Amvasc BE

Amvasc BE Special Precautions





United Lab
Full Prescribing Info
Special Precautions
Use with caution in patients with severe bradycardia, heart failure (particularly in combination with a β-blocker), cardiogenic shock because of the risk of a slight negative inotropic effect and potent hypotensive effects.
Monitor signs and symptoms of worsening heart failure in patients with left ventricular dysfunction who are receiving amlodipine for the treatment of angina.
Although hemodynamic studies and a controlled trial in NYHA class II-III heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptomatology, studies have not been performed in patients with NYHA class IV heart failure. In general, all calcium channel blockers should be used with caution in patients with heart failure.
Amlodipine decreases peripheral resistance and can worsen hypotension; hence, it should not be used in patients with systolic blood pressure <90 mm Hg. Dizziness induced by hypotensive effect may occur.
Amlodipine is not a β-blocker and therefore gives no protection against the dangers of abrupt β-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of β-blocker.
Use with caution in patients with hepatic disease. The amlodipine plasma elimination t½ is prolonged (56 hrs) in patients with hepatic disease and dosage adjustment is recommended.
Effects on the Ability to Drive or Operate Machinery: Patients should observe caution while driving, operating machinery or performing other tasks requiring alertness.
Use in pregnancy: Pregnancy Category C: Amlodipine has been shown to be fetotoxic in laboratory animals. No adequate or well-controlled studies have been done in humans. Amlodipine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether amlodipine is excreted into human milk, so clinicians should consider risk/benefit ratio for breastfeeding women.
Use in children: The effect of amlodipine on blood pressure in patients <6 years is not known.
Use in the elderly: Elderly patients are more likely to experience a delayed clearance of amlodipine and can be at greater risk for toxicity. Observe caution in amlodipine dose selection for an elderly. Start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Elderly patients have decreased amlodipine clearance with a resulting increase in AUC of approximately 40-60%, and a lower initial dose may be required.
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