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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 hydrochloride. 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 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 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 hydrochloride 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 hydrochloride. Labetalol hydrochloride 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cardiac failure continues, despite adequate digitalization and diuretic, therapy with labetalol hydrochloride should be withdrawn (gradually, if possible).

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal

Angina pectoris has not been reported upon labetalol hydrochloride 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, 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 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 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 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 is used, to use the smallest effective dose, so that inhibition of endogenous or exogenous beta-agonists is minimized.

Pheochromocytoma

Labetalol hydrochloride 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 hydrochloride 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 hydrochloride’s alpha-adrenergic activity has not been evaluated in this setting.

A synergism between labetalol hydrochloride 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 USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP 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 USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.

Labetalol hydrochloride 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:

Chemical Structure

Labetalol hydrochloride has the molecular formula C19H24N2O3•HCl and a molecular weight of 364.87. 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 hydrochloride is a white or off-white crystalline powder, soluble in water.

Labetalol hydrochloride tablets USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride USP.

In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, sodium starch glycolate (potato) and titanium dioxide.

Sore Throat Manufacturers


  • Safeway, Inc.
    Sore Throat (Phenol) Spray [Safeway, Inc.]
  • Top Care (Topco Associates Llc)
    Sore Throat (Phenol) Spray [Top Care (Topco Associates Llc)]
  • Preferred Plus (Kinray)
    Sore Throat (Phenol) Spray [Preferred Plus (Kinray)]
  • Preferred Plus (Kinray)
    Sore Throat (Phenol) Spray [Preferred Plus (Kinray)]
  • Apotheca Company
    Sore Throat (Echinacea Purpurea, Plantago Major, Baptisia Tinctoria) Spray [Apotheca Company]
  • Natural Health Supply
    Sore Throat (Mercury) Pellet [Natural Health Supply]
  • Natural Health Supply
    Sore Throat (Calcium Fluoride) Pellet [Natural Health Supply]
  • Natural Health Supply
    Sore Throat (Canis Lupus Familiaris Milk) Pellet [Natural Health Supply]
  • Natural Health Supply
    Sore Throat (Barium Cation) Pellet [Natural Health Supply]
  • Natural Health Supply
    Sore Throat (Lachesis Muta Venom) Pellet [Natural Health Supply]
  • Natural Health Supply
    Sore Throat (Virola Sebifera Resin) Pellet [Natural Health Supply]
  • H E B
    Sore Throat (Phenol) Spray [H E B]
  • Apotheca Company
    Sore Throat (Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Aranea Diadema,) Liquid [Apotheca Company]
  • Hyland’s
    Sore Throat (Belladonna Leaf, Phytolacca Americana Root, Barium Carbonate, And Mercuric Iodide) Tablet, Soluble [Hyland’s]
  • Deseret Biologicals, Inc.
    Sore Throat (Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale) Liquid [Deseret Biologicals, Inc.]
  • Hyvee Inc
    Sore Throat (Phenol) Spray [Hyvee Inc]
  • Deseret Biologicals, Inc.
    Sore Throat (Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis) Liquid [Deseret Biologicals, Inc.]
  • Meijer Distribution Inc
    Sore Throat (Phenol) Spray [Meijer Distribution Inc]
  • Equate (Walmart Stores, Inc.)
    Sore Throat (Phenol) Spray [Equate (Walmart Stores, Inc.)]
  • Good Sense (Geiss, Destin & Dunn, Inc.)
    Sore Throat (Phenol) Spray [Good Sense (Geiss, Destin & Dunn, Inc.)]
  • Good Sense (Geiss, Destin & Dunn, Inc.)
    Sore Throat (Phenol) Spray [Good Sense (Geiss, Destin & Dunn, Inc.)]
  • Nova Aurora Corp
    Sore Throat (Echinacea Purpurea, Plantago Major, Baptisia Tinctoria, Phytolacca Decandra, Apis Mellifica, Belladonna, Lachesis Mutus, Mercurius Solubilis, Hepar Sulphuris Calcareum) Spray [Nova Aurora Corp]

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