Metoclopramide

Metoclopramide is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing.

Metoclopramide is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines.

Metoclopramide is not recommended for use in children younger than 1 year due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.

Metoclopramide may also be used to prevent nausea/vomiting from chemotherapy or radiation treatments for cancer.

Metoclopramide is available under the following different brand names: Reglan, and Metozolv ODT.

Dosage Forms and Strengths

Injectable solution

• 5 mg/mL

Syrup

• 5 mg /5 mL

Tablet

• 5 mg
• 10 mg

Dispersible tablets

• 5 mg
• 10 mg

Dosage Considerations – Should be Given as Follows:

Chemotherapy-Induced Nausea and Vomiting

Adult

• 2 mg/kg intravenously (IV) (infused over at least 15 minutes) 30 minutes before chemotherapy, then repeated 2 more times every 2 hours (after initial dose)
• Vomiting suppressed: Decrease to 1 mg/kg IV every 3 hours for 3 doses
• Vomiting not suppressed: Continue same dose every 3 hours for 3 doses

Pediatric

• 1-2 mg/kg intravenously (IV) (infused over at least 15 minutes) 30 minutes before chemotherapy; repeat every 2-4 hours; pretreatment with diphenhydramine decreases risk of extrapyramidal adverse effects

Diabetic Gastroparesis

• Adult: 10 mg intravenously/intramuscularly/orally every 6 hours 30 minutes before meals and at bedtime; use injectable dosing only if severe symptoms are present
• Children under 6 years old: 0.1 mg/kg orally every 8 hours; not to exceed 0.1 mg/kg
• Children 6 years and older: 0.5 mg/kg/day orally divided every 8 hours

Small Bowel Intubation/Radiologic Examination of Upper GI Tract

• Adult: 10 mg intravenously (IV) over 1-2 minutes
• Children under 6 years old: 0.1 mg/kg IV over 1-2 minutes
• Children 6-14 years old: 2.5-5 mg IV over 1-2 minutes
• Children 14 years and older: 10 mg IV over 1-2 minutes

Gastroesophageal Reflux Disease (GERD)

• Adult: 10-15 mg orally every 6 hours 30 minutes before meals and at bedtime; not to exceed 80 mg/day
• Neonate: 0.15 mg/kg intravenously (IV) every 6 hours
• Infant: 0.1 mg/kg IV/IM/orally every 6-8 hours 30 minutes before meals and at bedtime
• Not to exceed 0.3-0.75 mg/kg/day

Postoperative Nausea & Vomiting (Off-label)

• Adult: 10-20 mg intramuscularly (IM) administered near end of procedure; may be repeated postoperatively every 4-6 hours as needed
• Pediatric: 0.1-2 mg/kg intravenously (IV) every 6-8 hours as needed

Dosing Modifications

• Renal impairment: CrCl less than 40 mL/min, decrease dose by 50%; CrCl less than 10 mL/min, decrease dose by 75%

Common side effects of metoclopramide include:

• Extrapyramidal symptoms (muscle spasms, restlessness, muscle rigidity, slowness of movement, tremor, and jerky movements)
• Fatigue
• Restlessness
• Sedation
• Headache
• Dizziness
• Drowsiness
• Decreased energy
• Tiredness
• Diarrhea
• Nausea
• Vomiting
• Feeling unwell (malaise)
• Trouble sleeping (insomnia)
• Breast tenderness or swelling
• Changes in your menstrual periods
• Urinating more than usual

Other side effects of metoclopramide include:

• Diarrhea
• Nausea
• Milky nipple discharge unrelated to breastfeeding
• Breast tissue enlargement in males
• Impotence
• Menstrual disorders
• Neuroleptic malignant syndrome
• Blood abnormalities

Serious side effects of metoclopramide include:

• Unusual muscle movements (tardive dyskinesia)
• Muscle stiffness
• Depression
• Agitation
• Difficulty breathing

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

• Severe Interactions of metoclopramide include:
  • lurasidone
• Metoclopramide has serious interactions with at least 21 different drugs.
• Metoclopramide has moderate interactions with at least 39 different drugs.
• Mild interactions of metoclopramide include:
  • acetaminophen
  • acetaminophen IV
  • acetaminophen rectal
  • atovaquone
  • ethanol
  • fosfomycin
  • meperidine
  • nitrofurantoin

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• May cause tardive dyskinesia (often irreversible).
• Risk of developing tardive dyskinesia increases with treatment duration and total cumulative dose.
• Discontinue with signs or symptoms of tardive dyskinesia.
• No known treatment exists for tardive dyskinesia.
• Symptoms may lessen or resolve after metoclopramide treatment is stopped.
• Do not administer for longer than 12 weeks, except in rare cases where therapeutic benefit is thought to outweigh risk of tardive dyskinesia.
• This medication contains metoclopramide.
• Do not take Reglan or Metozolv ODT if you are allergic to metoclopramide or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to metoclopramide or procainamide
• Gastrointestinal (GI) hemorrhage, mechanical obstruction, perforation, history of seizures, pheochromocytoma
• Other drugs causing extrapyramidal symptoms (e.g., phenothiazines, butyrophenones)

Effects of Drug Abuse

No information available

Short-Term Effects

• Pseudoparkisonism (e.g., tremor, rigidity) may occur within 6 months of therapy; reversible within 2-3 months of discontinuing therapy.
• See "What Are Side Effects Associated with Using Metoclopramide?"

Long-Term Effects

• May cause tardive dyskinesia (often irreversible). Risk of developing tardive dyskinesia increases with treatment duration and total cumulative dose. Do not administer for longer than 12 weeks, except in rare cases where therapeutic benefit is thought to outweigh risk of tardive dyskinesia.
• See "What Are Side Effects Associated with Using Metoclopramide?"

Cautions

• Mental depression reported; use with caution in patients with history of mental illness.
• Use with caution or avoid in Parkinson's disease patients; may have increased risk of extrapyramidal symptoms.
• Use with caution after gastrointestinal (GI) anastomosis or closure; promotility agents reported to increase pressure in suture lines.
• Use caution in patients with hypertension, congestive heart failure, renal impairment, cirrhosis.
• Use caution in patients who are at risk of fluid overload.
• Can cause tardive dyskinesia (see Warnings), especially in elderly; discontinue if signs or symptoms of tardive dyskinesia develop (metoclopramide itself may completely or partially suppress these manifestations); tardive dyskinesia may persist even after drug is discontinued.
• Diphenhydramine 50 mg intramuscularly (IM) can be given for extrapyramidal symptoms.
• Pseudoparkisonism (e.g., tremor, rigidity) may occur within 6 months of therapy; reversible within 2-3 months of discontinuing therapy.
• Metoclopramide intravenous (IV) administration associated with catecholamine release; use caution in patients with hypertension.
• Hypertensive crisis reported in patients with undiagnosed pheochromocytoma; discontinue therapy immediately with any sudden increase in blood pressure during therapy.
• May cause QT prolongation and torsades de pointes in some patients with heart failure patients that also have renal impairment; data on healthy males have failed to show similar effects; implications unclear; use caution in cardiovascular disease.

Pregnancy and Lactation

• Metoclopramide may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk. No association was observed between exposure to metoclopramide during pregnancy and an increased risk of birth defects, spontaneous abortion, or stillbirth, according to results of a large, register-based study [JAMA 2013 310(15)]. Other studies have also shown no association with first trimester use and major congenital malformations [N Engl J Med 2009 360(24)].
• Metoclopramide crosses into breast milk; use caution if breastfeeding. Concern may be warranted according to the American Academy of Pediatrics.