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Metoclopramide

METOCLOPRAMIDE

Manufacturer: ANI Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

Metoclopramide is used to treat symptomatic gastroesophageal reflux and acute and recurrent diabetic gastroparesis. It works by stimulating motility of the upper gastrointestinal tract and increasing the tone of the lower esophageal sphincter. The recommended adult dosage is 10-15 mg four times daily for 4-12 weeks for gastroesophageal reflux and 10 mg four times daily for 2-8 weeks for diabetic gastroparesis. However, treatment should not exceed 12 weeks due to the risk of developing tardive dyskinesia. Metoclopramide is contraindicated in patients with a history of tardive dyskinesia, epilepsy, and hypersensitivity to the drug. Special considerations are needed for pediatric, geriatric, and pregnant patients, as well as those with renal or hepatic impairment.

Key Clinical Findings and Indications

  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis

Important Safety Information

Warning

Metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible

Contraindications

  • History of tardive dyskinesia or dystonic reaction to metoclopramide
  • When stimulation of gastrointestinal motility might be dangerous
  • Pheochromocytoma or other catecholamine-releasing paragangliomas
  • Epilepsy
  • Hypersensitivity to metoclopramide

Adverse Reactions

  • Tardive dyskinesia
  • Other extrapyramidal effects
  • Neuroleptic malignant syndrome
  • Depression
  • Hypertension
  • Fluid retention
  • Hyperprolactinemia

Dosing Recommendations

General Guidance

Dosage reductions are recommended for elderly patients, patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers

Gastroesophageal reflux

Adult Dose

10-15 mg four times daily for 4-12 weeks

Pediatric Dose

Not recommended

Acute and recurrent diabetic gastroparesis

Adult Dose

10 mg four times daily for 2-8 weeks

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

  • Published studies do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy
  • Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates

Nursing Mothers

Pediatric Use

  • Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia and other extrapyramidal symptoms
  • Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults

Geriatric Use

  • Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide
  • Consider a reduced dosage of metoclopramide in elderly patients