Therapeutic Classification: antiarrhythmics (class III)
REMS
Betapace AF and Sotylize:
- Maintenance of sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter who are currently in sinus rhythm.
Absorption: Well absorbed following oral administration.
Distribution: Widely distributed to tissues.
Metabolism/Excretion: Primarily excreted as unchanged drug in the urine.
Half-life: 12 hr (↑ in renal impairment).
CV: ARRHYTHMIAS, BRADYCARDIA, HF, orthostatic hypotension.
Derm: itching, rash.
EENT: blurred vision, dry eyes, nasal stuffiness.
Endo: hyperglycemia, hypoglycemia.
GI: constipation, diarrhea, nausea.
GU: erectile dysfunction, ↓ libido.
MS: arthralgia, back pain, muscle cramps.
Neuro: fatigue, weakness, anxiety, depression, dizziness, drowsiness, insomnia, memory loss, mental status changes, nervousness, nightmares, paresthesia.
Resp: bronchospasm, PULMONARY EDEMA, wheezing.
Ventricular Arrhythmias
- PO (Adults): 80 mg twice daily; may gradually ↑ (usual maintenance dose is 160–320 mg/day in 2–3 divided doses; some patients may require up to 480–640 mg/day).
Renal Impairment
- PO (Adults): CCr 30–59 mL/min: initial dose of 80 mg, with subsequent doses given every 24 hr; CCr 10–29 mL/min: initial dose of 80 mg, with subsequent doses given every 36–48 hr.
Atrial Fibrillation/Atrial Flutter
- PO (Adults): 80 mg twice daily; may ↑ to 120 mg twice daily, if necessary.
Renal Impairment
- PO (Adults): CCr 40–60 mL/min: Administer every 24 hr.
Betapace, Betapace AF, Sorine, Sotylize
500 ms, reduce dose, prolong duration of infusion, or discontinue therapy.