WARNING: TARDIVE DYSKINESIA Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including metoclopramide injection, the risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dosage. Metoclopramide injection is contraindicated in patients with a ...
Diabetic Gastroparesis Metoclopramide injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis is in adults. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Metoclopramide injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy in adults. The Pre...
For the Relief of Symptoms Associated with Diabetic Gastroparesis If only the earliest manifestations of diabetic gastroparesis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, the recommended dosage of metoclopramide injection in adults is 10 mg administered intramuscularly or intravenously over at least 1 - to 2 - minutes. Administration of metoclopra...
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Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3.
Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 2.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration.
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
Metoclopramide Injection, USP is supplied in 2 mL single-dose vials.
Each 1 mL contains: Metoclopramide base 5 mg (as the monohydrochloride monohydrate), Sodium Chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.
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 1-2 hr 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 hr. 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 hr. 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 3.5 L/kg) which suggests extensive distribution of drug to the tissues (see Table 1).
Patients with Renal Impairment
In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide following intravenous administration in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of metoclopramide in patients with ESRD in dialysis was about 3.5-fold the AUC in subjects with normal renal function.
Patients with Hepatic Impairment
In a group of 8 patients with severe hepatic impairment (Child-Pugh C) administered intravenous metoclopramide, the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function.
Effect of CYP2D6 Inhibitors on Metoclopramide
In healthy subjects, 20 mg of oral metoclopramide and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant metoclopramide and fluoxetine had a 40% and 90% increase in metoclopramide Cmax and AUC0-, respectively, compared to patients who received metoclopramide alone (see Table 2).
Pediatric Patients
In pediatric patients, the pharmacodynamics of metoclopramide following oral and intravenous administration are highly variable and a concentration-effect relationship has not been established.
There are insufficient reliable data to conclude whether the pharmacokinetics of metoclopramide in adults and the pediatric population are similar.
Diabetic Gastroparesis
Metoclopramide injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis is in adults.
The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
Metoclopramide injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy in adults.
The Prevention of Postoperative Nausea and Vomiting
Metoclopramide injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable in adults.
Small Bowel Intubation
Metoclopramide injection is indicated to facilitate small bowel intubation in adult and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
Radiological Examination
Metoclopramide injection is indicated to stimulate gastric emptying and intestinal transit of barium where delayed emptying interferes with radiological examination of the stomach and/or small intestine in adults.
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.
Tardive Dyskinesia (see BOXED WARNING)
Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Metoclopramide, including metoclopramide injection, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD because it may mask the underlying disease process. The effect of the symptomatic suppression upon the long-term course of TD is unknown. TD may remit, partially or completely, if treatment with metoclopramide injection is discontinued.
In patients treated with metoclopramide, including metoclopramide injection, the risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased in elderly patients, especially in elderly women, and in patients with diabetes mellitus.
Prevention, Mitigation, and Monitoring for TD
Other Extrapyramidal Symptoms
In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue metoclopramide injection.
Neuroleptic Malignant Syndrome
Metoclopramide may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with metoclopramide overdosage and concomitant treatment with another drug associated with NMS. Avoid metoclopramide injection in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.
Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately.
In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology.
Management of NMS includes:
Depression
Depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
Hypertension
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; avoid metoclopramide injection in patients with hypertension or patients taking monoamine oxidase inhibitors (see PRECAUTIONS Drug Interactions).
There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Metoclopramide injection is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Discontinue metoclopramide injection in any patient with a rapid rise in blood pressure.
Fluid Overload
Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. Discontinue metoclopramide injection if any of these adverse reactions occur.
Adverse Reactions with Rapid Intravenous Administration
Intravenous injections of undiluted metoclopramide injection should be made slowly allowing 1 to 2 minutes for 10 mg since a transient but intense feeling of anxiety and restlessness, followed by drowsiness, may occur with rapid administration.
Intravenous administration of metoclopramide injection diluted in a parenteral solution should be made slowly over a period of not less than 15 minutes.
Anastamotic Dehiscence
Giving a promotility drug such as metoclopramide theoretically could put increased pressure on suture lines following a gut anastomosis or closure. This possibility should be considered and weighed when deciding whether to use metoclopramide injection or nasogastric suction in the prevention of postoperative nausea and vomiting.
Effects on the Ability to Drive and Operate Machinery
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. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid metoclopramide injection or the interacting drug, depending on the importance of the drug to the patient.
