Reglan


Reglan

 [reg´lan] trademark for preparations of metoclopramide hydrochloride, used to stimulate gastrointestinal motility.

metoclopramide hydrochloride

Apo-Metoclop (CA), Gastrobid (UK), Gastromax (UK), Maxeran (CA), Maxolon (UK), Maxolon SR (UK), Metozolv ODT, Nu-Metoclopramide (CA), Paramax (UK), PMS-Metoclopramide, Reglan

Pharmacologic class: Dopamine antagonist

Therapeutic class: Antiemetic, GI stimulant

Pregnancy risk category B

FDA Box Warning

• Drug can cause tardive dyskinesia, a serious movement disorder that's often irreversible. Risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

• Discontinue drug in patients who develop signs or symptoms of tardive dyskinesia, which has no known treatment. In some patients, signs and symptoms may lessen or resolve after drug is stopped.

• Avoid using metoclopramide for longer than 12 weeks except in rare cases in which potential benefit outweighs risk of developing tardive dyskinesia.

Action

Blocks dopamine receptors by disrupting CNS chemoreceptor trigger zone, increasing peristalsis and promoting gastric emptying

Availability

Injection: 5 mg/ml

Solution: 5 mg/5 ml

Solution (concentrated): 10 mg/ml

Tablets: 5 mg, 10 mg

Tablets (orally disintegrating): 5 mg, 10 mg

Indications and dosages

To prevent chemotherapy-induced vomiting

Adults: 1 to 2 mg/kg I.V. 30 minutes before chemotherapy, then q 2 hours for two doses, then q 3 hours for three additional doses

To facilitate small-bowel intubation; radiologic examination when delayed gastric emptying interferes

Adults and children older than age 14: 10 mg I.V. as a single dose

Children ages 6 to 14: 2.5 to 5 mg I.V. as a single dose

Children younger than age 6: 0.1 mg/kg I.V. as a single dose

Diabetic gastroparesis

Adults: 10 mg P.O. 30 minutes before meals and at bedtime for 2 to 8 weeks. If patient can't tolerate P.O. doses, give same dosage I.V. or I.M.

Gastroesophageal reflux

Adults: 10 to 15 mg P.O. 30 minutes before meals and at bedtime for up to 12 weeks. For prevention, single dose of 20 mg (some patients may respond to doses as small as 5 mg).

Prevention of postoperative nausea and vomiting

Adults: 10 to 20 mg I.M. near end of surgical procedure. Repeat dose q 4 to 6 hours, as needed.

Dosage adjustment

• Renal impairment

Off-label uses

• Hiccups

Contraindications

• Hypersensitivity to drug

• Pheochromocytoma

• Parkinson's disease

• Suspected GI obstruction, perforation, or hemorrhage

• History of seizure disorders

Precautions

Use cautiously in:

• diabetes mellitus, renal dysfunction

• history of depression

• elderly patients

• pregnant or breastfeeding patients

• children.

Administration

• Mix oral solution with water, juice, carbonated beverage, or semisolid food (such as applesauce or pudding) just before administration.

• Remove orally disintegrating tablets with dry hands immediately before administering. After removing, place tablet on patient's tongue, where it will dissolve in approximately 1 minute. Tell patient to swallow saliva.

• Give I.M. or direct I.V. without further dilution.

• Administer low doses (10 mg or less) by direct I.V. injection slowly over 2 minutes. (Rapid injection may cause intense anxiety and restlessness followed by drowsiness.)

• For I.V. infusion, dilute with 50 ml of 5% dextrose in 0.9% sodium chloride solution, 5% dextrose in 0.45% sodium chloride solution, or lactated Ringer's solution. Infuse over at least 15 minutes.

Adverse reactions

CNS: drowsiness, restlessness, anxiety, depression, irritability, fatigue, lassitude, insomnia, tardive dyskinesia, parkinsonian-like reactions, extrapyramidal reactions, akathisia, dystonia

CV: hypertension, hypotension, arrhythmias, neuroleptic malignant syndrome

GI: nausea, constipation, diarrhea, dry mouth

GU: gynecomastia

Interactions

Drug-drug. Anticholinergics, opioids: antagonism of metoclopramide's GI motility effect

Antidepressants, antihistamines, other CNS depressants (such as opioids, sedative-hypnotics): additive CNS depression

Cimetidine, digoxin: decreased blood levels of these drugs

General anesthestics: exaggerated hypotension

Haloperidol, phenothiazines: increased risk of extrapyramidal reactions

Levodopa: decreased metoclopramide efficacy

MAO inhibitors: increased catecholamine release

Drug-diagnostic tests. Aldosterone, prolactin: increased levels

Drug-behaviors. Alcohol use: increased blood alcohol level, increased CNS depression

Patient monitoring

• Monitor blood pressure during I.V. administration.

