Betaxolol (Systemic)

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how betaxolol affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Talk with your doctor before you drink alcohol.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• This medicine may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking betaxolol all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
• If you have had a very bad allergic reaction, talk with your doctor. You may have a chance of an even worse reaction if you come into contact with what caused your allergy. If you use epinephrine to treat very bad allergic reactions, talk with your doctor. Epinephrine may not work as well while you are taking this medicine.
• Do not stop taking betaxolol all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop this medicine as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
• If you are 65 or older, use betaxolol with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• Betaxolol HCl
• Betaxolol Hydrochloride

Atrial fibrillation (rate control)

Data from a prospective randomized crossover study using the combination of low-dose betaxolol with digoxin compared to the use of low-dose diltiazem and digoxin supports the use of betaxolol as an effective agent for rate control in patients with atrial fibrillation [Koh 1995]. Additional trials may be necessary to further define the role of betaxolol in the treatment of this condition.

Oral beta-blocker use is recommended as a rate control option by the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guidelines for the management of patients with atrial fibrillation. However, betaxolol is not one of the more commonly administered or studied beta-blockers for this indication.

Chronic stable angina

Data from a placebo-controlled trial demonstrated that betaxolol, when added to nifepidine or diltiazem, can reduce the onset of exercise-induced angina in those with stable angina. The addition of betaxolol to calcium channel blocker warrants monitoring of blood pressure and heart rate; syncope can occur with this combination of therapy [Glasser 1994]. Data from a randomized controlled trial which compared betaxolol to metoprolol tartrate in those with stable angina also supports the use of betaxolol as an effective antianginal [Kardas 2007]. Additional trials may be necessary to further define the role of betaxolol in the treatment of chronic stable angina.

Based on the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons guideline for the management of stable ischemic heart disease, beta-blocker therapy is effective in controlling anginal symptoms; efficacy appears equal among agents in this class.

Postoperative atrial fibrillation associated with cardiac surgery (prevention)

Data from an open-label randomized multicenter trial comparing once daily betaxolol to twice daily metoprolol tartrate administered 2 days before and after coronary artery bypass graft surgery to prevent postoperative atrial fibrillation supports the use of betaxolol as an effective agent to reduce the risk of rate of early postoperative atrial fibrillation [Iliuta 2009]. Additional trials may be necessary to further define the role of betaxolol in the prevention of atrial fibrillation following cardiac surgery.

Based on the American College of Cardiology Foundation/American Heart Association guideline for coronary artery bypass graft surgery beta-blockers should be administered at least 24 hours prior to bypass surgery and reinitiated after surgery, unless contraindicated, to reduce the risk and consequences of atrial fibrillation.

Absorption is not affected by food.

Oral betaxolol may interfere with glaucoma screening tests; may lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Concerns related to adverse events:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

Disease-related concerns:

• Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta-blockers; however, betaxolol, with B1 selectivity, may be used cautiously with the lowest possible dose (eg, 5-10 mg/day), availability of a bronchodilator, and close monitoring; if a dosage increase is indicated, administer in divided doses.

• Cerebrovascular insufficiency: Use with caution in patients with cerebrovascular insufficiency; hypotension and decreased heart rate may reduce cerebral blood flow.

• Conduction abnormality: Consider preexisting conditions such as sick sinus syndrome before initiating therapy.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate and/or mask signs and symptoms of hypoglycemia.

• Heart failure (HF): Use with caution in patients with compensated heart failure and monitor for a worsening of the condition. There is limited data evaluating the efficacy of betaxolol in HF; use is not recommended (Figulla HR 2006; Yancy 2013).

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may potentiate myasthenia-related muscle weakness, including diplopia and ptosis.

• Peripheral vascular disease (PVD) and Raynaud's disease: May precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud's disease. Use with caution and monitor for progression of arterial obstruction.

• Pheochromocytoma (untreated): Adequate alpha-blockade is required prior to use of any beta-blocker.

• Prinzmetal variant angina: Beta-blockers without alpha1-adrenergic receptor blocking activity should be avoided in patients with Prinzmetal variant angina since unopposed alpha1-adrenergic receptors mediate coronary vasoconstriction and can worsen anginal symptoms (Mayer, 1998).

• Psoriasis: Beta-blocker use has been associated with induction or exacerbation of psoriasis but cause and effect has not been firmly established.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in severe impairment and in patients on dialysis.

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If hyperthyroidism is suspected, carefully manage and monitor; abrupt withdrawal may precipitate thyroid storm.

Concurrent drug therapy issues:

• Calcium channel blockers: Use with caution in patients on concurrent verapamil or diltiazem; bradycardia or heart block can occur.

• Cardiac glycosides: Use with caution in patients receiving digoxin; bradycardia or heart block can occur.

• Inhaled anesthetic agents: Use with caution in patients receiving inhaled anesthetic agents known to depress myocardial contractility.

Special populations:

• Elderly: Bradycardia may be observed more frequently in elderly patients (>65 years of age); dosage reductions may be necessary.

Other warnings/precautions:

• Abrupt withdrawal: Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, ischemia, and/or angina exacerbation. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency.

• Major surgery: Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.

Blood pressure, pulse; baseline renal function