Medicine guide
Ivabradine
5 mg · Tablet, Film Coated
- Prescription only
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
- Active substance
- Ivabradine
- Made by
- Golden State Medical Supply, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-04-15
What it is
Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Used for
- 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.
The label’s usual adult dose
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. ( 2.1 ) 2.1
Full directions ↓Good to know
- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
Ivabradine is 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.
- ( 1.1 )
- 1.1 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.
From the official label · 2025-04-15 · DailyMed
How it works
From this product’s own US prescribing label.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ivabradine tablets 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.
Half-life2 h
Mostly cleared after≈ 10 hfive half-lives — our arithmetic
How the body breaks it down
Ivabradine is extensively metabolized in the liver and intestines by CYP3A4-mediated oxidation.
How it leaves the body
The total clearance of ivabradine is 24 L/h, and renal clearance is approximately 4.2 L/h, with ~ 4% of an oral dose excreted unchanged in urine.
With food
Food delays absorption by approximately 1 hour and increases plasma exposure by 20% to 40%.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-04-15
Do not take it if
- Ivabradine tablets are 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 (5.3) ] Severe hepatic impairment [see Use in Specific Populations (8.6) ] Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [see Drug Interactions (7.3) ] Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Drug Interactions (7.1) ] Acute decompensated heart failure ( 4 ) Clinically significant hypotension ( 4 ) Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present ( 4 ) Clinically significant bradycardia ( 4 ) Severe hepatic impairment ( 4 ) Heart rate maintained exclusively by the pacemaker ( 4 ) In combination with strong cytochrome CYP3A4 inhibitors ( 4 )
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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. ( 2.1 ) 2.1
- Adults The recommended starting dose of ivabradine tablets is 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, Corlanor oral solution can be used [see Clinical Pharmacology (12.3) ] . In patients with a history of conduction defects or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate [see Warnings and Precautions (5.3) ] . Table 1. Dose Adjustment for
- Adults * [see Warnings and Precautions (5.3) ] Heart Rate Dose Adjustment > 60 bpm Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg twice daily 50-60 bpm Maintain dose < 50 bpm or signs and symptoms of bradycardia Decrease dose by 2.5 mg (given twice daily); if current dose is 2.5 mg twice daily, discontinue therapy*
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Fetal toxicity: Females should use effective contraception.
- ( 5.1 ) Monitor patients for atrial fibrillation.
- ( 5.2 ) Monitor heart rate decreases and bradycardia symptoms during treatment.
- ( 5.3 ) Not recommended in patients with 2 nd degree AV block.
- ( 5.3 )
- 5.1 Fetal Toxicity Ivabradine tablets may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies.
- Embryo-fetal toxicity and cardiac teratogenic effects were observed in fetuses of pregnant rats treated during organogenesis at exposures 1 to 3 times the human exposures (AUC 0 - 24hr ) at the maximum recommended human dose (MRHD) [see Use in Specific Populations (8.1) ].
- Advise females of reproductive potential to use effective contraception when taking ivabradine tablets [see Use in Specific Populations (8.3) ] .
- 5.2 Atrial Fibrillation Ivabradine tablets increases the risk of atrial fibrillation.
- In the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT), the rate of atrial fibrillation was 5.0% per patient-year in patients treated with ivabradine tablets and 3.9% per patient-year in patients treated with placebo [see Clinical Studies (14) ] .
- Regularly monitor cardiac rhythm.
- Discontinue ivabradine tablets if atrial fibrillation develops.
- 5.3 Bradycardia and Conduction Disturbances Adult Patients Bradycardia, sinus arrest, and heart block have occurred with ivabradine tablets.
- The rate of bradycardia was 6.0% per patient-year in patients treated with ivabradine tablets (2.7% symptomatic; 3.4% asymptomatic) and 1.3% per patient-year in patients treated with placebo.
- Risk factors for bradycardia include sinus node dysfunction, conduction defects (e.g., 1 st or 2 nd degree atrioventricular block, bundle branch block), ventricular dyssynchrony, and use of other negative chronotropes (e.g., digoxin, diltiazem, verapamil, amiodarone).
- Bradycardia may increase the risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsade de pointes, especially in patients with risk factors such as use of QTc prolonging drugs [see Adverse Reactions (6.2) ] .
- Concurrent use of verapamil or diltiazem will increase ivabradine tablets exposure, may themselves contribute to heart rate lowering, and should be avoided [see Clinical Pharmacology (12.3) ] .
- Avoid use of ivabradine tablets in patients with 2 nd degree atrioventricular block unless a functioning demand pacemaker is present [see Contraindications (4) ].