Drug Interactions
Effects of Other Drugs on Metoclopramide
Table 3 displays the effects of other drugs on metoclopramide.
Effects of Metoclopramide on Other Drugs
Table 4 displays the effects of metoclopramide on other drugs.
*Interaction does not apply to posaconazole delayed-release tablets
Information for Patients
A patient Medication Guide is available for metoclopramide injection. 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 accompanying Medication Guide.
Tardive Dyskinesia and/or other Extrapyramidal Reactions
Metoclopramide injection may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately contact their healthcare provider if symptoms occur. See WARNINGS.
Neuroleptic Malignant Syndrome
Serious neuroleptic malignant syndrome (NMS) has been reported in association with concomitant treatment of metoclopramide with another drug associated with NMS. Advise patients to report all prescription and over-the-counter medications to the healthcare provider. Instruct patients to seek medical attention if symptoms occur.
Depression and/or Possible Suicidal Ideation
Symptoms of new onset or worsening depression as well as suicidal ideation have been reported in patients taking metoclopramide. Instruct patients to contact their healthcare provider if any of these symptoms occur.
Drug Interactions
Concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression. Advise patients to report all prescriptions and over the counter medications to the healthcare provider.
Effects on the Ability to Drive and Operate Machinery
Metoclopramide can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 77-week study was conducted in rats with oral doses up to about 40 times the maximum recommended human daily dose. Metoclopramide elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of metoclopramide is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of prolactin-stimulating neuroleptic drugs and metoclopramide. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is too limited to be conclusive at this time.
An Ames mutagenicity test performed on metoclopramide was negative.
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.
Fetal/Neonatal Adverse Reactions
Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with material administration during delivery. Monitor neonates for extrapyramidal signs.
Nursing Mothers
Metoclopramide is excreted in human milk. C Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia.
Pediatric Use
The safety and effectiveness of metoclopramide injection has been established as a single dose to facilitate small bowel intubation in pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
The safety and effectiveness of metoclopramide injection has not been established in pediatric patients for the following:
The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Neonates have reduced levels of NADH-cytochrome b5 reductase which, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE). 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).
Geriatric Use
Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including TD, may be greater in patients with impaired renal function (see WARNINGS – Tardive Dyskinesia).
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. If parkinsonian-like symptoms develop in a geriatric patient receiving metoclopramide injection, metoclopramide injection should generally be discontinued before initiating any specific anti-parkinsonian agents (see WARNINGS – Other Extrapyramidal Symptoms).
Sedation has been reported in metoclopramide injection users. Sedation may cause confusion and manifest as over-sedation in elderly (see CLINICAL PHARMACOLOGY, PRECAUTIONS – Information for Patients and ADVERSE REACTIONS – CNS Effects).
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
NADH-Cytochrome b5 Reductase Deficiency
Patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia when metoclopramide is administered. In patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency who experience metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended (see OVERDOSAGE).
CYP2D6 Poor Metabolizers
Metoclopramide is a substrate of CYP2D6. The elimination of metoclopramide may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive , or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to metoclopramide injection. Avoid metoclopramide injection in patients who are poor CYP2D6 metabolizers. If use in unavoidable, monitor for 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 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, 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 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.
To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784), or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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).
For the Relief of Symptoms Associated with Diabetic Gastroparesis
If only the earliest manifestations of diabetic gastroparesis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, the recommended dosage of metoclopramide injection in adults is 10 mg administered intramuscularly or intravenously over at least 1 - to 2 - minutes.
Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted.
Avoid a total duration of treatment with metoclopramide products, including metoclopramide injection, for longer than 12 weeks. If longer-term use us unavoidable, routinely monitor for signs and symptoms of TD (see WARNINGS – Tardive Dyskinesia).
For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
The recommended dosage of metoclopramide injection in adults is 2 mg/kg, with highly emetogenic drugs (e.g., cisplatin or dacarbazine) alone or in combination, and 1 mg/kg, with less emetogenic drugs, infused intravenously over at least 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.
For doses in excess of 10 mg, metoclopramide injection 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, can be stored frozen for up to 4 weeks. Metoclopramide injection is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide injection 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
The recommended dosage of metoclopramide injection in adults is 10 mg or 20 mg as a single intramuscular injection near the end of surgery.
