els of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24-hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Informat
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|SOURCE Avanir Pharmaceuticals, Inc.|
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. Avanir Pharmaceuticals Announces Date of Fiscal 2011 Fourth Quarter and Year End Financial Results and Conference Call2
. Avanir Pharmaceuticals to Participate in Piper Jaffray Health Care Conference3
. Avanir Pharmaceuticals Announces EMA Acceptance of Marketing Authorization Application for NUEDEXTA4
. Avanir Pharmaceuticals Submits European Marketing Authorization Application for NUEDEXTA5
. Avanir Pharmaceuticals to Present Data at the 2011 American Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine Annual Conference6
. Avanir Pharmaceuticals to Participate in Two Investor Conferences7
. Avanir Pharmaceuticals to Present at Stifel Nicolaus Healthcare Conference8
. Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents9
. Avanir Pharmaceuticals Reports Fiscal 2011 Third Quarter Financial Results10
. Avanir Pharmaceuticals Announces Appointment of Dr. Joao Siffert as Senior Vice President Research and Development11
. Avanir Pharmaceuticals to Present at Two Investor Conferences in August