Concore AM

Per 5 mg/5 mg tab Bisoprolol fumarate 5 mg, amlodipine (as besilate) 5 mg. Per 5 mg/10 mg tab Bisoprolol fumarate 5 mg, amlodipine (as besilate) 10 mg. Per 10 mg/5 mg tab Bisoprolol fumarate 10 mg, amlodipine (as besilate) 5 mg. Per 10 mg/10 mg tab Bisoprolol fumarate 10 mg, amlodipine (as besilate) 10 mg

HTN as substitution therapy in patients adequately controlled w/ the individual products given concurrently at the same doses level as in the combination, but as separate tab. HTN in patients whose BP cannot be controlled by bisoprolol or amlodipine therapy.

Patient whose BP is adequately controlled w/ separately administered mono-component products of the same dose as the recommended fixed dose combination 1 tab daily. Patient whose BP is inadequately controlled w/ bisoprolol or amlodipine alone Initially 5 mg/5 mg for the 1st 6 wk. May increase to 5 mg/10 mg after or 10 mg/5 mg after 6 wk, may further increase to 10 mg/10 mg after 6 wk. Severe renal impairment (CrCl <20 mL/min) Max: 10 mg daily. Hepatic impairment Max: 10 mg daily.

May be taken with or without food: Take in the morning. Swallow w/ some liqd, do not chew.

Hypersensitivity to bisoprolol, amlodipine or dihydropyridine derivatives. Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy, obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis), cardiogenic shock, 2nd or 3rd degree AV block (w/o a pacemaker), sick sinus syndrome, SA block, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma, severe forms of peripheral arterial occlusive diseases or Raynaud's syndrome, untreated pheochromocytoma, metabolic acidosis.

DM showing large fluctuations in blood glucose values, symptoms of hypoglycemia; strict fasting; ongoing desensitizaton therapy; 1st degree AV block; Prinzmetal's angina; peripheral arterial occlusive disease. Patients w/ or history of psoriasis. Symptoms of thyrotoxicosis may be masked. CV diseases. Pheochromocytoma. Avoid in patients w/ obstructive airway disease. Bronchial asthma, other COPD. May impair ability to drive or operate machinery. General anesth. Impaired hepatic function. Pregnancy & lactation. Childn. Elderly.

Dizziness, headache, somnolence; palpitations, bradycardia; flushing, feeling of coldness & numbness in the extremities; GI complaints eg, nausea, vomiting, diarrhea, constipation, abdominal pain; edema (eg, ankle edema), fatigue.

Ca antagonists of the verapamil type & to a lesser extent of the diltiazem type, centrally acting antihypertensives (clonidine, methyldopa, moxonidine, rilmenidine) is not recommended. Increase plasma conc of amlodipine w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, erythromycin& clarithromycin, verapamil or diltiazem). Monitor BP & dose regulation w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increase simvastatin plasma level. May potentiate the effect on AV conduction time & -ve inotropic effect w/ class I antiarrhythmic drugs (eg, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone). May potentiate the effect on AV conduction time w/ class III antiarrhythmic drugs (eg, amiodarone). Increased risk of bradycardia & AV conduction time w/ parasympthomimetic drugs. Topical β-blocker containing preparations (eg, eye drops for glaucoma) may contribute systemic effects. Intensification of lowering blood sugar effect & may mask symptoms of hypoglycemia w/ insulin & oral antidiabetic drugs. Increased risk of hypotension w/ anesth agents. Increased AV conduction time or reduction of heart rate w/ cardiac glycosides (digitalis). May reduced hypotensive effect of bisoprolol w/ NSAIDS. Reduce effect of agents w/ sympathomimetic agents (eg, isoprenaline, dobutamine). May lead do to increase BP & unmask α-adrenoreceptor-mediated vasoconstrictor effects w/ sympathomimetics (norepinephrine, epinephrine). Increased risk of hypotension w/ blood pressure lowering potential (eg, TCAs, barbiturates, phenothiazines). Increased tacrolimus blood levels. Cyclosporine. May increase risk of bradycardia w/ mefloquine. Enhanced hypotensive effect w/ MAOIs (except MAO-B) but also risk for hypertensive crisis. Exacerbation of peripheral circulatory disturbances w/ 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.

Rx