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  • Metoclopramide
    (Metoclopramide) - Various

    BOXED WARNING

    May cause tardive dyskinesia (TD); d/c if signs/symptoms of TD develop. Avoid use for >12 weeks of therapy unless benefit outweighs risk.

    OTHER BRAND NAMES

    Reglan Tablets (ANI), Reglan Injection (Baxter)

    THERAPEUTIC CLASS

    Dopamine antagonist/prokinetic

    DEA CLASS

    RX

    INDICATIONS

    (PO) Short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. (PO, Inj) Relief of symptoms associated with acute and recurrent diabetic gastric stasis in adults. (Inj) Prevention of postoperative N/V (PONV) or chemotherapy-induced N/V. Facilitates small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Stimulates gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

    ADULT DOSAGE

    Adults: (PO) GERD: 10-15mg up to qid 30 min ac and hs. Intermittent Symptoms: Up to 20mg as single dose prior to the provoking situation. Sensitive to Metoclopramide/Elderly: 5mg/dose. Esophageal Lesions Present: 15mg/dose qid. Max: 12 weeks of therapy. (PO, Inj) Diabetic Gastroparesis: 10mg PO 30 min ac and hs for 2-8 weeks. If severe, begin with IM or IV (may give 10mg IV slowly over 1-2 min); may need inj for up to 10 days before symptoms subside, at which time PO administration may be instituted. (Inj) Antiemetic: (PONV) 10-20mg IM near end of surgery. (Chemotherapy-Induced N/V) 1-2mg/kg IV infusion over a period of ≥15 min, 30 min before chemotherapy, then q2h for 2 doses, then q3h for 3 doses. Give the 2mg/kg dose for highly emetogenic drugs for the initial 2 doses. Small Bowel Intubation/Radiological Exam: 10mg IV single dose (undiluted) given slowly over 1-2 min. Renal Impairment: CrCl <40mL/min: Initial: 1/2 of recommended dose. May adjust as appropriate. Elderly: Start at lower end of dosing range.

    PEDIATRIC DOSAGE

    Pediatrics: (Inj) Small Bowel Intubation: Administer single dose (undiluted) IV slowly over 1-2 min. >14 Yrs: 10mg. 6-14 Yrs: 2.5-5mg. <6 Yrs: 0.1mg/kg. Renal Impairment: CrCl <40mL/min: Initial: 1/2 of recommended dose. May adjust as appropriate.

    HOW SUPPLIED

    Inj (Reglan): 5mg/mL [2mL, 10mL, 30mL]; Sol: 5mg/5mL [473mL]; Tab (Reglan): 5mg, 10mg* *scored

    CONTRAINDICATIONS

    When GI motility stimulation is dangerous (eg, GI hemorrhage, mechanical obstruction, perforation), pheochromocytoma, epilepsy, and concomitant drugs that cause extrapyramidal symptoms (EPS).

    WARNINGS/PRECAUTIONS

    Mental depression may occur; caution with prior history of depression. EPS, primarily as acute dystonic reactions, may occur. May cause parkinsonian-like symptoms; caution with preexisting Parkinson's disease. May suppress signs of TD; do not use for symptomatic control of TD. Neuroleptic malignant syndrome reported; d/c, monitor, and institute intensive symptomatic treatment. Risk of developing fluid retention and volume overload, especially in patients with cirrhosis or congestive heart failure (CHF); d/c if these occur. Caution with HTN, renal impairment, and/or in elderly. May increase risk of developing methemoglobinemia and/or sulfhemoglobinemia with NADH-cytochrome b5 reductase deficiency. May experience withdrawal symptoms after discontinuation. (Inj) Undiluted IV inj should be given slowly since rapid administration may cause anxiety, restlessness, and drowsiness. May increase pressure on suture lines after a gut anastomosis or closure; use caution with PONV.

    ADVERSE REACTIONS

    TD, restlessness, drowsiness, fatigue, lassitude.

    DRUG INTERACTIONS

    See Contraindications. GI motility effect antagonized by anticholinergics and narcotic analgesics. Additive sedation with alcohol, sedatives, hypnotics, narcotics, or tranquilizers. Caution with MAOIs. May diminish absorption of drugs from stomach (eg, digoxin) and increase rate and/or extent of absorption of drugs from small bowel (eg, acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Insulin dose or timing of dose may require adjustment. Rare cases of hepatotoxicity reported with drugs with hepatotoxic potential. Inhibits central and peripheral effects of apomorphine.

    PREGNANCY

    Category B, caution in nursing.

    MECHANISM OF ACTION

    Dopamine antagonist/prokinetic; not established. Appears to sensitize tissues to the action of acetylcholine; stimulates motility of upper GI tract without stimulating gastric, biliary, or pancreatic secretions and accelerates gastric emptying and intestinal transit. Also increases resting tone of the lower esophageal sphincter. Antiemetic; antagonizes central and peripheral dopamine receptors, thereby blocking stimulation of chemoreceptor trigger zone.

    PHARMACOKINETICS

    Absorption: Rapid and well-absorbed; (PO) absolute bioavailability (80%); (PO) Tmax=1-2 hrs; IV administration in pediatrics resulted in varying parameters. Distribution: Plasma protein binding (30%); Vd=3.5L/kg; found in breast milk. Elimination: (PO) Urine (85%; 50% free or conjugated); T1/2=5-6 hrs.

    ASSESSMENT

    Assess for conditions when GI motility stimulation is dangerous, pheochromocytoma, epilepsy, sensitivity or tolerance to the drug, CHF, cirrhosis, history of depression, Parkinson's disease, HTN, NADH-cytochrome b5 reductase and G6PD deficiency, diabetes mellitus, renal impairment, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for signs/symptoms of depression, EPS, parkinsonian-like symptoms, TD, NMS, HTN, fluid retention/volume overload, withdrawal symptoms, hypersensitivity reactions, and other adverse reactions.

    PATIENT COUNSELING

    Inform that drug may impair mental and physical abilities; advise to use caution while operating machinery/driving. Discuss the risks and benefits of treatment.

    ADMINISTRATION/STORAGE

    Administration: Oral, IV/IM route. Refer to PI for IV administration, preparation, and compatibility instructions. Storage: 20-25°C (68-77°F). (Inj) If diluted with NaCl, may be stored frozen for up to 4 weeks. Diluted sol may be stored up to 48 hrs (without freezing) if protected from light; 24 hrs in normal lighting conditions.