INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SotaHexal 80 tablets
SotaHexal 160 tablets
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

SotaHexal 80 tablets
SotaHexal 160 tablets

COMPOSITION:
SotaHexal 80 tablets - each tablet contains 80 mg sotalol hydrochloride.
SotaHexal 160 tablets - each tablet contains 160 mg sotalol hydrochloride:

PHARMACOLOGICAL CLASSIFICATION:
A.5.2 Medicines affecting autonomic functions - adrenolytics (sympatholytics)

PHARMACOLOGICAL ACTION:
Sotalol hydrochloride is a synthetic beta-adrenergic blocking agent. It is non-cardioselective and is reported to lack both intrinsic sympathomimetic and membrane-stabilising properties.
In addition to its class II anti-arrythmic activity, sotalol lengthens the duration of the action potential resulting in class III anti-arrythmic activity.
Sotalol is almost completely absorbed from the gastro-intestinal tract and peak plasma concentrations occur 2 to 3 hours after a dose. The plasma elimination half-life is about 10 to 15 hours. It is not metabolised and is excreted unchanged in the urine. It is not bound to plasma proteins, crosses the placenta and is found in breast, milk however only small amounts are reported to cross the blood brain barrier and enter the CSF. Sotalol is removed by dialysis.

INDICATIONS:
Sotalol hydrochloride is indicated in the management of hypertension, angina pectoris and cardiac arrythmias. Sotalol has been given following myocardial infarction to prevent reinfarction and in addition has been given to reduce symptoms of sympathetic overactivity in hyperthyroidism.

CONTRA-INDICATIONS:
Sotalol should not be given to patients with bronchospasm or asthma or to those with a history of obstructive airways disease.
Metabolic acidosis, sinus bradycardia and partial heart block.
Sotalol should not be given to patients with congestive heart failure unless their heart failure is controlled and even then great care is necessary. Similarly patients with phaeochromacytoma should not receive sotalol without concomitant alpha-adrenoreceptor blocking therapy.

WARNINGS
Torsade de pointes has been reported in patients given sotalol, usually due to prolongation of the Q-T interval. The Q-T interval should be monitored and the dose of sotalol reduced it the Q-T interval exceeds 0,5 seconds. As hypokalaemia may predispose patients to arrythmias, serum electrolyte concentrations should be monitored before and during treatment with sotalol.
Beta-blockers may mask the symptoms of hyperthyroidism and of hypoglycaemia. They may unmask myasthenia gravis. Psoriasis may be aggravated.
Patients undergoing long-term treatment with a beta-blocker should have their medication discontinued gradually over a period of 1 - 2 weeks as abrupt withdrawal may result in angina, myocardial infarction ventricular arrythmias and death.
Prior to surgery, awareness by the anaesthetist that beta-blockers are being taken is very important.

DOSAGE AND DIRECTIONS FOR USE:
Hypertension: Initial oral dose 160 mg daily as a single or divided dose, which may be increased a fortnightly intervals according to the response of the patient to 600 mg or more daily.
Angina pectoris: Optimum dose between 160 and 600 mg daily.
Cardiac arrythmias: 120 to 480 mg daily.
Post MI to prevent re-infarction: 320 mg daily.
Hyperthyroidism to reduce symptoms of sympathetic overactivity: 120 to 240 mg daily.
Reduced doses may be required in renal impairment, hepatic dysfunction and in the elderly.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Administration of beta-blockers to pregnant women shortly before delivery has occasionally resulted in bradycardia and other adverse effects in the neonate. Sotalol diffuses into breast milk.
Troublesome subjective side effects include fatigue and cold extremities.
Cardiovascular side effects include bradycardia and hypotension; congestive heart failure or heart block may be precipitated in patients with underlying cardiac disorders.
Bronchospasm may be precipitated in susceptible patients. Pneumonitis, pulmonary fibrosis, and pleurisy have been reported.
Central nervous system effects include depression, hallucinations, confusion and sleep disturbances.
Parasthesia, peripheral neuropathy and myopathies have been reported.
Adverse gastro-intestinal effects include nausea and vomiting, diarrhoea, constipation and abdominal cramping.
Skin rash, uritus and reversible alopecia have occurred.
Ocular symptoms include decreased tear production, blurred vision and pain.
Haematological reactions include nonthrombocytopenic purpura, thrombocytopenia and rarely agranulocytosis. Transient eosinophilia can occur.
Metabolic changes can affect glucose control and cholesterol concentrations.
Other adverse effects reported include a lupus-like syndrome, male impotence, sclerosing peritonitis and retroperitoneal fibrosis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may produce bradycardia and severe hypotension.
Bronchospasm and heart failure may be produced in certain individuals.
Cases of mild overdose should be observed for at least 4 hours, as apnoea and cardiovascular collapse may appear suddenly.
Effects can include bradycardia, cardiac conduction block, hypotension, cardiac failure and cardiogenic shock, however overdosage of sotalol usually presents as ventricular tachyarrythmia. Convulsions, coma, respiratory depression and bronchoconstriction, although infrequent, can occur.
Treatment involves gastric lavage which should be performed, if within 4 hours of suspected overdose. Repeated activated charcoal is necessary in severe overdoses. Atropine may be used to treat Bradycardia. If the response is inadequate, glucagon may be given intravenously.
Alternatively dobutamine or isoprenaline may be required to counteract the beta-blockade.
Transvenous cardiac pacing may be required for severe bradycardia. Bronchospasm should be treated with IV aminophylline or inhaled or IV beta-agonists, eg, Salbutamol. If antiarrythmic agents are required, lignocaine or phenytoin are preferred. When indicated additional measures may be instituted to counter hypotension. Mild hypotension may respond to fluid administration; if hypotension continues, glucagon or sympathomimetic agents may be used.

IDENTIFICATION:
SotaHexal 80 - white, round, biconvex tablets, scored on one side, imprint "SOT" on the other side.
7,0 ± 0,1 mm (Diameter), 2,8-3,2 mm (Height)
SotaHexal 160 - white, round, biconvex tablet, scored on one side imprint "SOT" on the other side.
9,0 ± 0,1 mm (Diameter), 3,8-4,2 mm (Height)

PRESENTATION:
SotaHexal 80         - securitainers containing 100 tablets.
SotaHexal 160         - securitainers containing 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
SotaHexal 80         - 29/5.2/0749
SotaHexal 160         - 29/5.2/0750

NAME AND ADDRESS OF APPLICANT:
Hexal Pharma (SA)(Pty) Ltd.
Unit A
19 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1996

                SOTP4
                Pro-Print

Updated on this site: December 2004
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005