DEXILANT had no clinically important impact on the antiplatelet activity of Plavix in healthy subjects
DEXILANT 60 mg had no clinically important effect on Plavix active metabolite pharmacodynamics, as measured by Inhibition of Platelet Aggregation (IPA) and inhibition of Platelet Reactivity Index (PRI) based on co-primary endpoints of
DEXILANT minimally reduced the mean AUC of the Plavix active metabolite
No dose adjustment of Plavix is necessary when administered with an approved dose of DEXILANT1
Conclusions of comparative efficacy and safety cannot be drawn from
The clinical relevance of these data has not been established.
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Indications for DEXILANT (dexlansoprazole)
Healing all grades of erosive esophagitis (EE) for up to 8 weeks
Maintaining healing of EE and relief of heartburn for up to 6 months
Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Important Safety Information
DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with DEXILANT use.
Symptomatic response with DEXILANT does not preclude the presence of
Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
Most commonly reported adverse reactions were 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 with DEXILANT because atazanavir systemic concentrations may be substantially decreased. DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. DEXILANT may increase serum levels
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References: 1. DEXILANT (dexlansoprazole) package insert, Takeda Pharmaceuticals America, Inc. 2. Frelinger AL III, Lee RD, Mulford DJ, et al. A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
J Am Coll Cardiol. 201259(14):1304-1311. Supplementary Online Appendix https://www.sciencedirect.com/science/article/pii/S073510971200246X.
Accessed March 27, 2012.
Dexilant KAPIDEX is the first and only acid reflux disease treatment that gives you two releases of medicine in one pill
Dexilant KAPIDEX works by releasing one shift of medicine within an hour of taking it to decrease the amount of acid in your stomach. Around 4?5 hours later, KAPIDEX releases a second shift of medicine. Two releases. One pill. Ask your doctor about KAPIDEX.
Uses of KAPIDEX
Persistent heartburn two or more days a week, despite treatment and diet changes, could be acid reflux disease (ARD). Prescription KAPIDEX capsules are used in adults to treat heartburn related to ARD, to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and to stop EE from coming back. Individual results may vary. Most damage (erosions) heals in 4?8 weeks.
Important Safety Information
KAPIDEX may not be right for everyone. You should not take KAPIDEX if you are allergic to KAPIDEX or any of its ingredients. Severe allergic reactions have been reported. Symptom relief does not rule out other serious stomach conditions. The most common side effects of KAPIDEX were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). KAPIDEX and certain other medicines can affect each other. Before taking KAPIDEX, tell your doctor if you are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, or tacrolimus. If you are taking KAPIDEX with warfarin, you may need to be monitored because serious risks could occur.
What you should tell your doctor before and while you take KAPIDEX
Tell your doctor about all your medical conditions. Be sure to tell your doctor if you:
* Are pregnant or could be p