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Ezetimibe (Zetia), NDA: 21-445. Ezetimibe /Simvastatin (Vytorin), NDA: 21687. Pediatric Exclusivity Date: February 14, 2008. Applicant/sponsor:

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Adverse effects occurring in patients receiving ezetimibe in combination with statins generally were similar to those reported in patients receiving statin therapy alone. However, the incidence of increased transaminase concentrations was higher in patients receiving combination therapy 1.Some drugs are strongly linked to causing ezetimibe tablet usp 10 mg and result in hair loss for most patients who take the drug, while other drugs may cause hair loss in some patients but not others.

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Patients may also receive adjunctive ezetimibe tablets e. LDL apheresis The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe.When ezetimibe is used as monotherapy, no dosage adjustment is necessary in patients with renal impairment.

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If Ezetimibe is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio INR should ezetimibe tabs10mg appropriately monitored see section 4.Drugs.

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It is unknown if this ezetimibe tablet passes into ezetimibe tablet milk.If the dose ofVYTORIN is changed or discontinued, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with daily had no significant effect on bioavailabilityof warfarin and prothrombin time in a study of twelve healthy adult males.


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