Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Amdipharm UK Limited, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF, United Kingdom
Trasicor Tablets are indicated in adults for the treatment of:
Angina Pectoris: For long-term prophylactic use (if necessary nitrates should be employed for alleviating acute attacks).
Hypertension: As monotherapy or for use in combination with other antihypertensives, e.g. with a diuretic, peripheral vasodilator, calcium channel blocker or ACE inhibitor.
Disturbances of cardiac rhythm: Especially supraventricular tachycardia, atrial fibrillation and digitalis-induced arrhythmias, ventricular tachycardia.
Short-term relief of functional cardiovascular disorders due to adrenergic hyperactivity: Such as cardiac neurosis, hyperkinetic heart syndrome and anxiety induced cardiovascular disorders.
The dosage should be individualised. Before raising the dosage, the heart rate at rest should always be checked. If it is 50-55 beats/min, the dosage should not be increased, see contraindications.
If the maximum recommended dose is insufficient to produce the desired response appropriate combined therapy should be considered.
When discontinuing prolonged treatment with a beta-blocker, the medication should not be interrupted abruptly, but withdrawn gradually.
Higher doses using conventional Trasicor Tablets may be administered in two or more divided doses.
No special dosage regime is necessary but concurrent hepatic insufficiency should be taken into account.
No adequate experience has been acquired on the use of Trasicor Tablets in children.
Hypertension: 80–160 mg total daily dose, given in 2 to 3 doses. If necessary, the dosage can be raised to 320 mg.
Angina pectoris: 80–160 mg total daily dose, given in 2 to 3 doses. If necessary, the dosage can be raised to 320 mg.
Distribution of cardiac rhythm: 40–240 mg total daily dose given in 2–3 doses. The maximum recommended dose is 240 mg/day.
Short-term relief of functional cardiovascular disorders due to adrenergic hyperactivity e.g. short-term relief of sympathomimetic symptoms of anxiety: 40–80 mg daily, given in 1 or 2 doses, is usually sufficient.
Trasicor Tablets should be swallowed with liquid.
Poisoning due to an overdosage of beta-blocker may lead to pronounced hypotension, bradycardia, hypoglycaemia, heart failure, cardiogenic shock, conduction abnormalities (first or second degree block, complete heart block, asystole), or even cardiac arrest. In addition, dyspnoea, bronchospasm, vomiting, impairment of consciousness and also generalised convulsions may occur. Rhabdomyolysis with myoglobinuria has been reported as a complication of severe overdosage with oxprenolol.
The manifestations of poisoning with beta-blocker are dependent on the pharmacological properties of the ingested drug. Although the onset of action is rapid, effects of massive overdose may persist for several days despite declining plasma levels. Watch carefully for cardiovascular or respiratory deterioration in an intensive care setting, particularly in the early hours. Observe mild overdose cases for at least 4 hours for the development of signs of poisoning.
Patients who are seen soon after potentially life-threatening overdosage (within 4 hours) should be treated by gastric lavage and activated charcoal.
Treatment of symptoms is based on modern methods of intensive care, with continuous monitoring of cardiac function, blood gases, and electrolytes, and if necessary intravenous fluid and electrolytes replacement, and emergency measures such as artificial respiration, resuscitation or cardiac pacemaker.
Significant bradycardia should be treated initially with atropine. Large doses of isoprenaline may be necessary for control of heart rate and hypotension. Glucagon has positive chronotropic and inotropic effects on the heart that are independent of interactions with beta-adrenergic receptors and it represents a useful alternative treatment for hypotension and heart failure.
For seizures, diazepam has been effective and is the drug of choice.
For bronchospasm, aminophylline, salbutamol or terbutaline (beta2-agonist) are effective bronchodilator drugs. Monitor the patient for dysrhythmias during and after administration.
Patients who recover should be observed for signs of beta-blocker withdrawal phenomenon (see section 4.4).
Shelf life: 5 years.
Protect from moisture.
PVC* Blister packs of 56 and 100 tablets.
* PVC 250 micron, aluminium foil 20 micron.
Not all pack sizes may be marketed.
None.
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