Drugplain

CARDENE IV .1 mg/mL

nicardipine hydrochloride · INJECTION, SOLUTION · Baxter Healthcare Corporation

No Recall History
Plain English

CARDENE IV is a injection, solution containing nicardipine hydrochloride at .1 mg/mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.

Key Facts

Brand Name
CARDENE IV
Generic Name
nicardipine hydrochloride
NDC Code (Product)
43066-026
Manufacturer
Baxter Healthcare Corporation
Strength
.1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019734
Marketing Start
01/30/1992

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

acute kidney injury110 reports
premature baby95 reports
hypotension94 reports
maternal exposure during pregnancy85 reports
off label use83 reports
foetal exposure during pregnancy73 reports
pyrexia70 reports
drug interaction66 reports
diarrhoea63 reports
hepatic cytolysis58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE • CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension in adults when oral therapy is not feasible. ( 1.1 ) 1.1 Hypertension CARDENE I.V. (nicardipine hydrochloride) is indicated in adults for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1) ].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • For Intravenous Use. ( 2.1 ) • No further dilution is required. ( 2.3 ) • When substituting for oral nicardipine therapy, use the intravenous infusion rate from the table below ( 2.1 ): Oral CARDENE Dose Equivalent I.V. Infusion Rate (0.1 mg/mL) Equivalent I.V. Infusion Rate (0.2 mg/mL) 20 mg q8h 0.5 mg/hr = 5 mL/hr 0.5 mg/hr = 2.5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 1.2 mg/hr = 6 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr 2.2 mg/hr = 11 mL/hr • In a patient not receiving oral nicardipine, initiate therapy at 5 mg/hr. Increase the infusion rate by 2.5 mg/hr every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 15 mg/hr until desired blood pressure reduction is achieved. ( 2.1 ) Conversion Table (mg/hr) Equivalent I.V. Infusion Rate (0.1 mg/mL) Equivalent I.V. Infusion Rate (0.2 mg/mL) 5 mg/hr 50 mL/hr 25 mL/hr 2.5 mg/hr 25 mL/hr 12.5 mL/hr 15 mg/hr 150 mL/hr 75 mL/hr • If unacceptable hypotension or tachycardia occurs, discontinue the infusion. When blood pressure and heart rate stabilize, restart the infusion at low doses such as 3-5 mg/hr. ( 2.2 ) 2.1 Recommended Dosing CARDENE I.V. is intended for intravenous use.…

Contraindications

4 CONTRAINDICATIONS • Do not use in patients with advanced aortic stenosis ( 4.1 ). 4.1 Advanced Aortic Stenosis CARDENE I.V. is contraindicated in patients with advanced aortic stenosis because part of the effect of CARDENE I.V. is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

Drug Interactions

7 DRUG INTERACTIONS • Cimetidine increases oral nicardipine plasma levels. ( 7.2 ) • Oral or intravenous nicardipine may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended when co-administering CARDENE I.V. ( 7.3 , 7.4 ) 7.1 Beta-Blockers In most patients, CARDENE I.V. can safely be used concomitantly with beta blockers. However, titrate slowly when using CARDENE I.V. in combination with a beta-blocker in heart failure patients [see Warnings and Precautions (5.2) ]. 7.2 Cimetidine 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. 7.3 Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of cyclosporine during CARDENE I.V. administration, and reduce the dose of cyclosporine accordingly. 7.4 Tacrolimus Concomitant admi…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions: are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 pa…

Frequently Asked Questions

What is CARDENE IV used for?

CARDENE IV contains nicardipine hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is CARDENE IV a controlled substance?

CARDENE IV is not classified as a controlled substance by the DEA.

What is the generic name for CARDENE IV?

The generic name for CARDENE IV is nicardipine hydrochloride. There are 9 other brand versions of nicardipine hydrochloride.

What is the NDC code for CARDENE IV .1 mg/mL?

The NDC (National Drug Code) for CARDENE IV .1 mg/mL is 43066-026, listed by Baxter Healthcare Corporation.

Product NDC

43066-026

Package NDC

43066-026-10

Other Nicardipine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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