DRONEDARONE FC TAB 400 MG 60 UNITS MULTAQ SANOFI AVENTIS

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DRONEDARONE FC TAB 400 MG 60 UNITS MULTAQ SANOFI AVENTIS

Contents Dronedarone Indications/Uses Patients w/ persistent or paroxysmal atrial fibrillation (AF) or atrial flutter (AFL), who are in sinus rhythm or will be cardioverted for maintenance of sinus rhythm &/or to prevent recurrence of AF/AFL or lower ventricular rate & reduce frequency of CV hospitalization. Dosage/Direction for Use Adult 400 mg bid as 1 tab in the morning & evening. Administration Should be taken with food: Avoid grapefruit juice. Contraindications Hypersensitivity. 2nd- or 3rd-degree AV block, complete bundle branch & distal block, sinus node dysfunction, atrial conduction defects or sick sinus syndrome (except when used in combination w/ functioning pacemaker); bradycardia <50 bpm; permanent AF patients w/ AF duration ≥6 mth or unknown duration & restoring sinus rhythm is no longer considered. Unstable hemodynamic conditions. History of, or current heart failure or left ventricular systolic dysfunction. Coadministration w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, cyclosporin & ritonavir. Torsades de Pointes-inducing drugs eg, phenothiazines, cisapride, bepridil, TCAs, terfenadine, oral macrolides, class I & III antiarrhythmics. QTc (Bazett) interval ≥500 ms. Severe hepatic insufficiency. Liver & lung toxicity related to previous amiodarone use. Pregnancy & lactation. Special Precautions Discontinue if permanent AF, signs & symptoms of heart failure (eg, wt gain, edema or increasing shortness of breath), left ventricular systolic dysfunction develop; QTc (Bazett) interval is ≥500 ms. W/draw treatment if ALT is confirmed >3x ULN. Not to be restarted in patients w/o another explanation for observed liver injury. Carefully evaluate onset of dyspnoea or non-productive cough related to pulmonary toxicity. Patients w/ heart failure or left ventricular systolic dysfunction; CAD; in unstable hemodynamic conditions, history of, or current heart failure or left ventricular systolic dysfunction. Larger increased in creatinine, including pre-renal azotaemia cases secondary to CHF, hypoperfusion or hypovolemia after treatment initiation. ILD including pneumonitis & pulmonary fibrosis. Perform ECG at least every 6 mth during treatment; assay of serum creatinine recommended 7 days after treatment initiation. Periodically monitor renal function. Obtain LFTs prior to treatment, then monitor after 1 wk & after 1 mth following treatment initiation, mthly for 6 mth, at mth 9 & 12, & periodically thereafter, & re-measure in elevated ALT >3x ULN levels. Correct hypokalemia, any K or Mg deficiency prior instituting & during treatment. Closely monitor INR in patients taking vit K antagonists after treatment initiation & should be appropriately anti-coagulated where applicable. Proarrhythmic effects may occur w/ concomitant use of drugs promoting arrhythmia &/or electrolyte disorders. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Premenopausal women who have not undergone hysterectomy or oophorectomy, & women of childbearing potential should use effective methods of contraception during treatment. Not recommended for childn & adolescents. Elderly ≥75 yr w/ multiple co-morbidities. Adverse Reactions Bradycardia; dysgeusia; diarrhea, vomiting, nausea, abdominal pain, dyspepsia; generalized, macular, maculopapular rash, pruritus; fatigue, asthenia. Drug Interactions Drugs inducing Torsades de Pointes, eg, phenothiazines, cisapride, bepridil, TCAs, certain oral macrolides, terfenadine & Class I & III antiarrhythmics; ketoconazole & other potent CYP3A4 inhibitors eg, itraconazole, voriconazole, ritonavir, telithromycin, clarithromycin, or cyclosporin. Increased exposure w/ diltiazem, verapamil, & nifedipine; grapefruit juice. Increased steady state exposure w/ erythromycin in repeated doses. Decreased exposure w/ rifampicin & other potent CYP3A4 inducers eg, phenobarb, carbamazepine, phenytoin, or St John's Wort. Increased exposure of simvastatin & simvastatin acid; lovastatin, atorvastatin & pravastatin; β-blockers, metoprolol; digoxin; rivaroxaban. Increased tacrolimus & sirolimus plasma conc. Minor interaction w/ antidepressants. Increased dabigatran AUC0-24, & Cmax. Inhibited P-gp w/ doxorubicin, fexofenadine & talinolol. Increased edoxaban AUC & Cmax. Increased INR w/ or w/o bleeding w/ oral vit K antagonists. MIMS Class Cardiac Drugs ATC Classification C01BD07 - dronedarone ; Belongs to class III antiarrhythmics. Thai FDA Category D

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