• Stay alert for depression and other adverse CNS effects.

See Watch for extrapyramidal reactions, which usually occur within first 24 to 48 hours of therapy. To reverse these symptoms, give diphenhydramine 50 mg I.M. or benztropine 1 to 2 mg I.M., as prescribed.

• Check for development of parkinsonian-like symptoms, which may occur within first 6 months of therapy and usually subside within 2 to 3 months after withdrawal.

See With long-term use, assess patient for tardive dyskinesia and discontinue drug if signs or symptoms of tardive dyskinesia develop. Avoid treatment for longer than 12 weeks in all but rare cases in which therapeutic benefit outweighs risk of developing tardive dyskinesia.

See Monitor patient closely for signs and symptoms of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability [irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias]); immediately discontinue drug if these symptoms occur.

• In diabetic patient, stay alert for gastric stasis. Insulin dosage may need to be adjusted.

Patient teaching

• Tell patient to take 30 minutes before meals.

• Tell patient taking orally disintegrating tablets to remove tablet with dry hands immediately before use. Instruct patient to place tablet on tongue, where it will dissolve in approximately 1 minute, and then swallow saliva.

See Instruct patient to report involuntary movements of face, eyes, or limbs; muscle rigidity; altered consciousness; irregular pulse or blood pressure; rapid or irregular heartbeats; or excessive sweating.

• Caution patient to avoid driving and other hazardous activities until drug's effects are known.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

metoclopramide

(met-oh-kloe-pra-mide) metoclopramide,

Metonia

(trade name),

Metozolv ODT

(trade name),

Reglan

(trade name)

Classification

Therapeutic: antiemetics
Pregnancy Category: B

Indications

Prevention of chemotherapy-induced emesis.Treatment of postsurgical and diabetic gastric stasis.Facilitation of small bowel intubation in radiographic procedures.Management of gastroesophageal reflux.Treatment and prevention of postoperative nausea and vomiting when nasogastric suctioning is undesirable.Treatment of hiccups.Adjunct management of migraine headaches.

Action

Blocks dopamine receptors in chemoreceptor trigger zone of the CNS.Stimulates motility of the upper GI tract and accelerates gastric emptying.

Therapeutic effects

Decreased nausea and vomiting.Decreased symptoms of gastric stasis.Easier passage of nasogastric tube into small bowel.

Pharmacokinetics

Absorption: Well absorbed from the GI tract, from rectal mucosa, and from IM sites.Distribution: Widely distributed into body tissues and fluids. Crosses blood-brain barrier and placenta. Enters breast milk in concentrations greater than plasma.Metabolism and Excretion: Partially metabolized by the liver; 25% eliminated unchanged in the urine.Half-life: 2.5–6 hr.

Time/action profile (effects on peristalsis)

ROUTEONSETPEAKDURATION
PO30–60 minunknown1–2 hr
IM10–15 minunknown1–2 hr
IV1–3 minimmediate1–2 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Possible GI obstruction or hemorrhage;History of seizure disorders;Pheochromocytoma;Parkinson’s disease.Use Cautiously in: History of depression;Diabetes (may alter response to insulin);Renal impairment (↓ dose in CCr <50 mL/min);Chronic use > 3 mo (↑ risk for tardive dyskinesia); Obstetric / Lactation: Safety not established; Pediatric: Prolonged clearance in neonates can result in high serum concentrations and ↑ the risk for methemoglobinemia. Side effects are more common in children, especially extrapyramidal reactions; Geriatric: More susceptible to oversedation, extrapyramidal reactions, and tardive dyskinesia.

