Metoclopramide 5 mg/mL Injection, Solution
Other active recalls for Metoclopramide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Dopamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Metoclopramide injection is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and feeling of fullness that lasts long after meals. Metoclopramide injection is also used to prevent nausea and vomiting caused by chemotherapy or that may occur after surgery. Metoclopramide injection is also sometimes used to empty the intestines during certain medical procedures. Metoclopramide injection is in a class of medications called prokinetic agents. It works by speeding the movement of food through t...
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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metoclopramide — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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8.5 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.529 | $26.45 / 50 ml |
| Medicaid paysCMS SDUD · 12 mo | $15.10 | $755.07 / 50 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2765 | $1.004 / J2765 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metoclopramide 5 mg/mL 00409-3414-01 | Hospira, | 25 vials | $0.529 | AP | Discontinued | — |
| Metoclopramide 5 mg/mLthis 00409-5255-15 | Hospira, | 25 vials | $0.529 | AP | Availability likely | — |
| Metoclopramide 5 mg/mL 00703-4502-04 | Teva | 25 vials | $0.529 | AP | Availability likely | — |
| Metoclopramide 5 mg/mL 23155-0240-41 | Heritage | 25 vials | $0.529 | AP | Availability likely | — |
| Metoclopramide 5 mg/mL 83634-0779-02 | Avenacy, | 25 vials | $0.529 | AP | Availability likely | — |
| Metoclopramide 5 mg/mL 00404-9771-02 | Henry | 1 vial | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 51662-1288-01 | HF | 2 ml | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 51662-1670-03 | HF | 25 pouches | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 55154-0450-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 55154-2353-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 55154-7832-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 71872-7076-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 71872-7265-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 71872-7346-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Metoclopramide 5 mg/mL 84549-0414-11 | ProPharma | 2 ml | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00409-5255-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5255-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-5255-02) | $0.5290 / mL | $26.45 | 2022-11-14 | Discontinued by firm |
| 00409-5255-15 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5255-15) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-5255-10) | $0.5290 / mL | $26.45 | 2024-08-26 | Active |
This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($0.5290 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00409-5255-15?
What NDC number is used to bill for this package of Metoclopramide 5 mg/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and 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 (see WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Metoclopramide Injection, USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting Metoclopramide Injection, USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
Small Bowel Intubation Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis) If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1 to 2 minute period.
Administration of Metoclopramide Injection, USP up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment. For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.
The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate. For doses in excess of 10 mg, Metoclopramide Injection, USP should be diluted in 50 mL of a parenteral solution.
The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with Metoclopramide Injection, USP, can be stored frozen for up to 4 weeks. Metoclopramide Injection, USP is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide Injection, USP diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer’s Injection, or Lactated Ringer’s Injection may be stored up to 48 hours (without freezing) after preparation if protected from light.
All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation. If acute dystonic reactions should occur, inject 50 mg Benadryl ® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside. For the Prevention of Postoperative Nausea and Vomiting Metoclopramide Injection, USP should be given intramuscularly near the end of surgery.
The usual adult dose is 10 mg; however, doses of 20 mg may be used. To Facilitate Small Bowel Intubation If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1 to 2 minute period. The recommended single dose is: Pediatric patients above 14 years of age and adults – 10 mg metoclopramide base.
Pediatric patients (6 to 14 years of age) – 2.5 to 5 mg metoclopramide base; (under 6 years of age) – 0.1 mg/kg metoclopramide base. To Aid in Radiological Examinations In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose may be administered slowly by the intravenous route over a 1 to 2 minute period. For dosage, see intubation, above.
Use in Patients with Renal or Hepatic Impairment Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate. See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
ADMIXTURE COMPATIBILITIES Metoclopramide Injection, USP is compati…
⛔ Contraindications ▾
CONTRAINDICATIONS 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 crisis, 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.
⚠️ Warnings ▾
WARNINGS Neuroleptic Malignant Syndrome (NMS) 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, etc.) 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 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) 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 have not been established (see ADVERSE REACTIONS ). Extrapyramidal Symptoms (EPS) Acute Dystonic Reactions 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, inject 50 mg Benadryl ® (diphenhydramine hydrochloride) intramuscularly, and they usually will subside.
