Generic
Bisoprolol Fumarate + Amlodipine Besilate
Dosage Administration
One tablet once daily in patients whose blood pressure is adequately controlled with separately administered monocomponent products of the same doses as the recommended fixed-dose combination.
Contraindications
Acute heart failure or during episodes of heart failure decompensation, obstruction of the outflow tract of the left ventricle (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 forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome, untreated phaeochromocytoma metabolic acidosis, hypersensitivity to bisoprolol, amlodipine, dihydropyridine derivates or to any of the excipients.
Side Effects
Common: Dizziness, headache, somnolence, palpitations, flushing, feeling of coldness or numbness in the extremities, gastrointestinal complaints such as nausea, vomiting, diarrhea, constipation, abdominal pain; edema (e.g. ankle edema), fatigue. 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 bronchial asthma or a history of obstructive airway disease, 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, weight decrease. Rare: Allergic reactions mainly affecting the skin, nightmares, hallucinations, confusion, decreased tear secretion, hearing disorders, allergic rhinitis, hepatitis, increased triglycerides, increased liver enzymes (ALAT, ASAT).
Pregnancy And Lactation
Pregnancy and Lactation: Not recommended.
Therapeutic
Most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, hypoglycemia. According to available data gross overdose of amlodipine could result in excessive peripheral vasodilation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported. In general, if overdose occurs, discontinuation of treatment and supportive and symptomatic treatment is recommended.
Storage Conditions
Anti-hypertensive
Over The Counter Products
