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Cardene I.V.

Last reviewed on RxList: 7/24/2017
Cardene IV Side Effects Center

Last reviewed on RxList 7/24/2017

Cardene I.V. (nicardipine hydrochloride) is a calcium channel blocker indicated for the short-term treatment of high blood pressure (hypertension) for patients who cannot take the medication orally. Cardene I.V. is available in generic form. Common side effects of Cardene I.V. include:

Cardene I.V. is intended for intravenous use and dosage is individualized depending on the patient's condition and response to treatment. Cardene I.V. may interact with beta blockers (particularly in heart failure patients), cimetidine, or cyclosporine. Tell your doctor all medications you are taking. Cardene I.V. should be used during pregnancy only if prescribed. This medication passes into breast milk. Breastfeeding while using this medication is not recommended.

Our Cardene I.V. (nicardipine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cardene IV Professional Information

SIDE EFFECTS

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.
(N=144)
Placebo
(N=100)
Body as a Whole
Headache, n (%) 21 (15) 2 (2)
Cardiovascular
Hypotension, n (%) 8 (6) 1 (1)
Tachycardia, n (%) 5 (4) 0
Digestive
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

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.

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 entire FDA prescribing information for Cardene IV (Nicardipine Hydrochloride)

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