Sore Throat

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failure continues, despite adequate digitalization and diuretic, therapy with labetalol hydrochloride should be withdrawn (gradually, if possible).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

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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

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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.

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History

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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:

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.

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Sore Throat Manufacturers

Safeway, Inc.

Sore Throat | Bluepoint Laboratories

DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days. The usual maintenance dosage of labetalol hydrochloride tablets is between 200 mg and 400 mg twice daily.

Since the full antihypertensive effect of labetalol hydrochloride tablets is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.

Patients with severe hypertension may require from 1200 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d.(twice daily), the same total daily dose administered t.i.d. (three times daily) may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg b.i.d. (twice daily).

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol hydrochloride tablet dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.

When transferring patients from other antihypertensive drugs, labetalol hydrochloride tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.

Elderly Patients

As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 mg and 200 mg b.i.d.

No Recall
Top Care (Topco Associates Llc)

Sore Throat | Top Care (topco Associates Llc)

apply to affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist

No Recall
Preferred Plus (Kinray)

Sore Throat | Preferred Plus (kinray)

apply to affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist

No Recall
Preferred Plus (Kinray)

Sore Throat | Preferred Plus (kinray)

apply to affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist

No Recall
Apotheca Company

Sore Throat | Apotheca Company

DIRECTIONS: Adults and children over 12 years of age, at onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.

To be used according to standard homeopathic indications or as directed by a homeopathic physician.

No Recall
Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

No Recall
Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

No Recall
Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

No Recall
Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

No Recall
Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

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Natural Health Supply

Sore Throat | Natural Health Supply

Take at onset of symptoms. Repeat every 2 hours or as needed until relieved. If condition persists or worsens discontinue use and consult a practitioner.

Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth. Children and infants: 1-5 pellets.

No Recall
H E B

Sore Throat | H E B

apply to the affected area allow to remain in place for at least 15 seconds, then spit out use every 2 hours or as directed by a doctor or dentist adults and children 12 years of age & older spray 5 times for each application children 3 to under 12 years (with adult supervision) spray 3 times for each application children under 3 years of age ask a doctor or dentist

No Recall
Apotheca Company

Sore Throat | Apotheca Company

DIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

No Recall
Hyland’s

Sore Throat | Hyland's

Adults
Dissolve 2-3 tablets under tongue every 4 hours or as needed.
Children 6 to 12 years old
1/2 adult dose.

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Deseret Biologicals, Inc.

Sore Throat | Deseret Biologicals, Inc.

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

No Recall
Hyvee Inc

Sore Throat | Hyvee Inc

Directions
Adults and children 3 years of age and older:
• apply to the affected are (one spray) • allow to remain in place for at least 15 seconds, then spit out • use every 2 hours or as directed by a doctor or dentist.
Children under 12 years of age should be supervised in the use of this product.

Children under 3 years of age: consult a doctor or dentist

No Recall
Deseret Biologicals, Inc.

Sore Throat | Deseret Biologicals, Inc.

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

No Recall
Meijer Distribution Inc

Sore Throat | Meijer Distribution Inc

Adults and children 3 years of age and older:
• apply to the affected area (one spray) • allow to remain in place for at least 15 seconds, then spit out • use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product.
Children under 3 years of age: consult a doctor or dentist

No Recall
Equate (Walmart Stores, Inc.)

Sore Throat | Equate (walmart Stores, Inc.)

apply to affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist

No Recall
Good Sense (Geiss, Destin & Dunn, Inc.)

Sore Throat | Meijer, Inc.

adults and children 12 years of age and older take 1 caplet (50 mg) at bedtime children under the age of 12 years: do not use

No Recall
Good Sense (Geiss, Destin & Dunn, Inc.)

Sore Throat | Unifirst First Aid Corporation

spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily not to be used on children under 12 years of age

No Recall
Nova Aurora Corp

Sore Throat | L.n.k. International, Inc.

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablets with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

No Recall