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness (most frequent)
  • extrapyramidal reactions (most frequent)
  • restlessness (most frequent)
  • neuroleptic malignant syndrome (life-threatening)
  • anxiety
  • depression
  • irritability
  • tardive dyskinesia

Cardiovascular

  • arrhythmias (supraventricular tachycardia, bradycardia)
  • hypertension
  • hypotension

Gastrointestinal

  • constipation
  • diarrhea
  • dry mouth
  • nausea

Endocrinologic

  • gynecomastia

Hematologic

  • methemoglobinemia
  • neutropenia
  • leukopenia
  • agranulocytosis

Interactions

Drug-Drug interaction

Additive CNS depression with other CNS depressants, including alcohol, antidepressants, antihistamines, opioid analgesics, and sedative/hypnotics.May ↑ absorption and risk of toxicity from cyclosporine.May affect the GI absorption of other orally administered drugs as a result of effect on GI motility.May exaggerate hypotension during general anesthesia.↑ risk of extrapyramidal reactions with agents such as haloperidol or phenothiazines.Opioids and anticholinergics may antagonize the GI effects of metoclopramide.Use cautiously with MAO inhibitors (causes release of catecholamines).May ↑ neuromuscular blockade from succinylcholine.May ↓ effectiveness of levodopa.May ↑ tacrolimus serum levels.

Route/Dosage

Prevention of Chemotherapy-Induced VomitingOral Intravenous (Adults and Children) 1–2 mg/kg 30 min before chemotherapy. Additional doses of 1–2 mg/kg may be given q 2–4 hr, pretreatment with diphenhydramine will ↓ the risk of extrapyramidal reactions to this dose.Facilitation of Small Bowel IntubationIntravenous (Adults and Children > 14 yr) 10 mg over 1–2 min.Intravenous (Children 6–14 yr) 2.5–5 mg (dose should not exceed 0.5 mg/kg) over 1–2 min.Intravenous (Children <6 yr) 0.1 mg/kg over 1–2 min.Diabetic GastroparesisOral Intravenous (Adults) 10 mg 30 min before meals and at bedtime for 2–8 weeks.Gastroesophageal RefluxOral Intramuscular Intravenous (Adults) 10–15 mg 30 min before meals and at bedtime (not to exceed 0.5 mg/kg/day). A single dose of 20 mg may be given preventively. Some patients may respond to doses as small as 5 mg.Oral Intramuscular Intravenous (Neonates, Infants, and Children) 0.4–0.8 mg/kg/day in 4 divided doses.Postoperative Nausea/VomitingIntramuscular Intravenous (Adults and Children > 14 yr) 10 mg at the end of surgical procedure, repeat in 6–8 hr if needed.Intramuscular Intravenous (Children <14 yr) 0.1–0.2 mg/kg/dose, repeat in 6–8 hr if needed.Treatment of HiccupsOral Intramuscular (Adults) 10–20 mg 4 times daily PO; may be preceded by a single 10-mg dose IM (unlabeled).

Availability (generic available)

Tablets: 5 mg, 10 mg Cost: Generic — 5 mg $11.04 / 100, 10 mg $7.18 / 100Orally disintegrating tablets: 5 mg Cost: $26.40 / 10Oral solutionapricot-peach flavor: 5 mg/5 mL Injection: 5 mg/mL

Nursing implications

Nursing assessment

  • Assessfor nausea, vomiting, abdominal distention, and bowel sounds before and after administration.
  • Assess for extrapyramidal side effects (parkinsonian—difficulty speaking or swallowing, loss of balance control, pill rolling, mask-like face, shuffling gait, rigidity, tremors; and dystonic—muscle spasms, twisting motions, twitching, inability to move eyes, weakness of arms or legs) periodically throughout course of therapy. May occur weeks to months after initiation of therapy and are reversible on discontinuation. Dystonic reactions may occur within minutes of IV infusion and stop within 24 hr of discontinuation of metoclopramide. May be treated with 50 mg of IM diphenhydramine or diphenhydramine 1 mg/kg IV may be administered prophylactically 15 min before metoclopramide IV infusion.
  • Monitor for tardive dyskinesia (uncontrolled rhythmic movement of mouth, face, and extremities; lip smacking or puckering; puffing of cheeks; uncontrolled chewing; rapid or worm-like movements of tongue). Usually occurs after a year or more of continued therapy; risk of tardive dyskinesia increases with total cumulative dose. Report immediately and discontinue metoclopramide; may be irreversible.
  • Monitor for neuroleptic malignant syndrome (hyperthermia, muscle rigidity, altered consciousness, irregular pulse or BP, tachycardia, and diaphoresis).
  • Assess for signs of depression periodically throughout therapy.
  • Lab Test Considerations: May alter hepatic function test results.
    • May cause ↑ serum prolactin and aldosterone concentrations.

