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KAPIDEX WORKS ASECOND SHIFTTO HELP SHUT DOWN ACID PUMPS
KAPIDEX is the first and only PPI with aDual Delayed Release (DDR) formulation,which provides a second release of drugMean plasma concentration (in healthy subjects; day 5; ng/mL) 112001000800600400200KAPIDEX 60 mgKAPIDEX 30 mg00 6 12 18 24Time (h)• KAPIDEX 30 mg provided full 24-hour heartburn relief in a majority of symptomaticnon-erosive gastroesophageal reflux disease patients at week 4 1• KAPIDEX 60 mg provided consistently high erosive esophagitis healing ratesat week 8 1• KAPIDEX offers a safety and tolerability profile similar to lansoprazole 1• KAPIDEX can be taken without regard to food 1KAPIDEX should be swallowed whole. Alternatively, capsules can be opened,sprinkled on 1 tablespoon of applesauce, and swallowed immediately. WhileKAPIDEX can be taken without regard to food, some patients may benefit fromadministering the dose prior to a meal if post-meal symptoms do not resolveunder post-fed conditions.Conclusions of comparative efficacy cannot be drawn from this information.IndicationsKAPIDEX is indicated for healing all grades of erosive esophagitis (EE) forup to 8 weeks, maintaining healing of EE for up to 6 months, and treatingheartburn associated with symptomatic non-erosive gastroesophageal refluxdisease (GERD) for 4 weeks.Important Safety InformationKAPIDEX is contraindicated in patients with known hypersensitivity toany component of the formulation. Hypersensitivity and anaphylaxis havebeen reported with KAPIDEX use. Symptomatic response with KAPIDEXdoes not preclude the presence of gastric malignancy. Most commonlyreported treatment-emergent adverse reactions (≥2%): diarrhea (4.8%),abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%),vomiting (1.6%), and flatulence (1.6%). Do not co-administer atazanavir withKAPIDEX because atazanavir systemic concentrations may be substantiallydecreased. KAPIDEX may interfere with absorption of drugs for which gastricpH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts,ketoconazole). Patients taking concomitant warfarin may require monitoringfor increases in international normalized ratio (INR) and prothrombin time.Increases in INR and prothrombin time may lead to abnormal bleeding, whichcan lead to serious consequences.Please see adjacent brief summary of prescribing information for KAPIDEX.
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