Creswell 80

Rx

Indications

• Treatment and prophylaxis of severe, life-threatening ventricular arrthythmias.
• Maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter.

Dosage

• The usual starting dose is 80mg/day, taken once or divided into two doses.
• The dose may be adjusted according to doctor’s instructions.
• Treatment with sotalol should not be discontinued suddenly.

Usage

• Orally administered.

• Hypersensitivity to sotalol, other beta-blockers or any of the excipients in the formulation.
• Children.
• Sick sinus syndrome.
• Second and third degree A-V heart block unless a functioning pacemaker is present.
• Congenital or acquired long QT syndromes.
• Torsades de pointes.
• Symptomatic sinus bradycardia.
• Uncontrolled congestive heart failure.
• Cardiogenic shock.
• Anaesthesia that produces myocardial depression.
• Untreated phaeochromocytoma.
• Hypotension (except due to arrhythmia).
• Raynaud’s phenomenon and severe peripheral circulatory disturbances.
• History of chronic obstructive airway disease or bronchial asthma.
• Metabolic acidosis.
• Renal failure.

Adverse effects are usually transient in nature and rarely necessitate interruption of, or withdrawal from treatment. These include dyspnoea, fatigue, dizziness, headache, fever, excessive bradycardia and/or hypotension. If they do occur, they usually disappear when the dosage is reduced. The most significant adverse effects, however, are those due to proarrhythmia, including torsades de pointes.

Common

• Bradycardia, dyspnoea, chest pain, palpitations, oedema,ECG abnormalities, hypotension, arrhythmia, syncope, heart failure, presyncope.
• Rash
• Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence.
• Muscle spasms.
• Fatigue, dizziness, asthenia, light-headedness, headache, paraesthesia, dysgeusia.
• Sleep disorder, mood altered, depression, anxiety.
• Sexual dysfunction.
• Visual disturbances.
• Hearing disturbances.
• Pyrexia.

• Treatment with sotalol should not be discontinued suddenly.
• The most dangerous adverse effect of the drug selatol is the aggravation of pre-existing arrhythmias or the provocation of new arrhythmias.
• Other risk factors for torsades de pointes were excessive prolongation of the QTc and history of cardiomegaly or congestive heart failure.
• Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of imbalance; Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhoea or patients receiving concomitant magnesium and/or potassium-depleting drugs.
• Caution is advised when initiating therapy in patients with left ventricular dysfunction controlled by therapy (i.e. ACE Inhibitors, diuretics, digitalis, etc);
• In post-infarction patients with impaired left ventricular function, the risk versus benefit of sotalol administration must be considered.
• People with asthma, severe heart failure, bradycardia, or long QT syndrome should not take this medication.
• Use with caution in patients with renal impairment or diabetes.
• Creswell 80 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Sotalol should be used in pregnancy only if the potential benefits outweigh the possible risk to the foetus.
• Breast feeding is therefore not recommended during administration of sotalol.
• There are no data available, but the occasional occurrence of side-effects such as dizziness and fatigue should be taken into account.