Trade Names:Kapidex- Capsules, delayed-release 30 mg- Capsules, delayed-release 60 mg
Suppresses gastric acid secretion by inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production.
Mean C max and AUC values increase approximately dose proportionally.
Protein binding ranges from 96.1% to 98.8%. Apparent Vd is 40.3 L.
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.
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
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.
Healing of all grades of erosive esophagitis; maintaining healing of erosive esophagitis; treatment of heartburn associated with nonerosive gastroesophageal reflux disease (GERD).
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.
Store at 59° to 86°F.
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.
None well documented.
Angina, arrhythmia, bradycardia, chest pain, deep vein thrombosis, edema, hot flush, hypertension, MI, palpitation, tachycardia (less than 2%).
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%).
Acne, dermatitis, pruritus, rash, skin lesion, sunburn, urticaria (less than 2%).
Ear pain, eye irritation, eye swelling, nasopharyngitis, pharyngitis, sore throat, tinnitus, vertigo (less than 2%); auditory hallucination.
Goiter (less than 2%); hypothyroidism.
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%).
Dysmenorrhea, dyspareunia, dysuria, menorrhagia, menstrual disorder, micturition urgency, vulvovaginal infection (less than 2%); rectal tenesmus.
Biliary colic, cholelithiasis, hepatomegaly (less than 2%); acute cholecystitis.
Anemia, lymphadenopathy (less than 2%); decreased hemoglobin, decreased mean corpuscular hemoglobin concentration, increased neutrophils, neutropenia, thrombocythemia.
Hypersensitivity (less than 2%); anaphylaxis.
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%).
Appetite changes, hypercalcemia, hypokalemia, weight increase (less than 2%); diabetes mellitus, hyperglycemia, hyperlipidemia.
Arthralgia, arthritis, fractures, joint sprains, muscle cramps, musculoskeletal pain, myalgia (less than 2%).
Upper respiratory tract infection (3%); aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, sinusitis (less than 2%).
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.
Category B .
Safety and efficacy not established.
No overall differences in safety and efficacy have been observed in subjects 65 yr of age and older compared with younger subjects.
No dosage adjustment is needed in patients with renal function impairment.
Adjust dosage in patients with moderate hepatic function impairment. Dosing in patients with severe hepatic function impairment has not been studied.
Symptomatic response does not preclude the presence of gastric malignancy.
Overdosage has not been reported.
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