Approximately 50% of labetalol in the blood is protein bound. There have been very rare reports of severe hepatocellular injury with labetalol therapy. Caution is advised in patients with peripheral arterial disease (Raynauds syndrome, claudicatio intermittens), as labetalol may exacerbate their symptoms.
Due to the pharmacological action of alpha- and beta-adrenoceptor blockade, adverse effects on the foetus and neonate when used in the later stages of pregnancy (bradycardia, hypotension, respiratory depression, hypoglycaemia), should be borne in mind, as labetalol crosses the placental barrier.
When suggestions are available use up and down arrows to review and ENTER to select. Concomitant use of tricyclic antidepressants may increase the incidence of tremor. Non-necessary. disopyramide and quinidine) and amiodarone (Class II antiarrhythmics).Risk of marked bradycardia and hypotension in combination with calcium antagonists with negative inotropic effect (e.g., verapamil, diltiazem), especially in patients with an impaired ventricular function and/or conduction disorders. The occurrence of intraoperative Floppy Iris Syndrome (IFIS, a variant of Small Pupil Syndrome) has been observed during cataract surgery in some patients on, or previously treated with, or previously treated with tamsulosin. In a study of 10 patients with histologically proven cirrhosis, exposure to oral labetalol was increased approximately three-fold compared with healthy controls. Beta blockers reduce the risk of arrhythmias during anaesthesia, but may lead to reduction of the reflectoric tachycardia and increase the risk of hypotension during anaesthesia. Beta-blockers may reduce uterine blood flow.Labetalol should only be used during pregnancy if the benefits for the mother outweigh the risks for the foetus.Labetalol is excreted in breast milk in small amounts (approximately 0.004- 0.07% of the maternal dose). References: 1. Gradual discontinuance of the medicinal product should be considered if any such reaction is not otherwise explicable. Close monitoring 24 - 48 hours after birth is required. 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. nitrates, antipsychotics (phenothiazine derivatives such as chloropromazine) and other antipsychotics, antidepressants.Based on experience during human pregnancy, labetalol is not expected to increase the risk of congenital malformations. Clipboard, Search History, and several other advanced features are temporarily unavailable.
Animal studies do not indicate teratogenicity. labetalol administration should be avoided since excessive postural hypotension may occur. No data are available.Precautions to be taken before handling or administering the medicinal product:Patients should always receive the medicinal product whilst in the supine or left lateral position.Raising the patient into the upright position within 3 h of I.V.
The hepatic injury is usually reversible and has occurred after both short- and long-term treatment. Such patients may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.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 section 4.5 Interaction with other medicinal products and other forms of interaction).Upon severe influence of adrenaline as in phaeochromocytoma, labetalol may cause a paradoxical blood pressure elevation. There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking medicinal products. A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the maximum recommended human dose revealed no evidence of drug-related harm to the foetus.Sodium hydroxide and hydrochloric acid (for pH adjustment).Labetalol injection has been shown to be incompatible with Sodium Bicarbonate injection BP 4.2% w/v.Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, 30°C and 40°C.From a microbiological point of view, the product should be used immediately. The effective dose is usually 50 to 200 mg, but larger doses may be needed, especially in patients with phaeochromocytoma.The safety and efficacy of labetalol in paediatric patients aged 0 to 18 years have not been established. Labetalol may enhance the hypotensive effect of volatile anaesthetics.