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Risk Summary Based on findings in animals, ivabradine tablets may cause fetal harm when administered to a pregnant woman.
- There are no adequate and well-controlled studies of ivabradine tablets in pregnant women to inform any drug-associated risks.
- In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC 0-24hr ) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interventricular septal defect, and complex anomalies of primary arteries.
- Increased post-natal mortality was associated with these teratogenic effects in rats.
- In pregnant rabbits, increased post-implantation loss was noted at an exposure (AUC 0-24hr ) 5 times the human exposure at the MRHD.
- Lower doses were not tested in rabbits.
- The background risk of major birth defects for the indicated population is unknown.
- The estimated background risk of major birth defects in the U.S. general population is 2 to 4%, however, and the estimated risk of miscarriage is 15 to 20% in clinically recognized pregnancies.
- Advise a pregnant woman of the potential risk to the fetus.
- Clinical Considerations Disease-associated Maternal and/or Embryo-fetal Risk Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester.
- Pregnant patients with left ventricular ejection fraction less than 35% on maximally tolerated doses of beta-blockers may be particularly heart rate dependent for augmenting cardiac output.
- Therefore, pregnant patients who are started on ivabradine tablets, especially during the first trimester, should be followed closely for destabilization of their congestive heart failure that could result from heart rate slowing.
- Monitor pregnant women with chronic heart failure in 3 rd trimester of pregnancy for preterm birth.
- Data Animal Data In pregnant rats, oral administration of ivabradine during the period of organogenesis (gestation day 6-15) at doses of 2.3, 4.6, 9.3, or 19 mg/kg/day resulted in fetal toxicity and teratogenic effects.
- Increased intrauterine and post-natal mortality and cardiac malformations were observed at doses ≥ 2.3 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC 0-24hr ).
- Teratogenic effects including interventricular septal defect and complex anomalies of major arteries were observed at doses ≥ 4.6mg/kg/day (approximately 3 times the human exposure at the MRHD based on AUC 0-24hr ).
- In pregnant rabbits, oral administration of ivabradine during the period of organogenesis (gestation day 6-18) at doses of 7, 14, or 28 mg/kg/day resulted in fetal toxicity and teratogenicity.
- Treatment with all doses ≥ 7 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC 0-24hr ) caused an increase in post-implantation loss.
- At the high dose of 28 mg/kg/day (approximately 15 times the human exposure at the MRHD based on AUC 0-24hr ), reduced fetal and placental weights were observed, and evidence of teratogenicity (ectrodactylia observed in 2 of 148 fetuses from 2 of 18 litters) was demonstrated.
- In the pre- and post-natal study, pregnant rats received oral administration of ivabradine at doses of 2.5, 7, or 20 mg/kg/day from gestation day 6 to lactation day 20.
- Increased post-natal mortality associated with cardiac teratogenic findings was observed in the F1 pups delivered by dams treated at the high dose (approximately 15 times the human exposure at the MRHD based on AUC 0-24hr ).
- IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended.
- ( 8.2 )
- 8.1 Pregnancy Risk Summary Based on findings in animals, ivabradine tablets may cause fetal harm when administered to a pregnant woman.
- There are no adequate and well-controlled studies of ivabradine tablets in pregnant women to inform any drug-associated risks.
- In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC 0-24hr ) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interventricular septal defect, and complex anomalies of primary arteries.
- Increased post-natal mortality was associated with these teratogenic effects in rats.
- In pregnant rabbits, increased post-implantation loss was noted at an exposure (AUC 0-24hr ) 5 times the human exposure at the MRHD.
- Lower doses were not tested in rabbits.
- The background risk of major birth defects for the indicated population is unknown.
- The estimated background risk of major birth defects in the U.S. general population is 2 to 4%, however, and the estimated risk of miscarriage is 15 to 20% in clinically recognized pregnancies.
- Advise a pregnant woman of the potential risk to the fetus.
- Clinical Considerations Disease-associated Maternal and/or Embryo-fetal Risk Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester.
- Pregnant patients with left ventricular ejection fraction less than 35% on maximally tolerated doses of beta-blockers may be particularly heart rate dependent for augmenting cardiac output.
- Therefore, pregnant patients who are started on ivabradine tablets, especially during the first trimester, should be followed closely for destabilization of their congestive heart failure that could result from heart rate slowing.
- Monitor pregnant women with chronic heart failure in 3 rd trimester of pregnancy for preterm birth.
- Data Animal Data In pregnant rats, oral administration of ivabradine during the period of organogenesis (gestation day 6-15) at doses of 2.3, 4.6, 9.3, or 19 mg/kg/day resulted in fetal toxicity and teratogenic effects.
