Bisoprolol

ATC code

C07AB07

Therapeutic class

Agente beta-bloqueante · Agente beta-bloqueante selectivo (beta-1)

Forms

oral tablet

Brand names

Bisoprolol fumarate (US) · Bisoprolol Cinfa (ES) · Bisoprolol Sandoz (FR) · Concor (EU/International) · Zebeta (US)

Overall confidence

high

Regulatory sources consulted

openfda-label-e8b6cea1-8a7f-4255-8a24-ff96d6ceece2
aemps-ft-78905
ansm-rcp-69849486
OpenFDA · C07AB07
RxNorm rxcui 19484 ↗

Approved indications

Management of hypertension. It may be used alone or in combination with other antihypertensive agents.
Treatment of stable chronic heart failure.
Treatment of angina pectoris.

Contraindications

Absolute

Cardiogenic shock, overt or acute heart failure, second or third degree AV block, sick sinus syndrome, sino-atrial block, symptomatic bradycardia (<50 bpm), symptomatic hypotension, severe asthma or severe COPD.
Untreated pheochromocytoma, metabolic acidosis.

Clinical warnings

Major warning · Abrupt cessation of therapy can exacerbate angina pectoris and, in some cases, lead to myocardial infarction. Taper dose gradually over 1-2 weeks. — FDA
Major warning · Beta-blockers should generally not be used in patients with bronchospastic disease. Due to its relative beta-1 selectivity, bisoprolol may be used with caution in patients who do not respond to or cannot tolerate other antihypertensive treatment. — FDA
Beta-blockade can mask signs of hypoglycemia (e.g., tachycardia) in diabetic patients. — ANSM

Drug interactions

HighVerapamil, DiltiazemC08DA01
Mechanism: Negative effect on contractility and atrioventricular conduction. IV administration of verapamil in patients on beta-blocker therapy can lead to profound hypotension and AV block.
Recommendation: Concomitant use is generally not recommended. IV administration of verapamil is contraindicated in patients receiving beta-blockers.
ANSM RCP
HighClonidineC02AC01
Mechanism: Concomitant use can decrease central sympathetic tone. Abrupt withdrawal of clonidine can increase the risk of 'rebound hypertension', which is exacerbated by concurrent beta-blockade.
Recommendation: If concomitant therapy is discontinued, the beta-blocker should be discontinued several days before gradually discontinuing clonidine.
ANSM RCP
ModerateClass I Antiarrhythmics (e.g., Flecainide, Propafenone)C01BC04
Mechanism: Potentiation of effect on atrio-ventricular conduction time and increased negative inotropic effect.
Recommendation: Use with caution, especially in patients with heart failure. Clinical and ECG monitoring is advised.
ANSM RCP

Adverse events

Common (≥1%)

bradycardia · dizziness · headache · fatigue · asthenia · gastrointestinal disorders (nausea, diarrhea, constipation) · cold extremities · hypotension

Rare but serious

atrioventricular block · heart failure decompensation · bronchospasm · hepatitis · syncope · hallucinations · severe skin reactions

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. Beta-blockers decrease placental perfusion, which may cause intrauterine fetal death or premature delivery. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.