The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure
Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Patients with hepatic impairment
The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Aml …
Identical in all 10 labels. Surrounding text shown from Zydus Pharmaceuticals UK Ltd.
The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure:
Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1).
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
…
Identical in both labels. Surrounding text shown from Viatris (formerly Mylan or Upjohn).
The safety and efficacy of Amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure
Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the Amlodipine treated group than in the placebo group (see section 5.1). Calcium channel blockers, including Amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Patients with hepatic impairment
The half-life of Amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Aml …