- Increased intrauterine and post-natal mortality and cardiac malformations were observed at doses ≥ 2.3 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC 0-24hr ).
- Teratogenic effects including interventricular septal defect and complex anomalies of major arteries were observed at doses ≥ 4.6mg/kg/day (approximately 3 times the human exposure at the MRHD based on AUC 0-24hr ).
- In pregnant rabbits, oral administration of ivabradine during the period of organogenesis (gestation day 6-18) at doses of 7, 14, or 28 mg/kg/day resulted in fetal toxicity and teratogenicity.
- Treatment with all doses ≥ 7 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC 0-24hr ) caused an increase in post-implantation loss.
- At the high dose of 28 mg/kg/day (approximately 15 times the human exposure at the MRHD based on AUC 0-24hr ), reduced fetal and placental weights were observed, and evidence of teratogenicity (ectrodactylia observed in 2 of 148 fetuses from 2 of 18 litters) was demonstrated.
- In the pre- and post-natal study, pregnant rats received oral administration of ivabradine at doses of 2.5, 7, or 20 mg/kg/day from gestation day 6 to lactation day 20.
- Increased post-natal mortality associated with cardiac teratogenic findings was observed in the F1 pups delivered by dams treated at the high dose (approximately 15 times the human exposure at the MRHD based on AUC 0-24hr ).
- 8.2 Lactation Risk Summary There is no information regarding the presence of ivabradine in human milk, the effects of ivabradine on the breastfed infant, or the effects of the drug on milk production.
- Animal studies have shown, however, that ivabradine is present in rat milk [see Data].
- Because of the potential risk to breastfed infants from exposure to ivabradine tablets, breastfeeding is not recommended.
- Data Lactating rats received daily oral doses of [14C]-ivabradine (7 mg/kg) on post-parturition days 10 to 14; milk and maternal plasma were collected at 0.5 and 2.5 hours post-dose on day 14.
- The ratios of total radio activity associated with [14C]-ivabradine or its metabolites in milk vs. plasma were 1.5 and 1.8, respectively, indicating that ivabradine is transferred to milk after oral administration.
- 8.3 Females and Males of Reproductive Potential Contraception Females Ivabradine tablets may cause fetal harm, based on animal data.
- Advise females of reproductive potential to use effective contraception during ivabradine tablets treatment [see Use in Specific Populations (8.1) ].
- 8.4 Pediatric Use The safety and efficacy of ivabradine tablets have not been established in patients less than 6 months of age.
- 8.5 Geriatric Use No pharmacokinetic differences have been observed in elderly (≥ 65 years) or very elderly (≥ 75 years) patients compared to the overall population.
- However, ivabradine tablets has only been studied in a limited number of patients ≥ 75 years of age.
- 8.6 Hepatic Impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.
- Ivabradine tablets is contraindicated in patients with severe hepatic impairment (Child-Pugh C) as it has not been studied in this population and an increase in systemic exposure is anticipated [see Contraindications (4) and Clinical Pharmacology (12.3) ].
- 8.7 Renal Impairment No dosage adjustment is required for patients with creatinine clearance 15 to 60 mL/min.
- No data are available for patients with creatinine clearance below 15 mL/min [see Clinical Pharmacology (12.3) ].
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Avoid CYP3A4 inhibitors or inducers.
- ( 7.1 ) Negative chronotropes increase risk of bradycardia; monitor heart rate.
- ( 7.2 )
- 7.1 Cytochrome P450-Based Interactions Ivabradine is primarily metabolized by CYP3A4.
- Concomitant use of CYP3A4 inhibitors increases ivabradine plasma concentrations and use of CYP3A4 inducers decreases them.
- Increased plasma concentrations may exacerbate bradycardia and conduction disturbances.
- The concomitant use of strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) and Clinical Pharmacology (12.3) ].
- Examples of strong CYP3A4 inhibitors include azole antifungals (e.g.,itraconazole), macrolide antibiotics (e.g., clarithromycin, telithromycin), HIV protease inhibitors (e.g.nelfinavir), and nefazodone.
- Avoid concomitant use of moderate CYP3A4 inhibitors when using ivabradine tablets.
- Examples of moderate CYP3A4 inhibitors include diltiazem, verapamil, and grapefruit juice [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ].
- Avoid concomitant use of CYP3A4 inducers when using ivabradine tablets.
- Examples of CYP3A4 inducers include St.
- John's wort, rifampicin, barbiturates, and phenytoin [see Clinical Pharmacology (12.3) ].
