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 impairment (CrCl <20 mL/min) Not to exceed 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: 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 masked symptoms of hyperthyreosis. 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; palpitations; 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: Negative 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/ norephinephrine, 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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