Nicardipine Hydrochloride
Generic Name: nicardipine hydrochloride
Brand Names:
Nicardipine Hydrochloride
11 DESCRIPTION Nicardipine hydrochloride injection, USP is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride.
Overview
11 DESCRIPTION Nicardipine hydrochloride injection, USP is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride.
Uses
1 INDICATIONS AND USAGE Nicardipine hydrochloride injection USP 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 injection, USP 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
2 DOSAGE AND ADMINISTRATION For Intravenous Use. (2.1) Dilution is required. (2.3) When substituting for oral nicardipine therapy, use the intravenous infusion rate from the table below (2.1): Oral Nicardipine hydrochloride Dose Equivalent I.V. Infusion Rate (0.1 mg/ml) 20 mg q8h 0.5 mg/hr = 5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr In a patient not receiving oral nicardipine, initiate therapy at 50 mL/hr (5 mg/hr) 0.1 mg/ml solution. Increase the infusion rate by 25 mL/hr every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr until desired blood pressure reduction is achieved. (2.1) If unacceptable hypotension or tachycardia occurs, discontinue the infusion.
Side Effects
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 Lifestar Pharma LLC at 1-888-995-4337 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.
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 injection (7.3, 7.4) 7.1 Beta-Blockers In most patients, Nicardipine hydrochloride injection can safely be used concomitantly with beta-blockers. However, titrate slowly when using Nicardipine hydrochloride 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.
Warnings
5 WARNINGS AND PRECAUTIONS Closely monitor response in patients with angina, heart failure, impaired hepatic function, or renal impairment. (5.1, 5.2, 5.3, 5.4) To reduce the possibility of venous thrombosis, phlebitis, and vascular impairment, do not use small veins, such as those on the dorsum of the hand or wrist. Exercise extreme care to avoid intra-arterial administration or extravasation. (5.5) To minimize the risk of peripheral venous irritation, change the site of infusion of Nicardipine hydrochloride injection every 12 hours. (5.5) 5.1 Use in Patients with Angina Increases in frequency, duration, or severity of angina have been seen in chronic oral therapy with oral nicardipine. 4 CONTRAINDICATIONS Do not use in patients with advanced aortic stenosis (4.1). 4.1 Advanced Aortic Stenosis Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of Nicardipine hydrochloride injection is secondary to reduced afterload.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Nicardipine hydrochloride injection, USP 25 mg/10 mL (2.5 mglmL) single dose vials are available in cartons of 1 and cartons of 10 as follows: 25mg/10mL(2.5mg/mL) NDC 70756-686-86 Package of 1 vial NDC 70756-686-10 Packages of 10 vials 16.2 Storage Store at 20°-25°C (68°-77°F), (See USP Controlled Room Temperature).
Frequently Asked Questions
What is Nicardipine Hydrochloride used for?▼
1 INDICATIONS AND USAGE Nicardipine hydrochloride injection USP 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 injection, USP 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)] .
What are the side effects of Nicardipine Hydrochloride?▼
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 Lifestar Pharma LLC at 1-888-995-4337 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.
What are the important warnings for Nicardipine Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Closely monitor response in patients with angina, heart failure, impaired hepatic function, or renal impairment. (5.1, 5.2, 5.3, 5.4) To reduce the possibility of venous thrombosis, phlebitis, and vascular impairment, do not use small veins, such as those on the dorsum of the hand or wrist. Exercise extreme care to avoid intra-arterial administration or extravasation. (5.5) To minimize the risk of peripheral venous irritation, change the site of infusion of Nicardipine hydrochloride injection every 12 hours. (5.5) 5.1 Use in Patients with Angina Increases in frequency, duration, or severity of angina have been seen in chronic oral therapy with oral nicardipine. 4 CONTRAINDICATIONS Do not use in patients with advanced aortic stenosis (4.1). 4.1 Advanced Aortic Stenosis Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of Nicardipine hydrochloride injection is secondary to reduced afterload.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.