Metoclopramide Hydrochloride — Active Pharmaceutical Ingredient

Metoclopramide Hydrochloride is an active pharmaceutical ingredient found in 11 FDA-approved drug products. Forms: SOLUTION, TABLET, INJECTABLE, TABLET, ORALLY DISINTEGRATING, SPRAY, METERED. Routes: ORAL, INJECTION, NASAL.

This content is for informational purposes only. Always consult a healthcare professional.

Metoclopramide Hydrochloride (11 brand names, 6 dosage forms, 3 routes)

Available dosage forms: SOLUTION, TABLET, INJECTABLE, TABLET, ORALLY DISINTEGRATING, SPRAY, METERED, CONCENTRATE.

Routes of administration: ORAL, INJECTION, NASAL.

Brand Names

  • CLOPRA
  • CLOPRA-“YELLOW”
  • GIMOTI
  • MAXOLON
  • METOCLOPRAMIDE
  • METOCLOPRAMIDE HCL
  • METOCLOPRAMIDE HYDROCHLORIDE
  • METOCLOPRAMIDE INTENSOL
  • METOZOLV ODT
  • REGLAN
  • REGLAN ODT

Boxed Warning

Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including metoclopramide injection, the risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dosage. Metoclopramide injection, is contraindicated in patients with a history of TD. Immediately discontinue metoclopramide injection in patients who develop signs or symptoms of TD. In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including metoclopramide injection, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. See WARNINGS.

Contraindications

Metoclopramide injection is contraindicated: in patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. See WARNINGS . whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. in patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor. in patients with known sensitivity or intolerance to metoclopramide. in patients with epilepsy. Metoclopramide injection may increase the frequency and severity of seizures.

Adverse Reactions

In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency.

Overdosage

Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS (see WARNINGS ). There are no specific antidotes for metoclopramide injection overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal. Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.