Metoclopramide

Metoclopramide belongs to the Dopamine D2 antagonist / Serotonin 5-HT₄ Receptor Agonist acts as an Antiemetic agent.

Metoclopramide is an antiemetic agent and dopamine D2 antagonist used in the treatment of gastroesophageal reflux disease, prevention of nausea and vomiting, and to stimulate gastric emptying.

Metoclopramide is rapidly absorbed in the gastrointestinal tract with an absorption rate of about 84%. The volume of distribution of metoclopramide is approximately 3.5 L/kg. This implies a high level of tissue distribution. Metoclopramide is 30% bound to plasma proteins, mainly to alpha-1-acid glycoprotein. Metoclopramide undergoes first-pass metabolism and its metabolism varies according to the individual. This drug is metabolized by cytochrome P450 enzymes in the liver. CYP2D6 and CYP3A4 both contribute to its metabolism, with CYP2D6 being more heavily involved. CYP1A2 is also a minor contributing enzyme. The process of N-4 sulphate conjugation is a primary metabolic pathway of metoclopramide. About 85% of an orally administered dose was measured in the urine within 72 hours during a pharmacokinetic study.

Metoclopramide shows side effects like Drowsiness, excessive tiredness, weakness, headache, dizziness, diarrhea, nausea, vomiting, breast enlargement or discharge, missed menstrual period, decreased sexual ability, frequent urination, inability to control urination.

Metoclopramide is available in the form of oral tablet, Oral syrup, Injectable solution.

Metoclopramide is available in India, US, Australia, France, Italy, Canada, China, Spain, Russia, and Germany.

Metoclopramide belongs to the Antiemetic Agent acts as a Dopamine D2 antagonist / Serotonin 5-HT₄ receptors stimulator.

Metoclopramide causes antiemetic effects by inhibiting dopamine D2 and serotonin 5-HT3 receptors in the chemoreceptor trigger zone (CTZ) located in the area postrema of the brain. Administration of this drug leads to prokinetic effects via inhibitory actions on presynaptic and postsynaptic D2 receptors, agonism of serotonin 5-HT4 receptors, and antagonism of muscarinic receptor inhibition. This action enhances the release of acetylcholine, causing increased lower esophageal sphincter (LES) and gastric tone, accelerating gastric emptying and transit through the gut. Metoclopramide antagonizes the dopamine D2 receptors. Dopamine exerts relaxant effect on the gastrointestinal tract through binding to muscular D2 receptors.

The Onset of action of Metoclopramide is about 30 to 60 minutes (oral); 1 to 3 minutes (IV); 10 to 15 minutes (IM).

The Duration of action of Metoclopramide is approximately 1-2 hours, regardless of route.

Metoclopramide is available in the form of oral tablet, Oral syrup, Injectable solution.

Metoclopramide tablet and suspension is taken orally while injectable solution is given via intravenous or intramuscular route.

Metoclopramide is one of the effective anti-sickness medicines used to treat and prevent nausea and vomiting caused by cancer medicines (chemotherapy), surgery, and aid in some medical examinations involving the stomach or intestines. It is also used to treat heartburn caused by acid reflux disease when other medicines do not work well enough. In diabetic patients who have gastroparesis (poor emptying of the stomach), Metoclopramide is used to relieve symptoms of nausea, vomiting, and stomach discomfort/fullness by making a fast stomach emptying.

Metoclopramide belongs to the Dopamine D2 antagonist / Serotonin 5-HT₄ Receptor Agonist acts as an Antiemetic agent.

Metoclopramide blocks dopamine receptors and (when given in higher doses) also blocks serotonin receptors in chemoreceptor trigger zone of the CNS; enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying without stimulating gastric, biliary, or pancreatic secretions; increases lower esophageal sphincter tone.

Metoclopramide is approved for use in the following clinical indications

Adult indication

• Aspiration prophylaxis in patients undergoing anesthesia
• Bowel obstruction, malignant inoperable
• Chemotherapy-induced acute and delayed nausea or vomiting, prevention
• Dyspepsia, functional
• Gastroparesis, diabetic and nondiabetic
• Hiccups
• Medication-overuse headache or intractable migraine headache
• Migraine, severe, acute treatment
• Nausea and/or vomiting
• Radiation therapy-induced nausea and vomiting
• Tension-type headache, acute

Pediatric indication

• Chemotherapy-induced nausea and vomiting, prevention, alternative agent
• Gastroesophageal reflux, treatment
• Postoperative nausea and vomiting; prevention
• Postpyloric feeding tube placement

Adult Dose

• Aspiration prophylaxis in patients undergoing anesthesia

IV: 10 mg administered over 1 to 2 minutes as a single dose ~30 to 60 minutes prior to induction of anesthesia; usually given with nonparticulate antacid(s) (eg, oral sodium citrate, citric acid) and/or an H₂ receptor antagonist.

