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warnings
WARNINGS Increased Angina in Patients With Angina In short-term, placebo-controlled angina trials with CARDENE (an immediate release oral dosage form of nicardipine), about 7% of patients on CARDENE (compared with 4% of patients on placebo) have developed increased frequency, duration or severity of angina. Comparisons with beta-blockers also show a greater frequency of increased angina, 4% vs 1%. The mechanism of this effect has not been established. Use in Patients With Congestive Heart Failure Although preliminary hemodynamic studies in patients with congestive heart failure have shown that CARDENE reduced afterload without impairing myocardial contractility, it has a negative inotropic effect in vitro and in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker. Beta-Blocker Withdrawal CARDENE 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, preferably over 8 to 10 days.
ADVERSE REACTIONS In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR. In these studies adverse events were elicited by non-directed and in some cases directed questioning; adverse events were generally not serious and about 9% of patients withdrew prematurely from the studies because of them. Hypertension The incidence rates of adverse events in hypertensive patients were derived from placebo-controlled clinical trials. Following are the rates of adverse events for CARDENE SR (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR. These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema. Percentage of Patients With Probably Drug Related Adverse Events in Placebo-Controlled Studies Adverse Event CARDENE SR (n=322) Placebo (n=140) Headache 6.2 7.1 Pedal Edema 5.9 1.4 Vasodilatation 4.7 1.4 Palpitation 2.8 1.4 Nausea 1.9 0.7 Dizziness 1.6 0.7 Asthenia 0.9 0.7 Postural Hypotension 0.9 0 Increased UrinaryFrequency 0.6 0 Pain 0.6 0 Rash 0.6 0 Sweating Increased 0.6 0 Vomiting 0.6 0 Incidence (%) of Discontinuations Due to Any Adverse Event in Placebo-Controlled Studies Adverse Event CARDENE SR (n=322) Placebo (n=140) Headache 2.5 1.4 Palpitation 2.2 0.7 Dizziness 1.9 0.7 Asthenia 1.9 0 Pedal Edema 1.2 0 Nausea 1.2 0 Rash 0.9 0.7 Diarrhea 0.9 0 Tachycardia 0.9 0 Blurred Vision 0.6 0 Chest Pain 0.6 0 Face Edema 0.6 0 Myocardial Infarct 0.6 0 Vasodilatation 0.6 0 Vomiting 0.6 0 Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials. Rare Events The following rare adverse events have been reported in clinical trials or the literature: Body as a Whole: infection, allergic reaction Cardiovascular: hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia, angina pectoris Digestive: sore throat, abnormal liver chemistries Musculoskeletal: arthralgia Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety Respiratory: rhinitis, sinusitis Special Senses: tinnitus, abnormal vision, blurred vision Angina Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%).