Adult: As substitute when oral sotalol therapy is not feasible: Dose equivalences when converting between oral to IV dosing: 75 mg IV for 80 mg oral dose, 112.5 mg IV for 120 mg oral dose, and 150 mg IV for 160 mg oral dose (refer to detailed product information). Initially, 75 mg bid via infusion over 5 hours using a volumetric infusion pump. If initial dose does not decrease relapse frequency or does not produce excessive QT prolongation after 3 days, dose may be increased to 112.5 mg bid. If response is inadequate and without excessive QT prolongation after another 3 days, may further increase dose to Max of 150 mg bid. All doses must be individualised based on the patient's response. Dosage recommendations may vary between countries (refer to specific local treatment guidelines).
Oral Life-threatening ventricular arrhythmias
Adult: Initially, 80 mg daily as a single dose or in 2 divided doses, then increased gradually at intervals of 2-3 days according to individual response. Alternatively, a higher initial dose of 80 mg bid may be given, then gradually increase the dose every 3 days. Usual maintenance dose: 160-320 mg daily given in 2 divided doses. Doses as high as 480-640 mg daily may be needed in some patients with refractory cases. Dosage recommendations may vary between countries and among individual products (refer to specific product information or local treatment guidelines).
Adult: For the maintenance of normal sinus rhythm following conversion of atrial fibrillation or flutter, and treatment of symptomatic non-sustained ventricular tachyarrhythmias: Initially, 80 mg daily as a single dose or in 2 divided doses; increase the dose gradually at intervals of 2-3 days to 160-320 mg daily given in 2 divided doses according to individual response. Alternative dosing for the maintenance of normal sinus rhythm in atrial fibrillation or flutter: Initially, 80 mg bid, may be increased in increments of 80 mg daily every 3 days to 120 mg bid if QT interval is <500 milliseconds. Dosage recommendations may vary between countries and among individual products (refer to specific product information or local treatment guidelines).
Dosage recommendations may vary between countries and among individual products (refer to specific product information or local treatment guidelines).
Administration
May be taken with or without food.
Reconstitution
Concentrate for IV infusion: Dilute in an appropriate volume of NaCl 0.9% solution, dextrose 5% in water, or Ringer's lactate.
Contraindications
Bronchial asthma, history of chronic obstructive airway disease, other related bronchospastic conditions; 2nd- or 3rd-degree AV block (unless a functioning pacemaker is present), cardiogenic shock, sick sinus syndrome, congenital or acquired long QT syndrome, torsades de pointes, uncontrolled or decompensated heart failure, symptomatic sinus bradycardia (<50 bpm); untreated phaeochromocytoma; hypotension (except due to arrhythmia); severe peripheral circulatory disturbances; metabolic acidosis. Severe renal impairment (CrCl <10 mL/min). Concomitant use with anaesthetics that produce myocardial depression.
Special Precautions
Patient with 1st-degree AV block, recent MI (within 2 weeks), compensated heart failure, history of CHF, left ventricular dysfunction controlled by therapy (particularly ACE inhibitors, diuretics, or digitalis glycosides); electrolyte imbalance, diabetes mellitus, history of spontaneous hypoglycaemic episodes, thyroid disease, myasthenia gravis; peripheral vascular disease, Raynaud's disease; history of severe anaphylaxis to allergens. Patients undergoing major surgery. Use sotalol with extreme caution if the QT interval is >500 milliseconds during therapy; if the QT interval is >550 milliseconds, consider reducing sotalol dose or discontinuing the treatment. May mask signs or symptoms of hypoglycaemia and hyperthyroidism (e.g. tachycardia). Avoid abrupt withdrawal (particularly in patients with CAD). Mild to moderate renal impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: New onset or exacerbation of heart failure, sinus bradycardia (including heart block), hypotension; may precipitate or aggravate symptoms of arterial insufficiency; anaphylactic reactions. Rarely, exacerbation of psoriasis symptoms. Cardiac disorders: Chest pain, palpitations. Ear and labyrinth disorders: Hearing disturbances. Eye disorders: Visual disturbance. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, flatulence, dysgeusia. General disorders and administration site conditions: Fatigue, asthenia, pyrexia. Investigations: Abnormal ECG. Metabolism and nutrition disorders: Oedema. Musculoskeletal and connective tissue disorders: Muscle spasms, musculoskeletal pain. Nervous system disorders: Headache, dizziness, paraesthesia, syncope, presyncope. Psychiatric disorders: Sleep disorder, altered mood, depression, confusion, anxiety. Reproductive system and breast disorders: Sexual dysfunction. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis. Potentially Fatal: Severe ventricular arrhythmias (e.g. sustained ventricular tachycardia or ventricular fibrillation, particularly torsades de pointes).
