INHALED THERAPY FOR CARDIAC ARRHYTHMIA
The present disclosure relates to methods and kits for use in pharmacological treatment of cardiac arrhythmia (e.g., atrial fibrillation) in subjects with certain anthropometric characteristics, including overweight subjects.
1 - 315 . (canceled)
316 . A method of treating cardiac arrhythmia in a subject, wherein the method comprises:
(a) administering to said subject via oral inhalation a first dose of a pharmaceutical composition, wherein said pharmaceutical composition is an aqueous solution that comprises flecainide or a pharmaceutically acceptable salt thereof at a concentration that is at least 60 mg/mL;
(b) after the administering of (a), waiting for a period of time, wherein said period of time is at least about 10 minutes; and
(c) after the waiting, administering to said subject a second dose of said pharmaceutical composition via oral inhalation, wherein said second dose comprises said flecainide or salt thereof in an amount that is equivalent to about 40% to about 100% (w/w) of said first dose.
317 . The method of claim 316 , wherein said second dose comprises said flecainide or pharmaceutically acceptable salt thereof in an amount that is equivalent to about 40% to about 80% (w/w) of said first dose.
318 . The method of claim 316 , wherein said second dose comprises said flecainide or pharmaceutically acceptable salt thereof in an amount that is equivalent to said first dose.
319 . The method of claim 316 , wherein said pharmaceutical composition comprises flecainide acetate at a concentration of about 65 mg/mL to about 130 mg/mL.
320 . The method of claim 316 , wherein said pharmaceutical composition comprises flecainide acetate at a concentration of about 75 mg/mL.
321 . The method of claim 316 , wherein said cardiac arrhythmia comprises atrial arrhythmia.
322 . The method of claim 316 , wherein said cardiac arrhythmia comprises atrial fibrillation.
323 . A method of treating cardiac arrhythmia, the method comprising:
(a) identifying a subject that: (i) is suffering from said cardiac arrhythmia, and (ii) has a qualifying body mass index (BMI), wherein said qualifying BMI is a BMI of no more than about 40 kg/m 2 ;
(b) designating said subject as eligible for treatment at least on the basis that said subject has said qualifying BMI;
(c) administering to said subject via oral inhalation a pharmaceutical composition that comprises a therapeutically effective amount of flecainide or a pharmaceutically acceptable salt thereof in accordance with said designating.
324 . The method of claim 323 , wherein said subject has a systolic blood pressure that is greater than about 90 mmHg at initiation of said administering.
325 . The method of claim 323 , wherein said subject has a ventricular rate that is no more than 170 BPM at initiation of said administering.
326 . The method of claim 323 , wherein said subject has a ventricular rate that is from about 80 BPM to about 155 BPM at initiation of said administering.
327 . The method of claim 323 , wherein said qualifying BMI is a BMI of no more than about 35 kg/m 2 .
328 . The method of claim 323 , wherein said pharmaceutical composition comprises flecainide acetate at a concentration of about 65 mg/mL to about 130 mg/mL.
329 . The method of claim 323 , wherein said pharmaceutical composition comprises flecainide acetate at a concentration of about 75 mg/mL.
330 . The method of claim 328 , wherein about 100 mg to about 250 mg of flecainide acetate is administered to said subject via inhalation.
331 . The method of claim 323 , wherein said administration is performed via a nebulizer.
332 . The method of claim 331 , wherein said nebulizer is a vibrating mesh nebulizer.
333 . The method of claim 323 , wherein said cardiac arrhythmia comprises atrial fibrillation.
334 . A kit comprising a first dose and a second dose of a pharmaceutical composition formulated for oral inhalation, wherein:
(a) said pharmaceutical composition comprises flecainide or a pharmaceutically acceptable salt thereof;
(b) said second dose comprises said flecainide or a pharmaceutically acceptable salt thereof in an amount that is equivalent to about 40% to about 80% (w/w) of said first dose;
(c) said first dose is provided in a first vessel, and said second dose is provided in a second vessel.
335 . The kit of claim 334 , wherein said pharmaceutical composition comprises flecainide acetate at a concentration that is at least 60 mg/mL.