Nebivolol Stella

Nebivolol Stella

nebivolol

Manufacturer:

Stellapharm

Distributor:

Stadpharm
Concise Prescribing Info
Contents
Nebivolol HCl
Indications/Uses
Essential HTN. Stable mild & moderate chronic heart failure in addition to standard therapies in elderly ≥70 yr.
Dosage/Direction for Use
HTN Adult 5 mg daily. Combination w/ other antihypertensive agents 5 mg + hydrochlorothiazide 12.5-25 mg. Elderly >65 yr, renal impairment Start at 2.5 mg daily, may be increased to 5 mg daily. Chronic heart failure Initially 1.25 mg once daily, increase stepwise at 1-2 wk interval based on patient's tolerability to 2.5, 5 & 10 mg once daily. Max: 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy. Sick sinus syndrome including SA block; 2nd- & 3rd-degree heart block w/o pacemaker; history of bronchospasm & bronchial asthma; untreated pheochromocytoma; metabolic acidosis; bradycardia (heart rate <60 bpm); hypotension (systolic BP <90 mmHg); severe peripheral circulatory disturbances. Hepatic insufficiency or impairment.
Special Precautions
Increased sensitivity to allergens & severity of anaphylactoid reactions. Not to be used in untreated chronic heart failure. Ischaemic heart disease; peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication); 1st-degree heart block; Prinzmetal's angina; DM, hyperthyroidism; COPD; history of psoriasis. May induce bradycardia, mask hypoglycemic symptoms. Avoid abrupt w/drawal. Not to be taken in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ certain anaesth causing myocardial depression. Not recommended in concomitant use w/ verapamil- & diltiazem-type Ca-channel antagonists, class I antiarrhythmics & centrally-acting antihypertensive drugs. May affect ability to drive & use machines. Not recommended in severe renal insufficiency. Not to be used during pregnancy. Not recommended during lactation. Not recommended in childn & adolescents <18 yr. Elderly >75 yr.
Adverse Reactions
HTN: Headache, dizziness, paraesthesia; dyspnea; constipation, nausea, diarrhea; tiredness, oedema. Chronic heart failure: Bradycardia, dizziness; cardiac failure aggravation; postural hypotension; drug intolerance; 1st-degree AV block; lower limb oedema.
Drug Interactions
Potentiated effect on AV conduction time & increased -ve inotropic effect w/ class I antiarrhythmics eg, quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone. Negative influence on contractility & AV conduction w/ verapamil-/diltiazem-type Ca-channel antagonists. Profound hypotension & AV block w/ verapamil IV. Worsened heart failure w/ centrally-acting antihypertensives eg, clonidine, guanfacin, moxonidine, methyldopa, rilmenidine. Potentiated effect on AV conduction time w/ class III antiarrhythmics eg, amiodarone. Attenuated reflex tachycardia & increased risk of hypotension w/ volatile halogenated anaesth. May mask symptoms of hypoglycaemia w/ insulin & oral antidiabetic drugs. Increased BP fall w/ baclofen, amifostine. Increased risk of hypotension w/ dihydropyridine-type Ca antagonists eg, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine. Enhanced hypotensive effect w/ antipsychotics, antidepressants eg, phenothiazines, tricyclics, barbiturates. Counteracted effect w/ sympathicomimetic agents. Increased plasma levels w/ paroxetine, fluoxetine, thioridazine, quinidine; cimetidine; nicardipine.
MIMS Class
Beta-Blockers
ATC Classification
C07AB12 - nebivolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Nebivolol Stella tab 5 mg
Packing/Price
3 × 10's
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