- 7.2 Negative Chronotropes Most patients receiving ivabradine tablets will also be treated with a beta-blocker.
- The risk of bradycardia increases with concomitant administration of drugs that slow heart rate (e.g., digoxin, amiodarone, beta-blockers).
- Monitor heart rate in patients taking ivabradine tablets with other negative chronotropes.
- Pacemakers in
- Adults Ivabradine tablets dosing is based on heart rate reduction, targeting a heart rate of 50 to 60 beats per minute in
- adults [see Dosage and Administration (2.1) ].
- Patients with demand pacemakers set to a rate ≥ 60 beats per minute cannot achieve a target heart rate < 60 beats per minute, and these patients were excluded from clinical trials [see Clinical Studies (14.1) ].
- The use of ivabradine tablets is not recommended in patients with demand pacemakers set to rates ≥ 60 beats per minute.
Quoted from the official label, section “Drug Interactions”.
Side effects
- Clinically significant adverse reactions that appear in other sections of the labeling include:
- Atrial Fibrillation [see Warnings and Precautions (5.2) ] Bradycardia and Conduction Disturbances [see Warnings and Precautions (5.3) ] Most common adverse reactions occurring in ≥ 1% of patients are bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes).
- ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Adult Patients with Heart Failure In SHIFT, safety was evaluated in 3,260 patients treated with ivabradine tablets and 3,278 patients given placebo.
- The median duration of ivabradine tablets exposure was 21.5 months.
- The most common adverse drug reactions in the SHIFT trial are shown in Table 2 [see Warnings and Precautions (5.2) , ( 5.3 )].
- Table 2.
- Adverse Drug Reactions with Rates ≥ 1.0% Higher on Ivabradine than Placebo occurring in > 1% on Ivabradine in SHIFT Ivabradine N = 3,260 Placebo N = 3,278 Bradycardia 10 % 2.2 % Hypertension, Blood Pressure Increased 8.9 % 7.8 % Atrial fibrillation 8.3 % 6.6 % Phosphenes, visual brightness 2.8 % 0.5 % Luminous Phenomena (Phosphenes) Phosphenes are phenomena described as a transiently enhanced brightness in a limited area of the visual field, halos, image decomposition (stroboscopic or kaleidoscopic effects), colored bright lights, or multiple images (retinal persistency).
- Phosphenes are usually triggered by sudden variations in light intensity.
- Ivabradine tablets can cause phosphenes, thought to be mediated through ivabradine tablets effects on retinal photoreceptors [see Clinical Pharmacology (12.1) ].
- Onset is generally within the first 2 months of treatment, after which they may occur repeatedly.
- Phosphenes were generally reported to be of mild to moderate intensity and led to treatment discontinuation in < 1% of patients; most resolved during or after treatment.
- 6.2 Post marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.
- The following adverse reactions have been identified in
- adults during post-approval use of ivabradine tablets:
- syncope, hypotension, torsade de pointes, ventricular fibrillation, ventricular tachycardia, angioedema, erythema, rash, pruritus, urticaria, vertigo, and diplopia, and visual impairment.
Quoted from the official label, section “Adverse Reactions”.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Bulgaria7 matching products
European UnionNo exact match for this strength and form
Details
| Made by | Golden State Medical Supply, Inc. |
|---|---|
| Active substance | Ivabradine |
| Strength | 5 mg |
| Form | Tablet, Film Coated |
| Route | Oral |
| Packs | 60 TABLET, FILM COATED in 1 BOTTLE |
| NDC | 51407-592 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
21 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated17 products
5 mg9
5 mg · 9 companies
- Alembic Pharmaceuticals Inc.
- Alembic Pharmaceuticals Limited
- American Health Packaging
- Bionpharma Inc.
- Camber Pharmaceuticals, Inc.
- Golden State Medical Supply, Inc. · this page
- Ingenus Pharmaceuticals, LLC
- Northstar Rx LLC
- Tablet4 products
5 mg2
5 mg · 2 companies
7.5 mg2
7.5 mg · 2 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
Corlanor5 mgPrescription only Amgen Inc · IvabradineCorlanor7.5 mgPrescription only Amgen Inc · IvabradineCorlanor5 mg/5mLPrescription only Amgen Inc · IvabradineIvabradine5 mgPrescription only Camber Pharmaceuticals, Inc. · IvabradineIvabradine7.5 mgPrescription only Camber Pharmaceuticals, Inc. · IvabradineIvabradine5 mgPrescription only Alembic Pharmaceuticals Limited · Ivabradine