Ivabradine

What it is and how it works

Mechanism of Action Ivabradine blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker I f current, which regulates heart rate. In clinical electrophysiology studies, the cardiac effects were most pronounced in the sinoatrial (SA) node, but prolongation of the AH interval has occurred as has PR interval prolongation. There was no effect on ventricular repolarization and no effects on myocardial contractility [ see Clinical Pharmacology ] . Ivabradine can also inhibit the retinal current I h . I h is involved in curtailing retinal responses to bright light stimuli.

Indications

Ivabradine tablets are a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.

Dosage and administration (summary)

Adult patients Starting dose is 2.5 (vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg twice daily. Adults The recommended starting dose of ivabradine tablets are 5 mg twice daily with food. Assess patient after two weeks and adjust dose to achieve a resting heart rate between 50 and 60 beats per minute (bpm) as shown in Table 1. Thereafter, adjust dose as needed based on resting heart rate and tolerability. The maximum dose is 7.5 mg twice daily. In adult patients unable to swallow tablets, Ivabradine oral solution can be used .

Contraindications

Ivabradine is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present • Clinically significant bradycardia [ see Warnings and Precautions ] • Severe hepatic impairment [ see Use in Specific Populations ] • Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [ see Drug Interactions ] • Concomitant use of strong c…

Warnings and precautions

• Fetal toxicity: Females should use effective contraception. • Monitor patients for atrial fibrillation. • Monitor heart rate decreases and bradycardia symptoms during treatment. • Not recommended in patients with 2 nd degree AV block. Fetal Toxicity Ivabradine may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies.

Pregnancy

Pregnancy Risk Summary Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of ivabradine in pregnant women to inform any drug-associated risks.

Storage and supply

Tablets: Ivabradine 5 mg tablets are formulated as orange colored, capsule shaped, film-coated tablets , functionally scored with debossing "M" & "I" on one side and "2" on other side.

Source: Ivabradine (Ivabradine) — US FDA prescribing information, 2026-04-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.