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Reglan (Metoclopramide Hydrochloride)

Hikma · FDA-approved approved Small molecule Verified Quality 77/100

Metoclopramide stimulates upper GI tract motility by sensitizing tissues to acetylcholine action.

Metoclopramide is a prokinetic agent indicated for short-term treatment of gastroesophageal reflux and diabetic gastroparesis in adults who fail conventional therapy. The drug carries significant black box risks including tardive dyskinesia, extrapyramidal symptoms, and neuroleptic malignant syndrome, particularly with prolonged use and in combination with antipsychotics. It is contraindicated in patients with prior TD, dystonic reactions, pheochromocytoma, epilepsy, and conditions where GI stimulation is dangerous. Use requires careful patient selection, dose adjustment in renal/hepatic impairment, and avoidance of interacting medications, particularly CYP2D6 inhibitors and MAOIs.

At a glance

Generic nameMetoclopramide Hydrochloride
SponsorHikma
Drug classProkinetic agent
TargetAcetylcholine receptor sensitization; dopamine antagonism (implied)
ModalitySmall molecule
Therapeutic areaMetabolic
PhaseFDA-approved
First approval1979

Mechanism of action

Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism in treating gastroesophageal reflux and diabetic gastroparesis has not been fully established, but it appears to sensitize tissues to acetylcholine action. The effect on motility is independent of intact vagal innervation but can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric contractions (especially antral), relaxes the pyloric sphincter and duodenal bulb, and increases peristalsis of the duodenum and jejunum, resulting in accelerated gastric emptying and intestinal transit. It also increases the resting tone of the lower esophageal sphincter. The drug has little to no effect on colon or gallbladder motility.

Approved indications

Boxed warnings

Common side effects

Drug interactions

Key clinical trials

Patents

PatentExpiryType
110203612029-12-22Method of Use
121940092029-12-22Method of Use
121940082029-12-22Method of Use
83342812030-05-16Formulation
116281502029-12-22Formulation
123770642038-11-17Method of Use
118132312029-12-22Formulation

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

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