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warnings
WARNINGS Beta-Blocker Withdrawal Nicardipine 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 dose of beta-blocker. Rapid Decreases in Blood Pressure No clinical events have been reported suggestive of a too rapid decrease in blood pressure with nicardipine hydrochloride injection. However, as with any antihypertensive agent, blood pressure lowering should be accomplished over as long a time as is compatible with the patient’s clinical status. Use in Patients with Angina Increases in frequency, duration, or severity of angina have been seen in chronic oral therapy with nicardipine hydrochloride capsules. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with nicardipine hydrochloride injection. The mechanism of this effect has not been established. Use in Patients with Congestive Heart Failure Nicardipine hydrochloride injection reduced afterload without impairing myocardial contractility in preliminary hemodynamic studies of CHF patients. However, in vitro and in some patients, a negative inotropic effect has been observed. Therefore, caution should be exercised when using nicardipine hydrochloride injection, particularly in combination with a beta-blocker, in patients with CHF or significant left ventricular dysfunction. Use in Patients with Pheochromocytoma Only limited clinical experience exists in use of nicardipine hydrochloride injection for patients with hypertension associated with pheochromocytoma. Caution should therefore be exercised when using the drug in these patients. Peripheral Vein Infusion Site To minimize the risk of peripheral venous irritation, it is recommended that the site of infusion of nicardipine hydrochloride injection be changed every 12 hours.
ADVERSE REACTIONS Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine hydrochloride injection. Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse experiences occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia. Percent of Patients with Adverse Experiences During the Double-Blind Portion of Controlled Trials Adverse Experience Nicardipine Hydrochloride (n=144) Placebo (n=100) Body as a Whole Headache 14.6 2.0 Asthenia 0.7 0.0 Abdominal pain 0.7 0.0 Chest pain 0.7 0.0 Cardiovascular Hypotension 5.6 1.0 Tachycardia 3.5 0.0 ECG abnormality 1.4 0.0 Postural hypotension 1.4 0.0 Ventricular extrasystoles 1.4 0.0 Extrasystoles 0.7 0.0 Hemopericardium 0.7 0.0 Hypertension 0.7 0.0 Supraventricular tachycardia 0.7 0.0 Syncope 0.7 0.0 Vasodilation 0.7 0.0 Ventricular tachycardia 0.7 0.0 Digestive Nausea/vomiting 4.9 1.0 Injection Site Injection site reaction 1.4 0.0 Injection site pain 0.7 0.0 Metabolic and Nutritional Hypokalemia 0.7 0.0 Nervous Dizziness 1.4 0.0 Hypesthesia 0.7 0.0 Intracranial hemorrhage 0.7 0.0 Paresthesia 0.7 0.0 Respiratory Dyspnea 0.7 0.0 Skin and Appendages Sweating 1.4 0.0 Urogenital Polyuria 1.4 0.0 Hematuria 0.7 0.0 Rare Events The following rare events have been reported in clinical trials or in the literature in association with the use of intravenously administered nicardipine. Body as a Whole fever, neck pain Cardiovascular angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis Digestive dyspepsia Hemic and Lymphatic thrombocytopenia Metabolic and Nutritional hypophosphatemia, peripheral edema Nervous confusion, hypertonia Respiratory respiratory disorder Special Senses conjunctivitis, ear disorder, tinnitus Urogenital urinary frequency Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine.