Betaxolol (tablet)

Betaxolol (tablet)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

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Overview

Betaxolol (tablet) is a Template:Beta-adrenergic blocker that is FDA approved for the treatment of hypertension. Common adverse reactions include bradyarrhythmia, indigestion, nausea, arthralgia, chest pain, burning sensation in eye, fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

The initial dose of betaxolol tablets, USP in hypertension is ordinarily 10 mg once daily either alone or added to diuretic therapy. The full antihypertensive effect is usually seen within 7 to 14 days. If the desired response is not achieved the dose can be doubled after 7 to 14 days. Increasing the dose beyond 20 mg has not been shown to produce a statistically significant additional antihypertensive effect; but the 40-mg dose has been studied and is well tolerated. An increased effect (reduction) on heart rate should be anticipated with increasing dosage. If monotherapy with betaxolol tablets, USP does not produce the desired response, the addition of a diuretic agent or other antihypertensive should be considered.

Dosage Adjustments For Specific Patients

• Patients with renal failure: In patients with renal impairment, clearance of betaxolol declines with decreasing renal function. In patients with severe renal impairment and those undergoing dialysis, the initial dose of betaxolol tablets, USP is 5 mg once daily. If the desired response is not achieved, dosage may be increased by 5 mg/day increments every 2 weeks to a maximum dose of 20 mg/day.
• Patients with hepatic disease: Patients with hepatic disease do not have significantly altered clearance. Dosage adjustments are not routinely needed.
• Elderly patients: Consideration should be given to reduction in the starting dose to 5 mg in elderly patients. These patients are especially prone to beta-blocker-induced bradycardia, which appears to be dose related and sometimes responds to reductions in dose.
• Cessation of therapy: If withdrawal of betaxolol tablets, USP therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed and advised to limit physical activity to a minimum.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Betaxolol in adult patients.

Non–Guideline-Supported Use

Angina Pectoris

• Dosing Information

• Monotherapy: 5-80 mg/day.
• Combination therapy: Betaxolol 20 mg/day + nifedipine to a maximum of 60 mg/day or diltiazem to a maximum of 360 mg/day.

Atrial Fibrilation

• Dosing Information

• 20 mg/day.

Atrioventricular Reentrant Tachycardia

• Dosing Information

• Oral: 20 mg/day.
• IV: 0.15 mg/kg.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Betaxolol (tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Betaxolol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Betaxolol in pediatric patients.

Contraindications

• Sinus bradycardia
• Second degree heart block and third degree heart block
• Cardiogenic shock
• Overt cardiac failure
• Hypersensitivity to the drug. Betaxolol

Warnings

=Cardiac Failure

Sympathetic stimulation may be a vital component supporting circulatory function in congestive heart failure, and beta-adrenergic receptor blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe heart failure. In hypertensive patients who have congestive heart failure controlled by digitalis and diuretics, beta-blockers should be administered cautiously. Both digitalis and beta-adrenergic receptor blocking agents slow AV conduction.

Patients Without a History of Cardiac Failure

Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of cardiac failure, discontinuation of betaxolol tablets, USP should be considered. In some cases beta-blocker therapy can be continued while cardiac failure is treated with cardiac glycosides, diuretics, and other agents, as appropriate.

Exacerbation of Angina Pectoris Upon Withdrawal

Abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease has been followed by exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore such patients should be warned against interruption of therapy without the physician’s advice. Even in the absence of overt angina pectoris, when discontinuation of betaxolol tablets, USP is planned, the patient should be carefully observed and therapy should be reinstituted, at least temporarily, if withdrawal symptoms occur.

Bronchospastic diseases

PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD NOT IN GENERAL RECEIVE BETA-BLOCKERS. Because of its relative ß1 selectivity (cardioselectivity), low doses of betaxolol tablets, USP may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate alternative treatment. Since ß1 selectivity is not absolute and is inversely related to dose, the lowest possible dose of betaxolol tablets, USP should be used (5 to 10 mg once daily) and a bronchodilator should be made available. If dosage must be increased, divided dosage should be considered to avoid the higher peak blood levels associated with once-daily dosing.

Major Surgery

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures (see Precautions, Drug Interactions). Titrate Betaxolol Hydrochloride tablet dose to maintain effective heart rate control while avoiding frank hypotension and bradycardia.

Diabetes and Hypoglycemia

Beta-blockers should be used with caution in diabetic patients. Beta-blockers may mask tachycardia occurring with hypoglycemia (patients should be warned of this), although other manifestations such as dizziness and sweating may not be significantly affected. Unlike nonselective beta-blockers, betaxolol such as dizziness and sweating may not be significantly affected. Unlike nonselective beta-blockers, betaxolol tablets, USP does not prolong insulin-induced hypoglycemia.

Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Abrupt withdrawal of beta-blockade might precipitate a thyroid storm; therefore, patients known or suspected of being thyrotoxic from whom betaxolol tablets, USP is to be withdrawn should be monitored closely. Betaxolol tablets, USP should not be given to patients with untreated pheochromocytoma.

Risk of Anaphylactic Reaction

Although it is known that patients on beta-blockers may be refractory to epinephrine in the treatment of anaphylactic shock, beta-blockers can, in addition, interfere with the modulation of allergic reaction and lead to an increased severity and/or frequency of attacks. Severe allergic reactions including anaphylaxis have been reported in patients exposed to a variety of allergens either by repeated challenge, or accidental contact, and with diagnostic or therapeutic agents while receiving beta-blockers. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Postmarketing Experience

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Drug Interactions

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• Drug 4
• Drug 5

Drug 1

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Drug 2

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Drug 3

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Drug 4

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Drug 5

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Use in Specific Populations

Pregnancy

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Pregnancy Category (AUS): (Description)

Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

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Monitoring

Condition 1

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Condition 2

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Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Betaxolol (tablet)
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Mechanism of Action

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Structure

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Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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Condition 2

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How Supplied

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Storage

There is limited information regarding Betaxolol (tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of betaxolol tablets, USP therapy without the physician’s advice. Although cardiac failure rarely occurs in appropriately selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult a physician at the first sign or symptom of failure.

Patients should know how they react to this medicine before they operate automobiles and machinery or engage in other tasks requiring alertness. Patients should contact their physician if any difficulty in breathing occurs, and before surgery of any type. Patients should inform their physicians, ophthalmologist, or dentists that they are taking betaxolol tablets, USP. Patients with diabetes should be warned that beta-blockers may mask tachycardia occurring with hypoglycemia.

Precautions with Alcohol

Alcohol-Betaxolol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Betaxolol (tablet) Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.