Cogentin ® (benztropine mesylate), 1 to 2 mg intramuscularly, may also be used to reverse these reactions. Tardive Dyskinesia (see Boxed Warnings ) 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 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 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 t…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In general, 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 of metoclopramide injection.
Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation also may occur (see WARNINGS ). In cancer chemotherapy patients being treated with 1 to 2 mg/kg per dose, incidence of drowsiness is about 70%. There are isolated reports of convulsive seizures without a clear-cut relationship to metoclopramide.
Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. In cancer chemotherapy patients receiving 1 to 2 mg/kg per dose, the incidence is 2% in patients over the ages of 30 to 35, and 25% or higher in pediatric patients and adult patients less than 30 years of age who have not had prophylactic administration of diphenhydramine.
Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions) and rarely, stridor and dyspnea, possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ). Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS ).
Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage. Neuroleptic Malignant Syndrome 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 (see WARNINGS ). Endocrine Disturbances Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS ). Fluid retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY ).
Cardiovascular Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure, and possible atrioventricular (AV) block (see CONTRAINDICATIONS and PRECAUTIONS ). Gastrointestinal Nausea and bowel disturbances, primarily diarrhea. Hepatic Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential.
Renal Urinary frequency and incontinence. Hematologic A few cases of neutropenia, leukopenia, or agranulocytosis, generally without a clear-cut relationship to metoclopramide. Methemoglobinemia, in adults and especially with overdosage in neonates (see OVERDOSAGE ).
Sulfhemoglobinemia in adults. Allergic Reactions A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.
Miscellaneous Visual disturbances, Porphyria. Transient flushing of the face and upper body, without alterations in vital signs, following high doses intravenously.
🔄 Drug Interactions ▾
Drug Interactions 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. The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.
Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia.
Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.
🤰 Pregnancy ▾
Pregnancy Reproduction studies performed in rats, mice, and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established except as stated to facilitate small bowel intubation (see OVERDOSAGE and DOSAGE AND ADMINISTRATION ). Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY - Pharmacokinetics ). In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE ).
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 (see WARNINGS and ADVERSE REACTIONS – Extrapyramidal Reactions (EPS)).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of metoclopramide did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. The risk of developing parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of metoclopramide that is effective.
If parkinsonian-like symptoms develop in a geriatric patient receiving metoclopramide, metoclopramide should generally be discontinued before initiating any specific anti-parkinsonian agents (see WARNINGS ). The elderly may be at greater risk for tardive dyskinesia (see WARNINGS – Tardive Dyskinesia ). Sedation has been reported in metoclopramide users.
Sedation may cause confusion and manifest as over-sedation in elderly (see CLINICAL PHARMACOLOGY , PRECAUTIONS – Information for Patients and ADVERSE REACTIONS – CNS Effects ). Metoclopramide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see DOSAGE AND ADMINISTRATION – Use in Patients with Renal or Hepatic Impairment ). For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly (see DOSAGE AND ADMINISTRATION – Use in Patients with Renal or Hepatic Impairment ).
Other Special Populations Patients with NADH-cytochrome b 5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia when metoclopramide is administered. In patients with G6PD deficiency who experience metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended (see OVERDOSAGE ).
🆘 Overdosage ▾
OVERDOSAGE Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours.
Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis.
Dialysis is not likely to be an effective method of drug removal in overdose situations. Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide syrup. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions and lethargy.
Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal (see PRECAUTIONS – Other Special Populations ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. 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. In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter pressure), single oral doses of metoclopramide produce dose-related increases in LESP. Effects begin at about 5 mg and increase through 20 mg (the largest dose tested).
The increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate of stomach emptying has been observed with single oral doses of 10 mg. The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors.
Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like l‑dopa or apomorphine which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine. Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (see WARNINGS ).
Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention. The onset of pharmacological action of metoclopramide is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes following intramuscular administration, and 30 to 60 minutes following an oral dose, pharmacological effects persist for 1 to 2 hours. Pharmacokinetics Metoclopramide is rapidly and well absorbed.
Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hours after a single oral dose. Similar time to peak is observed after individual doses at steady state.
In a single-dose study of 12 subjects, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hours.
Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hours. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide.
