Concor AM

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

HTN.

1 tab daily. Severe hepatic or renal (CrCl <20 mL/min) impairment Not to exceed bisoprolol 10 mg daily.

May be taken with or without food: Take in the morning w/ or w/o food. 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, symptomatic bradycardia & hypotension, severe bronchial asthma, severe forms of peripheral arterial occlusive disease & Raynaud's syndrome, untreated phaeochromocytoma, metabolic acidosis.

Avoid abrupt discontinuation especially in patients w/ ischaemic heart disease. May affect ability to drive & use machines. Hepatic &/or renal impairment. Not recommended during pregnancy & lactation. Childn & adolescents <18 yr. Elderly. Amlodipine: Hypertensive crisis, severe heart failure (NYHA class III & IV), CHF. Bisoprolol: Avoid use in patients w/ obstructive airway diseases. Ischaemic heart disease, HTN or angina associated w/ heart failure, DM, 1st degree AV block, Prinzmetal's angina, peripheral arterial occlusive disease, psoriasis or history of psoriasis, phaeochromocytoma, bronchial asthma or other chronic obstructive lung diseases. May mask hypoglycaemia & hyperthyreosis symptoms. Strict fasting/diet. Patients undergoing general anaesth. Concomitant desensitisation therapy.

Dizziness, headache; nausea, altered bowel habits eg, diarrhoea, constipation; fatigue. Amlodipine: Oedema. Somnolence; visual disturbances eg, diplopia; palpitation; flushing; dyspnoea; abdominal pain, dyspepsia; ankle swelling, muscle cramps; asthenia. Bisoprolol: Feeling of coldness & numbness in extremities; vomiting.

Amlodipine: Increased risk of hypotension w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides, verapamil, diltiazem. Different plasma conc w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased BP-lowering effects w/ grapefruit or grapefruit juice. Lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia w/ verapamil & IV dantrolene. Increased tacrolimus blood levels. Monitor cyclosporine levels in renal transplant patients. Increased exposure to simvastatin. Bisoprolol: -ve influence in contractility, AV conduction & BP w/ verapamil- & diltiazem-type Ca antagonists. Reduced heart rate, cardiac output & vasodilation w/ centrally acting antihypertensive drugs eg, clonidine, methyldopa, moxonodine, rilmenidine. Increased risk of hypotension & deterioration of ventricular pump function w/ dihydropyridine-type Ca antagonists eg, nifedipine. Potentiated AV conduction time & -ve inotropic effect w/ class I antiarrhythmics eg, disopyramide, quinidine, lidocaine, phenytoin, flecainide, propafenone. Potentiated AV conduction time w/ class III antiarrhythmics eg, amiodarone. Increased AV conduction time & risk of bradycardia w/ parasympathomimetic drugs. Additive systemic effects w/ topical β-blocker-containing prep. Intensification of blood sugar-lowering effect w/ insulin & oral antidiabetics. Attenuated reflex tachycardia & increased risk of hypotension w/ anaesth. Reduced heart rate, increased AV conduction time w/ digitalis glycosides. Reduced hypotensive effect w/ NSAIDs. Reduced effect w/ β-sympathomimetics eg, isoprenaline, dobutamine. Increased BP w/ norepinephrine, epinephrine. Increased risk of hypotension w/ antihypertensive agents & other drugs w/ BP-lowering potential eg, TCAs, barbiturates, phenothiazines. Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effect w/ MAOIs (except MAO-B inhibitors).

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.

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