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Bisoprolol (Lexi-Drugs)
Pronunciation
(bis OH proe lol)
Brand Names: US
Zebeta [DSC]
Brand Names: Canada
APO-Bisoprolol; MINT-Bisoprolol; MYLAN-Bisoprolol [DSC]; PMS-Bisoprolol; PRO-Bisoprolol-10; PRO-Bisoprolol-5; RIVA-Bisoprolol; SANDOZ
Bisoprolol; TEVA-Bisoprolol
Pharmacologic Category
Antihypertensive; Beta-Blocker, Beta-1 Selective
Dosing: Adult
Atrial fibrillation (rate control) (off-label use): Usual maintenance dose: 2.5 to 10 mg once daily (AHA/ACC/HRS [January 2014])
Heart failure with reduced ejection fraction (HFrEF) (off-label use): Note: Initiate only in stable patients. In hospitalized patients, volume status
should be optimized and IV diuretics, vasodilators, and inotropic agents successfully discontinued. Use caution when initiating in patients with
NYHA class IV symptoms or recent HF exacerbation (particularly if inotropes were required during hospital course) (ACCF/AHA [Yancy 2013];
Colucci 2018).
Oral: Initial: 1.25 mg once daily; gradually titrate (eg, doubling the dose every 2 or more weeks) to the maximum tolerated dose while monitoring
for signs and symptoms of HF; maximum dose: 10 mg/day (ACC/AHA/HFSA [Yancy 2017]; ACCF/AHA [Yancy 2013]; CIBIS-II Investigators
and Committees 1999)
Hypertension (alternative agent): Oral: Initial: 2.5 to 5 mg once daily; titrate as needed based on patient response to 10 mg once daily and then up
to no more than 20 mg once daily; usual dosage range: 2.5 to 10 mg once daily (ACC/AHA [Whelton 2017]).
Ventricular arrhythmias (off-label use): Oral: 2.5 to 10 mg once daily (AHA/ACC/HRS [Al-Khatib 2017])
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
Hypertension:
CrCl ≥ 40 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling.
CrCl <40 mL/minute: Initial: 2.5 mg daily; increase cautiously.
Heart failure (off-label use): In clinical trials, the initial recommended dosage (ie, 1.25 mg once daily) was not reduced further based on CrCl;
however, patients with serum creatinine ≥3.4 mg/dL were excluded in one trial (CIBIS-II Investigators and Committees, 1999) and those with a
serum creatinine ≥2.5 mg/dL were excluded in another trial (Willenheimer 2005).
Hemodialysis: Not dialyzable
Dosing: Hepatic Impairment: Adult
Hepatitis or cirrhosis: Initial: 2.5 mg once daily; increase cautiously.
Calculations
Creatinine Clearance by Cockcroft-Gault
Creatinine Clearance by Cockcroft-Gault (SI units)
Creatinine Clearance by Cockcroft-Gault with IBW
Creatinine Clearance by Cockcroft-Gault with IBW (SI units)
Use: Labeled Indications
Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2017]).
* See Uses in AHFS Essentials for additional information.
Use: Off-Label: Adult
Acute MI Level of Evidence [G]
According to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of ST-elevation
myocardial infarction (STEMI) and the ACC/AHA guidelines for the management of non-ST-elevation ACS (NSTE-ACS), oral beta-blockers
should be initiated within the first 24 hours unless the patient has signs of heart failure, evidence of a low-output state, an increased risk for
cardiogenic shock, or other contraindications. However, recommendations do not specify any particular beta-blocking agent for optimal treatment
of NSTE-ACS. Thus, clinicians must use practical experience to determine proper therapy in managing patients Ref.
Atrial fibrillation (rate control) Level of Evidence [G]
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Based on the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for the
management of patients with atrial fibrillation (AF), the use of beta-blockers, including bisoprolol, for ventricular rate control in patients with
paroxysmal, persistent, or permanent AF is effective and recommended for this condition.
Heart failure with reduced ejection fraction (HFrEF) Level of Evidence [A, G]
Data from a European multicenter double-blind randomized placebo-controlled trial supports the use of bisoprolol in the treatment of patients with
heart failure Ref.
Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) 2013 heart failure guidelines, the use of 1 of
the 3 beta-blockers (ie, bisoprolol, carvedilol, or extended-release metoprolol succinate) is effective and recommended for all patients with recent
or remote history of MI or ACS and reduced ejection fraction (rEF) to reduce mortality, for all patients with rEF to prevent symptomatic heart
failure (HF) even if no history of MI, and for all patients with current or prior symptoms of HF with reduced ejection fraction (HFrEF), unless
contraindicated to reduce morbidity and mortality.
Ventricular arrhythmias Level of Evidence [G]
Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for management of
patients with ventricular arrhythmias and prevention of sudden cardiac death, beta-blockers are effective for control of ventricular arrhythmias
and ventricular premature beats.
Additional Off-Label Uses
Chronic stable angina; Supraventricular arrhythmias
Level of Evidence Definitions
Level of Evidence Scale
Class and Related Monographs
Beta-Adrenergic Blocking Agents (Beta-Blockers)
Clinical Practice Guidelines
Arrhythmias:
AHA/ACC/HRS, "2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac
Death," October 2017
AHA/ACC/HRS, "2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial
Fibrillation," January 2019
AHA/ACC/HRS, "2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation," March 2014
Canadian Cardiovascular Society, "2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial
Fibrillation," 2016
Coronary Artery Bypass Graft Surgery:
“2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery,” November 2011
Heart Failure:
ACC/AHA/HFSA, “2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure,” May 2016
ACC/AHA/HFSA “Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure,” August 2017
ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of Heart Failure,” June 2013
Hypertension:
"2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of
High Blood Pressure in Adults," November 2017.
AHA/ACC/ASH, “Treatment of Hypertension in Patients with Coronary Artery Disease: A Scientific Statement by the American Heart Association,
American College of Cardiology and American Society of Hypertension,” May 2015
ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the community: a statement by the American Society of
Hypertension and the International Society of Hypertension,” January 2014
ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of Heart Failure,” June 2013
"ACCF/AHA Expert Consensus Document on Hypertension in the Elderly," 2011
AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013
Eighth Joint National Committee (JNC 8), "2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults," December
2013.
The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents, August 2004
Ischemic Heart Disease:
ACC/AHA/AATS/PCNA/SCAI/STS, "2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic
Heart Disease," July 2014
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ACCF/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,”
November 2012
AHA/ACC, "2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014
ACCF/AHA, "2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction," December 2012
Prevention:
“AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011
Update,” November 2011
Surgery:
ACC/AHA, “2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac
Surgery,” August 2014
Valvular Heart Disease:
AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease,” March 2014
Administration: Oral
May be administered without regard to meals.
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Loss of strength and energy
• Common cold symptoms
• Headache
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Severe dizziness
• Passing out
• Shortness of breath
• Excessive weight gain
• Swelling of arms or legs
• Slow heartbeat
• Cold extremities
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or
throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other
medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information
does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general
information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse
effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the
healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
Contraindications
Cardiogenic shock; overt cardiac failure; marked sinus bradycardia or heart block greater than first-degree (except in patients with a functioning
artificial pacemaker)
Documentation of allergenic cross-reactivity for beta-blockers is limited. However, because of similarities in chemical structure and/or pharmacologic
actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Warnings/Precautions
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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; for patients with bronchospastic
disease who do not respond to or cannot tolerate other therapies, initial low doses of beta1-selective bisoprolol may be employed and used
cautiously with close monitoring. Ensure patient has an inhaled beta2-agonist immediately available. At doses ≥20 mg/day, slight
asymptomatic increases in airway resistance and decreases in forced expiratory volume (FEV1) has been observed.
• Conduction abnormality: Consider preexisting conditions such as sick sinus syndrome before initiating.
• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.
• Heart failure (HF): Use with caution in patients with compensated heart failure and monitor for a worsening of the condition. Patients should be
stabilized on heart failure regimen prior to initiation of beta-blocker. Beta-blocker therapy should be initiated at very low doses with gradual
and very careful titration. Adjustment of other medications (ACE inhibitors and/or diuretics) may be required
• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment required with severe impairment.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis.
