Warnings: Increased Angina and/or Myocardial Infarction: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.
Precautions: General: Since the vasodilation induced by AMCARDIA is gradual in onset, acute hypotension has rarely been reported after oral administration of AMCARDIA. Nonetheless, caution should be exercised when administering AMCARDIA as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Use in Patients with Heart Failure: Patients with cardiac failure should be treated with caution. In a long-term, placebo controlled study in patients suffering from severe heart failure (NYHA III and IV) of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Beta-Blocker Withdrawal: AMCARDIA is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.
Patients with Hepatic Failure: Since AMCARDIA is extensively metabolized by the liver and the plasma elimination half-life (t 1/2) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering AMCARDIA to patients with severe hepatic impairment.
Use in Children: Safety and effectiveness of AMCARDIA in children have not been established.