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Bisoprolol Uses, Dosage, Side Effects & Warnings | DrugsAtlas

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Therapeutic Class

Beta-adrenoceptor blocker

Subclass

Cardioselective β1-blocker

Speciality

Cardiology

Schedule (India)

Schedule H

Routes

Oral

Formulations

Form	Available Strengths
Tablets	1.25 mg, 2.5 mg, 5 mg, 10 mg
FDC with Amlodipine	Bisoprolol 2.5 mg/5 mg + Amlodipine 5 mg
FDC with Hydrochlorothiazide	Bisoprolol 2.5 mg/5 mg + HCTZ 6.25 mg

Note: 1.25 mg tablets available from select manufacturers; alternatively, 2.5 mg tablets may be halved for initial HF dosing.

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension

Parameter	Recommendation
Starting dose	2.5–5 mg orally once daily (morning)
Titration	Increase by 2.5–5 mg every 2–4 weeks based on BP response
Usual maintenance dose	5–10 mg once daily
Maximum dose	20 mg once daily

Clinical Notes:

Can be used as first-line or add-on therapy
Once-daily dosing ensures good compliance
Effect on BP seen within 1–2 weeks; maximum effect by 4–8 weeks

2. Stable Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) — NYHA Class II–IV

Parameter	Recommendation
Starting dose	1.25 mg orally once daily
Titration	Double dose every 1–2 weeks as tolerated
Titration steps	1.25 mg → 2.5 mg → 3.75 mg → 5 mg → 7.5 mg → 10 mg
Usual maintenance dose	10 mg once daily (target dose)
Maximum dose	10 mg once daily

Pre-initiation Requirements:

Patient must be clinically stable (no IV diuretics, no fluid overload)
On optimised ACE inhibitor/ARB and diuretic therapy
No recent decompensation (<4 weeks)

Clinical Notes:

Evidence-based mortality benefit (CIBIS-II trial)
Initiate only when patient euvolaemic and stable
Temporary worsening of HF symptoms may occur during up-titration — manage with diuretic adjustment, not beta-blocker discontinuation
Never withdraw abruptly — risk of acute decompensation

3. Stable Angina Pectoris

Parameter	Recommendation
Starting dose	5 mg orally once daily
Titration	Increase to 10 mg once daily after 1–2 weeks if symptoms persist
Usual maintenance dose	5–10 mg once daily
Maximum dose	20 mg once daily

Clinical Notes:

Aim for resting HR 55–60 bpm for optimal anti-anginal effect
Often combined with long-acting nitrates or dihydropyridine CCBs (amlodipine)
Avoid combination with rate-limiting CCBs (verapamil, diltiazem) — risk of severe bradycardia

4. Cardiac Arrhythmias — Ventricular Rate Control

Parameter	Recommendation
Starting dose	2.5 mg orally once daily
Titration	Increase every 1–2 weeks based on HR control
Usual maintenance dose	5–10 mg once daily
Maximum dose	10 mg once daily for rate control

Clinical Notes:

Useful for rate control in atrial fibrillation/flutter when rapid ventricular response
Less effective in high catecholamine states compared to non-selective beta-blockers
Monitor for excessive bradycardia

Secondary Indications — Adults (Off-label)

Indication	Dose	Duration	Notes
Atrial fibrillation (rate control)	2.5–10 mg once daily	Long-term	OFF-LABEL; Cardiology specialist; established Indian practice
Premature ventricular complexes (PVCs)	2.5–10 mg once daily	Long-term	OFF-LABEL; Cardiology specialist; symptomatic patients
Thyrotoxicosis (symptomatic control)	5–10 mg once daily	Until euthyroid	OFF-LABEL; For palpitations/tremor control; non-selective preferred for severe cases
Migraine prophylaxis	5–10 mg once daily	≥3 months trial	OFF-LABEL; Neurology practice; propranolol more commonly used
Performance anxiety	2.5–5 mg single dose PRN	As needed	OFF-LABEL; Situational use

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Limited approved paediatric indications in India. Use is OFF-LABEL and requires paediatric cardiology supervision.

Heart Failure / Cardiomyopathy (Paediatric)

Age/Weight	Starting Dose	Titration	Maximum Dose
Children ≥6 years	0.05–0.1 mg/kg/day once daily	Double every 1–2 weeks as tolerated	0.2 mg/kg/day (max 10 mg/day)
Adolescents ≥12 years	1.25 mg once daily	As per adult HF protocol	10 mg once daily

Secondary Indications — Paediatrics (Off-label)

Indication	Age	Dose	Duration	Notes
Congenital long QT syndrome	≥5 years	0.1–0.2 mg/kg/day	Long-term	OFF-LABEL; Paediatric cardiology only
Hypertrophic cardiomyopathy	≥5 years	0.1–0.2 mg/kg/day	Long-term	OFF-LABEL; Specialist only
Paediatric hypertension	≥6 years	0.05–0.2 mg/kg/day	Long-term	OFF-LABEL; Limited data

Paediatric Safety Notes

Parameter	Recommendation
Minimum age	Not recommended <5 years except under paediatric cardiologist supervision
Monitoring	HR, BP, ECG at baseline and during titration
Formulation	Use tablets (no liquid formulation available in India); may need extemporaneous preparation
Contraindications	Same as adults — asthma, severe bradycardia, AV block

Renal Adjustments

eGFR (mL/min/1.73 m²)	Dose Modification
>60	No adjustment required
30–60	No adjustment; monitor for accumulation
10–30	Start 1.25–2.5 mg once daily; titrate cautiously
<10 or Dialysis	Start 1.25 mg once daily; maximum 5 mg/day; not significantly dialysed

Note: Bisoprolol has balanced hepatic (50%) and renal (50%) elimination — dose reduction needed mainly in severe combined impairment.

