Betaxolol is a β1-selective adrenergic blocking agent (β-blocker).1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24, 25
The choice of a β-adrenergic blocking agent (β-blocker) depends on numerous factors, including pharmacologic properties (e.g., relative β-selectivity, intrinsic sympathomimetic activity, membrane-stabilizing activity, lipophilicity), pharmacokinetics, intended use, and adverse effect profile, as well as the patient's coexisting disease states or conditions, response, and tolerance.38, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55 While specific pharmacologic properties and other factors may appropriately influence the choice of a β-blocker in individual patients,1235 evidence of clinically important differences among the agents in terms of overall efficacy and/or safety is limited.44, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55 Patients who do not respond to or cannot tolerate one β-blocker may be successfully treated with a different agent.46, 47, 48, 49, 52, 54, 55
Betaxolol is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.1, 1200
Current evidence-based practice guidelines for the management of hypertension in adults generally recommend the use of drugs from 4 classes of antihypertensive agents (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics).501, 502, 503, 504, 1200 Most guidelines no longer recommend β-blockers as first-line therapy for hypertension because of the lack of established superiority over other recommended drug classes and evidence from at least one study demonstrating that β-blockers may be less effective than angiotensin II receptor antagonists in preventing cardiovascular death, myocardial infarction (MI), or stroke.56, 501, 503, 504, 515, 1200 However, therapy with a β-blocker may still be considered in hypertensive patients who have a compelling indication (e.g., prior MI, ischemic heart disease, heart failure) for their use or as add-on therapy in those who do not respond adequately to the preferred drug classes.501, 502, 503, 504, 523, 524, 527, 700, 1200 (See Considerations for Drug Therapy in Patients with Underlying Cardiovascular and Other Risk Factors under Uses: Hypertension, in Atenolol 24:24 and in Metoprolol 24:24.) Ultimately, choice of antihypertensive therapy should be individualized, considering the clinical characteristics of the patient (e.g., age, ethnicity/race, comorbid conditions, cardiovascular risk factors) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, costs).501, 502, 503, 504, 515, 1200, 1201
A 2017 multidisciplinary hypertension guideline of the American College of Cardiology (ACC), American Heart Association (AHA), and a number of other professional organizations generally recommends a target blood pressure goal (i.e., blood pressure to achieve with drug therapy and/or nonpharmacologic intervention) of less than 130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200 In addition, a systolic blood pressure goal of less than 130 mm Hg generally is recommended for noninstitutionalized ambulatory patients 65 years of age or older with an average systolic blood pressure of at least 130 mm Hg.1200 These blood pressure goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of systolic blood pressure.1200, 1202, 1210 Previous hypertension guidelines, such as those from an expert panel of the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), generally have recommended initiation of antihypertensive treatment in patients with a systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg, targeted a blood pressure goal of less than 140/90 mm Hg regardless of cardiovascular risk, and used higher systolic blood pressure thresholds and targets in geriatric patients501, 504, 536 compared with those recommended by the 2017 ACC/AHA hypertension guideline.1200 The blood pressure thresholds used to define hypertension, the optimum blood pressure threshold at which to initiate antihypertensive drug therapy, and the ideal target blood pressure values remain controversial.501, 503, 504, 505, 506, 507, 508, 515, 523, 526, 530, 1200, 1201, 1207, 1209, 1222, 1223, 1229
Most patients with hypertension, especially black patients, will require at least 2 antihypertensive drugs to achieve adequate blood pressure control.1200 In general, black hypertensive patients tend to respond better to monotherapy with thiazide diuretics or calcium-channel blocking agents than to monotherapy with β-blockers.38, 42, 43, 501, 504, 1200 Although β-blockers have lowered blood pressure in all races studied, monotherapy with these agents has produced a smaller reduction in blood pressure in black hypertensive patients; however, this population difference in response does not appear to occur during combined therapy with a β-blocker and a thiazide diuretic.500 (See Race under Hypertension: Other Special Considerations for Antihypertensive Drug Therapy, in Uses in Atenolol 24:24 and in Metoprolol 24:24)