• Bowel obstruction, malignant inoperable

Oral, IV, Subcutaneously: 10 mg every 4 to 6 hours; if insufficient relief with intermittent dosing, may switch to an IV or Subcutaneously continuous infusion.

Continuous IV or Subcutaneously infusion (off-label): Initial: 1.25 to 1.75 mg/hour; titrate as needed and tolerated up to 5 mg/hour.

• Chemotherapy-induced acute and delayed nausea or vomiting, prevention

Low-emetic-risk IV chemotherapy

Oral: Dosing regimen based on expert opinion: 10 mg before chemotherapy or 10 mg every 6 hours as needed.

Prophylaxis of delayed emesis (high-emetic-risk chemotherapy regimen) (alternative agent) (off-label use)

Oral: 10 to 20 mg 4 times daily on post-chemotherapy days 2 through 4; given in combination with dexamethasone.

• Dyspepsia, functional

Oral: 5 to 10 mg 3 to 4 times daily administered prior to meals and at bedtime. A lower dose of 2 mg 3 times daily (using oral liquid formulation) may provide sufficient response.

• Gastroparesis, diabetic and nondiabetic

Nasal: One spray (15 mg) in one nostril 4 times daily (30 minutes prior to each meal and at bedtime) for 2 to 8 weeks depending on symptomatic response; maximum: 4 sprays (60 mg)/day.

Oral (preferred), IM, IV, Subcutaneously: 5 to 10 mg 2 to 3 times daily administered prior to meals. Titrate to the lowest effective dose; maximum: 40 mg/day in 4 divided doses. If parenteral administration is indicated, a maximum of 30 mg/day in 3 divided doses is suggested by some experts. In gastroparesis associated with anorexia nervosa, a lower oral dose of 2.5 mg administered prior to each meal and at bedtime may provide sufficient symptom relief according to some experts.

• Hiccups

IV: 5 to 10 mg every 8 hours.

Oral: 10 mg every 6 to 8 hours.

• Medication-overuse headache or intractable migraine headache

IV: Initial: 10 mg administered immediately prior to dihydroergotamine; repeat as needed every 8 hours, either prior to each intermittent dihydroergotamine dose or during continuous IV administration of dihydroergotamine. Doses of metoclopramide up to 20 mg have been used in patients experiencing severe nausea.

• Migraine, severe, acute treatment

IV (preferred), IM, Oral, Subcutaneously: 10 mg as a single dose; for migraine with severe nausea and vomiting, some experts increase the dose to 20 mg.

• Nausea and/or vomiting

IV: 10 mg or 20 mg as a single dose; avoid rapid IV administration of doses >10 mg.

Oral: 10 mg as a single dose; may repeat after 4 to 6 hours if needed.

• Radiation therapy-induced nausea and vomiting

Low-emetic-risk radiation therapy (head and neck, thorax, or pelvis):

Oral, IV: 5 to 20 mg if needed after each radiation treatment and repeated every 6 to 8 hours; depending on symptom severity and remaining duration of radiation therapy, patients can receive subsequent rescue therapy as needed or begin prophylactic therapy.

Minimal-emetic-risk radiation therapy (extremities, breast):

Oral, IV: 5 to 20 mg if needed after each radiation treatment.

• Tension-type headache, acute

IV: 10 mg as a single dose or 20 mg as a single dose; premedicate with IV diphenhydramine to prevent akathisia and other acute dystonic reactions.

Paediatric Dose

• Chemotherapy-induced nausea and vomiting, prevention, alternative agent

Children and Adolescents

IV: 0.5 to 2 mg/kg/dose prior to chemotherapy; may repeat up to 4 times daily; usual adult dose: 10 mg/dose; although more frequent dosing has been described (every 2 to 4 hours), adverse events were more common. To limit the risk of extrapyramidal symptoms, more restrictive dosing of 0.1 to 0.15 mg/kg/dose every 6 hours for up to 3 doses (maximum daily dose: 0.5 mg/kg/day).

