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LANCORA is a brand name for Ivabradine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY). 7.1.4. Geriatrics ( 75 years of age) LANCORA® has only been studied in a limited number of patients 75 years of age and older. The SHIFT trial showed a higher risk of bradycardia among patients aged ≥ 75 years treated with LANCORA®, at a starting dose of 5…
Verbatim from this product's HC label. Tap a section to expand.
). 1.
Pediatrics Pediatrics (<18 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of LANCORA® in pediatric patients aged below 18 years has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
2.
Geriatrics Geriatrics (≥ 75 years of age):
Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). 2. Contraindications • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
g. congenital long QT syndrome) • Cardiogenic shock • Acute myocardial infarction • Severe hypotension (<90/50 mmHg) (see 7 WARNINGS AND PRECAUTIONS) • Severe hepatic impairment • Sick sinus syndrome • Sino-atrial block • Third degree atrioventricular block • Pacemaker dependence (heart rate imposed exclusively by the pacemaker) (see 7 WARNINGS AND PRECAUTIONS) • Concomitant use of strong cytochrome P450 3A4 (CYP 3A4) inhibitors (see 9 DRUG INTERACTIONS) • Concomitant use of verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate LANCORA® (ivabradine tablets) Page 5 of 41 Unclassified / Non classifié reducing properties (see 9 DRUG INTERACTIONS) • Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see 7 WARNINGS AND PRECAUTIONS, Special Populations) • Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency as LANCORA® contains lactose.
4. 1. Dosing Considerations Situations where adjustment in LANCORA® dosing is recommended: • Concomitant use with drugs inhibiting or inducing the CYP3A4 enzyme • Patients with arrhythmias • Geriatric patients aged 75 years or above LANCORA® should be initiated and up- or down- titrated under the supervision of a physician who is experienced with the treatment of patients with chronic heart failure.
As LANCORA® treatment decisions are based on resting heart rate, an accurate measure of the resting heart rate based on serial heart rate measurements, electrocardiograms or ambulatory 24-hour monitoring, conducted on at least three separate visits, should be obtained prior to initiating or modifying treatment with LANCORA®.
). It is recommended to regularly monitor patients for the occurrence of atrial fibrillation, which should include ECG monitoring if clinically indicated. Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Discontinue treatment with LANCORA® if atrial fibrillation occurs. Atrial fibrillation appears more common in ivabradine-treated patients concomitantly treated with amiodarone, although the mechanism involved remains unclear. Concomitant use of LANCORA® and amiodarone should be avoided.
If the combination is deemed necessary, close cardiac monitoring is required (see
, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY). 2.
Geriatrics Geriatrics (≥ 75 years of age):
Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). 2. Contraindications • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
g. congenital long QT syndrome) • Cardiogenic shock • Acute myocardial infarction • Severe hypotension (<90/50 mmHg) (see 7 WARNINGS AND PRECAUTIONS) • Severe hepatic impairment • Sick sinus syndrome • Sino-atrial block • Third degree atrioventricular block • Pacemaker dependence (heart rate imposed exclusively by the pacemaker) (see 7 WARNINGS AND PRECAUTIONS) • Concomitant use of strong cytochrome P450 3A4 (CYP 3A4) inhibitors (see 9 DRUG INTERACTIONS) • Concomitant use of verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate LANCORA® (ivabradine tablets) Page 5 of 41 Unclassified / Non classifié reducing properties (see 9 DRUG INTERACTIONS) • Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see 7 WARNINGS AND PRECAUTIONS, Special Populations) • Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency as LANCORA® contains lactose.
4. 1. Dosing Considerations Situations where adjustment in LANCORA® dosing is recommended: • Concomitant use with drugs inhibiting or inducing the CYP3A4 enzyme • Patients with arrhythmias • Geriatric patients aged 75 years or above LANCORA® should be initiated and up- or down- titrated under the supervision of a physician who is experienced with the treatment of patients with chronic heart failure.