• Peripheral vascular disease (PVD) and Raynaud disease: Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD
and Raynaud 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 have not been firmly
established.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required with CrCl <40 mL/minute.
• 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:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or
selection of alternative therapy. Consult drug interactions database for more detailed information.
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, and/or ischemia. 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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Due to alterations in the beta-adrenergic autonomic nervous system, beta-adrenergic blockade may result in less hemodynamic response than seen
in younger adults. Studies indicate that despite decreased sensitivity to the chronotropic effects of beta-blockade with age, there appears to be an
increased myocardial sensitivity to the negative inotropic effect during stress (ie, exercise). Controlled trials have shown the overall response rate for
propranolol to be only 20% to 50% in elderly populations. Therefore, all beta-adrenergic blocking drugs may result in a decreased response as
compared to younger adults.
The AHA/ACC/ASH 2015 scientific statement on the treatment of hypertension in patients with CAD warns to use caution to avoid decreases in DBP
<60 mm Hg especially in patients >60 years of age since reduced coronary perfusion may occur. When lowering SBP in older hypertensive patients
with wide pulse pressures, very low DBP values (<60 mm Hg) may result. In patients with obstructive CAD, clinicians should lower blood pressure
slowly and carefully monitor for any untoward signs or symptoms, especially those resulting from myocardial ischemia and worsening heart failure
(AHA/ACC/ASH [Rosendorff 2015]).
Pregnancy Risk Factor
C
Pregnancy Considerations
Exposure to beta-blockers during pregnancy may increase the risk for adverse events in the neonate. If maternal use of a beta-blocker is needed,
fetal growth should be monitored during pregnancy and the newborn should be monitored for 48 hours after delivery for bradycardia, hypoglycemia,
and respiratory depression (ESC [Regitz-Zagrosek 2018]).
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Chronic maternal hypertension is also associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth
defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to duration and severity of
maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes,
preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 203 2019).
When treatment of chronic hypertension in pregnancy is indicated, agents other than bisoprolol are preferred (ACOG 203 2019; ESC [RegitzZagrosek 2018]; Magee 2014). Females with preexisting hypertension may continue their medication during pregnancy unless contraindications exist
(ESC [Regitz-Zagrosek 2018]).
Breast-Feeding Considerations
It is not known if bisoprolol is present in breast milk.
The manufacturer recommends that caution be exercised when administering bisoprolol to breastfeeding women. Use of a beta-blocker other than
bisoprolol may be preferred in a lactating female (Anderson 2017; Ito 2000).
Lexicomp Pregnancy & Lactation, In-Depth
Bisoprolol
Briggs' Drugs in Pregnancy & Lactation
Bisoprolol
Adverse Reactions
1% to 10%:
Cardiovascular: Chest pain (1%)
Central nervous system: Fatigue (7%), hypoesthesia (1%)
Gastrointestinal: Diarrhea (3%), vomiting (1%)
Hepatic: Increased serum alanine aminotransferase (≤4%), increased serum aspartate aminotransferase (≤4%)
Respiratory: Upper respiratory tract infection (5%), dyspnea (1%)
Frequency not defined:
Cardiovascular: Cardiac arrhythmia, cardiac failure, claudication, cold extremities, edema, flushing, hypersensitivity angiitis, hypotension,
orthostatic hypotension, palpitations
Central nervous system: Anxiety, depression, dizziness, drowsiness, headache, hyperesthesia, insomnia, lack of concentration, malaise, memory
impairment, paresthesia, restlessness, sensation of eye pressure, twitching, vertigo, vivid dream
Dermatologic: Acne vulgaris, alopecia, diaphoresis, eczema, pruritus, skin irritation, skin rash
Endocrine & metabolic: Decreased libido, gout, increased serum glucose, increased serum phosphate, increased serum potassium, increased
serum triglycerides, increased uric acid, weight gain
Gastrointestinal: Abdominal pain, constipation, dysgeusia, dyspepsia, epigastric pain, gastric pain, gastritis, nausea, peptic ulcer, xerostomia
Genitourinary: Cystitis, impotence
Hematologic & oncologic: Decreased white blood cell count, positive ANA titer, purpuric rash, thrombocytopenia
Neuromuscular & skeletal: Back pain, muscle cramps, myalgia, neck pain, tremor
Ophthalmic: Abnormal lacrimation, eye pain, visual disturbance
Otic: Otalgia, tinnitus
Renal: increased blood urea nitrogen, increased serum creatinine, polyuria, renal colic
Respiratory: Asthma, bronchitis, bronchospasm, cough, dyspnea on exertion, pharyngitis, rhinitis, sinusitis
<1%, postmarketing, and/or case reports: Angioedema, arthralgia, asthenia, auditory impairment, bradycardia, dermatitis, exfoliative dermatitis,
Peyronie disease, psoriasis, sleep disturbance, syncope, unsteadiness
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Beta-Blocker Allergy
Toxicology
Beta-Blockers
Metabolism/Transport Effects
Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction
potential
Drug Interactions
Open Interactions
Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy
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Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Alpha1-Blockers: Beta-Blockers may enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is
probably less than systemic products. Risk C: Monitor therapy
Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance
the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely
monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when
possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Exceptions: Apraclonidine. Risk D:
Consider therapy modification
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at
chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure
lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification
Aminoquinolines (Antimalarial): May decrease the metabolism of Beta-Blockers. Risk C: Monitor therapy
Amiodarone: May enhance the bradycardic effect of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase the serum
concentration of Beta-Blockers. Risk C: Monitor therapy
Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of
Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Risk C: Monitor
therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents
(Second Generation [Atypical]). Risk C: Monitor therapy
Barbiturates: May decrease the serum concentration of Beta-Blockers. Risk C: Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Beta2-Agonists: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective
beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy
Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy
Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive
Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect
of Blood Pressure Lowering Agents. Risk X: Avoid combination
Bupivacaine: Beta-Blockers may increase the serum concentration of Bupivacaine. Risk C: Monitor therapy
Calcium Channel Blockers (Nondihydropyridine): May enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have
also been reported. Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Beta-Blockers. Exceptions:
Bepridil. Risk C: Monitor therapy
Cardiac Glycosides: Beta-Blockers may enhance the bradycardic effect of Cardiac Glycosides. Risk C: Monitor therapy
Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor
patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in
separate monographs. Risk D: Consider therapy modification
Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac
conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for
one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D:
Consider therapy modification
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4
substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic
effects). Risk D: Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy
Disopyramide: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Risk
C: Monitor therapy
Dronedarone: May enhance the bradycardic effect of Beta-Blockers. Dronedarone may increase the serum concentration of Beta-Blockers. This likely
applies only to those agents that are metabolized by CYP2D6. Management: Use lower initial beta-blocker doses; adequate tolerance of the
combination, based on ECG findings, should be confirmed prior to any increase in beta-blocker dose. Risk D: Consider therapy modification
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
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Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of
enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4
substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification
EPINEPHrine (Nasal): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Nasal). Risk C: Monitor therapy
EPINEPHrine (Oral Inhalation): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Oral Inhalation). Risk C: Monitor
therapy
Epinephrine (Racemic): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of Epinephrine (Racemic). Risk C: Monitor therapy
EPINEPHrine (Systemic): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Systemic). Risk C: Monitor therapy
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Ergot Derivatives: Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives. Exceptions: Nicergoline. Risk D: Consider therapy
modification
Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Risk X: Avoid combination
Fingolimod: Beta-Blockers may enhance the bradycardic effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and betablockers if possible. If coadministration is necessary, patients should have overnight continuous ECG monitoring conducted after the first dose of
fingolimod. Monitor patients for bradycardia. Risk D: Consider therapy modification
Floctafenine: May enhance the adverse/toxic effect of Beta-Blockers. Risk X: Avoid combination
Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass
Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5
Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment
with Beta-Blockers. Risk D: Consider therapy modification
Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C:
Monitor therapy
Insulins: Beta-Blockers may enhance the hypoglycemic effect of Insulins. Risk C: Monitor therapy
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy
Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy
Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C:
Monitor therapy
Lidocaine (Systemic): Beta-Blockers may increase the serum concentration of Lidocaine (Systemic). Risk C: Monitor therapy
Lidocaine (Topical): Beta-Blockers may increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy
Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib
with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and
serious clinical consequences. Risk D: Consider therapy modification
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Mepivacaine: Beta-Blockers may increase the serum concentration of Mepivacaine. Risk C: Monitor therapy
Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Risk C: Monitor therapy
Methoxyflurane: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy
Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may
need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Risk C:
Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood
pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D:
Consider therapy modification
Opioids (Anilidopiperidine): May enhance the bradycardic effect of Beta-Blockers. Opioids (Anilidopiperidine) may enhance the hypotensive effect of
Beta-Blockers. Risk C: Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
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Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Propafenone: May increase the serum concentration of Beta-Blockers. Propafenone possesses some independent beta blocking activity. Risk C:
Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Regorafenib: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy
Reserpine: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy
Rifamycin Derivatives: May decrease the serum concentration of Beta-Blockers. Exceptions: Rifabutin. Risk C: Monitor therapy
Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Risk X: Avoid combination
Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends
avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy
Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with
drugs that may cause bradycardia. Risk D: Consider therapy modification
Sulfonylureas: Beta-Blockers may enhance the hypoglycemic effect of Sulfonylureas. Cardioselective beta-blockers (eg, acebutolol, atenolol,
metoprolol, and penbutolol) may be safer than nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial symptom of
hypoglycemia. Ophthalmic beta-blockers are probably associated with lower risk than systemic agents. Risk C: Monitor therapy
Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Theophylline Derivatives: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Theophylline Derivatives. Management: Monitor
for reduced theophylline efficacy during concomitant use with any beta-blocker. Beta-1 selective agents are less likely to antagonize theophylline
than nonselective agents, but selectivity may be lost at higher doses. Risk C: Monitor therapy
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Test Interactions
May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)
Genes of Interest
Angiotensin I Converting Enzyme 1
Angiotensinogen (Serpin Peptidase Inhibitor, Clade A, Member 8)
Beta-1 Receptor
Bradykinin Receptor B2
Cytochrome P450 3A4
G Protein-Coupled Receptor Kinase 5
Monitoring Parameters
Blood pressure, heart rate, ECG; serum glucose (in diabetic patients)
Hypertension: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton
2017]):
Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended.
Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable.
Advanced Practitioners Physical Assessment/Monitoring
Obtain renal function tests and liver function tests (dosage adjustments may be needed) and serum glucose (diabetic patients). Obtain ECG. Screen
patient for history of diabetes, heart failure, myasthenia gravis, peripheral vascular disease, pheochromocytoma, renal impairment, liver impairment,
psoriasis, or thyroid disease. Evaluate risk vs benefit in patients with bronchospastic disease or Prinzmetal variant angina. Assess blood pressure and
heart rate prior to and following first dose of therapy and after any change in dosage. Teach patient how to handle orthostatic/postural hypotension
and hypotension precautions. When discontinuing therapy, taper dosage slowly.
Nursing Physical Assessment/Monitoring
Check ordered labs and tests and report any abnormalities. Monitor blood pressure and heart rate prior to and following first dose and with any
change in dosage. Instruct patients to discontinue medicine slowly. Teach patients with diabetes possible side effects/appropriate interventions,
including altered glucose tolerance and monitoring glucose levels closely. Teach patients orthostatic precautions (rise slowly, call for assistance, notify
nurse if feeling dizzy or faint). Monitor for and educate patient to report any signs and symptoms of new or worsening heart failure (edema, new
cough, difficulty breathing, unintentional weight gain, unresolved fatigue).
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral, as fumarate:
Zebeta: 5 mg [DSC], 10 mg [DSC]
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Generic: 5 mg, 10 mg
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as fumarate:
Generic: 5 mg, 10 mg
Anatomic Therapeutic Chemical (ATC) Classification
C07AB07
Generic Available (US)
Yes
Pricing: US
Tablets (Bisoprolol Fumarate Oral)
5 mg (per each): $1.22 - $2.25
10 mg (per each): $1.22 - $2.25
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when
more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The
pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement
or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of
any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its
solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range
data. Pricing data is updated monthly.
