United States - English - NLM (National Library of Medicine)

amgen inc - ivabradine hydrochloride (unii: tp19837bzk) (ivabradine - unii:3h48l0lpzq) - ivabradine 5 mg - 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 3rd 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 dependence (heart rate maintained exclu

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - ivabradine hydrochloride (unii: tp19837bzk) (ivabradine - unii:3h48l0lpzq) - 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

European Union - English - EMA (European Medicines Agency)

jensonr+ limited - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. treatment of chronic heart failure ivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.,

European Union - English - EMA (European Medicines Agency)

"anpharm" przedsiębiorstwo farmaceutyczne s.a. - ivabradine - angina pectoris; heart failure - other cardiac preparations - symptomatic treatment of chronic stable angina pectorisivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectorisivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)

European Union - English - EMA (European Medicines Agency)

zentiva, k.s. - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectoris ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. treatment of chronic heart failure ivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

United States - English - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 100 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventric

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 180 mg - verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive d

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventric

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations). in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo- fetal toxicity at dos