trailer 0000007607 00000 n trailer 0000000016 00000 n In addition, if required, the following therapeutic measures are suggested:Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing. %PDF-1.5 %���� 0000000995 00000 n 0000004780 00000 n 0000008918 00000 n 0000026506 00000 n 0000012376 00000 n 0000009818 00000 n 0000005902 00000 n It is supplied as a white, capsule-shaped tablet for oral administration. 0000009866 00000 n 0000014939 00000 n 0000029741 00000 n 0000008283 00000 n Approved by UHS Pharmacy & Therapeutics Cardiovascular Subcommittee: 4/2018 0000004633 00000 n 621 34 1415 0 obj <>stream %%EOF Alternatively, during hospitalization, the dose can be increased to 120 mg BID and the patient followed for 3 days on this dose (followed for 5 or If the 80 mg dose level (given BID or QD depending upon the creatinine clearance) does not reduce the frequency of relapses of AFIB/AFL and is tolerated without excessive QT interval prolongation (i.e., ≥520 msec), the dose level may be increased to 120 mg (BID or QD depending upon the creatinine clearance). You may report side effects to Health Canada at 1-866-234-2345.Sotalol may cause a condition that affects the heart rhythm (QT prolongation in the The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. 1372 44 Your fast/irregular heartbeat is more likely to return if you do not take sotalol properly. Betapace/Betapace AF is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. 0000003416 00000 n Do not double the dose to catch up.Store at room temperature away from light and moisture. 0000015870 00000 n 0000015049 00000 n 0000002325 00000 n 0000005139 00000 n

SOTALOL HYDROCHLORIDE, INDICATIONS AND USAGE Betapace AF is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFI DESCRIPTION . Page 6: Bayer HealthCare Pharmaceuticals Inc.: Betapace AF is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Betapace AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. 0000012436 00000 n Limitation of Use: Because Betapace/Betapace AF can cause life-threatening ventricular arrhythmias, reserve its use for

0000004158 00000 n 0000012991 00000 n Ɗ�/����J%�F���Kg~V}�;ý�����ν� �` Mylan manufactures SOTALOL HYDROCHLORIDE Tablets, USP (AF) (Betapace AF) in strengths of 80 mg120 mg160 mg Some conditions may become worse when you suddenly stop this drug.

0000016705 00000 n Betapace AF [package insert]. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. 0000010534 00000 n 0000004404 00000 n 0000090397 00000 n

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0000025812 00000 n Voluntary reports since introduction also include rare reports of: emotional liability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia. 0000090143 00000 n