Hepatic adjustment

Contraindications

Severe sinus bradycardia (HR <50 bpm at rest)
Sick sinus syndrome (without pacemaker)
Second- or third-degree AV block (without pacemaker)
Cardiogenic shock
Decompensated heart failure requiring IV inotropes
Severe bronchial asthma or severe COPD with bronchospasm
Symptomatic hypotension (SBP <90 mmHg)
Untreated phaeochromocytoma
Severe peripheral arterial disease with rest pain/gangrene
Metabolic acidosis
Known hypersensitivity to bisoprolol or other beta-blockers

Cautions

Controlled asthma / mild-moderate COPD — use with caution; β1-selectivity reduces but does not eliminate bronchospasm risk
Diabetes mellitus — may mask tachycardia and tremor of hypoglycaemia; sweating preserved
Peripheral vascular disease — may worsen claudication
Prinzmetal's (variant) angina — unopposed alpha-mediated vasoconstriction may worsen
First-degree AV block — monitor for progression
Psoriasis — may exacerbate
History of anaphylaxis — may reduce efficacy of adrenaline
Concurrent use with rate-limiting CCBs (verapamil, diltiazem) — risk of severe bradycardia/AV block
Myasthenia gravis — may worsen symptoms
Depression — caution advised
Abrupt withdrawal — may precipitate rebound angina, MI, or arrhythmias; always taper over 1–2 weeks

Pregnancy

Parameter	Recommendation
Overall safety	Use only if potential benefit outweighs risk
Known risks	Fetal bradycardia, hypoglycaemia, intrauterine growth restriction
Trimester considerations	Relatively more data in 3rd trimester; limited 1st trimester data
Preferred alternatives	Labetalol (first choice in pregnancy), Methyldopa
When to use	Maternal cardiac conditions (HF, arrhythmias) where beta-blockade essential
Monitoring	Serial fetal growth scans, fetal HR monitoring, neonatal observation for 48–72 hours post-delivery

Lactation

Parameter	Recommendation
Compatibility	Generally compatible with breastfeeding
Drug levels in milk	Low (milk:plasma ratio ~0.1–0.3)
Preferred alternatives	Metoprolol, Propranolol (more lactation data available)
Infant monitoring	Heart rate, feeding patterns, weight gain, signs of beta-blockade (lethargy, poor feeding)

Elderly

Parameter	Recommendation
Starting dose	1.25–2.5 mg once daily
Titration	Slower than standard — increase every 2–4 weeks
Maximum dose	As per indication; often lower doses sufficient
Extra risks	Bradycardia, orthostatic hypotension, falls, fatigue, cognitive effects, reduced cardiac reserve
Monitoring	Orthostatic BP measurement; HR; renal function

Major drug interactions

Interacting Drug	Effect	Recommendation
Verapamil, Diltiazem	Additive negative chronotropic and inotropic effects → severe bradycardia, AV block, hypotension	Avoid combination or use only with continuous ECG monitoring; specialist supervision
Class I antiarrhythmics (Disopyramide, Flecainide, Propafenone)	Additive cardiac depression	Avoid or use with extreme caution; ECG monitoring
Clonidine	Rebound hypertension if clonidine stopped first	Withdraw bisoprolol first, then taper clonidine
MAO inhibitors (non-selective)	Exaggerated hypotension	Avoid concurrent use
Adrenaline (Epinephrine)	Unopposed alpha-stimulation → severe hypertension	Avoid in patients on beta-blockers; use with caution in anaphylaxis
Fingolimod	Additive bradycardia at initiation	Avoid combination; specialist supervision if essential

Moderate drug interactions

Interacting Drug	Effect	Recommendation
Insulin / Sulfonylureas	Masking of hypoglycaemia symptoms (except sweating)	Counsel diabetic patients; monitor glucose closely
Digoxin	Additive bradycardia; AV conduction delay	Monitor HR and ECG; digoxin levels if toxicity suspected
NSAIDs (Ibuprofen, Diclofenac)	Blunted antihypertensive effect	Monitor BP; consider paracetamol for analgesia
Rifampicin	Reduced bisoprolol levels (CYP3A4 induction)	May need higher bisoprolol dose; monitor BP and HR
Dihydropyridine CCBs (Amlodipine, Nifedipine)	Additive hypotension	Generally safe combination; monitor BP
Mefloquine	Additive bradycardia	Monitor HR
Amiodarone	Additive bradycardia, AV block	Monitor ECG; often used together in AF but requires monitoring
Anaesthetic agents	Enhanced hypotension and bradycardia	Inform anaesthetist; usually continued perioperatively
Ergot alkaloids	Increased peripheral vasoconstriction	Avoid combination
Lidocaine	Increased lidocaine levels	Monitor for toxicity if IV lidocaine used

