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IVARIN

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IVARIN

Generic Name

Ivabradine

Composition

Ivabradine Hydrochloride 5/7.5 mg

Dosage Type

Tablet

Pack Size

2x15

Strength

5/7.5mg

MRP

Rs. 30/35

Ivabradine is indicated by the FDA 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. It is also indicated for treatment of stable symptomatic heart failure as a result of dilated cardiomyopathy.

  • Individualize dosage according to patient’s heart rate response and tolerance (target resting heart rate 50–60 bpm).

Oral Administration

Administer twice daily with meals.

  • If a dose is missed, take next dose at the regularly scheduled time; do not double the dose.
  • Allow 2 weeks to assess response to initial dosage. After initial adjustment period, adjust dosage as needed based on resting heart rate and tolerability to achieve resting heart rate of 50–60 beats/minute.
  • If heart rate is >60 beats/minute, increase dosage by 2.5 mg (given twice daily) up to maximum of 7.5 mg twice daily.
  • If heart rate is <50 beats/minute or patient is experiencing signs and symptoms of bradycardia, decrease dosage by 2.5 mg (given twice daily).
  • Discontinue therapy if patient is receiving ivabradine 2.5 mg twice daily and heart rate is <50 beats/minute or patient is experiencing signs and symptoms of bradycardia.

Angina† [off-label]

Oral

Dosages of 2.5–10 mg twice daily have been used. In clinical trials, ivabradine initiated at dosages of 5 or 7.5 mg twice daily and titrated after 2–4 weeks to a target heart rate of 50–60 beats/minute.

In clinical trials, dosage was titrated downward in patients with resting heart rate <50 beats/minute or if signs or symptoms of bradycardia were present.

 

  • Acute decompensated heart failure.
  • BP <90/50 mm Hg.
  • Resting heart rate <60 bpm prior to treatment.
  • Severe hepatic impairment. (See Hepatic Impairment under Cautions.)
  • Pacemaker dependence (heart rate maintained exclusively by pacemaker).
  • Concomitant use of potent CYP3A4 inhibitors. (See Drugs and Foods Affecting Hepatic Microsomal Enzymes under Interactions.)
  • Sick sinus syndrome, SA block, or third-degree AV block, unless a functioning demand pacemaker is present.

Fetal Toxicity

May cause fetal toxicity and teratogenicity when administered to pregnant women based on findings in animals.

Atrial Fibrillation

Increases risk of atrial fibrillation.

Bradycardia and Conduction Disturbances

Bradycardia, sinus arrest, and heart block reported with ivabradine use. Risk factors for bradycardia include sinus node dysfunction, conduction defects (e.g., first or second degree AV block, bundle branch block).

Specific Populations

Pregnancy: May cause fetal harm.

Lactation: Distributed into milk

  • Bradycardia
  • Hypertension
  • Atrial Fibrillation
  • Luminous Visual Phenomena (Phosphenes)

Store at room temperature.

IVARIN 5:  2×15’s
IVARIN 7.5: 2×15’s

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