dexlansoprazole


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dexlansoprazole

Dexilant

Pharmacologic class: Proton pump inhibitor

Therapeutic class: GI agent

Pregnancy risk category B

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• moderate renal impairment
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).

Administration

• 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

Interactions

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.

dexlansoprazole

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

Dexilant

(trade name)

Classification

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

Indications

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

Action

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.

Pharmacokinetics

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)

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

Contraindications/Precautions

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

Gastrointestinal

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

Fluid and Electrolyte

  • hypomagnesemia (especially if treatment duration ≥3 mo)

Musculoskeletal

  • bone fracture

Interactions

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.

Route/Dosage

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.

Availability

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)

Implementation

  • 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.
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References in periodicals archive ?
We are pleased to resolve the patent litigation with Takeda related to our pending ANDA for dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths.
Following its evaluation, the RMS and all Concerned Member States (CMS) reached consensus that dexlansoprazole is approvable.
With the approval of dexlansoprazole in Europe, Takeda expands its profile in the Gastrointestinal area as an innovative and ethical company producing medicine that improves people's lives.
Under the terms of the agreement, Par made a payment to Handa for the ANDA, giving it the exclusive rights to market, sell and distribute dexlansoprazole capsules in the U.
Handa is currently involved in patent litigation concerning dexlansoprazole in the U.
We found that in healthy subjects the co-administration of Plavix with dexlansoprazole or lansoprazole reduced the antiplatelet effect of Plavix less than the co-administration of Plavix with esomeprazole.
The study showed that, while all PPIs decreased clopidogrel active metabolite peak plasma concentration, the area under the curve (AUC) decreased with treatment with esomeprazole, but not with dexlansoprazole or lansoprazole.
Takeda recently announced that the product trade name for dexlansoprazole in the United States would be changed to DEXILANT from KAPIDEX[TM] (dexlansoprazole).
This analysis is entitled Lack of Acid and Symptom Rebound After Withdrawal of 4 to 8 Weeks of Dexlansoprazole MR or Lansoprazole Therapy.
announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects.
This clinical trial, titled "A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects," is currently enrolling subjects and is expected to be completed within the 2010 calendar year.