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Metoclopramide

METOCLOPRAMIDE HYDROCHLORIDE

Manufacturer: Fresenius Kabi USA, LLC

Score: 141.0

Quick Summary

Metoclopramide hydrochloride is a dopamine-2 (D2) antagonist used for the treatment of symptomatic, documented gastroesophageal reflux disease (GERD) and relief of symptoms associated with acute and recurrent diabetic gastroparesis. The drug has a boxed warning for tardive dyskinesia, a serious movement disorder that is often irreversible. Metoclopramide is contraindicated in patients with a history of tardive dyskinesia, epilepsy, and hypersensitivity to the drug. The recommended dosage for GERD is 10-15 mg four times daily for 4-12 weeks, and for diabetic gastroparesis, it is 10 mg four times daily for 2-8 weeks. Special population considerations include reduced dosages for elderly patients, patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.

Key Clinical Findings and Indications

  • Treatment of symptomatic, documented gastroesophageal reflux disease (GERD)
  • Relief of symptoms associated with acute and recurrent diabetic gastroparesis
  • Increased risk of tardive dyskinesia with long-term use

Important Safety Information

Warning

Tardive dyskinesia, a serious movement disorder that is often irreversible

Contraindications

  • History of tardive dyskinesia
  • Epilepsy
  • Hypersensitivity to metoclopramide
  • Pheochromocytoma or other catecholamine-releasing paragangliomas

Adverse Reactions

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

Dosing Recommendations

General Guidance

Reduced dosages for elderly patients, patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers

GERD

Adult Dose

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

Pediatric Dose

Not recommended

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
  • Potential risks to the neonate following exposure in utero to metoclopramide during delivery

Nursing Mothers

  • Not recommended due to potential risks to the infant

Pediatric Use

  • Not recommended due to risk of tardive dyskinesia and other extrapyramidal symptoms

Geriatric Use

  • Reduced dosages recommended due to increased risk of adverse reactions
  • Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide