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Basic Drug Info
Drug Name:Labetalol Hydrochloride
Manufacturer:Hospira, Inc.
Other Info:



Clinical Trials:


Indications and Usage
Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.
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 injection is 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 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 compound, dilevalol HCl, including two deaths.

Dilevalol HCl is one of the four isomers of labetalol.

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

Laboratory testing should also be done at the very first symptom or 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 jaundice or laboratory evidence of liver injury, 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 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.

Labetalol 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 lead, in some cases, 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, labetalol therapy should be withdrawn (gradually if possible).Ischemic Heart Disease Angina pectoris has not been reported upon labetalol discontinuation. However, following abrupt cessation of therapy with some beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported.

Therefore, such patients should be cautioned against interruption of therapy without the physician’s advice.

Even in the absence of overt angina pectoris, when discontinuation of labetalol is planned, the patient should be carefully observed and should be advised to limit physical activity.

If angina markedly worsens or acute coronary insufficiency develops, labetalol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken.Nonallergic Bronchospasm (e.g., chronic bronchitis and emphysema) Since labetalol injection at the usual intravenous therapeutic doses has not been studied in patients with nonallergic bronchospastic disease, it should not be used in such patients.Pheochromocytoma Intravenous labetalol has been shown to be effective in lowering the blood pressure and relieving symptoms in patients with pheochromocytoma; higher than usual doses may be required.

However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, use caution when administering labetalol 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 prior to 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’s alpha-adrenergic activity has not been evaluated in this setting.Several deaths have occurred when labetalol injection was used during surgery (including when used in cases to control bleeding).A synergism between labetalol and halothane anesthesia has been shown (see PRECAUTIONS - Drug Interactions).Rapid Decreases of Blood Pressure Caution must be observed when reducing severely elevated blood pressure.

A number of adverse reactions, including cerebral infarction, optic nerve infarction, angina, and ischemic changes in the electrocardiogram, have been reported with other agents when severely elevated blood pressure was reduced over time courses of several hours to as long as 1 or 2 days.

The desired blood pressure lowering should therefore be achieved over as long a period of time as is compatible with the patient's status.
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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