Ivabradine Hydrochloride and Topiramate ER Capsules

• Generic Name: ivabradine
• Dosage Forms: n.a.
• Other Brand Names: Corlanor

Used to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic, mild to severe chronic heart failure (NYHA class II–IV) with reduced ejection fraction (LVEF ≤35%), who are in sinus rhythm with a resting heart rate ≥70 bpm and are either on maximally tolerated dosages of a β-adrenergic blocking agent (β-blocker) or have a contraindication to β-blocker use.

Current heart failure guidelines generally recommend clinical trial-proven β-blockers (e.g., carvedilol, bisoprolol, extended-release metoprolol succinate) in conjunction with neurohormonal antagonists (e.g., ACE inhibitors, angiotensin II receptor antagonists, angiotensin receptor-neprilysin inhibitors [ARNIs]) to inhibit the renin-angiotensin-aldosterone (RAA) system in patients with heart failure and reduced LVEF due to favorable effects of these drugs on survival and disease progression. If patients cannot tolerate therapy with a β-blocker or if increasing the β-blocker dosage is ineffective, consider ivabradine in symptomatic patients as an alternative or additional treatment option to reduce heart failure-related hospitalizations.

Initiate and titrate the dosage of β-blockers upwards to optimal level for prevention of cardiovascular mortality, as tolerated, before assessing resting heart rate for consideration of ivabradine therapy.

No reduction in cardiovascular mortality demonstrated with ivabradine in patients with chronic heart failure.

Not established whether ivabradine can improve cardiovascular outcomes when added to optimally managed heart failure therapies.

Adjunct to or substitute for β-blocker therapy for treatment of chronic stable angina pectoris in patients with inadequately controlled symptoms or a contraindication or intolerance to β-blockers.

Reduces heart rate, improves exercise capacity, and decreases the number of anginal attacks.

No benefit with ivabradine in terms of cardiovascular outcomes (e.g., MI, cardiovascular death) in patients with stable coronary artery disease with or without stable heart failure who are receiving guideline-based therapy for angina (e.g., aspirin, statins, ACE inhibitors, β-blockers).

Some clinical trial data suggest ivabradine use was associated with possible increase in the risk of death from cardiovascular causes or nonfatal MI in patients with more severe forms of angina and no clinical heart failure; further study and experience needed.

• Generic Name: topiramate
• Dosage Forms: capsule, extended release
• Other Brand Names: Qudexy XR Sprinkle, Topamax, Topamax Sprinkle, Trokendi XR, Topiragen, Qudexy XR

Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat seizures in adults and children who are at least 2 years old. Trokendi XR is for use in adults and children who are at least 6 years old.

Some brands of topiramate are also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. These medicines will only prevent migraine headaches or reduce the number of attacks, but will not treat a headache that has already begun.

Topiramate may also be used for purposes not listed in this medication guide.