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At a glance

Bisoprolol + Amlodipine is a combination medicine used in the treatment of hypertension (high blood pressure). It is a combination of two medicines that effectively controls blood pressure when a single medication is not effective.

Indications
  • Hypertension (high blood pressure)
Pharmacology

Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It selectively inhibits calcium ion influx across cell membranes, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine acts directly on vessels to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Bisoprolol Fumarate is a synthetic, β1-selective (cardioselective) adrenoceptor blocking agent, lacking intrinsic sympathomimetic and relevant membrane stabilizing activity.

Dosage

Adults: 1 tablet once daily (at the dose at which the patient was adequately controlled with individual components).

Hepatic impairment: Elimination of amlodipine may be prolonged; special caution required. In severe hepatic impairment, bisoprolol daily dose must not exceed 10 mg.

Renal impairment: No dosage adjustment for mild to moderate impairment. In severe renal impairment (CrCl <20 mL/min), bisoprolol daily dose must not exceed 10 mg. Amlodipine is not dialyzable; caution in dialysis patients.

Elderly: Usual doses can be used, but caution when increasing dose.

Children: Safety and efficacy not established in patients under 18 years.

Side effects

Common:
Dizziness, headache, somnolence, palpitations, flushing (sense of warmth in face, ears, neck and trunk), feeling of coldness or numbness in extremities, nausea, vomiting, diarrhea, constipation, abdominal pain, edema (ankle swelling), fatigue, bradycardia.

Uncommon:
Insomnia, mood changes (incl. anxiety), depression, sleep disorders, hypaesthesia, paresthesia, dysgeusia, tremor, visual disturbances (incl. diplopia), tinnitus, AV conduction disturbances, worsening of pre-existing heart failure, bradycardia, hypotension, syncope, dyspnea, bronchospasm (in patients with asthma or obstructive airway disease history), rhinitis, dyspepsia, dry mouth, alopecia, purpura, skin discoloration, pruritus, exanthema, arthralgia, myalgia, muscular weakness, muscle cramps, back pain, micturition disorder, nocturia, pollakisuria, potency disorders, gynecomastia, asthenia, chest pain, pain, malaise, weight increase/decrease.

Rare:
Allergic reactions (mainly skin), nightmares, hallucinations, confusion, decreased tear secretion, hearing disorders, allergic rhinitis, hepatitis, increased triglycerides, elevated liver enzymes (ALAT, ASAT).

Use in pregnancy

May be unsafe during pregnancy. Limited human studies available; animal studies have shown harmful effects on the developing baby. Your doctor will weigh benefits and risks. Not recommended during pregnancy and lactation. Consult your doctor.

Pregnancy Category: C — always consult a doctor before taking during pregnancy.

Precautions & warnings
  • May cause dizziness; get up slowly from sitting or lying position.
  • Do not stop suddenly (may worsen clinical condition, especially in ischemic heart disease).
  • Diabetic patients should monitor blood glucose regularly (may mask hypoglycemia symptoms).
  • Caution in obstructive airway disease (concomitant bronchodilating therapy may be recommended).
  • Use with caution in patients with psoriasis or history of psoriasis.
  • May mask symptoms of thyrotoxicosis.
  • If withdrawal before surgery is necessary, do so gradually and complete about 48 hours before anesthesia.
  • Caution in liver and kidney disease.
  • May affect ability to drive; be cautious.
  • Alcohol consumption is unsafe.
  • Use along with proper diet, salt restriction, and regular exercise.
Overdose effects

Beta-blocker overdose: Bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, hypoglycemia.

Amlodipine overdose: Excessive peripheral vasodilation and possibly reflex tachycardia. Marked and prolonged systemic hypotension up to shock with fatal outcome reported.

In overdose, discontinue treatment and provide supportive and symptomatic treatment.

Storage conditions

Store in a dry place below 30°C. Protect from light. Keep out of reach of children.

Bisoprolol + Amlodipine — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.