• Gastroesophageal reflux, treatment

Infants, Children, and Adolescents

Oral: 0.1 to 0.2 mg/kg/dose every 6 to 8 hours; maximum dose: 10 mg/dose.

• Postoperative nausea and vomiting; prevention

Children and Adolescents: IV: 0.1 to 0.25 mg/kg/dose as a single dose administered after induction or on arrival to postanesthetic care unit; maximum dose: 10 mg/dose.

• Postpyloric feeding tube placement

Infants and Children <6 years: IV: 0.1 mg/kg as a single dose.

Children ≥6 years and Adolescents ≤14 years: IV: 2.5 to 5 mg as a single dose.

Adolescents ≥15 years: IV: 10 mg as a single dose.

Metoclopramide is available in various strengths as 10 mg; 5 mg; 5 mg/5 mL; 5 mg/mL; 10 mg/mL; 15 mg/actuation.

Metoclopramide is available in the form of oral tablet, Oral syrup, Injectable solution.

• Dosage Adjustment in Kidney Patient

Injection, Oral

Altered kidney function

CrCl >60 mL/minute: No dosage adjustment necessary.

CrCl >10 to 60 mL/minute: Administer ~50% of usual total daily dose.

CrCl ≤10 mL/minute: Administer ~33% (or less) of usual total daily dose.

Nasal

CrCl >60 mL/minute: No dosage adjustment necessary.

CrCl ≤60 mL/minute: Use not recommended; dose cannot be easily adjusted.

• Dosage Adjustment in Hepatic impairment Patient

IV: There are no dosage adjustments provided in the manufacturer's labeling; however, metoclopramide has been used safely in patients with advanced liver disease with normal renal function.

Nasal:

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate or severe impairment (Child-Pugh class B or C): Use not recommended; dose cannot be easily adjusted.

Oral:

Diabetic gastroparesis:

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate or severe impairment (Child-Pugh class B or C): 5 mg 4 times daily (maximum: 20 mg/day).

Metoclopramide is contraindicated in patients with

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metaclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor
  
• In patients with epilepsy. Metaclopramide may increase the frequency and severity of seizures
  
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.

• Tardive Dyskinesia

Metoclopramide 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. Movements may be choreoathetotic in appearance. 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 among the elderly, especially elderly women, and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with Metaclopramide for longer than 12 weeks and reduce the dosage in elderly patients. Discontinue Metaclopramide immediately in patients who develop signs and 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 Metaclopramide is withdrawn. Metaclopramide 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. Metaclopramide is contraindicated in patients with a history of TD. Avoid Metaclopramide in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).

• 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 Metaclopramide. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (Metaclopramide is not approved for Symptoms can occur in the first 24 to 48 hours after starting metoclopramide. Symptoms included 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 were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. Avoid Metaclopramide in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of Metaclopramide. Avoid Metaclopramide in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. Avoid treatment with Metaclopramide for more than 12 weeks, Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. If symptoms resolve, consider restarting at a lower dosage.

• 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 Metaclopramide 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: Immediate discontinuation of Metaclopramide and other drugs not essential to concurrent therapy Intensive symptomatic treatment and medical monitoring. Treatment of any concomitant serious medical problems for which specific treatments are available.

• Depression

Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid Metaclopramide use in patients with a history of depression.

• Hypertension

Metoclopramide may elevate blood pressure. In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, avoid use in patients with hypertension or in patients taking monoamine oxidase inhibitors. There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Metaclopramide is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Discontinue Metaclopramide in any patient with a rapid rise in blood pressure.

• Fluid Retention

Because Metaclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue Metaclopramide if any of these adverse reactions occur.

• Hyperprolactinemia

As with other dopamine D2 receptor antagonists, metoclopramide elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide. Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D2 receptor antagonists and tumorigenesis in humans.

Avoid consumption of alcohol, it can make the side effects of metoclopramide worse.

The presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort, and increased intestinal gas formation. Metoclopramide elevates prolactin levels however; the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Metaclopramide and any potential adverse effects on the breastfed child from Metaclopramide or from the underlying maternal condition.

