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betaxolol 10 mg tablet

Out of Stock Manufacturer EPIC PHARMA LLC 42806003801
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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. While specific pharmacologic properties and other factors may appropriately influence the choice of a β-blocker in individual patients, evidence of clinically important differences among the agents in terms of overall efficacy and/or safety is limited. Patients who do not respond to or cannot tolerate one β-blocker may be successfully treated with a different agent.


Betaxolol is used alone or in combination with other classes of antihypertensive agents in the management of hypertension. Although β-blockers were previously considered a drug of choice for the initial management of hypertension, most current guidelines no longer recommend these drugs as first-line therapy because of the lack of established superiority over other recommended drug classes and at least one study demonstrating that they may be less effective than angiotensin II receptor antagonists in preventing cardiovascular death, myocardial infarction, or stroke. However, β-blockers may still be considered in hypertensive patients who have a compelling indication (e.g., prior myocardial infarction, 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 (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, or thiazide diuretics). (See Antihypertensive Therapy for Patients with Underlying Cardiovascular or Other Risk Factors under Uses: Hypertension, in and in .)

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. 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. and in )

Betaxolol's efficacy in the management of hypertension is similar to that of other β-blockers.

For additional information on the role of β-blockers in the management of hypertension, see Uses in and in . For information on overall principles and expert recommendations for treatment of hypertension, .

Dosage and Administration


Betaxolol hydrochloride is administered orally. GI absorption of the drug does not appear to be affected by food or alcohol.


Dosage of betaxolol hydrochloride must be individualized and adjusted according to the patient's blood pressure response and tolerance, generally at intervals of at least 1-2 weeks.

The manufacturer states that the safety and efficacy of betaxolol hydrochloride in children have not been established.


Usual Dosage

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. 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. 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. Subsequent dosage should be adjusted according to blood pressure response and patient tolerance. Although dosages up to 40 mg daily have been used and generally were well tolerated, increasing dosage beyond 20 mg daily generally has not been shown to improve blood pressure response substantially. 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. 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. However, an increased effect on heart rate (reduction) should be anticipated as dosage is increased.

The panel members appointed to the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8 expert panel) state that evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) should be used when available to determine target dosages of antihypertensive agents. Target dosages generally can be achieved within 2-4 weeks, but it may take up to several months. In patients who experience intolerable adverse effects with betaxolol, dosage reduction should be considered; if adverse effects worsen or fail to resolve, it may be necessary to discontinue the β-adrenergic blocking agent (β-blocker) and initiate another class of antihypertensive agent.

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.

Blood Pressure Monitoring and Treatment Goals

Careful monitoring of blood pressure during initial titration or subsequent upward adjustment in dosage of betaxolol hydrochloride is recommended.

The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure; specific target levels of blood pressure should be individualized based on consideration of multiple factors, including patient age and comorbidities, and the currently available evidence from clinical studies.

For additional information on initiating and adjusting betaxolol hydrochloride dosage in the management of hypertension, .

Drug Withdrawal

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. Therefore, patients receiving betaxolol (especially those with ischemic heart disease) should be warned not to interrupt or discontinue therapy without consulting their clinician. 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). 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. 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.

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. When such cessation of therapy is planned, the manufacturer recommends that therapy with the drug be withdrawn gradually over approximately 2 weeks. 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.

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. 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.

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). 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.

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