Sotalex 80

Sotalex 8080mg

Type:10 Tablets

Generic Name:Sotalol Hydrochloride

Manufacturer:Unimed Unihealth Pharmaceuticals Ltd.

Price:100.00

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Indication

Supraventricular arrhythmias, Ventricular arrhythmias, Acute arrhythmias

Administration

Should be taken on an empty stomach. Take 1-2 hr before meals.

Adult Dose

Oral Supraventricular and ventricular arrhythmias Adult: Initially, 80 mg/day as single or in 2 divided doses, increased gradually every 2-3 days. Usual dose: 160-320 mg/day in 2 divided doses. Life-threatening ventricular arrhythmias Adult: Initially, 80 mg bid, increased gradually every 3 days to 240-320 mg/day in divided doses if needed. Maintenance: 160-320 mg/day in divided doses. Max: 480-640 mg in divided doses.

Renal Dose

Renal impairment: CrCl (ml/min) Dosage Recommendation 30-60 Half the usual dose. 10-30 Quarter the usual dose. <10 Not recommended.

Contraindication

Bronchial asthma or history of COPD, sick sinus syndrome, symptomatic sinus bradycardia, cardiogenic shock. 2nd and 3rd degree AV block, untreated phaeochromocytoma, torsades de pointes, congenital or acquired long QT syndromes, uncontrolled cardiac failure, cardiogenic shock, metabolic acidosis, hypotension, severe peripheral arterial disease, Raynaud's disease, anaesthesia that causes myocardial depression. Renal impairment (CrCl <10 mL/min). Concomitant use w/ Ca channel blockers (e.g. verapamil and diltiazem).

Mode of Action

Sotalol is a non-cardioselective beta-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties.

Precaution

Patients w/ well-compensated heart failure, myasthenia gravis, DM, 1st degree AV block. May mask symptoms of hyperthyroidism and hypoglycaemia. May worsen psoriasis. Patients undergoing major surgery requiring general anaesth. Avoid abrupt withdrawal as it may precipitate thyroid storm and exacerbate angina and MI. Renal impairment. Pregnancy and lactation. Monitoring Parameters Monitor BP, heart rate, serum creatinine; Mg and K levels.

Side Effect

>10% Dyspnea (21%),Dizziness (20%),Fatigue (20%),Bradycardia (16%),Chest pain (16%),Palpitation (14%),Weakness (13%),Lightheadedness (12%) 1-10% Nausea/vomiting (10%),Edema (8%),Headache (8%),Sleep disturbances (8%),Abnormal ECG (7%),Diarrhea (7%),Extremity pain (7%),Hypotension (6%),Mental confusion (6%),Congestive heart failure (5%),Itching/rash (5%),Syncope (5%),Anxiety (4%),Depression (4%),Torsades de pointes or new ventricular tachycardia/fibrillation in patients with supraventricular arrhythmia (4%),Peripheral vascular disorders (3%),Impotence (2%),Proarrhythmic effect (1.5-2%),Torsades de pointes with history of sustained ventricular tachycardia (1%) Frequency Not Defined Catechol hypersensitivity after abrupt withdrawal,Increased insulin requirement in diabetics Potentially Fatal: Polymorphic ventricular tachycardia (very rare). Rebound hypertension.

Interaction

May increase risk of bradycardia w/ digoxin. May increase risk of arrhythmias w/ diuretics. May potentiate rebound HTN w/ clonidine. May prolong refractoriness w/ disopyramide, quinidine, procainamide, amiodarone and bepridil. May prolong QT interval w/ TCAs, phenothiazines, terfenadine and astemizole. Increased risk of torsades de pointes w/ K-depleting diuretics, erythromycin IV, halofantrine, pentamidine, and quinolones. May prolong neuromuscular blockade of tubocurarine. May reduce response to insulin and oral hypoglycaemics. Potentially Fatal: Additive effect on AV conduction and ventricular function w/ verapamil and diltiazem.

Alternative brand of Sotalex 80