Bilkate 5

Bilkate 5

nebivolol

Manufacturer:

Unison

Distributor:

Medispec
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 hypertensive agents 5 mg + hydrochlorothiazide 12.5-25 mg. Elderly >65 yr & renal insufficiency Initially 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 wkly intervals depending on patient tolerability to 2.5, 5 & 10 mg once daily. Max: 10 mg once daily.
Administration
Should be taken with 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 (<60 bpm); hypotension (systolic BP <90 mmHg); severe peripheral circulatory disturbances. Hepatic insufficiency or impairment.
Special Precautions
Sensitivity to allergens & severe anaphylactic reactions. Not to be used in untreated CHF. Ischemic heart disease, bradycardia, peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), 1st-degree heart block, Prinzmetal's angina; diabetes; COPD; history of psoriasis. May mask symptoms of hypoglycemia or tachycardic symptoms in hyperthyroidism. Avoid abrupt w/drawal. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. Discontinue use at least 24 hr prior to use of certain anesth causing myocardial depression. Not recommended in combination w/ verapamil- & diltiazem-type Ca-channel antagonists, class I antiarrhythmics, centrally-acting antihypertensives. May affect ability to drive & use machines. Not recommended in severe renal insufficiency. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr. Elderly >75 yr.
Adverse Reactions
Angioneurotic edema, hypersensitivity; nightmares, depression; headache, dizziness, paresthesia, syncope; impaired vision; bradycardia, heart failure, slowed AV conduction/block; hypotension, intermittent claudication; dyspnea, bronchospasm; constipation, nausea, diarrhea, dyspepsia, flatulence, vomiting; pruritus, erythematous rash, aggravated psoriasis, urticaria; impotence; tiredness, edema.
Drug Interactions
Negative effect on contractility & AV conduction w/ verapamil- or diltiazem-type Ca antagonists. Potentiated atrial conduction time & -ve inotropic effect w/ class I antiarrhythmics eg, amiodarone. Reduced heart rate & cardiac output, vasodilation w/ centrally-acting antihypertensives eg, clonidine, guanfacin, moxonidine, methyldopa, rilmenidine. Increased AV conduction time w/ digitalis glycosides. Attenuated reflex tachycardia & increased risk of hypotension w/ anesth. Increased fall in BP w/ baclofen, amifostine. Increased risk of hypotension w/ dihydropyridine-type Ca antagonists eg, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine. Increased plasma level w/ cimetidine, nicardipine. Counteracted effect w/ sympathicomimetic agents. Unopposed α-adrenergic activity of sympathicomimetic agents. Increased BP-lowering effect w/ TCAs, barbiturates, phenothiazines. Concomitant use w/ serotonin reuptake inhibitors, dextromethorphan, other CYP2D6-metabolised compds.
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
Bilkate 5 FC tab 5 mg
Packing/Price
3 × 10's
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