Trandate Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
Liver disease: Care should be taken in liver disease. There have been very rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long term treatment. However, hepatic necrosis, in some cases with fatal outcome, has been reported. Appropriate laboratory testing should be done at the first sign or symptom of liver dysfunction.
If there is laboratory evidence of liver injury or the patient is jaundiced, labetalol therapy should be stopped and not re-started.
Tablet: Particular care should be taken when labetalol is used in patients with hepatic impairment as these patients metabolise labetalol more slowly than patients without hepatic impairment. Lower doses may be required (see Dosage & Administration, Pharmacology: Pharmacokinetics: Special Patient Populations under Actions.)
Injection: Particular care should be taken when labetalol is used in patients with hepatic impairment as these patients metabolise labetalol more slowly than patients without hepatic impairment.
Peripheral vascular disease: Labetalol should be used with caution in patients with peripheral vascular disease as their symptoms may be exacerbated. Caution is advised in patients with peripheral arteriolarydisease (Raynauds syndrome, claudicatio intermittens) as labetalol may exacerbate their symptoms. Alpha-block may counter the unfortunate effect of beta-blockers.
Symptomatic bradycardia: If the patient develops symptomatic bradycardia, then the dosage of labetalol should be reduced.
First-degree atrio ventricular block: Given the negative effect of beta-adrenoceptor blocking drugs on atrioventricular conduction time, labetalol should be administered with caution to patients with first-degree atrio-ventricular block.
Diabetes mellitus: Care should be taken in case of uncontrolled or difficult-to-control diabetes mellitus. As with other beta-adrenoceptor blocking medicinal products, labetalol may mask the symptoms of hypoglycaemia (tachycardia and tremor) in diabetic patients. The hypoglycaemic effect of insulin and oral hypoglycaemic agents may be enhanced by beta blockers.
Thyrotoxicosis: Beta blockers may mask the symptoms of thyrotoxicosis, but the thyroid function is not altered.
Hypersensitivity to beta blockers: Risk of anaphylactic reaction: while taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Adrenaline: If patients receiving labetalol require adrenaline treatment, a reduced dosage of adrenaline should be used as concomitant administration of labetalol with adrenaline may result in bradycardia and hypertension (see Interactions).
Upon severe influence of adrenaline as in pheochromocytoma, labetalol may cause a paradoxical blood pressure elevation.
Skin rashes and/or dry eyes: There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn. Gradual discontinuance of the drug should be considered if any such reaction is not otherwise explicable.
Intraoperative Floppy Iris Syndrome: The occurrence of Intraoperative Floppy Iris Syndrome (IFIS, a variation of Small Pupil Syndrome) has been observed during cataract surgery in some patients on, or previously treated with, tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation, current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Heart failure or poor left ventricular function: Special care should be taken with patients who suffer from heart failure or poor left ventricular systolic function. Labetalol is contraindicated in uncontrolled heart failure, but may be used with caution in patients who are well managed and free of symptoms. Heart failure should be controlled with appropriate therapy before use of labetalol.
Use of beta blockers implies a risk of inducing or exacerbating heart failure or obstructive lung disease. In case of heart failure the myocardial contractility should be maintained and the failure should be compensated. Patients with reduced contractility, particularly the elderly, should be monitored regularly for development of heart failure.
It is strongly recommended not to stop treatment with labetalol abruptly especially in patients with heart failure and patients with angina pectoris (risk of exacerbation of angina, myocardial infarction and ventricular fibrillation).
Inhalation anaesthetics: Care should be taken with concomitant treatment with inhalation anaesthetics (see Interactions). Labetalol need not be discontinued prior to anaesthesia but patients should receive i.v. atropine prior to induction. Labetalol may enhance the hypotensive effects of volatile anaesthetics.
Metabolic acidosis and pheochromocytoma: Care should be taken in cases of metabolic acidosis and pheochromocytoma. In patients with pheochromocytoma, labetalol may be administered only after adequate alpha-blockade is achieved.
Calcium antagonists: Care should be taken if labetalol is used concomitantly with calcium antagonists, particularly the "calcium entry blockers", which influence contractility and AV conduction negatively.
Care should be taken with concomitant administration of adrenaline, verapamil or Class-1 antiarrhythmics.
Beta blockers have negative inotropic effect, but do not affect the positive inotropic effect of digitalis.
Tablet: Patients, particularly those with ischaemic heart disease, should not interrupt/discontinue abruptly labetalol therapy. Discontinuation in patients with ischemic heart disease should be done gradually during a period of 7-10 days, if possible.
Injection: Sudden haemorrhage: During anaesthesia, labetalol injection may mask the compensatory physiological responses of sudden haemorrhage (tachycardia and vasoconstriction). Close attention must therefore be paid to blood loss and the blood volume maintained.
Ability to Perform Tasks That Require Judgement, Motor or Cognitive Skills: Tablet: The use of labetalol tablets is unlikely to result in an impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that occasionally dizziness or fatigue may occur.
No common information.
Renal impairment: Caution is advised when labetalol is used in patients with severe renal impairment (GFR = 15-29 ml/min/1.73m2).
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