Drugs which have been taken by many pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

Common Adverse effects

• Dysgeusia, Drowsiness dystonic reaction, Fatigue, lassitude, restlessness , Atrioventricular block, bradycardia, flushing, hypertension, hypotension, supraventricular tachycardia, Skin rash, urticaria, Amenorrhea, endocrine disease (elevation of aldosterone), fluid retention, hyperprolactinemia, porphyria, Change in bowel habits, diarrhea, nausea, Urinary frequency, urinary incontinence, Leukopenia, methemoglobinemia, neutropenia, Tongue edema, Confusion, dizziness, hallucination, headache, insomnia, seizure, Laryngospasm (rare), Visual disturbance, Bronchospasm, laryngeal edema.

Rare Adverse effects

• Cardiac failure, sinoatrial arrest, Gynecomastia, Agranulocytosis, sulfhemoglobinemia, Angioedema, Akathisia, depression, drug-induced extrapyramidal reaction, neuroleptic malignant syndrome, parkinsonism, suicidal ideation, tardive dyskinesia.

• Anticholinergic drugs and narcotic analgesics

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.

• Monoamine oxidase inhibitors

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.

• Insulin

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.

• With other drugs

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).

The common side effect of Metoclopramide includes the following

Common

• Drowsiness, excessive tiredness, weakness, headache, dizziness, diarrhea, nausea, vomiting, breast enlargement or discharge, missed menstrual period, decreased sexual ability, frequent urination, inability to control urination.

Rare

• Tightening of the muscles, especially in the jaw or neck, speech problems, depression, fever, muscle stiffness, confusion, fast, slow, or irregular heartbeat, sweating, restlessness, nervousness or jitteriness, agitation, difficulty falling asleep or staying asleep, pacing, foot tapping, slow or stiff movements, blank facial expression, uncontrollable shaking of a part of the body, difficulty keeping your balance, rash, hives, swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs, sudden weight gain, difficulty breathing or swallowing, high-pitched sounds while breathing, vision problems.

• Pregnancy

Pregnancy Category B

Retrospective cohort studies, national registry studies, and meta-analysis, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

• Nursing Mothers

The presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation. Metoclopramide elevates prolactin levels however, the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Metaclopramide and any potential adverse effects on the breastfed child from Metaclopramide or from the underlying maternal condition.

• Pediatric Use

Metaclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of Metaclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults. In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates.

• Geriatric Use

Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function, Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of Metaclopramide in elderly patients.

Symptoms: Extrapyramidal disorders, drowsiness, headache, vertigo, restlessness, weakness decreased level of consciousness, anxiety, confusion, hallucination, nausea, vomiting, xerostomia, constipation, hypotension and cardio-respiratory arrest. Rarely, AV block. Methemoglobinemia and generalized seizures may also occur in premature and full-term neonates.

Management: Symptomatic and supportive treatment. Extrapyramidal reactions may be controlled by administration of anticholinergic agents (e.g. diphenhydramine, benztropine). Administer IV methylene blue in cases of methaemoglobinaemia however, the use of methylene blue in patients with G6PD deficiency is not recommended due to an increased risk of hemolytic anaemia which may be fatal. Monitor CV and respiratory functions.

Pharmacodynamic

Metoclopramide increases gastric emptying by decreasing lower esophageal sphincter (LES) pressure. It also exerts effects on the area postrema of the brain, preventing and relieving the symptoms of nausea and vomiting. In addition, this drug increases gastrointestinal motility without increasing biliary, gastric, or pancreatic secretions.

Pharmacokinetics

• Absorption

Metoclopramide is rapidly absorbed in the gastrointestinal tract with an absorption rate of about 84%

• Distribution

The volume of distribution of metoclopramide is approximately 3.5 L/kg. This implies a high level of tissue distribution. Metoclopramide is 30% bound to plasma proteins, mainly to alpha-1-acid glycoprotein.

• Metabolism and Excretion

Metoclopramide undergoes first-pass metabolism and its metabolism varies according to the individual. This drug is metabolized by cytochrome P450 enzymes in the liver. CYP2D6 and CYP3A4 both contribute to its metabolism, with CYP2D6 being more heavily involved. CYP1A2 is also a minor contributing enzyme. The process of N-4 sulphate conjugation is a primary metabolic pathway of metoclopramide. About 85% of an orally administered dose was measured in the urine within 72 hours during a pharmacokinetic study.

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