Biolet

Biolet

nebivolol

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm
Concise Prescribing Info
Contents
Nebivolol
Indications/Uses
Essential HTN. Stable mild & moderate chronic heart failure in addition to standard therapies in elderly patients ≥70 yr.
Dosage/Direction for Use
HTN Adult 1 tab daily, preferably at the same time of the day. Combination w/ other antihypertensive agents 12.5-25 mg hydrochlorothiazide. Elderly >65 yr & renal insufficiency Initially 2.5 mg daily. May be increased to 5 mg, if needed. Chronic heart failure Initiate dose w/ gradual uptitration until optimal individual maintenance dose is reached. Initial uptitration (at 1-2 wkly intervals): 1.25 mg to be increased to 2.5 mg once daily, then to 5 mg once daily & further to 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 prior to start therapy). Hypotension (systolic BP <90 mmHg). Severe peripheral circulatory disturbances. Liver insufficiency or impairment.
Special Precautions
Not to interrupt or abruptly discontinue therapy. Discontinue treatment if heart failure worsens. History of anaphylactic reactions. Severe, protracted hypotension & difficulty in restarting or maintaining heart beat may occur during surgery. May mask signs & symptoms of hypoglycemia & signs of hyperthyroidism eg, tachycardia. May exacerbate manifestations of hyperthyroidism or precipitate thyroid storm upon abrupt treatment w/drawal. May precipitate or aggravate symptoms of arterial insufficiency in patients w/ peripheral vascular disease. Patients w/ inadequate cardiac function, since further depression of myocardial contractility & cardiac failure may be precipitated; well-compensated heart failure; angina pectoris or recent MI; undergoing major surgery involving general anesth; bronchospastic disease; subject to spontaneous hypoglycemia & diabetic patients receiving insulin or oral hypoglycemic agents. Carefully monitor & advise patients to temporarily limit physical activity. Prior treatment w/ α-adrenergic blocking agent before β-blocker therapy in patients w/ known or suspected pheochromocytoma. Concomitant use w/ nondihydropyridine Ca-channel blocking agents eg, verapamil, diltiazem. Not recommended in severe renal insufficiency (serum creatinine ≥250 μmol/L). Not to be used during pregnancy. Lactation. Hypoglycemia & bradycardia in fetus & neonate. Increased risk of cardiac & pulmonary complications in neonate in postnatal period. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Peripheral edema, bradycardia, chest pain; headache, fatigue, dizziness, insomnia, paresthesia; skin rash; decreased HDL cholesterol, hypercholesterolemia, increased serum triglycerides & uric acid; diarrhea, nausea, abdominal pain; decreased platelet count; weakness; increased BUN; dyspnea. Raynaud's phenomenon.
Drug Interactions
Increased plasma conc w/ potent CYP2D6 inhibitors (eg, quinidine, propafenone, fluoxetine, paroxetine) & cimetidine. Possible conduction disturbance w/ antiarrhythmic agents (eg, amiodarone, disopyramide) & nondihydropyridine Ca-channel blockers (eg, diltiazem, verapamil). Possible additive -ve effects on AV conduction & heart rate w/ β-blockers & digoxin. Potential additive effects (eg, hypotension, bradycardia) w/ catecholamine-depleting agents eg, reserpine, guanethidine. Increased rebound HTN following discontinuance of clonidine. Decreased in peak plasma conc & AUC of sildenafil. Additive effects on BP & pulse w/ sildenafil.
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
Biolet tab 5 mg
Packing/Price
4 × 7's
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