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Metoclopramide


Pronunciation

 (met oh kloe PRA mide)


U.S. Brand Names

 Reglan®


Generic Available

 Yes


Canadian Brand Names

 Apo-Metoclop®; Nu-Metoclopramide


Use

 Symptomatic treatment of diabetic gastric stasis; gastroesophageal reflux


Use - Unlabeled/Investigational

 Post-pyloric placement of enteral feeding tubes; prevention and/or treatment of nausea and vomiting associated with chemotherapy, radiation therapy, or postsurgery


Pregnancy Risk Factor

 B


Pregnancy Implications

 Crosses the placenta; available evidence suggests safe use during pregnancy.


Lactation

 Enters breast milk/not recommended (AAP rates "of concern")


Contraindications

 Hypersensitivity to metoclopramide or any component of the formulation; GI obstruction, perforation or hemorrhage; pheochromocytoma; history of seizures


Warnings/Precautions

 Use with caution in patients with Parkinson's disease and in patients with a history of mental illness; has been associated with extrapyramidal symptoms and depression. The frequency of EPS is higher in pediatric patients and adults <30 years of age; risk is increased at higher dosages. Extrapyramidal reactions typically occur within the initial 24-48 hours of treatment. Use caution with concurrent use of other drugs associated with EPS. Neuroleptic malignant syndrome (NMS) has been reported (rarely) with metoclopramide. Use lowest recommended doses initially; may cause transient increase in serum aldosterone; use caution in patients who are at risk of fluid overload (CHF, cirrhosis). Use caution in patients with hypertension or following surgical anastomosis/closure. Patients with NADH-cytochrome b5 reductase deficiency are at increased risk of methemoglobinemia and/or sulfhemoglobinemia. Use caution in patients with a history of seizures; risk of metoclopramide-associated seizures is increased. Abrupt discontinuation may (rarely) result in withdrawal symptoms (dizziness, headache, nervousness). Use caution and adjust dose in renal impairment.


Adverse Reactions

 Adverse reactions are more common/severe at dosages used for prophylaxis of chemotherapy-induced emesis.

>10%:

Central nervous system: Restlessness, drowsiness, extrapyramidal symptoms (high-dose, up to 34%; 0.2% at doses of 30-40 mg/day)

Gastrointestinal: Diarrhea (may be dose-limiting)

Neuromuscular & skeletal: Weakness

1% to 10%:

Central nervous system: Insomnia, depression, confusion, headache

Dermatologic: Rash

Endocrine & metabolic: Breast tenderness, prolactin stimulation

Gastrointestinal: Nausea, xerostomia

<1%: Agitation, agranulocytosis, allergic reaction, amenorrhea, angioedema, anxiety, AV block, bradycardia, bronchospasm, CHF, constipation, fatigue, fluid retention, galactorrhea, gynecomastia, hepatotoxicity, hyper-/hypotension, hyperprolactinemia, jaundice, laryngeal edema, methemoglobinemia, neuroleptic malignant syndrome (NMS), neutropenia, porphyria, seizure, suicidal ideation, sulfhemoglobinemia, tachycardia, tardive dyskinesia, urticaria


Overdosage/Toxicology

 Symptoms of overdose include drowsiness, ataxia, extrapyramidal symptoms, seizures, methemoglobinemia (in infants). Disorientation, muscle hypertonia, irritability, and agitation are common. Metoclopramide often causes extrapyramidal symptoms (eg, dystonic reactions) requiring management with diphenhydramine 1-2 mg/kg (adults) up to a maximum of 50-100 mg I.M. or I.V. slow push followed by a maintenance dose (25-50 mg orally every 4-6 hours) for 48-72 hours. When these reactions are unresponsive to diphenhydramine, benztropine mesylate I.V. 1-2 mg (adults) may be effective. These agents are generally effective within 2-5 minutes. Methylene blue is not recommended in patients with G6PD deficiency who experience methemoglobinemia due to metoclopramide.


Drug Interactions

 Substrate (minor) of CYP1A2, 2D6; Inhibits CYP2D6 (weak)

Anticholinergic agents antagonize metoclopramide's actions

Antipsychotic agents: Metoclopramide may increase extrapyramidal symptoms (EPS) or risk when used concurrently.

