Betaxolol
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Questions & Answers
Side Effects & Adverse Reactions
Topically applied beta-adrenergic blocking agents may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents.
Betaxolol Ophthalmic Solution has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betaxolol Ophthalmic Solution should be discontinued at the first signs of cardiac failure.
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
Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs.
In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.
History
There is currently no drug history available for this drug.
Other Information
Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below:
Molecular Formula: C18H29NO3•HCl
Chemical Name: (±)-1[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.
Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Purified Water; Preservative: Benzalkonium Chloride 0.01%.
Sources
Betaxolol Manufacturers
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Akorn, Inc.
![Betaxolol (Betaxolol Hydrochloride) Solution/ Drops [Akorn, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Betaxolol | Akorn, Inc.
The recommended dose is one to two drops of Betaxolol Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.
If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.
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Physicians Total Care, Inc.
Betaxolol | Physicians Total Care, Inc.
The initial dose of betaxolol 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 does not produce the desired response, the addition of a diuretic agent or other antihypertensive should be considered (see, Drug Interactions).
Dosage adjustments for specific patients Patients with renal failureIn 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 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 diseasePatients with hepatic disease do not have significantly altered clearance. Dosage adjustments are not routinely needed.
Elderly patientsConsideration 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 therapyIf withdrawal of betaxolol 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.
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Golden State Medical Supply, Inc.
Betaxolol | Golden State Medical Supply, Inc.
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 (see PRECAUTIONS, Drug Interactions).
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 therapyIf 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.
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Epic Pharma Llc
Betaxolol | Epic Pharma Llc
The initial dose of betaxolol 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 does not produce the desired response, the addition of a diuretic agent or other antihypertensive should be considered (see, Drug Interactions).
Dosage adjustments for specific patients Patients with renal failureIn 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 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 diseasePatients with hepatic disease do not have significantly altered clearance. Dosage adjustments are not routinely needed.
Elderly patientsConsideration 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 therapyIf withdrawal of betaxolol 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.
![Betaxolol Tablet, Film Coated [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=94fa6c50-de10-4c07-a668-1880061561cc&name=4932.jpg)
![Betaxolol Tablet, Film Coated [Golden State Medical Supply, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9a58c45d-4b14-44d7-86ed-2997ac6942dd&name=9a58c45d-4b14-44d7-86ed-2997ac6942dd-02.jpg)
![Betaxolol Tablet, Film Coated [Epic Pharma Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bf716efe-0a9f-43b1-9d8a-c69330b82e18&name=597997e7-9086-4b1a-833c-b2ad3ea03fa7-02.jpg)
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