For additional information on the role of β-blockers in the management of hypertension, see Uses: Hypertension, in Atenolol 24:24 and in Metoprolol 24:24. For information on overall principles and expert recommendations for treatment of hypertension, see Uses: Hypertension in Adults and also see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Betaxolol hydrochloride is administered orally.1 GI absorption of the drug does not appear to be affected by food or alcohol.1
Dosage of betaxolol hydrochloride must be individualized and adjusted according to the patient's blood pressure response and tolerance, generally at intervals of at least30 1-2 weeks.1
The manufacturer states that the safety and efficacy of betaxolol hydrochloride in children have not been established.1
For the management of hypertension in adults, the usual initial dosage of betaxolol hydrochloride is 5-10 mg once daily, given alone or in combination with a diuretic.1, 30, 600 An initial dosage of 5 mg once daily is suggested for geriatric patients since they are particularly prone to betaxolol-induced bradycardia, which appears to be dose related and may respond to dosage reduction.1 In patients whose blood pressure is not controlled adequately with the initial betaxolol hydrochloride dosage, dosage can be doubled after 7-14 days up to a maximum of 20 mg daily.1, 2, 3, 16, 30, 600 Subsequent dosage should be adjusted according to blood pressure response and patient tolerance.1 Some experts state that the usual dosage range is 5-20 mg once daily.1200 Although dosages up to 40 mg daily have been used and generally were well tolerated,1 increasing dosage beyond 20 mg daily generally has not been shown to improve blood pressure response substantially.1 In a dose-ranging study, the antihypertensive effect of a 5-mg dose was approximately half that of a 20-mg dose, and that of a 10-mg dose was approximately 80% of that of a 20-mg dose.1 In other studies, increasing the dosage beyond 20 mg up to 40 mg was not shown to produce statistically significant improvement in blood pressure control.1 However, an increased effect on heart rate (reduction) should be anticipated as dosage is increased.1
Because the β1-adrenergic blocking selectivity of betaxolol hydrochloride is not absolute (diminishing with increasing dose), the drug should be used cautiously in patients with bronchospastic disease, employing the lowest possible dosage (5-10 mg once daily); if dosage must be increased, divided administration of the daily dose should be considered to avoid the higher peak plasma concentrations associated with once-daily dosing.1
Blood Pressure Monitoring and Treatment Goals
Blood pressure should be monitored regularly (i.e., monthly) during therapy and dosage of the antihypertensive drug adjusted until blood pressure is controlled.1200 If an adequate blood pressure response is not achieved, the dosage may be increased or another antihypertensive agent with demonstrated benefit and preferably with a complementary mechanism of action (e.g., angiotensin-converting enzyme [ACE] inhibitor, angiotensin II receptor antagonist, calcium-channel blocker, thiazide diuretic) may be added; if target blood pressure is still not achieved with the use of 2 antihypertensive agents, a third drug may be added.1200, 1216 (See Uses: Hypertension.) In patients who develop unacceptable adverse effects with betaxolol, the drug should be discontinued and another antihypertensive agent from a different pharmacologic class should be initiated.1200, 1216
The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure.1200 However, the optimum blood pressure threshold for initiating antihypertensive drug therapy and specific treatment goals remain controversial.505, 506, 507, 508, 515, 523, 530, 1201, 1207, 1209, 1222 While previous hypertension guidelines have based target blood pressure goals on age and comorbidities,501, 504, 536 the 2017 American College of Cardiology/American Heart Association (ACC/AHA) hypertension guideline incorporates underlying cardiovascular risk into decision making regarding treatment and generally recommends the same target blood pressure (i.e., less than 130/80 mm Hg) for all adults.1200 Many patients will require at least 2 drugs from different pharmacologic classes to achieve this blood pressure goal; the potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs also should be considered when deciding a patient's blood pressure treatment goal.1200, 1220
For additional information on target levels of blood pressure and on monitoring therapy in the management of hypertension, see Blood Pressure Monitoring and Treatment Goals under Dosage: Hypertension, in Dosage and Administration in the Thiazides General Statement 40:28.20.
