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Cardene IV

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Cardene I.V.

Cardene I.V.

Cardene IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cardene I.V. (nicardipine hydrochloride) is indicated for the short-term treatment of high blood pressure (hypertension) for patients who cannot take the medication orally. It is a calcium channel blocker. This medication is available in generic form. Common side effects include headache, low blood pressure (hypotension), rapid heart rate (tachycardia), or nausea/vomiting.

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. Breast-feeding 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cardene IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

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. (nicardipine hydrochloride) 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. (nicardipine hydrochloride) 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.

Read the entire FDA prescribing information for Cardene IV (Nicardipine Hydrochloride) »

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Report Problems to the Food and Drug Administration

 

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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