5 mg: salmon-colored, oval-shaped, film-coated tablet, functionally scored on both edges, debossed with “5” on one face and bisected on the other face. The tablet is scored and can be divided into equal halves to provide a 2.5 mg dose.

7.5 mg: salmon-colored, triangular-shaped, film-coated tablet debossed with “7.5” on one face and plain on the other face.

Corlanor 5 mg/5 mL (1 mg/mL) oral solution is a colorless liquid in an opaque, plastic, ampule containing 5 mg of Corlanor in 5 mL of liquid.

Corlanor is contraindicated in patients with:

• Acute decompensated heart failure

• Clinically significant hypotension

• Sick sinus syndrome, sinoatrial block or 3

• Clinically significant bradycardia 

• Severe hepatic impairment 

• Pacemaker dependence (heart rate maintained exclusively by the pacemaker) 

• Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors

Clinically significant adverse reactions that appear in other sections of the labeling include:

Overdose may lead to severe and prolonged bradycardia. In the event of bradycardia with poor hemodynamic tolerance, temporary cardiac pacing may be required. Supportive treatment, including intravenous (IV) fluids, atropine, and intravenous beta-stimulating agents such as isoproterenol, may be considered.

Corlanor (ivabradine) tablets and oral solution contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I

The chemical name for ivabradine hydrochloride is 3-(3-{[((7

Corlanor tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, and yellow iron oxide.

Corlanor 5 mg/5 mL (1 mg/mL) oral solution is formulated as a sterile, preservative-free, colorless solution for oral administration. Each 5 mL ampule contains 5 mg of ivabradine, equivalent to 5.39 mg ivabradine hydrochloride, as the active ingredient. The solution contains the following inactive ingredients: maltitol and water.

Corlanor (ivabradine) 5 mg tablets are formulated as salmon-colored, oval-shaped, film-coated tablets functionally scored on both edges, marked with “5” on one face and bisected on the other face. They are supplied as follows:

Corlanor (ivabradine) 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:

Corlanor (ivabradine) oral solution is a colorless liquid supplied in an opaque, low density polyethylene (LDPE) plastic ampule. Each 5 mL ampule is individually packaged in a child-resistant foil pouch and supplied in cartons containing 28 foil pouches. Corlanor oral solution is supplied as 5 mg/5 mL (1 mg/mL) (NDC 55513-813-01).

Store Corlanor tablets and oral solution at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F)

Advise the patient to read the FDA-approved patient labeling

Corlanor

Patent:

© 2015, 2017, 2019, 2021 Amgen Inc. All rights reserved.

AMGEN

NDC 55513-800-60

5

Corlanor

Each tablet contains 5 mg ivabradine equivalent

Rx Only

60

AMGEN

NDC 55513-810-60

7.5

Corlanor

Each tablet contains 7.5 mg ivabradine equivalent

Rx Only

60

NDC 55513-813-28

Caregiver/Patient: Read the included "Instructions for Use" insert to be sure you prepare and administer the correct dose.

AMGEN

ATTENTION

Corlanor

5 mg/5 mL (1 mg/mL)

Sterile Oral Solution in an Ampule

Rx Only

Contains 28