Ivaset

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Ivaset Product Information Leaflets
Brand Name:
Ivaset
Generic Name:
Ivabradine

DESCRIPTION:

Ivaset (Ivabradine) is a newer medication which is indicated in chronic stable angina and chronic heart failure. It is available as a film-coated tablet for oral administration.

COMPOSITION:

Ivaset 5 mg film-coated tablets contains ivabradine 5 mg and Ivaset 7.5 mg film-coated tablets contains ivabradine 7.5 mg

INDICATIONS:

Coronary artery disease: Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Indicated in patients unable to tolerate or with a contra-indication to the use of beta-blockers, or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm. Chronic heart failure: NYHA class II to IV with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

DOSAGE & ADMINISTRATION:

Usual recommended starting dose is 5 mg twice daily which may be increased after three or four weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Discontinue treatment if heart rate remains below 50 bpm or symptoms of bradycardia persist. Chronic heart failure: Initiate only in patients with stable heart failure. Recommended starting dose is 5 mg twice daily increased after two weeks to 7.5 mg twice daily, if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or if symptoms related to bradycardia occur. Discontinue if heart rate remains below 50 bpm or symptoms of bradycardia persist.

CONTRAINDICATIONS:

History of hypersensitivity to ivabradine, resting heart rate below 60 bpm before treatment & severe hepatic impairment

UNDESIRABLE EFFECTS:

Visual symptoms (Luminous phenomena, blurred vision, bradycardia, 1st degree AV block, ECG prolonged QT interval.

PRESENTATION:

Ivaset 5mg & 7.5mg are available as pack of 14’s film coated tablets.

PREGNANCY & LACTATION:

Not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function. Combination with calcium channel blockers: Concomitant use of ivabradine with heart rate reducing calcium channel blockers is not recommended.

Patients should consult with their physician before taking any medicine.