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Pharmacologic class: Proton pump inhibitor

Therapeutic class: GI agent

Pregnancy risk category B


Suppresses gastric acid secretion by specific inhibition of (H+, K+)-ATPase in the gastric parietal cell.


Capsule: 30 mg, 60 mg

Indications and dosages

Healing of all grades of erosive esophagitis (EE)

Adults: 60 mg P.O. daily for up to 8 weeks

Maintaining healing of EE

Adults: 30 mg P.O. daily for up to 6 months

Symptomatic nonerosive gastro-esophageal reflux disease (GERD)

Adults: 30 mg P.O. daily for up to 4 weeks

Dosage adjustment

• Moderate hepatic impairment


• Hypersensitivity to drug or its components


Use cautiously in:

• moderate renal impairment

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).


• Administer with or without food.

Adverse reactions

CNS: asthenia, dizziness, headache, migraine headache, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia, abnormal dreams, anxiety, depression, insomnia, seizures

CV: angina, bradycardia, chest pain, palpitations, tachycardia, hypertension, deep vein thrombosis, arrhythmias, myocardial infarction

EENT: eye irritation, eye swelling, ear pain, tinnitus, vertigo, nasopharyngitis, pharyngitis, sinusitis

GI: nausea; vomiting; diarrhea; abdominal pain, discomfort, tenderness; flatulence; abnormal feces; anal discomfort; Barrett's esophagus; bezoar; abnormal bowel sounds; breath odor; microscopic colitis; colon and gastric polyps; constipation; dry mouth; duodenitis; dyspepsia; dysphagia; enteritis; eructation; esophagitis; gastritis; gastroenteritis; GI disorders; GI hypermotility disorders; GERD; ulcers and perforation; hematemesis; hematochezia; hemorrhoids; impaired gastric emptying; irritable bowel syndrome; mucus stools; oral mucosa blistering; painful defecation; proctitis; oral paresthesia; oral herpes; rectal hemorrhage

GU: vulvovaginal infection, libido changes, dysuria, micturition urgency, dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder

Hematologic: anemia, lymphadenopathy

Hepatic: biliary colic, cholelithiasis, hepatomegaly

Metabolic: goiter

Musculoskeletal: arthralgia, arthritis, cramps, musculoskeletal pain, myalgia; hip, wrist, spine fracture (with long-term daily use)

Respiratory: upper respiratory tract infection, aspiration, asthma, bronchitis, cough, dyspnea, hyperventilation, respiratory tract congestion, sore throat

Skin: rash, sunburn, acne, dermatitis, erythema, pruritus, lesions, urticaria

Other: edema, chills, abnormal feeling, inflammation, mucosal inflammation, nodule, pain, pyrexia, candidal infection, viral infection, influenza, falls, overdose, procedural pain, weight gain, appetite changes, altered taste, hiccups, hot flushes, hypersensitivity


Drug-drug. Atazanavir: decreased atazanavir level

Drugs with pH-dependent absorption (such as ampicillin esters, digoxin, iron salts, ketoconazole): interference with absorption of these drugs

Tacrolimus: increased tacrolimus whole blood concentration

Warfarin: increased International Normalized Ratio and prothrombin time

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood glucose, gastrin, potassium, serum creatinine, total protein: increased levels

Bilirubin: increased or decreased level

Liver function tests: abnormal results

Platelets, serum calcium: decreased levels

Patient monitoring

• Monitor renal function tests closely.

Patient teaching

• Instruct patient to take drug with or without food.

• Tell patient to swallow capsule whole or open capsule and sprinkle contents on 1 tablespoon of applesauce and swallow immediately.

• Instruct patient to report allergic reactions (such as rash or itching) to prescriber.

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

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(dex-lan-soe-pra-zole) ,


(trade name)


Therapeutic: antiulcer agents
Pharmacologic: proton pump inhibitors
Pregnancy Category: B


Healing of erosive esophagitis (EE).Maintenance of healed EE and relief of heartburn.Treatment of heartburn from nonerosive gastroesopahageal reflux disease (GERD).


Binds to an enzyme in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen.

Therapeutic effects

Diminished accumulation of acid in the gastric lumen, with lessened acid reflux.


Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: 96–99%.
Metabolism and Excretion: Extensively metabolized by the liver (CYP2C19 and CYP3A4 enzyme systems are involved); genetic implication the CYP2C19 enzyme system exhibits genetic polymorphism; 15–20% of Asian patients and 3–5% of Caucasian and Black patients may be poor metabolizers and may have significantly ↑ dexlansoprazole concentrations and an ↑ risk of adverse effects); no active metabolites. No renal elimination.
Half-life: 1–2 hr.

Time/action profile (blood levels)

POunknown1–2 hr (1st); 4–5 hr (2nd)24 hr
*Reflects effects of delayed release capsule.


Contraindicated in: Hypersensitivity;Severe hepatic impairment; Lactation: Lactation.
Use Cautiously in: Moderate hepatic impairment (daily dose should not exceed 30 mg);Patients using high doses for >1 year (↑ risk of hip, wrist, or spine fractures); Pediatric: Safety not established.