Abrupt withdrawal of betaxolol may exacerbate angina symptoms and/or precipitate myocardial infarction and ventricular arrhythmias in patients with coronary artery disease, or may precipitate thyroid storm in patients with thyrotoxicosis.1 Therefore, patients receiving betaxolol (especially those with ischemic heart disease) should be warned not to interrupt or discontinue therapy without consulting their clinician.1 Because coronary artery disease is common and may be undiagnosed, abrupt withdrawal also should be avoided in patients receiving betaxolol for other conditions (e.g., hypertension).1, 2 When betaxolol is discontinued in patients with coronary artery disease or suspected thyrotoxicosis, the patient should be observed carefully; patients with coronary artery disease should be advised to temporarily limit their physical activity.1 If exacerbation of angina occurs or acute coronary insufficiency develops after betaxolol therapy is interrupted or discontinued, treatment with the drug should be reinstituted, at least temporarily.1
If betaxolol hydrochloride therapy, alone or combined with another antihypertensive agent (e.g., a thiazide diuretic), is to be discontinued, dosage should be reduced gradually in a deliberate and progressive manner, if possible.1, 30 When such cessation of therapy is planned, the manufacturer recommends that therapy with the drug be withdrawn gradually over approximately 2 weeks.1 Patients should be monitored closely during this period and, if manifestations of withdrawal (e.g., angina, exacerbation of hypertension) develop, dosage should be increased or the drug reinstituted, at least temporarily.1, 30
Dosage in Renal and Hepatic Impairment
Since pharmacokinetics of betaxolol may be altered in patients with renal impairment, the manufacturer states that betaxolol hydrochloride should be initiated at 5 mg once daily in those with severe impairment or undergoing dialysis.1 If necessary, dosage of betaxolol hydrochloride may be increased in increments of 5 mg daily, no more frequently than at 2-week intervals, up to a maximum of 20 mg daily.1
While the elimination half-life of betaxolol may be increased in patients with hepatic impairment, clearance of the drug may remain unchanged, resulting in little change in the area under the plasma concentration-time curve (AUC).1 Therefore, the manufacturer states that dosage reductions in patients with hepatic insufficiency are not routinely necessary, although the drug should be used with caution and observation in such patients.1
Betaxolol hydrochloride is a β1-selective adrenergic blocking agent.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24, 25 Betaxolol is related structurally to metoprolol, differing only by the addition of a cyclopropyl group at the terminal carbon of the methoxyethyl side chain of metoprolol.6, 21, 23 The presence of large substituents in the para position is believed to account in part for the selective β1-adrenergic blocking effect of betaxolol.2, 6, 21, 25
Betaxolol is one of the most potent2, 6, 11, 14, 15, 17, 19, 20, 25 and selective2, 11, 14, 15, 17, 20, 25β1-adrenergic blocking agents currently available. In vitro studies indicate that the β1-adrenergic blocking activity of betaxolol on a molar basis is approximately the same as that of propranolol,6, 11, 17 2-8 times that of metoprolol,6, 17 and 9 times that of atenolol.17 The drug does not exhibit intrinsic sympathomimetic (β1-agonist) activity1, 11, 13, 15, 22 and does not have substantial membrane-stabilizing (local anesthetic) activity.1, 2, 8, 9, 11, 16, 17, 18, 22, 24, 25 At low dosages, betaxolol hydrochloride selectively inhibits response to adrenergic stimuli by competitively blocking cardiac β1-adrenergic receptors, while having little effect on the β2-adrenergic receptors of bronchial and vascular smooth muscle.1 At high doses, the selectivity of betaxolol hydrochloride for β1-adrenergic receptors usually diminishes, and the drug will competitively inhibit β1- and β2-adrenergic receptors.1
USP currently states that potency of betaxolol hydrochloride preparations should be expressed both in terms of the salt and the base (“active moiety”).27 Commercially available tablets containing 10 or 20 mg of betaxolol hydrochloride contain 8.94 or 17.88 mg of betaxolol, respectively.1 Whereas dosage and potency of betaxolol hydrochloride tablets are expressed in terms of the salt,1 dosage of ophthalmic preparations of the drug are expressed in terms of the base.24 Therefore, care should be taken to avoid confusion between labeled potencies as the salt and base and dosage of betaxolol hydrochloride.26
Additional Information
SumMon® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for detailed information on the usual cautions, precautions, and contraindications.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 10 mg* | Betaxolol Hydrochloride Tablets | |
20 mg* | Betaxolol Hydrochloride Tablets |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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