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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of Cardene I.V. 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.
The table below shows percentage of patients with adverse events where the rate is > 3% more common on Cardene I.V. than placebo.
|Adverse Event||Cardene I.V.
|Body as a Whole|
|Headache, n (%)||21 (15)||2 (2)|
|Hypotension, n (%)||8 (6)||1 (1)|
|Tachycardia, n (%)||5 (4)||0|
|Nausea/vomiting, n (%)||7 (5)||1 (1)|
Other adverse 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
Hemic and Lymphatic: thrombocytopenia
Metabolic and Nutritional: hypophosphatemia, peripheral edema
Nervous: confusion, hypertonia
Respiratory: respiratory disorder
Urogenital: urinary frequency
Post-Marketing And Other Clincal Experience
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. The following adverse reaction has been identified during post-approval use of Cardene I.V.: decreased oxygen saturation (possible pulmonary shunting).
Read the Cardene I.V. (nicardipine hydrochloride) Side Effects Center for a complete guide to possible side effects
In most patients, Cardene I.V. Premixed Injection can safely be used concomitantly with beta blockers. However, titrate slowly when using Cardene I.V. Premixed Injection in combination with a beta-blocker in heart failure patients [see WARNINGS AND PRECAUTIONS].
Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration. Frequently monitor response in patients receiving both drugs. Data with other histamine-2 antagonists are not available.
Concomitant administration of oral nicardipine and cyclosporine results in elevated plasma cyclosporine levels. Closely monitor plasma concentrations of cyclosporine during Cardene I.V. Premixed Injection administration, and reduce the dose of cyclosporine accordingly.
In Vitro Interaction
The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/4/2014
Additional Cardene I.V. Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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