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Basic Drug Info
Drug Name:Labetalol hydrochloride
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage

Labetalol hydrochloride tablets are indicated in the management of hypertension.

Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications
Labetalol HCl tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS).Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

First degree atrioventricular block -- A delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval beyond 200 milliseconds.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Hepatic Injury: Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with therapy with labetalol therapy.

The hepatic injury is usually reversible, but hepatic necrosis and death have been reported.

Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology.

Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths.

Dilevalol HCl is one of the four isomers of labetalol HCl.

Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate.

Appropriate laboratory testing should also be done at the very first symptom/sign of liver dysfunction (e.g, pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms).

If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted.Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure.

Beta-blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure.

Although beta-blockers should be avoided in overt congestive heart failure, if necessary, labetalol HCl can be used with caution in patients with a history of heart failure who are well compensated.

Congestive heart failure has been observed in patients receiving labetalol HCl.

Labetalol HCl does not abolish the inotropic action of digitalis on heart muscle.In Patients Without A History Of Cardiac Failure: In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure.

At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response observed closely.

If cardiac failure continues, despite adequate digitalization and diuretic, therapy with labetalol HCl tablets should be withdrawn (gradually, if possible).Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal: Angina pectoris has not been reported upon labetalol HCl discontinuation.

However, hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.

When discontinuing chronically administered labetalol HCl tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored.

If angina markedly worsens or acute coronary insufficiency develops, therapy with labetalol HCl tablets should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken.

Patients should be warned against interruption or discontinuation of therapy without the physician’s advice.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with labetalol HCl tablets abruptly in patients being treated for hypertension.Nonallergic Bronchospasm (e.g., Chronic Bronchitis and Emphysema) Patients with bronchospastic disease should, in general, not receive beta-blockers.

Labetalol HCl tablets may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents.

It is prudent, if labetalol HCl tablets are used, to use the smallest effective dose, so that inhibition of endogenous or exogenous beta-agonists is minimized.Pheochromocytoma: Labetalol HCl has been shown to be effective in lowering the blood pressure and relieving symptoms in patients with pheochromocytoma.

However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, use caution when administering labetalol HCl to patients with pheochromocytoma.Diabetes Mellitus and Hypoglycemia: Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g, tachycardia) of acute hypoglycemia.

This is especially important with labile diabetics.

Beta-blockade also reduces the release of insulin in response to hyperglycemia; it may therefore be necessary to adjust the dose of antidiabetic drugs.Major Surgery: The necessity or desirability of withdrawing beta-blocking therapy before major surgery is controversial.

Protracted severe hypotension and difficulty in restarting or maintaining a heartbeat have been reported with beta-blockers.

The effect of labetalol HCl’s alpha-adrenergic activity has not been evaluated in this setting.A synergism between labetalol HCl and halothane anesthesia has been shown (see PRECAUTIONS: Drug Interactions).
Branded Drugs
The following US Branded drugs contain Labetalol hydrochloride


NORMOZIDE -- SCHERING CORP SUB SCHERING PLOUGH CORP

TRANDATE HCT -- GLAXOSMITHKLINE

NORMODYNE -- SCHERING CORP SUB SCHERING PLOUGH CORP

TRANDATE -- PROMETHEUS LABORATORIES INC


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