To Facilitate Small Bowel Intubation
In adult and pediatric patients undergoing small bowel intubation, in whom the tube has not passed the pylorus with conventional maneuvers after 10 minutes, the recommended dosage of metoclopramide injection is a single dose administered (undiluted) by the intravenous route over at least 1 to 2 minutes:
To Aid in Radiological Examinations
In adult patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, the recommended dosage of metoclopramide injection is a single 10 mg dose administered (undiluted) by the intravenous route over at least 1- to 2 - minutes.
Use in Patients With Renal or Hepatic Impairment
The clearance of metoclopramide is decreased, and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions.
There is no dosage adjustment for patients with mild renal impairment (creatinine clearance greater than 60 mL/minute).
For patients with moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), who are receiving more than a single dose of metoclopramide injection, reduce the metoclopramide injection dosage to one-half the dosage recommended for patients with normal renal function.
For patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis or continuous ambulatory peritoneal dialysis, who are receiving more than a single dose of metoclopramide injection, reduce the metoclopramide injection dosage to one-fourth the dosage recommended for patients with normal renal function.
See OVERDOSAGE section for information regarding dialysis.
Use in Patients with Hepatic Impairment
Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide clearance (by approximately 50%) following intravenous administration compared to patients with normal hepatic function. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B).
There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A). For patients with moderate and severe hepatic impairment (Child-Pugh B or C), who are receiving more than a single dose of metoclopramide injection, reduce the metoclopramide injection dosage to one-half the dosage recommended for patients with normal hepatic function.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
ADMIXTURES COMPATIBILITIES
Metoclopramide injection is compatible for mixing and injection with the following dosage forms to the extent indicated below:
Physically and Chemically Compatible Up to 48 Hours
Cimetidine Hydrochloride (SK&F), Mannitol, USP (Abbott), Potassium Acetate, USP (Invenex), Potassium Phosphate, USP (Invenex).
Physically Compatible Up to 48 Hours
Ascorbic Acid, USP (Abbott), Benztropine Mesylate, USP (MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate, USP (ESI, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis), Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (ESI), Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride, USP (ESI), Multi-Vitamin Infusion (must be refrigerated-USV), Vitamin B Complex with Ascorbic Acid (Roche).
Physically Compatible Up to 24 Hours
(Do not use if precipitation occurs)
Clindamycin Phosphate, USP (Upjohn), Cyclophosphamide, USP (Mead-Johnson), Insulin, USP (Lilly).
Conditionally Compatible
(Use within one hour after mixing or may be infused directly into the same running IV line)
Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol), Erythromycin Lactobionate, USP (Abbott), Methotrexate Sodium, USP (Lederle), Penicillin G Potassium, USP (Squibb), Tetracycline Hydrochloride, USP (Lederle).
Incompatible
(Do Not Mix)
Cephalothin Sodium, USP (Lilly), Chloramphenicol Sodium, USP (Parke-Davis), Sodium Bicarbonate, USP (Abbott).
Metoclopramide Injection, USP 5 mg metoclopramide base (as the monohydrochloride monohydrate) per mL; available in:
2 mL single dose vials (NDC 23155-240-31 ) in cartons of 25 (NDC 23155-240-41),
10 mL single dose vials (NDC 23155-240-32) in cartons of 25 (NDC 23155-240-42),
30 mL single dose vials (NDC 23155-240-33) in cartons of 25 (NDC 23155-240-43).
| From Original Manufacturer/Distributor's NDC and Unit of Sale | To Henry Schein Repackaged Product NDC and Unit of Sale | Total Strength/Total Volume (Concentration) per unit |
| NDC 23155-240-41 Cartons of 25 | NDC 0404-9771-02 1 2 mL single dose vial in a bag (Vial bears NDC 23155-240-31) | 10 mg (5 mg/mL) |
Retain in carton until time of use. Do not store open single dose vials for later use, as they contain no preservative.
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
Dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation.
Metoclopramide Injection, USP should be stored at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Other brands mentioned are trademarks of their respective owners.
Dispense with Medication Guide available at: www.avetpharma.com/product
Manufactured by:
Emcure Pharmaceuticals Ltd.,
Sanand, Ahmedabad - 382110, India.
Manufactured for:
Avet Pharmaceuticals Inc.
East Brunswick, NJ 08816
1.866.901.DRUG (3784)
Avet Pharma®
Revised: 03/2026
Dispense with Medication Guide available at www.avetpharma.com/product
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 tablets, orally disintegrating tablets, oral syrup, or nasal spray), 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 injection?
Tardive Dyskinesia:
Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder.
Your chances for getting TD go up:
It is not possible for your doctor to know if you will get TD if you take metoclopramide injection.
