Rx Item-Corlanor ivabradine 5Mg Tab 60 By Amgen

For: Chronic Heart Failure

Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated for the treatment of chronic heart failure. CORLANOR- ivabradine hydrochloride tablet, film coated
Amgen Inc

1. 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.

2. DOSAGE AND ADMINIST R ATION



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*
*[ see Warnings and Precautions (5.3). ]

3. DOSAGE FORMS AND STRENGT HS

Corlanor 5 mg: salmon-colored, oval-shaped, film-coated tablet, 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.

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

RX ITEM-Corlanor 5Mg Tab 60 By Amgen
NDC 55513-0800-60 UPC/GTIN No.3-55513-80060-0 Mfg.Part No.80060

Corlanor 5Mg Tab 60 By Amgen
BRAND: CORLANOR NDC: 55513-0800-60,55513080060 UPC: 3-55513-80060-0,355513800600 Amgen Inc

IVABRADINE HCL ORAL TABLE
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