Mechanism of Action
Selective inhibitor of beta1-adrenergic receptors; competitively blocks beta1-receptors, with little or no effect on beta2-receptors at doses ≤20 mg
Pharmacodynamics/Kinetics
Onset of action: 1 to 2 hours
Absorption: Rapid and almost complete
Distribution: Widely; highest concentrations in heart, liver, lungs, and saliva; crosses blood-brain barrier
Protein binding: ~30%
Metabolism: Extensively hepatic; significant first-pass effect (~20%)
Bioavailability: ~80%
Half-life elimination: Normal renal function: 9 to 12 hours; CrCl <40 mL/minute: 27 to 36 hours; Hepatic cirrhosis: 8 to 22 hours
Time to peak: 2 to 4 hours
Excretion: Urine (50% as unchanged drug, remainder as inactive metabolites); feces (<2%)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
Bisoprolol is a cardioselective beta-blocker. Local anesthetic with vasoconstrictor can be safely used in patients medicated with bisoprolol.
Nonselective beta-blockers (ie, propranolol, nadolol) enhance the pressor response to epinephrine, resulting in hypertension and bradycardia; this
has not been reported for bisoprolol. Many nonsteroidal anti-inflammatory drugs, such as ibuprofen and indomethacin, can reduce the hypotensive
effect of beta-blockers after 3 or more weeks of therapy with the NSAID. Short-term NSAID use (ie, 3 days) requires no special precautions in
patients taking beta-blockers.
Effects on Bleeding
No information available to require special precautions
Related Information
Beta-Blockers
Index Terms
Bisoprolol Fumarate
FDA Approval Date
July 31, 1992
References
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Brand Names: International
Adroten (MY); Ancor (BD); B-Beta (ID); B-Cor (BH, JO, LB); Beprol (AU); Beta-One (ID, KR); Betabis (BD); Betacor (TH, TW); Betapro (BD); Bicard
(AU); Bicor (AU); Bilocor (ZW); Biol (CH); Bipro (ID); Biprolol (UA); Biscor (BH, JO, QA, SA, TW); Bisloc (MY, TH); Biso (DE); Biso 5 (TW); Bisoblock
(VN); Bisocard (EG, UA); Bisocor (LB, LK, MY); Bisodac-HF (MY); Bisohexal (SG); Bisol (MY); Bisolock (EG); Bisomerck (DE); Bisono Tape (JP);
Bisop (IE); Bisopine (IE); Bisostad (VN); Bisosten (PH); Bisoten (JO); Bisotrol (ZW); Bispro (AU); Bistol (EG); Biteven (TW); Bosvate (NZ); Caprol
(EG); Cardensiel (FR); Cardex (BH); Cardicor (DK, IE); Cardiloc (IL); Cardiosafe (QA); Cobis (KR); Comed 5 (TH); Concor (AE, AR, AT, BG, BH, BR,
BS, CH, CL, CN, CO, CR, CY, CZ, DE, DO, EC, EE, EG, GT, HK, HN, HR, HU, ID, IL, IN, IT, JM, JO, KR, KW, LB, LK, LU, LV, MX, MY, NI, NL, PA,
PE, PK, PL, PT, QA, RO, RU, SA, SI, SK, SV, TH, TR, TT, TW, UA, VE, VN, ZA); Concor COR (DE, HR, VN); Concor-Cor (LK); Concore (PH); Corbis
(AR); Corbloc (LK); Cordinorm (UA); Corentel (PE, PY, UY); Detensiel (FR); Emconcor (BE, DK, ES, FI, NO, SE); Euradal (ES); Hapsen (ID);
Hypercor (TH); Isoten (BE); Jutabis (DE); Kenco (TW); Maintate (JP); Monocor (TW); Novacor (TH); Pactens (GR); Probis (BD); Sopalol (TH); Soprol
(DO); Soprol-5 (PH); Vasoten (MY); Zabesta (LK)
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Last Updated 1/15/20
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