Bisoprolol BSS
Bisoprolol Sandoz. Each film-coated tablet contains 2.5 mg /10 mg bisoprolol fumarate.
Excipients with known effect: Lactose monohydrate. Indications. Treatment of hypertension, coronary heart disease (angina pectoris), stable chronic heart failure (CHF), hyperkinetic heart syndrome, ventricular extrasystoles. Posology. Treatment of hypertension or angina pectoris. 5 mg bisoprolol hemifumarate once daily. The dose may be increased to 10 mg once daily. Maximum recommended dose is 20 mg once daily. Treatment of stable chronic heart failure. Patients should be stable (without acute failure) when bisoprolol treatment is initiated. Titration phase. Recommended starting dose is 1.25 mg once daily. Depending on individual tolerance the dose is increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily in intervals of two weeks or longer. Treatment modification. If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered. The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition. Hypertension or angina pectoris. In patients with severe renal impairment (creatinine clearance <20 ml/min) and in patients with severe hepatic impairment it is recommended that a daily dose of 10 mg bisoprolol is not exceeded. There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired liver or renal function. No dose adjustment is required in elderly. Contraindications. In patients with acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy, cardiogenic shock, second or third degree AV block, sick sinus syndrome, sinoatrial block, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome, untreated phaeochromocytoma, metabolic acidosis. Patients with hypersensitivity to bisoprolol or to any of the excipients. Precautions for use. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated. The initiation and cessation of treatment of stable chronic heart failure with bisoprolol necessitates regular monitoring. Bisoprolol must be used with caution in bronchospasm (bronchial asthma, obstructive airways diseases), diabetes mellitus showing large fluctuations in blood glucose values. Symptoms of hypoglycaemia can be masked, strict fasting, ongoing desensitisation therapy. As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Epinephrine treatment does not always yield the expected therapeutic effect, First degree AV block, Prinzmetal's angina, peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting therapy. Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g. bisoprolol) after a careful balancing of benefits against risks. The symptoms of thyrotoxicosis may be masked under treatment with bisoprolol. In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade. In patients undergoing general anaesthesia the anaesthesist must be aware of beta-blockade. Beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Bisoprolol is not recommended during pregnancy unless clearly necessary. Breastfeeding is not recommended. Adverse Events. Dizziness, headache. Bradycardia, Worsening of pre-existing heart failure. Feeling of coldness or numbness in the extremities, hypotension. Gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation. Asthenia, fatigue.