Labetalol Hydrochloride

Labetalol Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

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 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 be done at the 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 should be observed closely. If cardiac failure continues despite adequate digitalization and diuretic, therapy with Labetalol Hydrochloride Tablets should be withdrawn (gradually, if possible).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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 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:

Do not routinely withdraw chronic beta blocker therapy prior to surgery. The effect of labetalol'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).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.

Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure:

Structure

Labetalol HCl has the empirical formula C19H24N2O3•HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol.

Labetalol HCl is a white or off-white crystalline powder, soluble in water.

Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100 mg- and 300mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.

Labetalol Hydrochloride Manufacturers


  • County Line Pharmaceuticals Llc
    Labetalol Hydrochloride Tablet [County Line Pharmaceuticals Llc]
  • Cardinal Health
    Labetalol Hydrochloride Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Labetalol Hydrochloride (Labetalol Hydrochloride) Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Labetalol Hydrochloride Tablet [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Labetalol Hydrochloride Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Stat Rx Usa Llc
    Labetalol Hydrochloride Tablet, Film Coated [Stat Rx Usa Llc]
  • Remedyrepack Inc.
    Labetalol Hydrochloride Tablet [Remedyrepack Inc. ]
  • Watson Laboratories, Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Watson Laboratories, Inc.]
  • Rebel Distributors Corp
    Labetalol Hydrochloride Tablet, Film Coated [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Labetalol Hydrochloride Tablet, Film Coated [Rebel Distributors Corp]
  • Akorn, Inc.
    Labetalol Hydrochloride Injection, Solution [Akorn, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Labetalol Hydrochloride Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Physicians Total Care, Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Physicians Total Care, Inc.]
  • Gland Pharma Limited
    Labetalol Hydrochloride (Labetalol Hydrochloride ) Injection, Solution [Gland Pharma Limited ]
  • Mckesson Contract Packaging
    Labetalol Hydrochloride Tablet, Film Coated [Mckesson Contract Packaging]
  • Mylan Institutional Llc
    Labetalol Hydrochloride (Labetalol) Injection, Solution [Mylan Institutional Llc]
  • Cardinal Health
    Labetalol Hydrochloride Tablet, Film Coated [Cardinal Health]
  • Lake Erie Medical Dba Quality Care Products Llc
    Labetalol Hydrochloride Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Golden State Medical Supply, Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Golden State Medical Supply, Inc.]
  • Remedyrepack Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
  • Unit Dose Services
    Labetalol Hydrochloride Tablet, Film Coated [Unit Dose Services]
  • Unit Dose Services
    Labetalol Hydrochloride Tablet, Film Coated [Unit Dose Services]
  • American Health Packaging
    Labetalol Hydrochloride Tablet, Film Coated [American Health Packaging]
  • Dispensing Solutions, Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Major Pharmaceuticals
    Labetalol Hydrochloride Tablet [Major Pharmaceuticals]
  • Hospira, Inc.
    Labetalol Hydrochloride Injection, Solution [Hospira, Inc.]
  • St Marys Medical Park Pharmacy
    Labetalol Hydrochloride Tablet, Film Coated [St Marys Medical Park Pharmacy]
  • Bryant Ranch Prepack
    Labetalol Hydrochloride Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Labetalol Hydrochloride Tablet, Film Coated [Bryant Ranch Prepack]
  • Ivax Pharmaceuticals, Inc.
    Labetalol Hydrochloride Tablet, Film Coated [Ivax Pharmaceuticals, Inc.]
  • Cardinal Health
    Labetalol Hydrochloride Injection, Solution [Cardinal Health]
  • Cardinal Health
    Labetalol Hydrochloride Tablet [Cardinal Health]
  • Hospira, Inc.
    Labetalol Hydrochloride Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Labetalol Hydrochloride Injection, Solution [Hospira, Inc.]

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