Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g. in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crises, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine.
Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug.
Metoclopramide should not be used in epileptics or patients receiving other drugs, which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.
Rare occurrences of Neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, muscular rigidity, altered consciousness, and autonomic instability. Discontinue metoclopramide immediately and treat symptoms as appropriate.
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 the higher doses used in prophylaxis of vomiting due to cancer chemotherapy. 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 should occur, Benadryl® (diphenhydramine hydrochloride) injected intramuscularly may help symptoms subside. Cogentin® (benztropine mesylate) injected intramuscularly may also be used to reverse these reactions.
Patients with preexisting Parkinson’s disease should be given Metoclopramide cautiously, if at all, since such patients may experience exacerbation of Parkinsonian symptoms when taking Metoclopramide.
Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.
Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established except as stated to facilitate small bowel intubation. The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults.
Geriatric Use: The risk of developing Parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of Metoclopramide Injection that is effective. The elderly may be at greater risk for tardive dyskinesia.
Adverse Reactions: The incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS effects (restlessness, drowsiness, fatigue and lassitude) may occur in patients receiving the recommended prescribed dosage, Extrapyramidal Reactions (most commonly acute dystonic reactions), Parkinsonian-like symptoms, Tardive dyskinesia, Motor restlessness (akathisia), Neuroleptic Malignant Syndrome, Endocrine Disturbances and Fluid Retention, Cardiovascular reactions (hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure and possible atrioventricular (AVA) block, Gastrointestinal (nausea and bowel disturbances, primary diarrhea), Hepatotoxicity (rare), Renal (urinary frequency and incontinence) Hematologic (Methemoglobinemia in adults and especially with overdosage in neonates; Sulfhemoglobinemia in adults), Allergic reactions (rash, urticaria, or bronchospasm,
especially in patients with a history of asthma), Visual disturbances, Porphyria, and Transient flushing of the face and upper body, without alterations in vital signs, following high doses intravenously.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, at 1-800-551-7176 option 5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This important safety information does not include all the information needed to use Metoclopramide Injection, USP safely and effectively. Please see full prescribing information for Metoclopramide Injection, USP, including BOXED WARNING, at www.simplist-us.com.
