Concor AMLO

Per 5/5 mg tab Bisoprolol fumarate 5 mg, amlodipine 5 mg. Per 5/10 mg tab Bisoprolol fumarate 5 mg, amlodipine 10 mg

HTN as substitution therapy in patients adequately controlled w/ individual products given concurrently at the same dose level as in combination.

Recommended dose: 1 tab daily. Severe hepatic & renal (CrCl <20 mL/min) impairment Max bisoprolol dose: 10 mg daily.

May be taken with or without food: Take in the morning. Do not chew.

Hypersensitivity to amlodipine, dihydropyridine derivatives & bisoprolol. Amlodipine: Severe hypotension, shock (including cardiogenic shock), left ventricle outflow tract obstruction (eg, high grade aortic stenosis), haemodynamically unstable heart failure after acute MI. Bisoprolol: Acute heart failure or during episodes of heart failure requiring IV inotropic therapy, cardiogenic shock, 2nd or 3rd degree AV block (w/o pacemaker), sick sinus syndrome, SA block, bradycardia (heart rate <60 beats/min) prior to start of therapy, hypotension (systolic BP <100 mmHg), severe bronchial asthma, severe forms of peripheral arterial occlusive disease & Raynaud's syndrome, untreated phaeochromocytoma, metabolic acidosis.

Treatment must not be abruptly discontinued. Minor or moderate influence on ability to drive & use machines. Pregnancy. Not recommended during breast-feeding. Childn & adolescents <18 yr. Elderly. Amlodipine: Hypertensive crisis. Patients w/ heart failure. Impaired hepatic function. Not dialyzable. Bisoprolol: Abrupt cessation of therapy must not be done in patients suffering from ischaemic heart disease. Patients w/ HTN or angina associated w/ heart failure; DM w/ large fluctuations in blood glucose levels; 1st degree AV block; Prinzmetal's angina (potential coronary vasospasm); peripheral arterial occlusive disease; existing or history of psoriasis; phaeochromocytoma; bronchial asthma or other COPD. May mask symptoms of hypoglycaemia (eg, tachycardia, palpitations or sweating); hyperthyreosis. Strict fasting/diet. Concomitant desensitisation therapy. Patients undergoing general anaesth.

Amlodipine: Headache, dizziness, somnolence; palpitations; flushing, cold & numb feeling in the extremities; GI complaints (eg, nausea, vomiting, diarrhoea, constipation, abdominal pain); oedema (eg, ankle oedema), fatigue (especially at the beginning of therapy).

Amlodipine: Increased plasma conc by strong or moderate CYP3A4 inhibitors [eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem]. Plasma conc may be decreased by CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Risk of increased tacrolimus blood levels. May increase simvastatin plasma level. Bisoprolol: -ve influence on contractility, AV conduction & BP w/ Ca antagonists of verapamil type & to a lesser extent of diltiazem type. Possible profound hypotension & AV block w/ verapamil IV. Potential reduction of heart rate, cardiac output & vasodilation w/ centrally acting antihypertensive drugs (eg, clonidine, methyldopa, moxonodine, rilmenidine). May increase risk of hypotension & further deterioration of the ventricular pump function in patients w/ heart failure by dihydropyridine type Ca antagonists (eg, nifedipine). May potentiate AV conduction time & -ve inotropic effects w/ class I antiarrhythmics (eg, disopyramide, quinidine, lidocaine, phenytoin, flecainide, propafenone). May potentiate AV conduction time w/ class III antiarrhythmics (eg, amiodarone). May increase AV conduction time & risk of bradycardia w/ parasympathomimetics. Additive systemic effects w/ topical β-blocker-containing prep (eg, eye drops for glaucoma). Intensified blood sugar lowering effect of insulin & oral antidiabetics. Attenuated reflex tachycardia & increased hypotension risk w/ anaesth agents. Reduction of heart rate, increased AV conduction time w/ digitalis glycosides. Hypotensive effect may be reduced by NSAIDs. Potential mutual reduced effect w/ β-sympathomimetics (eg, isoprenaline, dobutamine). May unmask α-adrenoceptor-mediated vasoconstrictor effects of sympathomimetics activating both β- & α-adrenoceptors (eg, norepinephrine, epinephrine) leading to BP increase. Risk of hypotension may be increased w/ antihypertensive agents as well as other drugs w/ BP lowering potential (eg, TCAs, barbiturates, phenothiazines). Increased risk of bradycardia by mefloquine. Enhanced hypotensive effect; risk for hypertensive crisis w/ MAOIs (except MAO-B inhibitors). Slight t_½ reduction by rifampicin. Exacerbation of peripheral circulatory disturbances by ergotamine derivatives.

Beta-Blockers / Calcium Antagonists

C07FB07 - bisoprolol and amlodipine ; Belongs to the class of selective beta-blocking agents in combination with other antihypertensives. Used in the treatment of cardiovascular diseases.

POM