Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in adult 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. Corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. Corlanor is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present • Clinically significant bradycardia [see Warnings and Precautions ( 5.3 )] • Severe hepatic impairment [see Use in Specific Populations ( 8.6 )] • Pacemaker
Tablets: 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: NDC: 70518-3309-00 PACKAGING: 28 in 1 BLISTER PACK Storage Store Corlanor tablets and oral solution at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect Corlanor ampule from light by storing in the foil pouch until use. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
New Drug Application
REMEDYREPACK INC. ---------- MEDICATION GUIDE Corlanor ® (core lan ore) (ivabradine) tablets and oral solution What is the most important information I should know about Corlanor? Corlanor may cause serious side effects in adults and children, including: • Harm to an unborn baby. Females who are able to get pregnant: ○ Must use effective birth control during treatment with Corlanor. ○ Tell your doctor right away if you become pregnant during treatment with Corlanor. • Increased risk of irregular or rapid heartbeat (atrial fibrillation or heart rhythm problems).Tell your doctor if you feel any of the following symptoms of an irregular or rapid heartbeat: ○ heart is pounding or racing (palpitations). ○ chest pressure. ○ worsened shortness of breath. ○ near fainting or fainting. • Slower than normal heart rate (bradycardia). Tell your doctor if you have: ○ a slowing of heart rate, or ○ symptoms of a slow heart rate such as dizziness, fatigue, lack of energy. In young children signs and symptoms of slow heart rate may include: poor feeding, difficulty breathing or turning blue. What is Corlanor? Corlanor is a prescription medicine used: • to treat adults who have chronic (lasting a long time) heart failure, with symptoms, to reduce their risk of hospitalization for worsening heart failure. • to treat certain children 6 months of age and older who have stable heart failure, with symptoms, that is due to an enlarged heart (dilated cardiomyopathy). Who should not take Corlanor? Do not take Corlanor if you have: • symptoms of heart failure that recently worsened • very low blood pressure (hypotension) • certain heart conditions: sick sinus syndrome, sinoatrial block, or 3 rd degree atrioventricular block • a slow resting heart rate before treatment with Corlanor. Ask your doctor what a slow resting heart rate is for you. • certain liver problems • been prescribed any medicines that can increase the effects of Corlanor. Ask your doctor if you are not sure if you have any of the medic Soma hati kamili
CORLANOR- IVABRADINE TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USECORLANORSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FORCORLANOR. CORLANOR (IVABRADINE) TABLETS, FOR ORAL USE CORLANOR (IVABRADINE) ORAL SOLUTION 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 adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. ( 1.1) For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. ( 1.2) DOSAGE AND ADMINISTRATION ADULT AND PEDIATRIC PATIENTS GREATER THAN 40 KG Starting dose is 2.5 (pediatrics and vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg twice daily. ( 2.1) PEDIATRIC PATIENTS LESS THAN 40 KG Starting dose is 0.05 mg/kg twice daily with food. Adjust dose at two-week intervals by 0.05 mg/kg based on heart rate. Maximum dose is 0.2 mg/kg (patients 6 months to less than 1 year old) or 0.3 mg/kg (patients 1 year old and older), up to a total of 7.5 mg twice daily. DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 7.5 mg ( 3) Oral Solution: 5 mg/5 mL (1 mg/mL) ( 3) CONTRAINDICATIONS Acute decompensated heart failure ( 4) Clinically significant hypotension ( 4) Sick sinus syndrome, sinoatrial block or 3 degree AV block, unless a functioning demand pacemaker is present ( 4) Clinically significant bradycardia ( 4) Severe hepatic impairment ( 4) Heart rate maintained exclusively by the pacemaker ( 4) In combination with strong cytochrome CYP3A4 inhibitors ( 4) WARNINGS AND PRECAUTIONS Fetal toxicity: Females should use effective contraception. ( 5.1) Monitor patients for atrial fibrillation. ( 5.2) Monitor heart rate decrea Soma hati kamili