NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE- nicardipine hydrochloride injection, solution
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use CARDENE IV safely and effectively. See full prescribing information for CARDENE IV.
CARDENE IV (nicardipine hydrochloride in dextrose injection) for intravenous use
CARDENE IV (nicardipine hydrochloride in sodium chloride injection), for intravenous use Initial U.S. Approval: 1988

INDICATIONS AND USAGE

Cardene I.V. Premixed Injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. ( 1-1.1)

DOSAGE AND ADMINISTRATION

For Intravenous Use. ( 2-2.1)

No further dilution is required. ( 2-2.3)

When substituting for oral nicardipine therapy, use the intravenous infusion rate from the table below ( 2-2.1):

HIGHLIGHTS 1
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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. ( 2-2.1)

HIGHLIGHTS 2
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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)

DOSAGE FORMS AND STRENGTHS

Injection: 200 mL nicardipine (0.1 mg/mL) in either dextrose (4.8%) or sodium chloride (0.86%) in a single use, ready-to-use, iso-osmotic solution in a GALAXY container ( 3)

Injection: 200 mL nicardipine (0.2 mg/mL) in sodium chloride (0.83%) in a single use, ready-to-use, iso-osmotic solution in a GALAXY container ( 3)

CONTRAINDICATIONS

Do not use in patients with advanced aortic stenosis ( 4-4.1).

WARNINGS AND PRECAUTIONS

Closely monitor response in patients with angina, heart failure, impaired hepatic function, or renal impairment. ( 5-5.1, 5-5.2, 5-5.3, 5-5.4)
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. ( 5-5.5)
To minimize the risk of peripheral venous irritation, change the site of infusion of Cardene I.V. Premixed Injection every 12 hours. ( 5-5.5)

ADVERSE REACTIONS

Most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%). ( 6-6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Cimetidine increases oral nicardipine plasma levels. ( 7-7.2)
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. Premixed Injection. ( 7-7.3, 7-7.4)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data may cause fetal harm. ( 8-8.1)
Nursing mothers: Minimally excreted into human milk. ( 8-8.3)
Safety and efficacy in patients under the age of 18 have not been established. ( 8-8.4)

Revised: 1/2019

TABLE OF CONTENTS

FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
1.1 Hypertension
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Monitoring
2.3 Instructions for Administration
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
4.1 Advanced Aortic Stenosis
5. WARNINGS AND PRECAUTIONS
5.1 Exacerbation of Angina
5.2 Exacerbation of Heart Failure
5.3 Increased effect with Impaired Hepatic Function
5.4. Prolonged effect with Impaired Renal Function
5.5 Local Irritation
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7. DRUG INTERACTIONS
7.1 Beta-Blockers
7.2 Cimetidine
7.3 Cyclosporine
7.4 Tacrolimus
7.5 In Vitro Interaction
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3 Reproductive and Developmental Toxicology
14. CLINICAL STUDIES
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling

* Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

1.1 Hypertension

Cardene® I.V. (nicardipine hydrochloride) Premixed 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 ( 2-2.1)].

2 DOSAGE & ADMINISTRATION

2.1 Recommended Dosing

Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

DOSAGE
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Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

Cardene I.V. 20 mg in 200 mL (0.1 mg/mL): Initiate therapy at 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

Cardene I.V. 40 mg in 200 mL (0.2 mg/mL): Initiate therapy at 25 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 mL/hr (3 mg/hr).

Drug Discontinuation and Transition to an Oral Antihypertensive Agent

Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

Special Populations

Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions ( 5-5.2, 5-5.3 and 5-5.4)]

2.2 Monitoring

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 30‑50 mL/hr (3 — 5 mg/hr) for 20 mg in 200 mL or 15-25 mL/hr (3 — 5 mg/hr) for 40 mg in 200 mL and adjusted to maintain desired blood pressure.

2.3 Instructions for Administration

Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Warnings and Precautions ( 5-5.5)].

Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

Preparation for administration

1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

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