Call your doctor right away if you get movements you cannot stop or control, such as:
Your doctor may stop treatment with metoclopramide injection if you develop signs or symptoms of TD.
See the section “What are the possible side effects of metoclopramide injection?” for more information about side effects.
What is metoclopramide injection?
Metoclopramide injection is a prescription medicine used to:
It is not known if metoclopramide injection is safe and effective in children except when used to help insert a tube into the small intestine.
Who should not receive metoclopramide injection?
Do not receive metoclopramide injection if you:
What should I tell my doctor before receiving metoclopramide injection?
Tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Metoclopramide injection and some other medicines can affect each other and may not work as well, or cause possible side effects. Do not start any new medicines while receiving metoclopramide injection until you talk with your doctor.
Especially tell your doctor if you take:
If you are not sure if your medicine is one listed above, ask your doctor or pharmacist. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How will I receive metoclopramide injection?
What should I avoid while receiving metoclopramide injection?
What are the possible side effects of metoclopramide injection?
Metoclopramide injection can cause serious side effects, including:
Call your doctor and get medical help right away if you:
Common side effects of metoclopramide injection include:
Infusion related side effects can happen if metoclopramide injection is given too fast. You may feel very anxious and restless for a short time, and then become sleepy while you are receiving a dose of metoclopramide injection. Tell your doctor or nurse right away if this happens.
You may have more side effects the longer you take metoclopramide injection and the more metoclopramide injection you take.
Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of metoclopramide injection.
Call your doctor for medical advice about side effects. You may report side effects to Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088.
General information about metoclopramide injection
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about metoclopramide injection. If you would like more information about metoclopramide injection, talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide injection that is written for healthcare professionals. For more information, call Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784).
What are the ingredients in metoclopramide injection?
Active ingredient: metoclopramide, USP
Inactive ingredients: sodium chloride, water, hydrochloric acid or sodium hydroxide
Dispense with Medication Guide available at: www.avetpharma.com/product
Manufactured by:
Emcure Pharmaceuticals Ltd.,
Sanand, Ahmedabad - 382110, India.
Manufactured for:
Avet Pharmaceuticals Inc.
East Brunswick, NJ 08816
1.866.901.DRUG (3784)
Avet Pharma®
Revised: 03/2026
This Medication Guide has been approved by the U.S. Food and Drug Administration.
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | 019999999999999921999999999999\&179999991099999 | Label1.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 86441fd8-22b8-41db-bb26-c70dffc3923b | Product name | 1 | 20210111 |
| 340a6817-217a-4b71-9e83-8e2e60c4b0c5 | Product name | 1 | 20150319 |
| 1f2c49ec-0a44-8021-ecde-b27ece080b13 | Product name | 1 | 20140508 |
| 46471181-3fa6-5fcd-1d9f-1bb9d2b06171 | Product name | 1 | 20140508 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
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| 23155-240-31 | ML - Milliliter | 23155-240 | 0760a73b-793f-4019-8c59-8c2f6223f358 | 1 | 2014-06-03 |
| 23155-240-41 | ML - Milliliter | 23155-240 | d6486bdb-89e5-4d97-8f90-c9d3bd70cff1 | 1 | 2014-06-03 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0404-9771 | 0404-9771-02 |
| 23155-240 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | W1792A2RVD | ACTIM |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-04-30 | full-release | 2026-05-31 22:18:12 |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204756-001 | METOCLOPRAMIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 |
| Application-product | TE code |
|---|---|
| A204756-001 | AP |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A204756-001 | METOCLOPRAMIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-12-20 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204756-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204756-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204756-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204756-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204756-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204756-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204756-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204756-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204756-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204756-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204756-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204756-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204756-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204756-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204756-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204756-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204756-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204756-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204756-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204756-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204756-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204756-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204756-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204756-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204756-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204756-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204756-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204756-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204756-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204756-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A204756-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A204756-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204756-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204756-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204756-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204756-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A204756-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A204756-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204756-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204756-001 | AP | 1 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| METOCLOPRAMIDE | METOCLOPRAMIDE HYDROCHLORIDE | Henry Schein, Inc. | f50c8fb4-23c4-4762-95bb-e4ca7b289a4d | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 0404-9771-02 0404-9771 00404977102 f50c8fb4-23c4-4762-95bb-e4ca7b289a4d |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 50a3cf38-66dc-4fa5-8a45-adf959c987ab | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 23155-240 |
Adverse event summaries are temporarily unavailable. Other product information remains available.