Description

Labetalol in combination with tricyclic antidepressants may cause tremor; Cimetidine has been shown to increase the bioavailability of Labetalol. If Labetalol is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur; Care should be taken if Labetalol is used concomitantly with calcium antagonists of the verapamil type; Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Pregnancy Category C. Teratogenic studies were performed with Labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Labetalol Hydrochloride given to pregnant women with hypertension did not appear to affect the usual course of labor and delivery. Small amounts of Labetalol (approximately 0.004% of the maternal dose) are excreted in human milk. Caution should be exercised when Labetalol tablets are administered to a nursing woman.

Labetalol Hydrochloride should be used with caution in patients with Impaired Hepatic Function, Congestive Heart Failure, Exacerbation of Ischemic Heart Disease, Nonallergic Bronchospasm, Pheochromocytoma, Diabetes Mellitus and Hypoglycemia.

Overdosage with Labetalol causes excessive hypotension and sometimes, excessive bradycardia. If overdosage with Labetalol follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary: Excessive bradycardia-administer atropine or epinephrine; Cardiac failure-administer a digitalis glycoside and a diuretic; Hypotension-administer vasopressors, e.g., norepinephrine; Bronchospasm administer epinephrine and/or an aerosolized beta2-agonist; Seizures-administer diazepam. In severe beta blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves).

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs

Labetalol tablets should be stored below 30°C. Keep out of the reach of children. Store in a cool and dry place protected from light.