CARDENE IV nicardipine hydrochloride .2 mg/mL Injection, Solution — NDC 43066-016-10 (Billing 43066-0016-10)
This is a package of CARDENE IV nicardipine hydrochloride .2 mg/mL Injection, Solution from Baxter Healthcare Corporation, marketed since Jan 1992 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 43066-016-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 43066 labeler · 016 product · 10 package
- Package marketed since
- Oct 26, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 4306601610 4
- Medicaid fills, this package
- 67 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Other active recalls for Nicardipine Hydrochloride (different manufacturers) — 5 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 064611
- GCN: 15826
- GPI-14 (Medi-Span): 34000018142040
- HICL (First Databank): 035779
- AHFS class code: 24:12.92.00
- RxCUI (RxNorm): 858599
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Nicardipine treats high blood pressure. The capsules are also used for chronic stable angina, which is chest pain brought on by effort. The IV form is used short term in a medical...
- You take them by mouth, usually three times a day, and your prescriber adjusts the dose to your blood pressure. Doses shouldn't be raised more often than every 3 days. Food can low...
- Common ones include ankle swelling, dizziness, headache, flushing, weakness and a pounding heartbeat. These come from the blood vessels widening. Call your doctor if your chest pai...
- Tell me about everything you take. Nicardipine raises levels of cyclosporine and tacrolimus, and cimetidine raises nicardipine levels. Your doctor may check digoxin levels after yo...
Patient education
Supplement & herbal interactions
Nicardipine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.7930 | $1,586.00 / 2000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 43066-0016-10 You're viewing this Main listing | 10 BAG in 1 CARTON / 200 mL in 1 BAG | 2020-10-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nicardipine Hydrochloride .2 mg/mL 00143-9633-10 | Hikma | 200 ml | — | AP | FDA listed | — |
| Cardene Iv .2 mg/mLthis 43066-0016-10 | Baxter | 200 ml | — | AP | FDA listed | — |
| Cardene IV .2 mg/mL 43066-0024-10 | Baxter | 200 ml | — | AP | FDA listed | — |
| Cardene Iv .2 mg/mL 43066-0028-10 | Baxter | 200 ml | — | AP | FDA listed | — |
| Nicardipine Hydrochloride in Sodium Chloride .2 mg/mL 44567-0851-12 | WG | 200 ml | — | AP | FDA listed | — |
| Nicardipine Hydrochloride .2 mg/mL 65145-0198-01 | Caplin | 1 pouch | — | AP | FDA listed | — |
| Nicardipine Hydrochloride .2 mg/mL 69097-0008-22 | Cipla | 200 ml | — | AP | FDA listed | — |
| Nicardipine Hydrochloride .2 mg/mL 70069-0876-10 | Somerset | 10 pouches | — | AP | FDA listed | — |
| Nicardipine Hydrochloride .2 mg/mL 65219-0298-20 | Fresenius | 200 ml | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8455524 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 8455524 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 7659291 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 7659291 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 8455524 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 7659291 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 11547758 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 11547758 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 11547758 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 8455524 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 7659291 ↗ | Method of use | U-1029 | Apr 18, 2027 |
| US 9364564 ↗ | Drug product | — | Dec 26, 2027 |
| US 7612102 ↗ | Drug product | — | Dec 26, 2027 |
| US 9364564 ↗ | Drug product | — | Dec 26, 2027 |
| US 10758616 ↗ | Drug product | — | Apr 18, 2027 |
| US 10758616 ↗ | Drug product | — | Apr 18, 2027 |
| US 7612102 ↗ | Drug product | — | Dec 26, 2027 |
| US 7612102 ↗ | Drug product | — | Dec 26, 2027 |
| US 9364564 ↗ | Drug product | — | Dec 26, 2027 |
| US 9364564 ↗ | Drug product | — | Dec 26, 2027 |
| US 10758616 ↗ | Drug product | — | Apr 18, 2027 |
| US 7612102 ↗ | Drug product | — | Dec 26, 2027 |
Is there a generic version of CARDENE-NACL 40 MG/200 ML IV?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Nicardipine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.0384 mg / 1 mL
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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8.30 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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3.84 mg / 1 mL
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Baxter Healthcare Corporation labeler code 43066