As LANCORA® treatment decisions are based on resting heart rate, an accurate measure of the resting heart rate based on serial heart rate measurements, electrocardiograms or ambulatory 24-hour monitoring, conducted on at least three separate visits, should be obtained prior to initiating or modifying treatment with LANCORA®.
). 5 mg twice daily (Table 1). Caution should be exercised if treatment with a CYP3A4 inducer needs to be interrupted after LANCORA® had been titrated. Close heart rate monitoring is recommended and LANCORA® dosing may need to be reduced.
Concomitant use of St John’s Wort, which is known to induce CYP3A4, should be avoided (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). 5 mg of LANCORA® twice daily before increasing the dose based on heart rate (Table 1) (see 7 WARNINGS AND PRECAUTIONS).
Hepatic impairment:
No dose adjustment is required in patients with mild to moderate hepatic impairment. Use of LANCORA® in patients with severe hepatic impairment is contraindicated (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Renal impairment:
No dose adjustment is required in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). e. one half 5 mg tablet twice daily) (see 7 WARNINGS AND LANCORA® (ivabradine tablets) Page 6 of 41 Unclassified / Non classifié PRECAUTIONS).
Up-titration may follow depending on the therapeutic response (Table 1).
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). 2. Recommended Dose and Dosage Adjustment LANCORA® 5 mg twice daily is the recommended starting dose for patients with stable chronic heart failure who are in sinus rhythm with a resting heart rate at or above 77 beats per minute.
After two weeks of treatment, assess the patient and adjust the dose based on the patient resting heart rate according to the instructions provided in Table 1. At any time during treatment, the dose may be adjusted as needed depending on the heart rate and tolerability of the patient (Table 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg of LANCORA® twice daily is recommended in conjunction with heart rate monitoring. LANCORA® is not recommended with grapefruit products as they are known to inhibit CYP3A4. Concomitant use with diltiazem or verapamil is contraindicated (see 9 DRUG INTERACTIONS and 2 CONTRAINDICATIONS).
5 mg twice daily (Table 1). Caution should be exercised if treatment with a CYP3A4 inducer needs to be interrupted after LANCORA® had been titrated. Close heart rate monitoring is recommended and LANCORA® dosing may need to be reduced.
Concomitant use of St John’s Wort, which is known to induce CYP3A4, should be avoided (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). 5 mg of LANCORA® twice daily before increasing the dose based on heart rate (Table 1) (see 7 WARNINGS AND PRECAUTIONS).
Hepatic impairment:
No dose adjustment is required in patients with mild to moderate hepatic impairment. Use of LANCORA® in patients with severe hepatic impairment is contraindicated (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Renal impairment:
No dose adjustment is required in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). e. one half 5 mg tablet twice daily) (see 7 WARNINGS AND LANCORA® (ivabradine tablets) Page 6 of 41 Unclassified / Non classifié PRECAUTIONS).
Up-titration may follow depending on the therapeutic response (Table 1).
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). 2. Recommended Dose and Dosage Adjustment LANCORA® 5 mg twice daily is the recommended starting dose for patients with stable chronic heart failure who are in sinus rhythm with a resting heart rate at or above 77 beats per minute.
After two weeks of treatment, assess the patient and adjust the dose based on the patient resting heart rate according to the instructions provided in Table 1. At any time during treatment, the dose may be adjusted as needed depending on the heart rate and tolerability of the patient (Table 1).
5 mg twice daily. 5 mg twice daily, discontinue therapy **Such as dizziness, fatigue […]
5 mg of LANCORA® twice daily is recommended in conjunction with heart rate monitoring. LANCORA® is not recommended with grapefruit products as they are known to inhibit CYP3A4. Concomitant use with diltiazem or verapamil is contraindicated (see 9 DRUG INTERACTIONS and 2 CONTRAINDICATIONS).