Common Adverse effects'

Fatigue, tiredness (most common)
Bradycardia
Dizziness, lightheadedness
Cold extremities (less common than non-selective beta-blockers)
Headache
Gastrointestinal disturbances (nausea, diarrhoea, constipation)
Sleep disturbances (insomnia, vivid dreams — less common than lipophilic beta-blockers)
Erectile dysfunction

Serious Adverse effects

Adverse Effect	Clinical Notes
Severe bradycardia / Sinus arrest	Discontinue or reduce dose; atropine if symptomatic
High-grade AV block	May require temporary/permanent pacing
Acute heart failure decompensation	Usually during up-titration; manage with diuretics, do not abruptly stop beta-blocker
Bronchospasm	Rare with bisoprolol; more likely in asthmatics; discontinue immediately
Severe hypotension	Reduce dose; IV fluids if needed
Masked hypoglycaemia	Diabetic patients may not recognise symptoms
Raynaud's phenomenon / Worsening PVD	Consider dose reduction or alternative
Psoriasis exacerbation	Consider alternative agent
Depression	Rare; monitor mood

Monitoring requirements

Timing	Parameters
Baseline	HR, BP (including orthostatic), ECG, renal function, LFTs (if hepatic disease); blood glucose in diabetics
After initiation / dose change	HR and BP at 1–2 weeks; earlier if HF up-titration
During HF titration	Weekly assessment of symptoms (dyspnoea, weight gain, oedema)
Long-term	HR and BP every 3–6 months; annual renal function; ECG if concerns about conduction
Special populations	More frequent monitoring in elderly, CKD, diabetes

Target HR: 55–65 bpm in stable angina/HF for optimal benefit

Brands in India

Brand Name	Manufacturer	Strengths
Concor	Merck/Abbott	1.25 mg, 2.5 mg, 5 mg, 10 mg
Corbis	Torrent	2.5 mg, 5 mg
Biselect	Intas	2.5 mg, 5 mg, 10 mg
Zabesta	Zydus	2.5 mg, 5 mg
Bisoprol	Cipla	2.5 mg, 5 mg, 10 mg
Cardibeta	Cadila	5 mg
Lodoz	Merck	FDC with HCTZ

Fixed-Dose Combinations:

Brand	Composition
Concor AM	Bisoprolol 5 mg + Amlodipine 5 mg
Corbis-AM	Bisoprolol 2.5 mg/5 mg + Amlodipine 5 mg
Lodoz	Bisoprolol 2.5 mg/5 mg/10 mg + HCTZ 6.25 mg

Price range (INR)

Formulation	Approximate Price per Tablet
1.25 mg tablet	₹4–8
2.5 mg tablet	₹2–5
5 mg tablet	₹3–7
10 mg tablet	₹5–10
FDC (Bisoprolol + Amlodipine)	₹8–15

NLEM 2022 Status: Bisoprolol included (2.5 mg, 5 mg tablets) — NPPA price ceiling applicable

Jan Aushadhi Availability: Available at subsidised rates

Clinical pearls

Most β1-selective: Bisoprolol has highest β1-selectivity among commonly used beta-blockers (selectivity ratio ~75:1) — preferred choice in patients with mild controlled asthma/COPD where beta-blockade is essential.
Heart failure gold standard: One of only three beta-blockers with proven mortality benefit in HFrEF (along with carvedilol, metoprolol succinate). Target dose is 10 mg — aim to reach it, but any tolerated dose is better than none.
Start low, go slow in HF: Never start at full dose in HF. Transient worsening is expected during up-titration — manage with diuretic adjustment, not beta-blocker cessation.
Never stop abruptly: Sudden withdrawal in IHD patients can precipitate acute coronary syndrome. Taper over 1–2 weeks if discontinuation needed.
Once-daily advantage: Long half-life (~10–12 hours) allows reliable once-daily dosing with consistent 24-hour effect, improving compliance.
Diabetes counselling essential: Warn diabetic patients that hypoglycaemia symptoms (palpitations, tremor) may be masked; sweating is preserved as warning sign.

Version

RxIndia v1.1 — 30 May 2025

Reference

CDSCO approved prescribing information
Indian Pharmacopoeia (IP)
National List of Essential Medicines (NLEM) 2022
API Textbook of Medicine
ICMR Guidelines for Management of Hypertension
Cardiological Society of India — Heart Failure Guidelines
AIIMS Drug Formulary
CIBIS-II Trial (Lancet 1999) — HF mortality evidence
Indian Heart Journal — Guidelines and reviews
Goodman & Gilman's The Pharmacological Basis of Therapeutics

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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