Toricard-5

Toricard-5

nebivolol

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Nebivolol
Indications/Uses
Essential HTN. Stable mild & moderate chronic heart failure in addition to standard therapies in elderly patients.
Dosage/Direction for Use
HTN Adult 1 tab daily, preferably at the same time of the day, alone or concomitantly w/ other antihypertensive agents eg, hydrochlorothiazide 12.5-25 mg. Patient w/ renal insufficiency & elderly >65 yr Initially 2.5 mg daily, may be increased to 5 mg daily. Chronic heart failure Initially 1.25 mg, up-titrated at 1-2 wkly intervals based on tolerability to 2.5 mg once daily, then to 5 mg once daily & then 10 mg once daily. Max: 10 mg once daily.
Administration
May be taken with or without food: Tab may be broken in half-line if required.
Contraindications
Hypersensitivity. Acute heart failure, cardiogenic shock or episodes of heart failure decomposition 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 of therapy); hypotension (systolic BP <90 mmHg); severe peripheral circulatory disturbances. Liver insufficiency or liver function impairment.
Special Precautions
May increase sensitivity to allergens & the severity of anaphylactic reactions. Discontinue use at least 24 hr beforehand in prep for surgery. Not to be used in untreated CHF unless condition has been stabilized. Gradually discontinue (ie, over 1-2 wk) in patients w/ ischaemic heart disease if necessary replacement therapy should be initiated at the same time. May induce bradycardia; reduce dose if pulse rate drops <50-55 bpm at rest &/or patient experiences symptoms of bradycardia. Caution in 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 hypoglycemia (eg, tachycardia, palpitations) in diabetic patients & tachycardic symptoms in hyperthyroidism. Regular monitoring is necessary in the initiation of treatment for chronic heart failure. Treatment discontinuation should not be done abruptly unless clearly indicated. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Caution w/ certain anaesth that cause myocardial depression. Not recommended in combination w/ Ca channel antagonists of verapamil & diltiazem type, class I antiarrhythmic drugs, & centrally acting antihypertensive drugs. Not recommended in patients w/ chronic heart failure w/ severe renal insufficiency (serum creatinine >250 micromol/L). Take into account that dizziness & fatigue may occasionally occur when driving vehicles or operating machines. Not to be used during pregnancy unless clearly necessary. Breast-feeding is not recommended during treatment. Not recommended in childn & adolescents. Caution in the elderly >75 yr w/ HTN.
Adverse Reactions
Dizziness. HTN: Headache, paraesthesia; dyspnea; constipation, nausea, diarrhea; tiredness, oedema. Chronic heart failure: Bradycardia.
Drug Interactions
Effect on AV conduction time may be potentiated & -ve inotropic effect increased w/ class I antiarrhythmics (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 (clonidine, guanfacine, monoxidine, methyldopa, rilmenidine). Effect on AV conduction time may be potentiated w/ class III antiarrhythmics (amiodarone). May attenuate reflex tachycardia & increase risk of hypotension w/ volatile halogenated anaesth. May mask certain symptoms of hypoglycemia (palpitations, tachycardia) w/ insulin & oral antidiabetic drugs. Increased fall in BP w/ baclofen (antispastic agent) & amifostine (antineoplastic adjunct). May increase AV conduction time w/ digitalis glycosides. May increase risk of hypotension & risk of further deterioration of ventricular pump fraction in patients w/ heart failure w/ Ca antagonists of dihydropyridine type (amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine). Hypotensive effect may be enhanced (additive effect) w/ antipsychotics & antidepressants (tricyclics, barbiturates & phenothiazines). Effect may be counteracted w/ sympathicomimetic agents. May lead to increased plasma levels associated w/ increased risk of excessive bradycardia & adverse events w/ CYP2D6 inhibitors especially paroxetine, fluoxetine, thioridazine & quinidine. Increased plasma levels w/ cimetidine. Combination w/ nebivolol slightly increased plasma levels of both drugs.
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
Toricard-5 tab 5 mg
Packing/Price
100's (P1,975/box)