Potential Nursing Diagnoses

Imbalanced nutrition: less than body requirements (Indications)
Risk for injury (Side Effects)

Implementation

  • Oral: Administer doses 30 min before meals and at bedtime.
    • Do not to remove orally disintegrating tablets from the bottle until just prior to dosing. Remove tablet from bottle with dry hands and immediately place on tongue to disintegrate and swallow with saliva. Tablet typically disintegrates in 1–1.5 minutes. Administration with liquid is not necessary.
  • Intramuscular: For prevention of postoperative nausea and vomiting, inject IM near the end of surgery.
  • Intravenous Administration
  • Administer IV dose 30 min before administration of chemotherapeutic agent.
  • Rate: Doses may be given slowly over 1–2 min. Rapid administration causes a transient but intense feeling of anxiety and restlessness followed by drowsiness.
  • Intermittent Infusion: Diluent: May be diluted for IV infusion in 50 mL of D5W, 0.9% NaCl, D5/0.45% NaCl, Ringer’s solution, or LR. Diluted solution is stable for 48 hr if protected from light or 24 hr under normal light.Concentration: May dilute to 0.2 mg/mL or give undiluted at 5 mg/mL.
  • Rate: Infuse slowly (maximum rate 5 mg/min) over at least 15–30 min.
  • Y-Site Compatibility: aldesleukin, alemtuzumab, alfentanil, amifostine, amikacin, aminophylline, amphotericin B lipid complex, anidulafungin, argatroban, ascorbic acid, atropine, azathioprine, aztreonam, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, caspofungin, cefazolin, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftaroline, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, cladribine, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daptomycin, dexamethasone, dexmedetomidine, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doripenem, doxapram, doxorubicin hydrochloride, doxycyline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, eptifibatide, ertapenam, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, folic acid, foscarnet, gemcitabine, gentamicin, glycopyrrolate, granisetron, heparin, hetastarch, hydrocortisone sodium succinate, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, indomethacin, insulin, irinotecan, isoproterenol, ketamine, ketorolac, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, meropenem, methadone, methotrexate, methoxamine, methyldopate, methylprednisolone, metoprolol, metronidazole, midazolam, milrinone, mitomycin, mitoxantrone, morphine, multiple vitamins, mycophenolate, nafcillin, nalbuphine, naloxone, nesiritide, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxacillin, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pantoprazole, papaverine, pemetrexed, penicillin G, pentamidine, pentazocine, pentobarbital, phenobarbital, phentolamine, phenylephrine, phytonadione, piperacillin/tazobactam, potassium acetate, potassium chloride, procainamide, prochlorperazine, promethazine, propranolol, protamine, pyridoxine, quinupristin/dalfopristin, ranitidine, remifentanil, rituximab, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, streptokinase, succinylcholine, sufentanil, tacrolimus, telavancin, teniposide, theophylline, thiamine, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, tolazoline, topotecan, trastuzumab, trimetaphan, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B liposome, amsacrine, carmustine, cefepime, dantrolene, diazepam, diazoxide, doxorubicin liposome, ganciclovir, phenytoin, propofol, trimethoprim/sulfamethoxazole

Patient/Family Teaching

  • Instruct patient to take metoclopramide as directed. Take missed doses as soon as remembered if not almost time for next dose. Advise patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Pediatric: Unintentional overdose has been reported in infants and children with the use of metoclopramide oral solution. Teach parents how to accurately read labels and administer medication.
  • May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to avoid concurrent use of alcohol and other CNS depressants while taking this medication.
  • Inform patient of risk of extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome. Advise patient to notify health care professional immediately if involuntary or repetitive movements of eyes, face, or limbs occur.

Evaluation/Desired Outcomes

  • Prevention or relief of nausea and vomiting.
  • Decreased symptoms of gastric stasis.
  • Facilitation of small bowel intubation.
  • Decreased symptoms of esophageal reflux.
    • Metoclopramide should not be used for more than 12 wk due to risk of tardive dyskinesia.

Reglan

(rĕg′lăn′) A trademark for the drug metoclopramide hydrochloride.