Bralon

Bralon

ivabradine

Manufacturer:

Unison

Distributor:

Medline

Marketer:

Medline
Concise Prescribing Info
Contents
Ivabradine
Indications/Uses
Symptomatic treatment of chronic stable angina pectoris in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm. In adults who are unable to tolerate or contraindicated to β-blockers, or in combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose. CHF.
Dosage/Direction for Use
CAD Initially 5 mg bid, may be increased to 7.5 mg bid after 3-4 wk if well tolerated & resting heart remains >60 bpm. Titrate dose downward if heart rate is <50 bpm persist or bradycardia occurs. CHF Initially 5 mg bid; adjust dose based on heart rate after 2 wk. If >60 bpm Increase dose by 2.5 mg bid, 50-60 bpm Continue current dose, <50 bpm or signs or  symptoms of bradycardia Decrease by 2.5 mg bid. Max: 7.5 mg bid.
Administration
Should be taken with food: Avoid excessive consumption of grapefruit juice.
Contraindications
Acute decompensated heart failure. Clinically significant HTN & bradycardia. Concomitant use w/ strong CYP3A4 inhibitors. Pacemaker dependent. Severe hepatic impairment. Sick-sinus syndrome, sinoatrial block, or 3rd-degree AV block, except in presence of functioning demand pacemaker.
Special Precautions
Avoid use w/ 2nd-degree AV block in patients w/o functioning demand pacemaker. Patients w/ demand pacemakers set to ≥60 bpm is not recommended. Monitor patients due to increased risk of atrial fibrillation; sinus node dysfunction, conduction defects, ventricular dyssynchrony. Sinus arrest, bradycardia & heart block may occur. Increased risk of QT prolongation which may lead to severe ventricular arrhythmias including Torsades de pointes. Concomitant use w/ other negative chronotrophic agents, QTc prolonging drugs. Avoid use w/ verapamil, diltiazem, CYP3A4 inducers or moderate CYP3A4 inhibitors.
Adverse Reactions
Headache, dizziness; luminous phenomena (phosphenes); blurred vision; bradycardia, 1st-degree AV block (ECG-prolonged PQ interval), ventricular extrasystoles; uncontrolled BP, eosinophilia, hyperuricaemia, syncope, diplopia, visual impairment, vertigo, palpitations, supraventricular extrasystoles, hypotension, dyspnoea, nausea, constipation, diarrhoea, abdominal pain, angioedema, rash, muscle cramps, asthenia, fatigue, elevated creatinine in blood, ECG prolonged QT interval, erythema, pruritus, urticaria, malaise, atrial fibrillation, AV 2nd & 3rd degree block, sick sinus syndrome.
Drug Interactions
Strong CYP3A4 inhibitors; verapamil & diltiazem. QT prolonging drugs, moderate CYP3A4 inhibitors, grapefruit juice. K-depleting diuretics (thiazide & loop diuretics), other moderate CYP3A4 inhibitors, CYP3A4 inducers.
MIMS Class
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Bralon FC tab 5 mg
Packing/Price
10 × 10's
Form
Bralon FC tab 7.5 mg
Packing/Price
10 × 10's
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