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Kapidex (Dexlansoprazole) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

7.1 Drugs with pH-Dependent Absorption Pharmacokinetics

KAPIDEX causes inhibition of gastric acid secretion. KAPIDEX is likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, KAPIDEX should not be co-administered with atazanavir.

It is theoretically possible that KAPIDEX may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole).

7.2 Warfarin

Co-administration of KAPIDEX 90 mg and warfarin 25 mg did not affect the pharmacokinetics of warfarin or INR [see Clinical Pharmacology ]. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with KAPIDEX and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

OVERDOSAGE

There have been no reports of significant overdose of KAPIDEX. Multiple doses of KAPIDEX 120 mg and a single dose of KAPIDEX 300 mg did not result in death or other severe adverse events. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis. If an overdose occurs, treatment should be symptomatic and supportive.

CONTRAINDICATIONS

KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description ]. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use [see Adverse Reactions ].

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