Presentation

Labegest 100: Each tablet contains Labetalol Hydrochloride BP 100 mg.

Labegest 200: Each tablet contains Labetalol Hydrochloride BP 200 mg.

Description

Labetalol HCl is an adrenergic receptor blocking agents that have both selective

alpha1-adrenergic and nonselective beta adrenergic receptor blocking actions. Both the alpha and beta-blocking actions of orally administered Labetalol HCl contribute to a decrease in blood pressure in hypertensive patients.

Indications

Labetalol HCl indicated in the management of hypertension. Labetalol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Dosage & Administration

The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic?regimen. The usual maintenance dosage of Labetalol Hydrochloride is between 200 and 400 mg?twice daily.

Patients with severe hypertension may require from 1,200 to 2,400 mg per day, with or without thiazide diuretics. Titration increments should not exceed 200 mg twice daily.?Elderly Patients: The majority of elderly patients will require between 100 and 200 mg twice daily.

Side Effects

Most side effects are mild and transient and occur early in the course of treatment. The incidences?of adverse reactions include Fatigue, Asthenia, Headache, Nausea, Vomiting, Dyspepsia,?Abdominal pain, Diarrhea, Taste distortion, Dizziness, Paresthesia, Nasal stuffiness, Increased?sweating, Edema, Postural hypotension, Bradycardia, Dyspnea, Rash, Vision abnormality and?Vertigo.

Precautions

Labetalol HCl 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.

Use in Pregnancy & Lactation

P r e g n a n c y : 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 HCl given to pregnant women with hypertension did not appear to affect the usual?course of labor and delivery.

L a c t a t i o n : 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.

Drug Interaction

Labetalol HCl in combination with tricyclic antidepressants may cause tremor; Cimetidine has?been shown to increase the bioavailability of Labetalol HCl. If Labetalol HCl 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.

Over Dose

Overdosage with Labetalol HCl causes excessive hypotension and sometimes, excessive?bradycardia. If overdosage with Labetalol HCl 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).

Storage

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

Commercial Pack

Labegest 100: Each box contains 3 Alu-PVC opaque blister strips of 10 tablets.

Labegest 200: Each box contains 3 Alu-PVC opaque blister strips of 10 tablets.