Drugplain

Nicardipine Hydrochloride in Sodium Chloride .1 mg/mL

Nicardipine Hydrochloride · INJECTION, SOLUTION · WG Critical Care, LLC

No Recall History
Plain English

Nicardipine Hydrochloride in Sodium Chloride is a injection, solution containing nicardipine hydrochloride at .1 mg/mL, taken intravenous. Manufactured by WG Critical Care, LLC.

Key Facts

Brand Name
Nicardipine Hydrochloride in Sodium Chloride
Generic Name
Nicardipine Hydrochloride
NDC Code (Product)
44567-850
Manufacturer
WG Critical Care, LLC
Strength
.1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA203978
Marketing Start
07/10/2025

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 • Nicardipine hydrochloride in sodium chloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1.1) 1.1 Hypertension Nicardipine hydrochloride in sodium chloride injection is indicated 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 Nicardipine 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 to 5 mg/hr. (2.2) 2.1 Recommended Dosing Nicardipine hydrochloride in sodium chloride inj…

Contraindications

4 CONTRAINDICATIONS • Do not use in patients with advanced aortic stenosis (4.1). 4.1 Advanced Aortic Stenosis Nicardipine hydrochloride in sodium chloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of Nicardipine hydrochloride in sodium chloride injection 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 nicardipine hydrochloride in sodium chloride injection. (7.3, 7.4) 7.1 Beta-Blockers In most patients, Nicardipine hydrochloride in sodium chloride injection can safely be used concomitantly with beta blockers. However, titrate slowly when using Nicardipine hydrochloride in sodium chloride injection 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 cyclospo…

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 WG Critical Care, LLC at 1-866-562-4708, 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 Nicardipine hydrochloride in sodium chloride injection. 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 t…

Frequently Asked Questions

What is Nicardipine Hydrochloride in Sodium Chloride used for?

Nicardipine Hydrochloride in Sodium Chloride contains Nicardipine Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Nicardipine Hydrochloride in Sodium Chloride a controlled substance?

Nicardipine Hydrochloride in Sodium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Nicardipine Hydrochloride in Sodium Chloride?

The generic name for Nicardipine Hydrochloride in Sodium Chloride is Nicardipine Hydrochloride. There are 10 other brand versions of Nicardipine Hydrochloride.

What is the NDC code for Nicardipine Hydrochloride in Sodium Chloride .1 mg/mL?

The NDC (National Drug Code) for Nicardipine Hydrochloride in Sodium Chloride .1 mg/mL is 44567-850, listed by WG Critical Care, LLC.

Product NDC

44567-850

Package NDC

44567-850-12

Other Nicardipine Hydrochloride in Sodium Chloride Dosages

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

Data from openFDA · Public domain (CC0 1.0)