CORLANOR*
Manufacturer DetailsAMGEN INC
Compositions:
Ivabradine -mg,
Ivabradine -mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- To reduce the Risk of Hospitalization for Worsening Heart Failure in Patients with Stable, Symptomatic Chronic Heart Failure with Left Ventricular Ejection Fraction <35%, who are in Sinus Rhythm with Resting Heart Rate of >70 Beats Per Minute and either are on Maximally Tolerated Doses of Beta-Blockers or have a Contraindication to Beta-Blocker Use
List Of Drugs:
- Ivabradine -Corlanor -@- (Apr 2015)- Anti-anginals drugs
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
CYP3A4 inhibitors increase Corlanor plasma concentrations
and CYP3A4 inducers decrease Corlanor plasma concentrations.
Negative chronotropes: Increased risk of bradycardia, monitor heart rate.
Pacemakers: Not recommended for use with demand pacemakers set to
rates . 60 beats per minute.
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
152. Ivabradine (HCL) 5mg/7.5mg tablets 24-06-08
For the treatment of chronic stable angiopectoris
in patients with normal sinus rhythm who have a
contraindication or intolerance for Beta-blockers
CORLANOR (ivabradine) tablets, for oral use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated
channel blocker indicated to reduce the risk of hospitalization for
worsening heart failure in 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.
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ivabradine Hcl 03-07-2008
5mg/7.5mg tablets
For the treatment of chronic stable angina pectis factors in patients
with normal sinus rhythm who have contraindication or intolerance
for Beta-blockers
2.Ivabradine Hcl 10-02-2010
5/7.5mg tablets
(Addl.Indcn.)
For Symptomatic treatment of chronic stable angina pectoris in
coronary heart disease patients with normal sinus rhythm, indicated
in combination wirh Beta-blockers in patients inadequately controlled
with an optimal Beta-blockers dose and whose heart rate is >60 BPM
Proprietary Name- CORLANOR
Established Name- Ivabradine
Applicant- Amgen Inc.
Indication- To reduce the risk of hospitalization for Worsening Heart
Failure in 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 or on Maximally Tolerated Doses of
Beta-Blockers or have a Contraindication to Beta-Blocker
use
Approval Date- 4/15/2015
Approved by U.S.FDA on 30-06-2015 (Ref- FDA approved List- 2015)
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.11
Drug Name - Ivabradine
Active Ingredient- Corlanor
Date of approval - 4/15/2015
FDA-approved use - To reduce hospitalization from worsening heart failure
Approved by US FDA on 4/15/2015- (Ref- FDA approved List- 2015)
Chronic stable angina
Adverse Reaction:
Most common adverse reactions occurring in . 1% of patients are bradycardia,
hypertension, atrial fibrillation and luminous phenomena (phosphenes).
Contra-Indications:
CONTRAINDICATIONS
Acute decompensated heart failure
Blood pressure less than 90/50 mmHg
Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a
functioning demand pacemaker is present
Resting heart rate less than 60 bpm prior to treatment
Severe hepatic impairment .
Pacemaker dependence (heart rate
In combination with strong cytochrome CYP3A4 inhibitors
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 2nd degree AV block.
Dosages/ Overdosage Etc:
Indication-
Chronic stable angina
Dosage-
Intially 5mg twice daily with morning and evening meals Increase if nrcessary after 3-4 weeks to 7.5mg twice daily Reduce dose to 2.5mg twice daily if bradycardia develops
INDICATIONS AND USAGE
Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated
channel blocker indicated to reduce the risk of hospitalization for
worsening heart failure in 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
Starting dose is 5 mg twice daily. After 2 weeks of treatment, adjust dose
based on heart rate. The maximum dose is 7.5 mg twice daily.
.
In patients with conduction defects or in whom bradycardia could
lead to hemodynamic compromise, initiate dosing at 2.5 mg twice daily.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 7.5 mg
Patient Information:
. PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Fetal Toxicity
Advise pregnant women of the potential risks to a fetus.
Advise females of reproductive potential to use effective contraception and to notify
their healthcare provider with a known or suspected pregnancy
.
Low Heart Rate Advise patients to report significant decreases in heart rate or
symptoms such as dizziness, fatigue, or hypotension
Atrial fibrillation Advise patients to report symptoms of atrial fibrillation, such as
heart palpitations or racing, chest pressure, or worsened shortness of breath
Phosphenes Advise patients about the possible occurrence of luminous
phenomena (phosphenes). Advise patients to use caution if they are driving or
using machines in situations where sudden changes in light intensity may occur,
especially when driving at night.
Advise patients that phosphenes may subside spontaneously during continued
treatment with Corlanor
Drug Interactions Advise patients to avoid ingestion of grapefruit juice and
St. John’s wort
Intake with Food Advise patients to take Corlanor twice daily with meals
.
Pharmacology/ Pharmacokinetics:
. CLINICAL PHARMACOLOGY
1 Mechanism of Action
Corlanor blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel
responsible for the cardiac pacemaker If 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
on the surface ECG, as has PR interval prolongation. There was no effect on
ventricular repolarization and no effects on myocardial contractility
2. Pharmacokinetics
Absorption and Bioavailability
Following oral administration, peak plasma ivabradine concentrations are reached in
approximately 1 hour under fasting conditions. The absolute oral bioavailability
of ivabradine is approximately 40% because of first-pass elimination in the gut and liver.
Food delays absorption by approximately 1 hour and increases plasma exposure
by 20% to 40%. Corlanor should be taken with meals
Interaction with Food:
To be taken with morning and evening meals
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Risk Summary- Based on findings in animals, Corlanor may cause fetal harm when
administered to a pregnant woman. There are no adequate and well-controlled
studies of Corlanor in pregnant women to inform any drug-associated risks.
.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.
Because of the potential risk to breastfed infants from exposure to Corlanor,
breastfeeding is not recommended
3. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4. Geriatric Use
No pharmacokinetic differences have been observed in elderly (. 65 years)
or very elderly (. 75 years) patients compared to the overall population.
However, Corlanor has only been studied in a limited number of patients .
75 years of age
