influenced [18:4 for 17 hours per day with dexlansoprazole 60 mg versus 14 hours per day with lansoprazole 30 mg. 1 Food Administration in fed versus fasted state not associated with significant difference in mean gastric pH; however, effect on gastric pH during initial 4 hours after a dose may be decreased slightly when dexlansoprazole is taken after a meal. 1 13 (See Oral Administration under Dosage and Administration.) Distribution Plasma Protein Binding 96 99%. 1 Elimination Metabolism Extensively metabolized in the liver by oxidation, reduction, and subsequent formation of inactive sulfate, glucuronide, and glutathione conjugates. 1 CYP2C19 and CYP3A4 are involved. 1 Major circulating metabolite varies depending on CYP2C19 phenotype, but dexlansoprazole is the major circulating form of the drug regardless of CYP2C19 phenotype. 1 Elimination Route Eliminated in urine (51%) and feces (48%); unchanged drug is not recovered in urine. 1 Half-life Approximately 1 2 hours. 1 Special Populations Intermediate or poor metabolizers of CYP2C19 substrates: Systemic exposure to dexlansoprazole generally is increased. 1 In Japanese men, AUC increased twofold in intermediate metabolizers and up to 12-fold in poor metabolizers compared with extensive metabolizers. 1 Moderate hepatic impairment: Twofold increase in AUC. 1 Renal impairment: Pharmacokinetic alterations not expected. 1 Geriatric individuals: Half-life of 2.2 hours (versus 1.5 hours in younger individuals); not considered clinically important. 1 Stability Storage Oral Capsules 25 C (may be exposed to 15 30 C). 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Oral Capsules Immediately use extemporaneous mixtures of capsule contents and applesauce. 1 Actions Dexlansoprazole is the R -isomer of lansoprazole (a racemic mixture of R - and S -isomers). 1 5 22 Both isomers inhibit hydrogen-potassium ATPase, but plasma clearance of dexlansoprazole is slower than that of S -lansoprazole. 25 32 Proton-pump inhibitors inhibit basal and stimulated gastric acid secretion. 24 Dexlansoprazole binds to and inactivates hydrogen-potassium ATPase (proton, hydrogen, or acid pump) in gastric parietal cells, blocking the final step in secretion of hydrochloric acid; results in potent, long-lasting inhibition of gastric acid secretion. 1 22 Advice to Patients Importance of swallowing capsule whole or, alternatively, of opening capsule and sprinkling contents on a tablespoonful of applesauce and swallowing immediately without chewing. 1 Dexlansoprazole may be administered without regard to food (see Oral Administration under Dosage and Administration). 1 Importance of continuing therapy for the entire treatment course, unless directed otherwise. 1 Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine. 1 305 Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany). 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses. 1 Possible increased risk of Clostridium difficile infection; importance of contacting a clinician if persistent watery stools, abdominal pain, and fever occur. 335 Importance of informing clinicians of any symptoms suggestive of an allergic reaction (e.g., facial swelling, rash). 1 Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Dexlansoprazole Routes Dosage Forms Strengths Brand Names Manufacturer Oral Capsules, delayed-release (containing enteric-coated granules) 30 mg Dexilant Takeda 60 mg Dexilant Takeda AHFS DI Essentials. Copyright 2017, Selected Revisions February 4, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Takeda Pharmaceuticals America, Inc. Dexilant (dexlansoprazole) delayed-release capsules prescribing information. Deerfield, IL; 2012 May. 2. Sharma P, Shaheen NJ, Perez MC et al. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther . 2009; 29:731-41. [PubMed 19183157] 3. Fass R, Chey WD, Zakko SF et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with nonerosive reflux disease. Aliment Pharmacol Ther . 2009; :. [PubMed 19392864] 4. Metz DC, Howden CW, Perez MC et al. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther . 2009; 29:742-54. [PubMed 19210298] 5. . Dexlansoprazole (Kapidex) for GERD and erosive esophagitis. Med Lett Drugs Ther . 2009; 51:21-2. [PubMed 19305367] 6. 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From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website. 11. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2012 Mar. 12. Vakily M, Lee RD, Wu J et al. Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayed-release formulation: results of four randomized, double-blind, crossover, placebo-controlled, single-centre studies. Clin Drug Investig . 2009; 29:35-50. [PubMed 19067473] 13. Lee RD, Vakily M, Mulford D et al. Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility. Aliment Pharmacol Ther . 2009; 29:824-33. [PubMed 19243357] 14. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. 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New study: A common class of GI medications reduce protection against heart attack in patients taking widely prescribed cardiovascular drug. Franklin Lakes, NJ; 2008 Nov 11. Press release from website. 44. . PPI interactions with clopidogrel revisited. Med Lett Drugs Ther . 2009; 51:13-4. 45. Juurlink DN, Gomes T, Ko DT et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ . 2009; 180:713-8. [PubMed 19176635] 46. Food and Drug Administration. Information on clopidogrel bisulfate (marketed as Plavix). Rockville, MD; 2010 Oct 27. From FDA website. 216. Institute for Safe Medication Practices. Kapidex or Capadex? ISMP Medication Safety Alert! Community/Ambulatory Care edition. Horsham, PA; 2009 Aug. From ISMP website. 217. US Food and Drug Administration. FDA approves name change for heartburn drug Kapidex. Rockville, MD; 2010 Mar 4. News release from FDA website. 218. Institute for Safe Medication Practices. 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[PubMed 20844485] Next Interactions Print this page Add to My Med List More about dexlansoprazole Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 161 Reviews Add your own review/rating Drug class: proton pump inhibitors Consumer resources Dexlansoprazole Dexlansoprazole Capsules Dexlansoprazole (Advanced Reading) Professional resources Dexlansoprazole (Wolters Kluwer) Other brands: Dexilant , Kapidex Related treatment guides Barrett's Esophagus Erosive Esophagitis GERD]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Par Pharmaceutical, Inc. Drug Class Proton pump inhibitors Related Drugs Barrett's Esophagus omeprazole , pantoprazole , Nexium , Prilosec , Protonix , Dexilant , esomeprazole , lansoprazole , More... GERD omeprazole , pantoprazole , ranitidine , famotidine , Nexium , Prilosec , Protonix , Zantac , More... Erosive Esophagitis omeprazole , pantoprazole , ranitidine , famotidine , Nexium , Prilosec , Protonix , calcium carbonate , More... Dexlansoprazole Rating 161 User Reviews 7.6 /10 161 User Reviews 7.6 Rate it!} } the masses
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