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Drugs reference index «Dexlansoprazole»

Dexlansoprazole

Pronunciation: (DEX-lan-SOE-pra-zole)Class: Proton pump inhibitor

Trade Names:Kapidex- Capsules, delayed-release 30 mg- Capsules, delayed-release 60 mg

Pharmacology

Suppresses gastric acid secretion by inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production.

Pharmacokinetics

Absorption

Mean C max and AUC values increase approximately dose proportionally.

Distribution

Protein binding ranges from 96.1% to 98.8%. Apparent Vd is 40.3 L.

Metabolism

Extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide, and glutathione conjugates to inactive metabolites. Oxidative metabolites are formed by CYP enzyme systems, including hydroxylation primarily by CYP2C19, and oxidation to sulfones by CYP3A4.

Elimination

No unchanged drug is excreted in the urine. Approximately 50.7% is excreted in the urine and 47.6% in the feces. Apparent Cl is 11.5 L/h

Special Populations

Renal Function Impairment

No parent drug is excreted in the urine. Therefore, no dosage adjustment is needed in patients with renal function impairment.

Hepatic Function Impairment

Plasma exposure to the drug is greater in patients with hepatic function impairment compared with subjects with healthy hepatic function.

Elderly

Elimination half-life is increased in elderly subjects; however, no dosage adjustment is needed.

Gender

Systemic exposure is higher in women than men; however, no dosage adjustment is needed.

Indications and Usage

Healing of all grades of erosive esophagitis; maintaining healing of erosive esophagitis; treatment of heartburn associated with nonerosive gastroesophageal reflux disease (GERD).

Contraindications

Standard considerations.

Dosage and Administration

Healing of Erosive EsophagitisAdults

PO 60 mg once daily for up to 8 wk.

Maintenance of Healing of Erosive EsophagitisAdults

PO 30 mg once daily.

Symptomatic Nonerosive GERDAdults

PO 30 mg once daily for 4 wk.

Hepatic Function ImpairmentAdults

PO Moderate hepatic impairment: 30 mg once daily.

General Advice

  • May be taken without regard to meals.
  • Capsules should be taken whole; alternatively, capsule granules may be sprinkled intact on 1 Tbsp of applesauce and swallowed immediately.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Atazanavir

Absorption may be decreased, resulting in loss of therapeutic effect of atazanavir and development of HIV resistance. Do not coadminister dexlansoprazole and atazanavir.

Drugs affected by gastric pH (eg, ampicillin esters, iron salts)

Bioavailability may be altered.

Digoxin

Digoxin absorption may be increased, leading to elevated levels and increased risk of toxicity.

Ketoconazole

Ketoconazole absorption may be reduced, decreasing the pharmacologic effects.

Warfarin

Monitor patients for possible increases in INR and PT time.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Angina, arrhythmia, bradycardia, chest pain, deep vein thrombosis, edema, hot flush, hypertension, MI, palpitation, tachycardia (less than 2%).

CNS

Abnormal dreams, altered taste, anxiety, asthenia, convulsions, depression, dizziness, headaches, insomnia, libido changes, memory impairment, migraine, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia (less than 2%).

Dermatologic

Acne, dermatitis, pruritus, rash, skin lesion, sunburn, urticaria (less than 2%).

EENT

Ear pain, eye irritation, eye swelling, nasopharyngitis, pharyngitis, sore throat, tinnitus, vertigo (less than 2%); auditory hallucination.

Endocrine

Goiter (less than 2%); hypothyroidism.

GI

Diarrhea (5%); abdominal pain (4%); flatulence, nausea (3%); vomiting (2%); abdominal discomfort, abdominal tenderness, abnormal bowel sounds, abnormal feces, anal discomfort, Barrett esophagus, bezoar, breath odor, colonic polyp, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, GERD, GI disorders, GI hypermotility, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, microscopic colitis, mucus stools, oral herpes, oral mucosal blistering, oral paresthesia, painful defecation, proctitis, rectal hemorrhage (less than 2%).

Genitourinary

Dysmenorrhea, dyspareunia, dysuria, menorrhagia, menstrual disorder, micturition urgency, vulvovaginal infection (less than 2%); rectal tenesmus.

Hepatic

Biliary colic, cholelithiasis, hepatomegaly (less than 2%); acute cholecystitis.

Hematologic-Lymphatic

Anemia, lymphadenopathy (less than 2%); decreased hemoglobin, decreased mean corpuscular hemoglobin concentration, increased neutrophils, neutropenia, thrombocythemia.

Hypersensitivity

Hypersensitivity (less than 2%); anaphylaxis.

Lab Tests

Abnormal LFTs, decreased and increased bilirubin, increased alkaline phosphatase, decreased platelet count, increased ALT and AST, increased blood creatinine, increased blood gastrin, increased blood glucose, increased blood potassium, increased total protein (less than 2%).

Metabolic-Nutritional

Appetite changes, hypercalcemia, hypokalemia, weight increase (less than 2%); diabetes mellitus, hyperglycemia, hyperlipidemia.

Musculoskeletal

Arthralgia, arthritis, fractures, joint sprains, muscle cramps, musculoskeletal pain, myalgia (less than 2%).

Respiratory

Upper respiratory tract infection (3%); aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, sinusitis (less than 2%).

Miscellaneous

Candida infections, chest pain, chills, falls, feeling abnormal, inflammation, influenza, mucosal inflammation, nodule, overdosage, pain, procedural pain, pyrexia, viral infection (less than 2%); B-cell lymphoma.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

No overall differences in safety and efficacy have been observed in subjects 65 yr of age and older compared with younger subjects.

Renal Function

No dosage adjustment is needed in patients with renal function impairment.

Hepatic Function

Adjust dosage in patients with moderate hepatic function impairment. Dosing in patients with severe hepatic function impairment has not been studied.

Gastric malignancy

Symptomatic response does not preclude the presence of gastric malignancy.

Overdosage

Symptoms

Overdosage has not been reported.

Patient Information

  • Advise patients that product may be taken without regard to meals.
  • Advise patients to swallow capsules whole, or open capsule and sprinkle contents on a tablespoon of applesauce and swallow immediately.
  • Advise patients to immediately report diarrhea, stomach pain, common cold, vomiting, and gas to health care provider.

Copyright © 2009 Wolters Kluwer Health.

  • Dexlansoprazole Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
  • dexlansoprazole Advanced Consumer (Micromedex) - Includes Dosage Information
  • Kapidex Prescribing Information (FDA)
  • Kapidex Consumer Overview

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