Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Dronedarone (UNII: JQZ1L091Y2) (Dronedarone - UNII:JQZ1L091Y2)
sanofi-aventis U.S. LLC
Dronedarone
Dronedarone 400 mg
ORAL
PRESCRIPTION DRUG
MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)] . MULTAQ is contraindicated in patients with: - Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning, Warnings and Precautions (5.2)] - Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning, Warnings and Precautions (5.1)] - Second or third-degree atrioventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) - Bradycardia <50 bpm - Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see Drug Interactions (7.2)] - Concomitant use of erythromycin [see Clinical Pharmacology (12.3)] - Concomitant use of drugs or
MULTAQ 400-mg tablets are provided as white film-coated tablets for oral administration, oblong-shaped, engraved with a double wave marking on one side and "4142" code on the other side in: Store at room temperature between 68°F to 77°F (20°C to 25°C): excursions permitted to 59°F–86°F (15°C–30°C), [see USP controlled room temperature] .
New Drug Application
sanofi-aventis U.S. LLC ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2023 MEDICATION GUIDE MULTAQ® (MUL-tak) (dronedarone) tablets What is the most important information I should know about MULTAQ? MULTAQ may cause serious side effects, including: • Increased risk of death, stroke, and heart failure in people with: • A certain type of heart failure called decompensated heart failure. Heart failure is when your heart does not pump blood through your body as well as it should. MULTAQ can cause new or worsening heart failure. Do not take MULTAQ if you have symptoms of heart failure that recently worsened and you were hospitalized, or if you have severe heart failure. Call your healthcare provider right away if you develop any of the following signs or symptoms of heart failure during treatment with MULTAQ: • shortness of breath or wheezing at rest • wheezing, chest tightness or coughing up frothy sputum at rest, nighttime or after minor exercise • trouble sleeping or waking up at night because of breathing problems • using more pillows to prop yourself up at night so you can breathe more easily • gaining more than 5 pounds quickly • increasing swelling of feet or legs • A certain type of irregular heartbeat (rhythm) called permanent atrial fibrillation (AF). Permanent AF is when you and your healthcare provider decide not to try to change your heart rhythm back to a normal heart rhythm or your heart rhythm cannot be changed back to a normal rhythm. Do not take MULTAQ if you have permanent AF. Your healthcare provider should check your heart rhythm regularly to make sure your heart keeps a normal rhythm. Call your healthcare provider right away if you develop any of the following signs or symptoms of AF during treatment with MULTAQ such as: • fast or irregular heartbeat or pulse • chest pain • dizziness or lightheadedness • tiredness or weakness • reduced ability to exercise • shortness of breath MULTAQ doubles your risk o Lue koko asiakirja
MULTAQ- DRONEDARONE TABLET, FILM COATED SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MULTAQ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MULTAQ. MULTAQ® (DRONEDARONE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ MULTAQ IS CONTRAINDICATED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE WITH RECENT DECOMPENSATION REQUIRING HOSPITALIZATION OR NYHA CLASS IV HEART FAILURE. MULTAQ DOUBLES THE RISK OF DEATH IN THESE PATIENTS. (4, 5.1, 14.3) MULTAQ IS CONTRAINDICATED IN PATIENTS IN ATRIAL FIBRILLATION (AF) WHO WILL NOT OR CANNOT BE CARDIOVERTED INTO NORMAL SINUS RHYTHM. IN PATIENTS WITH PERMANENT AF, MULTAQ DOUBLES THE RISK OF DEATH, STROKE, AND HOSPITALIZATION FOR HEART FAILURE. (4, 5.2, 14.4) RECENT MAJOR CHANGES Dosage and Administration (2) 10/2023 Warnings and Precautions (5.8) 10/2023 INDICATIONS AND USAGE MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF (1, 14). DOSAGE AND ADMINISTRATION One tablet of 400 mg twice a day with morning and evening meals (2) DOSAGE FORMS AND STRENGTHS 400 mg film-coated tablets (3) CONTRAINDICATIONS Permanent AF (patients in whom normal sinus rhythm will not or cannot be restored) (Boxed Warning, 4) Recently decompensated heart failure requiring hospitalization or Class IV heart failure (Boxed Warning, 4) Second or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) (4) Bradycardia <50 bpm (4) Concomitant use of a strong CYP3A inhibitor (4) Concomitant use of erythromycin (4) Concomitant use of drugs or herbal products that prolong the QT interval and may induce torsade de Lue koko asiakirja