Opiate analgesics may increase CNS depression


Ethanol/Nutrition/Herb Interactions

 Ethanol: Avoid ethanol (may increase CNS depression).


Stability

Injection: Store intact vial at controlled room temperature; injection is photosensitive and should be protected from light during storage; parenteral admixtures in D5W or NS are stable for at least 24 hours, and do not require light protection if used within 24 hours.

Tablet: Store at controlled room temperature; protect from freezing


Compatibility

 Stable in D5 1 /2NS, D5W, mannitol 20%, LR, NS; variable stability (consult detailed reference) in TPN

Y-site administration: Compatible: Acyclovir, aldesleukin, amifostine, aztreonam, bleomycin, ciprofloxacin, cisatracurium, cisplatin, cladribine, clarithromycin, cyclophosphamide, cytarabine, diltiazem, docetaxel, doxorubicin, droperidol, etoposide phosphate, famotidine, filgrastim, fluconazole, fludarabine, fluorouracil, foscarnet, gatifloxacin, gemcitabine, granisetron, heparin, idarubicin, leucovorin, levofloxacin, linezolid, melphalan, meperidine, meropenem, methotrexate, mitomycin, morphine, ondansetron, paclitaxel, piperacillin/tazobactam, remifentanil, sargramostim, sufentanil, tacrolimus, teniposide, thiotepa, topotecan, vinblastine, vincristine, vinorelbine, zidovudine. Incompatible: Allopurinol, amphotericin B cholesteryl sulfate complex, amsacrine, cefepime, doxorubicin liposome, furosemide, propofol. Variable (consult detailed reference): TPN

Compatibility in syringe: Compatible: Aminophylline, ascorbic acid injection, atropine, benztropine, bleomycin, butorphanol, chlorpromazine, cisplatin, cyclophosphamide, cytarabine, dexamethasone sodium phosphate, diamorphine, dimenhydrinate, diphenhydramine, doxorubicin, droperidol, fentanyl, fluorouracil, heparin, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydroxyzine, insulin (regular), leucovorin, lidocaine, magnesium sulfate, meperidine, methotrimeprazine, methylprednisolone sodium succinate, midazolam, mitomycin, morphine, ondansetron, pentazocine, perphenazine, prochlorperazine edisylate, promazine, promethazine, ranitidine, scopolamine, sufentanil, vinblastine, vincristine, vitamin B complex with C. Incompatible: Ampicillin, calcium gluconate, chloramphenicol, furosemide, penicillin G potassium, sodium bicarbonate. Variable (consult detailed reference): Methotrexate

Compatibility when admixed: Compatible: Cimetidine, clindamycin, diamorphine, meperidine, meropenem, morphine, multivitamins, potassium acetate, potassium chloride, potassium phosphate, verapamil. Incompatible: Dexamethasone sodium phosphate with lorazepam and diphenhydramine, erythromycin lactobionate, floxacillin, fluorouracil, furosemide


Mechanism of Action

 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


Pharmacodynamics/Kinetics

Onset of action: Oral: 0.5-1 hour; I.V.: 1-3 minutes

Duration: Therapeutic: 1-2 hours, regardless of route

Distribution: Vd: 2-4 L/kg; Crosses placenta; enters breast milk

Protein binding: 30% to 40%, primarily to 1-acid glycoprotein

Bioavailability: 80%

Half-life elimination: Normal renal function: 4-7 hours (may be dose dependent)

Time to peak, serum: Oral: 1-3 hours; I.M.: 2-3 hours; I.V.: Within 5 minutes; Rectal: 1-8 hours

Excretion: Urine (70% to 85%, ~19% as unchanged drug); feces (2% to 3%)


Dosage

Children:

Gastroesophageal reflux: Oral: 0.1-0.2 mg/kg/dose up to 4 times/day; efficacy of continuing metoclopramide beyond 12 weeks in reflux has not been determined; total daily dose should not exceed 0.5 mg/kg/day

Gastrointestinal hypomotility (gastroparesis): Oral, I.M., I.V.: 0.1 mg/kg/dose up to 4 times/day, not to exceed 0.5 mg/kg/day

Antiemetic (chemotherapy-induced emesis) (unlabeled): I.V.: 1-2 mg/kg 30 minutes before chemotherapy and every 2-4 hours, for a total of 5 doses (5-10 mg/kg) daily

