Contraindications: Hypersensitivity to ivabradine. Acute decompensated HF B/P less than 90/50 mm Hg sick sinus syndrome; sinoatrial block or thirddegree AV block (unless a functional pacemaker is present) resting heart rate less than 60 bpm prior to initiation severe hepatic impairment pacemaker dependence (heart rate maintained exclusively by a pacemaker) concomitant use of strong CYP3A4 inhibitors.Pregnancy/Lactation: May cause fetal harm. Females of reproductive potential should use effective contraception. Unknown if distributed in breast milk. Must either discontinue drug or discontinue breastfeeding. If treatment is decided to be absolutely necessary pregnant pts should be closely monitored for desTabletilizing HF esp. during the first trimester. Pregnant women with chronic HF in the third trimester should be closely monitored for preterm birth. Children: Safety and efficacy not esTabletlished. Elderly: No age-related precautions noted.
To reduce the risk of hospitalization for worsening HF in pts with sTabletle
symptomatic chronic HF with left ventricular ejection fraction less than or equal
to 35% who are in sinus rhythm with a resting heart rate greater than or equal to
70 bpm and either are on maximally tolerated dose of beta blockers or have a
contraindication to beta blocker use.
Occasional (10%?3%): Bradycardia hypertension phosphenes (visual
disturbances luminous phenomena) visual brightness.
Adverse effects/toxic reactions
May increase risk of atrial fibrillation (8.3% of pts). Bradycardia sinus arrest or
heart block may occur. Bradycardia occurred in 10% of pts. Risk factors for
bradycardia may include sinus node dysfunction conduction defects (e.g. firstor
second-degree AV block bundle branch block) ventricular dyssynchrony or
use of negative chronotropic drugs. Phosphenes a transient enhanced brightness
in the visual field (which may include halos stroboscopic or kaleidoscopic
effect colored bright lights or multiple images) may occur. Phosphenes are
usually triggered by sudden variations in light intensity and generally occur
within the first 2 mos of treatment. Other adverse reactions such as angioedema
diplopia erythema hypotension pruritus rash syncope urticaria vertigo visual
impairment occur rarely. Overdose may lead to severe and prolonged
bradycardia requiring temporary cardiac pacing or infusion of IV betastimulating
History of atrial fibrillation
hypertension. Avoid concomitant use of diltiaZEM or verapamil. Avoid use in
pts with second-degree heart block (unless a functioning pacemaker is present).
Pts at risk for bradycardia. Not recommended with pacemakers set to rate of 60
bpm or greater.