Amlodipine / Bisoprolol Fumarate

What it is and how it works

Amlodipine blocks L-type calcium channels in vascular smooth muscle, causing arterial vasodilatation. Bisoprolol selectively blocks beta-1 adrenoceptors, reducing heart rate, cardiac output and renin release; the combination has complementary antihypertensive and antianginal effects.

Indications

Hypertension and/or stable angina in adults already controlled on amlodipine and bisoprolol given separately at the same doses.

Dosage and administration (summary)

One tablet orally once daily at the strength corresponding to the established individual doses (e.g. bisoprolol 5–10 mg with amlodipine 5–10 mg).

Contraindications

Acute or decompensated heart failure; cardiogenic shock; second- or third-degree AV block or sick sinus syndrome without pacemaker; symptomatic bradycardia or hypotension; severe asthma; severe aortic stenosis; severe peripheral arterial disease.

Warnings and precautions

Do not stop abruptly because of the risk of rebound angina. May mask hypoglycaemia and signs of thyrotoxicosis; caution in diabetes, COPD, psoriasis and hepatic impairment. Peripheral oedema is common with amlodipine.

Pregnancy

Not recommended in pregnancy unless clearly necessary; beta-blockers may cause fetal growth restriction and neonatal bradycardia or hypoglycaemia.

Storage and supply

Store below 30 °C, protected from light and moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.