The drug 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. Renal impairment affects the clearance of metoclopramide. In a study with patients with varying degrees of renal impairment, a reduction in creatinine clearance was correlated with a reduction in plasma clearance, renal clearance, non-renal clearance, and increase in elimination half-life. The kinetics of metocl…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PRESERVATIVE FREE. Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (present as the hydrochloride monohydrate) is supplied in the following: Unit of Sale Concentration NDC 0409-5255-25 Tray containing 25 single-dose clear glass vials 10 mg/2 mL (5 mg/mL) NDC 0409-5255-15 Tray containing 25 single-dose amber glass vials 10 mg/2 mL (5 mg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light. For clear glass vials - retain in carton until ready to use.
This product is light sensitive. Inspect before use and discard if either color or particulate is observed. Do not store open single-dose vials for later use, as they contain no preservative.
Discard unused portion. Benadryl ® is a registered trademark of Warner-Lambert Company. Cogentin ® is a registered trademark of Merck & Co., Inc.
For Medical Information about Metoclopramide Injection, please visit www.pfizermedinfo.com or call 1‑800-438-1985. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. LAB-1539-4.0 Revised: 09/2023 PREMIERProRx logo
📋 Description ▾
DESCRIPTION Metoclopramide hydrochloride 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, practically insoluble in ether. Chemically it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide monohydrochloride monohydrate.
It has the following structural formula: Molecular formula: C 14 H 22 ClN 3 O 2 • HCl • H 2 O Metoclopramide Injection, USP is a sterile, nonpyrogenic solution of metoclopramide hydrochloride in water for injection. Each milliliter contains metoclopramide base 5 mg (as the hydrochloride monohydrate); 8.5 mg sodium chloride. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH 4.4 (2.5 to 6.5).
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. This product is light sensitive.
It should be inspected before use and discarded if either color or particulate is observed. Metoclopramide Injection is intended for intravenous or intramuscular administration. structural formula metoclopramide hydrochloride
💬 Information for Patients ▾
Information for Patients A patient Medication Guide is available for metoclopramide. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
Refer to the accompanying Medication Guide. Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be cautioned accordingly.
💬 Medication Guide ▾
MEDICATION GUIDE Metoclopramide (met” oh kloe’ pra mide) Injection, USP You or your caregiver should read the Medication Guide before you start receiving metoclopramide injection and before you get another dose of metoclopramide injection. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide tablets, 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 Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about metoclopramide?
Metoclopramide can cause serious side effects, including: Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements.
They may not go away even after stopping metoclopramide. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking metoclopramide. Your chances for getting TD go up: • the longer you take metoclopramide and the more metoclopramide you take.
You should not take metoclopramide for more than 12 weeks. • if you are older, especially if you are a woman • if you have diabetes It is not possible for your doctor to know if you will get TD if you take metoclopramide. Call your doctor right away if you get movements you can not 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? ” for more information about side effects.
What is metoclopramide? Metoclopramide is a prescription medicine used to: • relieve symptoms of slow stomach emptying in people with diabetes • prevent nausea and vomiting that can happen with cancer chemotherapy • prevent nausea and vomiting that may happen after surgery, if your doctor decides that you should not be treated with a stomach tube and suction • help make it easier to insert a tube into the small intestine in both adults and children, if the tube does not pass into the stomach normally. • to help empty stomach contents or to help barium move through your intestine, when you get an X-ray examination of the stomach or small intestine.
It is not known if metoclopramide is safe and works in children except when used to help insert a tube into the small intestine. Who should not receive metoclopramide? Do not receive metoclopramide if you: • have stomach or intestine problems that could get worse with metoclopramide, such as bleeding, blockage or a tear in your stomach or bowel wall • have an adrenal gland tumor called pheochromocytoma • are allergic to metoclopramide or anything in it.
See the end of this Medication Guide for a list of ingredients in metoclopramide. • take medicines that can cause uncontrolled movements, such as medicines for mental illness • have seizures What should I tell my doctor before receiving metoclopramide? Tell your doctor about all of your medical conditions, including if you have: • depression • Parkinson’s disease • high blood pressure • kidney problems. Your doctor may start with a lower dose. • liver problems or heart failure.
Metoclopramide may cause your body to hold fluids. • diabetes. Your dose of insulin may need to be changed. • breast cancer • you are pregnant or plan to become pregnant. It is not known if metoclopramide will harm your unborn child. • you are breastfeeding.
Metoclopramide is passed into human milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Metoclopramide and some other medic…