Nebiloc CCB

Per 5 mg/5 mg tab Nebivolol HCl 5 mg, amlodipine besilate 5 mg. Per 5 mg/10 mg tab Nebivolol HCl 5 mg, amlodipine besilate 10 mg

Essential HTN & chronic stable angina.

Adult One 5 mg/5 mg tab once daily. Max daily dose: Not to exceed 5 mg/10 mg once daily. Elderly >65 yr Initially one 2.5 mg/5 mg tab daily. May be upward titrated to 5 mg/10 mg if needed. Severe renal (CrCl <30 mL/min) & moderate hepatic (Child-Pugh B) impairment Initially 2.5 mg/5 mg once daily. May be upward titrated cautiously if needed.

May be taken with or without food.

Hypersensitivity. Severe bradycardia (heart rate <60 bpm prior to start of treatment), heart block >1st degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome, history of bronchospasm & bronchial asthma. Severe hepatic impairment (Child-Pugh >B). Pregnancy & lactation.

Not recommended in severe hepatic impairment. Not recommended in childn & adolescents. Elderly. Nebivolol: May increase sensitivity to allergens & severity of anaphylactic reactions. Not to be used in patients w/ untreated CHF. Gradually discontinue in patients w/ ischaemic heart disease. May induce bradycardia. Patients w/ peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication); 1st degree heart block; Prinzmetal's angina; COPD; history of psoriasis. May mask certain symptoms of hypoglycaemia in diabetic patients & tachycardic symptoms in hyperthyroidism. Discontinue use at least 24 hr prior to surgery. Not recommended in combination w/ Ca channel antagonists of verapamil & diltiazem type, class I antiarrhythmic drugs & centrally acting antihypertensive drugs. Concomitant use w/ certain anaesth that cause myocardial depression. Amlodipine: Hypertensive crisis. Monotherapy during or w/in 1 mth of MI. Patients w/ CHF. Hepatic & renal impairment.

Headache, dizziness; dyspnoea; nausea. Nebivolol: Paraesthesia; constipation, diarrhoea; tiredness, oedema. Amlodipine: Oedema. Somnolence; visual disturbance (including diplopia); palpitations; flushing; abdominal pain, dyspepsia, altered bowel habits (including diarrhoea & constipation); ankle swelling, muscle cramps; fatigue, asthenia.

Nebivolol: Effect on AV conduction time may be potentiated & -ve inotropic effect be increased w/ class I antiarrhythmics eg, quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone. -ve influence on contractility & AV conduction w/ Ca channel antagonists of verapamil/diltiazem type. May lead to profound hypotension & AV block w/ IV verapamil. May worsen heart failure w/ centrally-acting antihypertensives eg, clonidine, guanfacin, moxonidine, methyldopa, rilmenidine. Effect on AV conduction time may be potentiated w/ class III antiarrhythmic drugs eg, amiodarone. May attenuate reflex tachycardia & increase risk of hypotension w/ volatile halogenated anaesth. May mask certain symptoms of hypoglycaemia (eg, palpitations, tachycardia) w/ insulin & oral antidiabetic drugs. Increased fall in BP w/ baclofen & amifostine. May increase AV conduction time w/ digitalis glycosides. May increase risk of hypotension & of further deterioration of ventricular pump function w/ Ca antagonists of dihydropyridine type (eg, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine) in patients w/ heart failure. Hypotensive effect may be enhanced w/ antipsychotics, antidepressants (eg, tricyclics, barbiturates & phenothiazines). Effect may be counteracted w/ sympathicomimetic agents. May lead to unopposed α-adrenergic activity of sympathicomimetic agents w/ both α- & β-adrenergic effects. Plasma levels may be increased w/ CYP2D6 inhibitors eg, paroxetine, fluoxetine, thioridazine & quinidine. Increased plasma levels w/ cimetidine. Increased plasma levels of & w/ nicardipine. Amlodipine: Plasma conc may be increased w/ grapefruit juice. Exposure may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Plasma conc may vary w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Risk of hyperkalemia w/ dantrolene infusion. Additive BP-lowering effects w/ other medicinal products w/ antihypertensive properties. Risk of increased tacrolimus blood levels. Increased exposure of simvastatin.

Beta-Blockers / Calcium Antagonists / Anti-Anginal Drugs

C07FB12 - nebivolol and amlodipine ; Belongs to the class of selective beta-blocking agents in combination with other antihypertensives. Used in the treatment of cardiovascular diseases.

Rx