Concor AM

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

Substitution therapy for HTN in patients adequately controlled w/ bisoprolol & amlodipine given concurrently at same dose level as in the combination, but as separate tab.

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

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

Hypersensitivity to amlodipine, dihydropyridine derivatives & bisoprolol. Cardiogenic shock. Amlodipine: Severe hypotension, 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; 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. May affect ability to drive & use machines. Hepatic impairment. Not recommended during pregnancy & lactation. Childn & adolescents <18 yr. Elderly. Amlodipine: Hypertensive crisis. Severe heart failure (NYHA class III & IV), CHF. Bisoprolol: Patients w/ ischaemic heart disease, HTN or angina associated w/ heart failure. DM w/ large fluctuations in blood glucose, 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 hypoglycaemia & hyperthyreosis. Strict fasting/diet. Patients undergoing general anaesth. Concomitant desensitisation therapy.

Dizziness, headache; nausea, diarrhoea, constipation; fatigue. Amlodipine: Somnolence, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema, fatigue. Visual disturbances eg, diplopia; dyspnoea; dyspepsia; 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. Additive BP-lowering effects w/ other antihypertensives. Increased exposure to simvastatin. Increased tacrolimus blood levels. Monitor cyclosporine levels in renal transplant patients. Bisoprolol: Negative influence on contractility, AV conduction & BP w/ verapamil- & diltiazem-type Ca antagonists. Profound hypotension & AV block w/ IV verapamil. Reduced heart rate, cardiac output & vasodilation w/ centrally-acting antihypertensive drugs eg, clonidine, methyldopa, moxonidine, rilmenidine. Increased risk of hypotension & further deterioration of ventricular pump function w/ dihydropyridine-type Ca antagonists eg, nifedipine. Potentiated AV conduction time & negative 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 eg, glaucoma treatment eye drops. Intensified 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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