METOCLOPRAMIDE hydrochloride

METOCLOPRAMIDE HYDROCHLORIDE

Manufacturer: Lupin Pharmaceuticals,Inc.

Score: 144.0

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

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