Post-pyloric feeding tube placement (unlabeled): I.V.:

<6 years: 0.1 mg/kg

6-14 years: 2.5-5 mg

Adults:

Gastroesophageal reflux: Oral: 10-15 mg/dose up to 4 times/day 30 minutes before meals or food and at bedtime; single doses of 20 mg are occasionally needed for provoking situations

Gastrointestinal hypomotility (gastroparesis):

Oral: 10 mg 30 minutes before each meal and at bedtime for 2-8 weeks

I.V. (for severe symptoms): 10 mg over 1-2 minutes; 10 days of I.V. therapy may be necessary for best response

Antiemetic (chemotherapy-induced emesis) (unlabeled): I.V.: 1-2 mg/kg 30 minutes before chemotherapy and every 2-4 hours, for a total of 5 doses (5-10 mg/kg) daily

Postoperative nausea and vomiting (unlabeled): I.M., I.V.: 10 mg near end of surgery; 20 mg doses may be used

Post-pyloric feeding tube placement (unlabeled): I.M., I.V.: 10 mg

Elderly:

Gastroesophageal reflux: Oral: 5 mg 4 times/day (30 minutes before meals and at bedtime); increase dose to 10 mg 4 times/day if no response at lower dose

Gastrointestinal hypomotility:

Oral: Initial: 5 mg 30 minutes before meals and at bedtime for 2-8 weeks; increase if necessary to 10 mg doses

I.V.: Initiate at 5 mg over 1-2 minutes; increase to 10 mg if necessary

Postoperative nausea and vomiting (unlabeled): I.M.: 5 mg near end of surgery; may repeat dose if necessary

Dosing adjustment in renal impairment:

Clcr 10-40 mL/minute: Administer at 50% of normal dose

Clcr<10 mL/minute: Administer at 25% of normal dose

Hemodialysis: Not dialyzable (0% to 5%); supplemental dose is not necessary


Administration

 Injection solution may be given I.M., direct I.V. push, short infusion (15-30 minutes), or continuous infusion; lower doses ( 10 mg) of metoclopramide can be given I.V. push undiluted over 1-2 minutes; higher doses to be given IVPB over at least 15 minutes; continuous SubQ infusion and rectal administration have been reported. Note: Rapid I.V. administration may be associated with a transient (but intense) feeling of anxiety and restlessness, followed by drowsiness.


Monitoring Parameters

 Periodic renal function test; monitor for dystonic reactions; monitor for signs of hypoglycemia in patients using insulin and those being treated for gastroparesis; monitor for agitation and irritable confusion


Test Interactions

 Increased aminotransferase [ALT (SGPT)/AST (SGOT)] (S), increased amylase (S)


Patient Education

 Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Oral: Take this drug as prescribed, 30 minutes prior to eating. Do not increase dosage. Avoid alcohol. May cause dizziness, drowsiness, or blurred vision (use caution when driving or engaging in tasks that require alertness until response to drug is known); cause restlessness, anxiety, depression, or insomnia (will reverse when medication is discontinued). Report any CNS changes, spasticity or involuntary movements, unresolved diarrhea. Breast-feeding precaution: Breast-feeding is not recommended.


Anesthesia and Critical Care Concerns/Other Considerations

 To prevent extrapyramidal symptoms associated with antiemetic dosages, patients may be pretreated with diphenhydramine.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 Drowsiness and restlessness are common; may cause insomnia or depression. Depression has occurred in patients with and without a prior history of depression. Symptoms have ranged from mild to severe, and have included suicidal ideation and suicide. Metoclopramide is a D2 blocker; may cause extrapyramidal symptoms especially when used in high dosages (dystonia) or in the elderly (tardive dyskinesia). Dystonic reactions occur in approximately 1 in 500 patients with the usual adult dosage of 30-40 mg/day. These reactions are usually seen during the first 1-2 days of therapy with metoclopramide, occurring more frequently in pediatric patients and adults <30 years of age, and are more frequent when higher doses are used in prophylaxis of vomiting due to cancer chemotherapy. NMS has rarely been reported.


