susceptibility to methemoglobinemia is increased due to prolonged clearance (may cause excessive serum concentrations) in combination with decreased neonatal levels of NADH-methemoglobin reductase.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients repond differently than younger adults.

Risk of adverse parkinsonian effects increases with increasing dosage; administer lowest effective dosage in the elderly. (See Geriatric Patients under Dosage and Administration).

Possible increased risk of tardive dyskinesia.

Hepatic Impairment

Possible increased risk of fluid retention and hypokalemia in patients with cirrhosis. (See Fluid and Electrolyte Effects under Cautions.)

Discontinue if fluid retention or volume overload occurs during the first few weeks of therapy.

Renal Impairment

Clearance may be reduced. Possible increased risk of adverse effects. Use with caution; reduce dosage during prolonged therapy in patients with renal impairment.

Common Adverse Effects

Restlessness, drowsiness, fatigue, lassitude, nausea, bowel disturbances (principally diarrhea).