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Beta-Blocker (Selective) Pregnancy: UK SPC 4.6, verbatim: 'Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the fetus and newborn infant. If treatment with beta-adrenoceptor blockers is necessary, beta 1 -selective adrenoceptor blockers are preferable. Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of harmful effects on pregnancy or the fetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.' Breast-feeding: 'It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol.'

Bisoprolol

Brand names: Cardicor, Emcor

Bisoprolol is a cardioselective beta-blocker used in the management of hypertension, angina, and chronic stable heart failure, and for rate control in certain arrhythmias.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Chronic heart failure, titration: 1.25 mg once daily for 1 week, then 2.5 mg once daily for a further week, then 3.75 mg once daily for a further week, then 5 mg once daily for the 4 following weeks, then 7.5 mg once daily for the 4 following weeks, then 10 mg once daily as maintenance therapy
Route: Oral
Frequency: Once daily
Max: Maximum 10 mg once daily in chronic heart failure - UK SPC section 4.2, verbatim: 'The maximum recommended dose is 10 mg once daily.'
SCOPE: the dose above is the UK SPC chronic-heart-failure regimen, which is the only indication dosed in the fetched UK SPC. HYPERTENSION IS NOT DOSED IN ANY UK SOURCE IN THIS BUNDLE - the hypertension figures below come from the US label only and US labelling may differ from UK. || VERBATIM UK SPC section 4.2 (titration phase): 'The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps: 1.25 mg once daily for 1 week, if well tolerated increase to 2.5 mg once daily for a further week, if well tolerated increase to 3.75 mg once daily for a further week, if well tolerated increase to 5 mg once daily for the 4 following weeks, if well tolerated increase to 7.5 mg once daily for the 4 following weeks, if well tolerated increase to 10 mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg once daily.' Also: 'Patients should be stable (without acute failure) when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure.' || WITHDRAWAL, verbatim: 'If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patients condition.' Section 4.4 adds: 'Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated' and, for surgery, 'If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia.' || TOLERABILITY: 'If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered. In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation.' || METHOD OF ADMINISTRATION, verbatim: 'Bisoprolol tablets should be taken in the morning and can be taken with food. They should not be chewed. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water.' || HYPERTENSION - US LABEL ONLY, verbatim: 'The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.' The US label states no explicit maximum, so the 20 mg figure is NOT published as a maxDose. || OLDER PEOPLE (UK SPC): 'No dosage adjustment is required.' US label: 'Dose adjustment based on age is not necessary.' || The page's existing angina indication is not dosed in either fetched label. || PRIOR HOLD ANSWERED: this record was previously held for 'INDICATION SCOPE' - the CHF titration ramp was published with no indication prefix and an unqualified '10 mg once daily' ceiling on a general-medicine page. Both the dose and the maxDose above are now explicitly prefixed 'chronic heart failure', and the US-label hypertension figures are quoted separately and are NOT presented as the ceiling.

Dose adjustments

Renal

UK SPC section 4.2, verbatim: 'There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.' Section 4.4 lists 'severely impaired renal function' among conditions in which there is no therapeutic experience of bisoprolol treatment of heart failure. US label (hypertension), verbatim: 'In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration. Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.' NOTE: the eGFR <20 mL/min ceiling shown on the current page does not appear in either fetched label and has not been carried over.