Mental Health: Effects on Psychiatric Treatment

 Anticholinergics may antagonize metoclopramide's effects; concurrent use with psychotropic may produce additive sedation


Oncology: Emetic Potential

 Very low (<10%)


Oncology: Vesicant

 No


Dosage Forms

Injection, solution, as hydrochloride (Reglan®): 5 mg/mL (2 mL, 10 mL, 30 mL)

Syrup, as hydrochloride: 5 mg/5 mL (10 mL, 480 mL) [some products contain sodium benzoate; sugar free]

Tablet, as hydrochloride (Reglan®): 5 mg, 10 mg


Extemporaneously Prepared

Metoclophen nausea suppository:

Metoclopramide powder (USP) 40 mg

Haloperidol powder (USP) 1 mg

Dexamethasone powder (USP) 10 mg

Diphenhydramine HCl (USP) 25 mg

Benztropine mesylate (USP) 1 mg

Silica gel powder 200 mg

Fatty base (emulsifying type) qs 2.2 g

Metoclophen-modified nausea suppository:

Metoclopramide powder (USP) 40 mg

Haloperidol powder (USP) 1 mg

Lorazepam (USP) 1 mg

Benztropine mesylate (USP) 1 mg

Fatty base (emulsifying type) qs 2.2 g

Grind all powders (and/or tablets) into a fine uniform powder. Melt the fatty base on low temperature, then add the powder. Stir the mixture until uniform. With continuous stirring, draw up part of the mixture and instill into calibrated suppository molds. Refrigerate.

Francom M, "Compounding Nausea Aid," Am Pharm , 1991, NS31(7):7.


References

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics , 2001, 108(3):776-89.

DiPalma JR, "Metoclopramide: A Dopamine Receptor Antagonist," Am Fam Physician , 1990, 41(3):919-24.

Harrington RA, Hamilton CW, Brogden RN, et al, "Metoclopramide. An Updated Review of Its Pharmacological Properties and Clinical Use," Drugs , 1983, 25(5):451-94.

Karadsheh NS, Shaker Q, and Ratroat B, "Metoclopramide-induced Methemoglobinemia in a Patient With Co-Existing Deficiency of Glucose-6-Phosphate Dehydrogenase and NADH-Cytochrome b5 Reductase: Failure of Methylene Blue Treatment," Haematologica , 2001, 86(6):659-60.

Mary AM and Bhupalam L, "Metoclopramide-induced Methemoglobinemia in an Adult," J Ky Med Assoc , 2000, 98(6):245-7.

Parrish RH and Bonzo SM, "Use of Metoclopramide Suppositories," Clin Pharm , 1983, 2:395-6.

Patterson JF, "Neuroleptic Malignant Syndrome Associated With Metoclopramide," South Med J , 1988, 81(5):674-5.

Schulze-Delrieu K, "Drug Therapy. Metoclopramide," N Engl J Med , 1981, 305(1):28-33.

Van Veldhuizen PJ and Wyatt A, "Metoclopramide-induced Sulfhemoglobinemia," Am J Gastroenterol , 1995, 90(6):1010-1.


