Bisoprolol + Amlodipine

Bisoprolol + Amlodipine is a combination medicine used for the treatment of hypertension. It contains Amlodipine and Bisoprolol which effectively control blood pressure when a single medication is not effective.

Amlodipine is a calcium channel blocker which works by relaxing blood vessels while Bisoprolol is a beta blocker that works specifically on the heart to slow down the heart rate. Together, they make the heart more efficient at pumping blood throughout the body. It helps to lower high blood pressure and reduces the chances of future heart attack and stroke.

This combination tablet is indicated for the treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose level.

• Hypertension (high blood pressure)

Amlodipine: Inhibits Ca²⁺ ion entry into slow channels or select voltage-sensitive channels of vascular smooth muscle and myocardium, causing peripheral and coronary vasodilation. It reduces peripheral vascular resistance and lowers blood pressure.

Bisoprolol: Selectively and competitively blocks β1-receptors, reducing heart rate and myocardial contractility, thereby lowering blood pressure and decreasing myocardial oxygen demand.

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.

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).

• 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.

• Acute heart failure or during episodes of heart failure decompensation
• Obstruction of the left ventricular outflow tract (e.g., high grade aortic stenosis)
• Cardiogenic shock
• Second or third degree AV block
• Sick sinus syndrome
• Sinoatrial block
• Symptomatic bradycardia or hypotension
• Severe bronchial asthma
• Severe peripheral arterial occlusive disease
• Severe Raynaud's syndrome
• Untreated phaeochromocytoma
• Metabolic acidosis
• Hypersensitivity to bisoprolol, amlodipine, dihydropyridine derivatives, or any excipient

Not recommended: Verapamil and diltiazem type calcium antagonists, centrally-acting antihypertensive drugs.

Use with caution: Strong or moderate CYP3A4 inhibitors, CYP3A4 inducers, simvastatin, tacrolimus, cyclosporine, class I antiarrhythmic drugs, class III antiarrhythmic drugs, parasympathomimetic drugs, topical beta-blockers (eye drops), insulin and oral antidiabetic drugs, anesthetic agents, digitalis glycosides, NSAIDs, sympathomimetic agents, other antihypertensive and blood pressure lowering drugs.

Consider: Mefloquine, rifampicin, ergotamine derivatives, MAO inhibitors (except MAO-B inhibitor).

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.