Hepatic

UK SPC section 4.2, verbatim: 'There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.' Section 4.4 lists 'severely impaired hepatic function' among conditions in which there is no therapeutic experience of bisoprolol treatment of heart failure. US label (hypertension), verbatim: 'In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration.' No maximum dose in hepatic impairment is stated in either fetched label.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy (UK SPC 4.3)
  • Cardiogenic shock (UK SPC 4.3; also US label)
  • Second or third degree AV block (UK SPC 4.3; also US label)
  • Sick sinus syndrome (UK SPC 4.3)
  • Sinoatrial block (UK SPC 4.3)
  • Symptomatic bradycardia (UK SPC 4.3); the US label states 'marked sinus bradycardia'
  • Symptomatic hypotension (UK SPC 4.3)
  • Severe bronchial asthma (UK SPC 4.3)
  • Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome (UK SPC 4.3)
  • Untreated phaeochromocytoma (UK SPC 4.3)
  • Metabolic acidosis (UK SPC 4.3)
  • Hypersensitivity to bisoprolol or to any of the excipients (UK SPC 4.3)
  • Overt cardiac failure - listed as a contraindication in the US hypertension label only (the UK CHF SPC instead contraindicates acute/decompensated heart failure)

Side effects

  • Very common (>=1/10): bradycardia (UK SPC 4.8)
  • Common: worsening of heart failure; dizziness; headache; gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation; feeling of coldness or numbness in the extremities; hypotension; asthenia; fatigue
  • Uncommon: AV-conduction disturbances; bronchospasm in patients with bronchial asthma or a history of obstructive airways disease; muscular weakness and cramps; orthostatic hypotension; sleep disorder; depression
  • Rare: increased triglycerides; increased liver enzymes (ALAT, ASAT); syncope; reduced tear flow (to be considered if the patient uses lenses); hearing disorders; allergic rhinitis; hypersensitivity reactions (pruritus, flush, rash and angioedema); hepatitis; erectile dysfunction; nightmare; hallucination
  • Very rare: conjunctivitis; alopecia
  • UK SPC 4.8 also notes: 'Beta-blockers may provoke or worsen psoriasis or induce psoriasis like rash'
  • UK SPC 4.4: symptoms of hypoglycaemia can be masked in diabetes mellitus with large fluctuations in blood glucose values
  • US label withdrawal rate: 3.3% for bisoprolol fumarate vs 6.8% for placebo; withdrawals were less than 1% for either bradycardia or fatigue/lack of energy

Monitoring

  • During the titration phase, UK SPC 4.2 verbatim: 'Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.'
  • UK SPC 4.4: 'The initiation and cessation of treatment with bisoprolol necessitates regular monitoring.'
  • Watch for transient worsening of heart failure, hypotension or bradycardia during and after titration (UK SPC 4.2)
  • Blood glucose awareness in diabetes - symptoms of hypoglycaemia can be masked (UK SPC 4.4)
  • Liver enzymes (ALAT, ASAT) and triglycerides are listed as rare laboratory changes in UK SPC 4.8; no routine testing schedule is specified in the fetched sections
  • Anaesthetic awareness: the anaesthetist must be told the patient is beta-blocked before general anaesthesia (UK SPC 4.4)

Clinical monograph

How it works

It selectively blocks beta-1 adrenoceptors, reducing heart rate, myocardial contractility and conduction, which lowers cardiac workload and, in heart failure, counters chronic sympathetic overactivity.

Prescribing in practice

  • Do not stop it abruptly, as sudden withdrawal can precipitate rebound tachycardia, worsening angina or myocardial infarction; taper the dose when discontinuing.
  • It is contraindicated in marked bradycardia, second- or third-degree heart block, sick sinus syndrome, decompensated heart failure and severe hypotension.
  • In heart failure it must be initiated at a low dose in a stable patient and titrated slowly upward, and used with caution in asthma and with rate-limiting calcium-channel blockers.

Monitoring

Monitor heart rate, blood pressure and, in heart failure, symptoms and clinical status during initiation and dose titration.

Counselling the patient

  • Take it regularly and never stop suddenly without medical advice.
  • Report a very slow pulse, dizziness, fainting or worsening breathlessness.
  • Be aware it may mask some warning signs of low blood sugar in diabetes.

Evidence & guidelines

Beta-blockers including bisoprolol have strong evidence for prognostic benefit in chronic heart failure with reduced ejection fraction and are recommended in NICE guidance.

Reference: NICE NG106 (Chronic Heart Failure); CIBIS-II Trial (Lancet 1999); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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