5 mg twice daily (Table 1). Caution should be exercised if treatment with a CYP3A4 inducer needs to be interrupted after LANCORA® had been titrated. Close heart rate monitoring is recommended and LANCORA® dosing may need to be reduced.
Concomitant use of St John’s Wort, which is known to induce CYP3A4, should be avoided (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). 5 mg of LANCORA® twice daily before increasing the dose based on heart rate (Table 1) (see 7 WARNINGS AND PRECAUTIONS).
Hepatic impairment:
No dose adjustment is required in patients with mild to moderate hepatic impairment. Use of LANCORA® in patients with severe hepatic impairment is contraindicated (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Renal impairment:
No dose adjustment is required in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). e. one half 5 mg tablet twice daily) (see 7 WARNINGS AND LANCORA® (ivabradine tablets) Page 6 of 41 Unclassified / Non classifié PRECAUTIONS).
Up-titration may follow depending on the therapeutic response (Table 1).
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). 2. Recommended Dose and Dosage Adjustment LANCORA® 5 mg twice daily is the recommended starting dose for patients with stable chronic heart failure who are in sinus rhythm with a resting heart rate at or above 77 beats per minute.
After two weeks of treatment, assess the patient and adjust the dose based on the patient resting heart rate according to the instructions provided in Table 1. At any time during treatment, the dose may be adjusted as needed depending on the heart rate and tolerability of the patient (Table 1).
5 mg twice daily. 5 mg BID), has a resting heart rate below 50 bpm or experiences signs or symptoms of bradycardia (see 7 WARNINGS AND PRECAUTIONS). Discontinuation of treatment should be considered if […]
5 mg twice daily. 5 mg BID), has a resting heart rate below 50 bpm or experiences signs or symptoms of bradycardia (see 7 WARNINGS AND PRECAUTIONS). 5 mg twice daily) for several months, there has been no clear decrease in the patient’s resting heart rate.
The physician should weigh the benefit of continuing treatment with LANCORA® against the risks. 4. e. 3 Pharmacokinetics section). 5. Missed Dose If a dose is missed, the next scheduled dose should be taken at the usual time. Doses should not be LANCORA® (ivabradine tablets) Page 7 of 41 Unclassified / Non classifié doubled to make up for the missed dose.
5. Overdose Overdose may lead to severe and prolonged bradycardia. Severe bradycardia should be treated symptomatically in a specialised environment. In the event of bradycardia with poor hemodynamic tolerance, symptomatic treatment including intravenous beta-stimulating agents may be considered.
Temporary cardiac electrical pacing may be instituted if required. The human lethal dose of ivabradine is unknown. The maximum dose reported with recovery is 750 mg (150 tablets of 5 mg). The patient was a 39-year-old female with a medical history of chronic obstructive pulmonary disease, tachycardia, myocardial ischemia and angina pectoris.
Her heart rate decreased as low as 30 bpm and an ECG showed bradycardia with sinus pauses superior to 5 seconds and up to 10 seconds. Urinary toxicology was positive for benzodiazepine and therefore, extreme bradycardia by sinusal dysfunction was considered resulting from intentional drug intoxication with ivabradine and benzodiazepines.
The patient was treated with atropine and isuprel (ineffective), then with external electro stimulation. The evolution was favorable with regain of regular sinus rhythm and the patient recovered. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6. Dosage Forms, Strengths, Composition, and Packaging Table 2 – Dosage Forms, Strengths, and Composition Description LANCORA® 5 mg: salmon-coloured, rod-shaped, film-coated tablet scored on both edges, engraved with “5” on one face and on the other face.
The tablet is breakable and it can be divided into equal halves. 5” on one face and on the other face. 5 mg Core Tablet colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, Film-coating glycerol, hypromellose, macrogol 6000, magnesium stearate, red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172) LANCORA® (ivabradine tablets) Page 8 of 41 […]