Perform baseline ECG to check the QT interval and obtain serum creatinine (for CrCl calculation), serum K, and serum Mg levels before treatment initiation; correct any electrolyte imbalance if present. Closely monitor QT interval 2-4 hours after each dose during treatment initiation and titration period; serum creatinine, serum Mg and K levels, heart rate, and blood pressure during therapy. Monitor serum glucose (in patients with diabetes) and lung function (in patients with a history of obstructive airway disease). Assess for signs and symptoms of heart failure.
Overdosage
Symptoms: Bradycardia, CHF, hypotension, bronchospasm, hypoglycaemia, QT interval prolongation, premature ventricular complexes, ventricular tachycardia, and torsades de pointes. Management: Symptomatic treatment. For bradycardia, administer IV atropine then consider giving another anticholinergic drug and β-adrenergic agonist (e.g. IV isoprenaline) if bradycardia persists; in refractory cases, a transvenous cardiac pacemaker may be considered. Perform transvenous cardiac pacing for 2nd- or 3rd-degree heart block. Epinephrine may be used for hypotension depending on associated factors. To treat bronchospasm, consider administering aminophylline or β2-receptor stimulant (aerosol). Treat torsades de pointes with cardioversion, transvenous cardiac pacing, epinephrine, and/or IV magnesium sulfate.
Drug Interactions
Additive effects on AV conduction and ventricular function with cardiodepressant Ca channel blockers (e.g. verapamil, diltiazem). May result in prolonged refractoriness with class Ia antiarrhythmics (e.g. disopyramide, quinidine, procainamide) and other class III antiarrhythmic drugs (e.g. amiodarone). Additive class II effects with other β-blockers. May increase the risk of provoking proarrhythmic effects (especially torsades de pointes) with other agents known to prolong QT interval (e.g. phenothiazines, TCAs, terfenadine, astemizole, quinolone antibiotics, IV erythromycin, halofantrine, pentamidine). May cause hypokalaemia/hypomagnesaemia which may increase the risk of torsades de pointes with K-depleting diuretics or other K-depleting agents (e.g. IV amphotericin B, systemic corticosteroids, some laxatives). May impede the compensatory CV reactions associated with hypotension or shock that may be induced by floctafenine. May cause an excessive reduction of resting sympathetic nervous tone with catecholamine-depleting drugs (e.g. reserpine, guanethidine). May result in protracted severe hypotension or difficulty restoring normal cardiac rhythm with anaesthesia. May enhance the rebound hypertension that can occur after the discontinuation of clonidine. May prolong neuromuscular blockade of tubocurarine. May lead to hyperglycaemia when given with insulin and oral hypoglycaemics.
Food Interaction
Reduced absorption by approx 20% with food.
Lab Interference
May falsely increase the urinary metanephrine levels when measured by fluorimetric or photometric methods. May result in false-positive aldosterone/renin ratio (ARR).
Action
Description: Mechanism of Action: Sotalol, a non-cardioselective β-blocker, is an antiarrhythmic agent that exhibits both β-adrenoceptor blocking (Vaughan Williams class II) and cardiac action potential duration prolongation (Vaughan Williams class III) properties. It is a competitive antagonist at both β1- and β2-receptors resulting in increased sinus cycle length, slowed heart rate, decreased AV nodal conduction, and increased AV nodal refractoriness. Additionally, sotalol delays the repolarisation phase thereby prolonging the action potential duration in the cardiac tissues. It does not possess intrinsic sympathomimetic and membrane-stabilising activities. Onset: 1-2 hours (oral); approx 5-10 minutes (IV). Pharmacokinetics: Absorption: Almost completely absorbed from the gastrointestinal tract. Reduced absorption by approx 20% with food. Bioavailability: 90-100% (oral). Time to peak plasma concentration: 2.5-4 hours (oral). Distribution: Crosses the placenta and enters breastmilk. Distributes in CSF (small amounts). Volume of distribution: 1.2-2.4 L/kg. Excretion: Mainly via urine (as unchanged drug). Elimination half-life: 10-20 hours.
Chemical Structure
Sotalol Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5253, Sotalol. https://pubchem.ncbi.nlm.nih.gov/compound/Sotalol. Accessed Sept. 24, 2024.
C07AA07 - sotalol ; Belongs to the class of non-selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
References
Anon. Sotalol Hydrochloride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/09/2024.Betapace Tablet and Betapace AF Tablet (Covis Pharma US, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/09/2024.Brayfield A, Cadart C (eds). Sotalol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2024.Joint Formulary Committee. Sotalol Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2024.Sopressor 80 Tablet (Imeks Pharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/09/2024.Sotacor 80 mg Tablets (Neon Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/09/2024.Sotalol Hydrochloride Injection (ALTATHERA Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 17/09/2024.Sotalol. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/09/2024.Sotylize Solution (Azurity Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/09/2024.Viatris Ltd. Sotalol 80 mg and 160 mg Tablet data sheet 27 May 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 03/09/2024.
Sign Out
Lanjutkan dengan Google