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CORLANOR ®- ivabradine hydrochloride tablet, film coated 

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CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION HOW SUPPLIED

CLINICAL PHARMACOLOGY: top of page

Initial U.S. Approval:  2015

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 [see CLINICAL PHARMACOLOGY (12.2)].

Corlanor can also inhibit the retinal current Ih. Ihis involved in curtailing retinal responses to bright light stimuli. Under triggering circumstances (e.g., rapid changes in luminosity), partial inhibition of Ih by Corlanor may underlie the luminous phenomena experienced by patients. Luminous phenomena (phosphenes) are described as a transient enhanced brightness in a limited area of the visual field

INDICATIONS AND USAGE  top of page


INDICATIONS AND USAGE:
Corlanor is 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  top of page

DOSAGE AND ADMINISTRATION
The recommended starting dose of Corlanor is 5 mg twice daily with meals. 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 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
 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*

HOW SUPPLIED top of page



HOW SUPPLIED/STORAGE AND HANDLING
Corlanor 5 mg tablets are formulated as salmon-colored, oval-shaped, film-coated tablets scored on both edges, marked with “5” on one face and bisected on the other face. They are supplied as follows:

Bottles of 60 tablets (NDC 55513-800-60)
Bottles of 180 tablets (NDC 55513-800-80)
Corlanor 7.5 mg tablets are formulated as salmon-colored, triangular-shaped, film-coated tablets debossed with “7.5” on one face and plain on the other face. They are supplied as follows:

Bottles of 60 tablets (NDC 55513-810-60)
Bottles of 180 tablets (NDC 55513-810-80)
Storage

Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF) [see USP Controlled Room Temperature].

REFERENCE

Drug UPDATES:  CORLANOR ®- ivabradine hydrochloride tablet, film coated  
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