Adverse Reactions/Side Effects


  • pseudomembranous colitis (life-threatening)
  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • flatulence
  • nausea
  • vomiting

Fluid and Electrolyte

  • hypomagnesemia (especially if treatment duration ≥3 mo)


  • bone fracture


Drug-Drug interaction

↓ levels of atazanavir ; do not administer concurrently.May ↓ absorption of drugs requiring acid pH for absorption, including ampicillin, iron salts, digoxin, erlotinib, and ketoconazole.May ↑ effect of warfarin.May ↑ tacrolimus and methotrexate levels.Hypomagnesemia ↑ risk of digoxin toxicity.


Oral (Adults) Healing of EE—60 mg once daily for up to 8 wk; Maintenance of healed EE—30 mg once daily for up to 6 mo; GERD—30 mg once daily for 4 wk.

Hepatic Impairment

Oral (Adults) Moderate hepatic impairment—daily dose should not exceed 30 mg.


Delayed release capsules: 30 mg, 60 mg

Nursing implications

Nursing assessment

  • Assess patient routinely for epigastric or abdominal pain and for frank or occult blood in stool, emesis, or gastric aspirate.
  • Monitor bowel elimination. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis.
  • Lab Test Considerations: May cause abnormal liver function tests, including ↑AST, ALT, and ↑ or ↓ serum bilirubin.
    • May cause ↑ serum creatinine and BUN, ↑ blood glucose, and ↑ serum potassium, and ↓ serum magnesium levels.
    • May cause ↓ platelet levels.
    • May also cause ↑ gastrin and total protein levels.
    • Monitor INR and prothrombin time in patients taking warfarin.

Potential Nursing Diagnoses

Acute pain (Indications)


  • Oral: May be administered without regard to food. Swallow capsules whole or may be opened and sprinkled on 1 tbsp of applesauce and swallowed immediately, without crushing or chewing, for patients with difficulty swallowing.
    • Capsules may be opened and granules emptied into 20 mL water. Withdraw entire mixture into syringe; swirl gently to mix. Administer mixture into mouth or NG tube immediately; do not save for later. Rinse syringe with 10 mL or water twice to ensure all medication administered.

Patient/Family Teaching

  • Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered. Brand name was formerly Kapidex.
  • Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
  • Advise patient to report onset of black, tarry stools; diarrhea; or abdominal pain to health care professional promptly, especially if accompanied by fever or bloody stools. Do not treat with antidiarrheals without consulting health care professional.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in abdominal pain, heartburn, gastric irritation, and bleeding in patients with GERD; may require up to 4 wk of therapy.
  • Healing in patients with erosive esophagitis; may require up to 8 wk of therapy for healing and 6 mo of therapy for maintenance.
Drug Guide, © 2015 Farlex and Partners
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References in periodicals archive ?
For the PPIs, six are available, but only the first two agents are OTC: lansoprazole (Prevacid), omeprazole (Prilosec), dexlansoprazole (Dexilant), esomeprazole (Nexium), pantoprazole (Protonix), and rabeprazole (AcipHex).
Dexlansoprazole MR is an R-enantiomer of lansoprazole with dual delayed-release benefit in prolonging plasma concentration and pharmacodynamic effects better than those of single-release PPIs with its administration allowed at any time of the day without regard to meals.
Pharmaceutical company Par Pharmaceutical Companies Inc (NYSE:PRX) revealed on Thursday that its Par Pharmaceutical Inc operating subsidiary has signed an exclusive acquisition and license agreement to acquire the dexlansoprazole capsules ANDA.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexilant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC), Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium), Wmaovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexilant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC);Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium); Vimovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
Esomeprazole magnesium (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec), omeprazole with sodium bicarbonate (Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), and naproxen with esomeprazole magnesium (Vimovo) are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), ulcers of the stomach and small intestine, and inflammation of the esophagus.
Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayed-release formulation:
However, the researchers concede that further studies are required to determine whether newer, less widely used PPIs-such as rabeprazole (Aciphex) and dexlansoprazole (Kapidex)-are also associated with increased cardiovascular risk in patients taking clopidogrel.
PROTON PUMP INHIBITORS Generic name Brand Name Dexlansoprazole Dexilant[R] Esomeprazole Nexium[R] Lansoprazole Prevacid[R] Omeprazole Prilosec[R], Zegerid[R] Pantoprazole Protonix[R] Rabeprazole Aciphex[R] * Non-prescription forms available
has entered into an acquisition and license agreement with Handa Pharmaceuticals LLC to secure Handa's Abbreviated New Drug Application (ANDA) for dexlansoprazole capsules, the generic version of Takeda Pharmaceutical's Dexilant.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexi-lant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC); Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium); Vimovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
Impax Laboratories Inc (Nasdaq:IPXL) has confirmed that it has initiated a challenge of patents listed by Takeda Pharmaceutical Company Ltd in connection with DEXILANT (dexlansoprazole) delayed-release capsules, 30 mg and 60 mg.