Mibefradil

What is Mibefradil

NOTE: This drug is discontinued in the US.

Mibefradil is an oral, tetraline calcium-channel blocker. Its chemical structure differs from that of existing calcium antagonists.

Mibefradil is the first in a new class of ‘vascular-specific’ calcium-channel antagonists and is the only drug that, at therapeutic concentrations, lowers both heart rate and blood pressure without producing a negative inotropic effect.

Additionally, mibefradil has an optimal pharmacokinetic profile and does not cause constipation.

Mibefradil was approved for the treatment of chronic stable angina and hypertension on June 16, 1997. More than 25 drugs have been found to be potentially dangerous if used with Posicor®.

Due to the complexity of the prescribing information needed to address these interactions, both the FDA and Roche agreed that it would be difficult to administer Posicor® safely.

On June 8, 1998, Roche Laboratories, the manufacturer of Posicor®, voluntarily withdrew the drug from the US market.

Indications

  • angina
  • hypertension

For the treatment of chronic stable angina pectoris either alone or in combination with other antianginal agents

Side Effects

  1. abdominal pain
  2. asthenia
  3. AV block
  4. bradycardia
  5. dizziness
  6. dyspepsia
  7. fatigue
  8. flushing
  9. gynecomastia
  10. headache
  11. hypotension
  12. nausea
  13. peripheral edema
  14. peripheral vasodilation
  15. rhinitis
  16. syncope
  17. vomiting

Monitoring Parameters

  • ECG

Contraindications

  • aortic stenosis
  • AV block
  • bradycardia
  • breast-feeding
  • children
  • gastroesophageal reflux disease (GERD)
  • geriatric
  • heart failure
  • hepatic disease
  • hiatal hernia
  • hypotension
  • labor
  • pregnancy
  • sick sinus syndrome
  • syncope
  • ventricular dysfunction

Mibefradil is contraindicated in patients with a known sensitivity to mibefradil.

Interactions

No information is available regarding drug interactions associated with Mibefradil