Propafenone oral tablet is used to treat and prevent irregular heart rhythms. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Propafenone is also indicated for the prophylaxis and treatment of paroxysmal supraventricular tachyarrhythmias which include paroxysmal atrial flutterfibrillation and paroxysmal reentrant tachycardias involving the av node or accessory bypass. Propafenone hydrochloride extendedrelease capsules is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation af in patients with episodic most likely paroxysmal or persistent af who do not have. Propafenone hydrochloride 150mg filmcoated tablets are supplied in aluminiumpvcpvdc blisters containing 20. The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. Its prescribed for people with atrial fibrillation or flutter, ventricular arrhythmias. Rytmonorm 150mg plevele dengtos tabletes n50 vaistai. You may need a lower dose of propafenone hydrochloride tablets if you are elderly, if you have problems with your kidneys or liver, or if you have a low bodyweight.
Labelingpackage insert, labelingpatient package insert. Sirdies ir kraujagysliu sistema veikiantys vaistai. Propafenone has some structural similarities to betablocking agents. Propafenone hydrochloride extendedrelease capsules contain nlt 90. Productspecific guidances for generic drug development. Propafenone hydrochloride is an antiarrhythmic drug supplied in filmcoated tablets of 150 mg, 225 mg and 300 mg for oral administration. Propafenone hydrochloride 300mg filmcoated tablets are white to off white, round shaped, biconvex, filmcoated tablets with a score line on one side and plain on the other side. Propafenone is indicated for the prophylaxis and treatment of ventricular arrhythmias. Drug name active ingredients strength dosage formroute marketing status te code rld rs.
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