International Brand Names

 Acumet® (ZA); Afipran® (NO); Anausin Métoclopramide® (FR); Antimet® (IE); Apo-Metoclop® (CA); Bondigest® (CO); Carnotprim® (MX); Cerucal® (CZ, DE, HU, RO, RU); Cerucal® [inj.] (RO); Chlorhydrate de Métoclopramide Renaudin® (FR); Citroplus® (IT); Clopamon® [inj.] (ZA); Clopamon® (ZA); Clopan® (EC, IT); Cloperan® (CY); Clopram® (BG, JO, KW, LB, MA, MY, SY); Clopramida® (PA); Cloridrato de Metoclopramida® (BR); Clorimet® (MX); Damaben® (ID); Degan® (SI); Dibertil® (BE, LU); Docmetoclo® (BE); Elieten® (JP); Elitan® (VN); Emetal® (TH); Emetic® (BR); Emetisan® (AR); Emperal® (DK, EG, HK, JO, KW, LB); Enzimar® (CO); Eucil® (BR); Fonderyl® (AR); Gastrobid® (BG); Gastrobid Continus® (GB, IE, RO); Gastroflux® (GB); Gastromax® (GB); Gastronerton® (DE, EG, LU); Gastronerton Milinda® (DE); Gastrosil® (AT, CH, DE, HK, LU, PL); Gastrotem® (RO); Gastro-Timelets® (AT, DK, LU, RO); Gastrotranquil® (DE); Gavistal® (ID); Gensil® (TH); Hawkperan® (TH); Hemibe® (CL); H-Peran® (TH); Hyrin® (DE); Imperan® (AR); Itan® (CL); Klometol® (YU); Lizarona® (AR); Maloxon® (HK); Maril® (SG, TH); Maxocol® (BD); Maxolon® (AU, GB, HK, IE, KW, NZ, ZA); Maxolon SR® (GB, IE); MCP 1A Pharma® (DE); MCP AL® (DE); MCP-beta® (DE); MCP Heumann® (DE); MCP Hexal® (CZ, DE); MCP-Isis® (DE); MCP-ratiopharm® (DE, LU); MCP Sandoz® (DE); MCP Stada® (DE); MCP von ct® (DE); Meclamide® (IL); Meclid® (BD); Meclomid® (BD, MX); Mepramid® (ID); Meramide® (TH); Merck-Metoclopramide® (ZA); Metagliz® (EG, ES); Metalon® (ZA); Metamide® (NZ); Methoclopramide Injection® (AU); Metoc® (AR); Metoclamid® (LU); Metoclan® (PT); Metoclopramida® (CL, CO); Metoclopramida Clorhidrato® (CL); Metoclopramida Drawer® (AR); Metoclopramida Fada® (AR); Metoclopramida Larjan® (AR); Metoclopramida L.CH.® (CL); Metoclopramida Martian® (AR); Metoclopramida Richmond® (AR); Metoclopramida Vannier® (AR); Metoclopramide Alpharma ApS® (SG); Metoclopramide® (AU, GB, NZ, RU); Metoclopramide cloridrato® (IT); Metoclopramide Dexa Medica® (ID); Metoclopramide EG® (BE); Metoclopramide-Eurogenerics® (LU); Metoclopramide Injection BP® (AU); Metoclopramid PB® (DE); Metoclopramid® (PL, RO, RU); Metoclopramidum® (PL); Metoclor® (TH); Metocol® (BD); Metocyl® (CY, EG, HK, IE, JO, KW, LB, MT); Metogastron® (AT); Metoklamide® (TR); Metolon® (ID, SG); Metopram® (FI); Metopran® (HR); Metoril® (CR, GT, HN, PA, SV); Met-Sil® (TH); Midatenk® (AR); Monocloridrato de Metoclopramida® (BR); Motilon® (BD); Movistal® (BE, LU); Nausil® (TH); Netaf® (AR); Nilatika® (ID); N-Metoclopramid® (RO); Nofoklam® (ID); Normastin® (ID); Novomit® (AR); No-Vomit® (BR); Nu-Metoclopramide (CA); Nutramid® (BD); Obteran® (ID); Opram® (ID); Paspertin® (AT, BG, CH, CZ, DE, HU); Peraprin® (JP); Perinorm® (IN, RU, ZA); Piralen® (ID); Plamin® (BR); Plasil® (BR, CO, IT, MX, TH); Pramidin® (IT, PL); Pramiel® (JP); Praminal® (ID); Pramin® (AU, IL); Praux® (AR); Premosan® (RO); Primavera-N® (AR); Primperan® (BE, CH, CO, CR, CZ, DK, DO, EC, ES, FI); Primpéran® (FR); Primperan® (GB, GT, HK, HN, ID, IE, LU, NL, NO, PA, SE, SG, SV, TR, ZA); Primpéran® [rect.] (FR); Primperil® (AR); Prinparl® (JP); Prokinyl® (LU, MC); Raclonid® (ID); Reglan® (HR, IN, RU, SI, YU); Reguloop® (ID); Reliveran® (AR); Rolab-Metoclopramide® (ZA); Rupemet® (AR); Setin® (ZA); Sintegran® (AR); Sintozima® (BR); Sotatic® (ID); Terperan® (JP); Tomit® (ID); Vertivom® (ID); Vilapon® (ID); Vomiles® (ID); Vomipram® (ID); Vomitol® (ID); Vomitrol® (ID); Vopax® (BR); Zumatrol® (ID)


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