- TRANEXAMIC ACID 100 mg/mL Injection NDC 43066-008-10
- CARDENE IV nicardipine hydrochloride .1 mg/mL Injection, Solution NDC 43066-009-10
- Docetaxel 10 mg/mL Injection, Solution NDC 43066-010-01
- Rocuronium Bromide 100 mg/10mL Injection NDC 43066-013-10
- Oxaliplatin 5 mg/mL Injection, Solution NDC 43066-014-01
- ROPIVACAINE HYDROCHLORIDE 2 mg/mL Injection NDC 43066-015-10
- Oxaliplatin 5 mg/mL Injection, Solution NDC 43066-018-01
- ROPIVACAINE HYDROCHLORIDE 5 mg/mL Injection NDC 43066-019-10
- Cardene IV nicardipine hydrochloride .1 mg/mL Injection, Solution NDC 43066-021-10
- ROPIVACAINE HYDROCHLORIDE 5 mg/mL Injection NDC 43066-023-10
- Cardene IV nicardipine hydrochloride .2 mg/mL Injection, Solution NDC 43066-024-10
- CARDENE IV nicardipine hydrochloride .1 mg/mL Injection, Solution NDC 43066-026-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and 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 )
1.1Hypertension 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 and 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 )
2.1Recommended 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: Oral CARDENE Dose Equivalent I.V. Infusion Rate 20 mg in 200 mL (0.1 mg/mL) Equivalent I.V. Infusion Rate 40 mg in 200 mL (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 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.
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. slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.2 , 5.3 and 5.4) ]
2.2Monitoring 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 t… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 200 mL nicardipine (0.1 mg/mL) in either dextrose (4.8%) or sodium chloride (0.86%) as a clear, colorless solution, ready-to-use, iso-osmotic solution in a single-dose GALAXY container Injection: 200 mL nicardipine (0.2 mg/mL) in sodium chloride (0.83%) as a clear, colorless solution, ready-to-use, iso-osmotic solution in a single-dose GALAXY container Injection: 200 mL nicardipine (0.1 mg/mL) in either dextrose (4.8%) or sodium chloride (0.86%) in a single-dose, 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-dose, ready-to-use, iso-osmotic solution in a GALAXY container ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Do not use in patients with advanced aortic stenosis ( 4.1 ).
4.1Advanced 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.
⚠️ Warnings and Cautions ▾
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 CARDENE I.V. every 12 hours. ( 5.5 )
5.1Exacerbation of Angina Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V. The mechanism of this effect has not been established.
5.2Exacerbation of Heart Failure Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects.
5.3Increased effect with Impaired Hepatic Function Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow.
5.4Prolonged effect with Impaired Renal Function When CARDENE I.V. was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment.
5.5Local Irritation To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.
🤒 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.
6.1Clinical 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 patients with adverse events where the rate is >3% more common on CARDENE I.V. 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.
6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. The following adverse reaction has been identified during post-approval use of CARDENE I.V.: decreased oxygen saturation (possible pulmonary shunting).
🔄 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 )
7.1Beta-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) ].
7.2Cimetidine 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.
7.3Cyclosporine 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.
7.4Tacrolimus Concomitant administration of intravenous nicardipine and tacrolimus may result in elevated plasma tacrolimus levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of tacrolimus during CARDENE I.V. administration, and adjust the dose of tacrolimus accordingly.
7.5In Vitro Interaction The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data may cause embryofetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Available data from published literature (clinical trials and case series) over decades of use of intravenous nicardipine during pregnancy have not identified a drug-associated risk of major birth defects or miscarriage. However, nicardipine is predominantly used in pregnancy after 20 gestational weeks. Use of nicardipine in women with preeclampsia or pre-term labor is associated with maternal and fetal/neonatal adverse events.
Maternal adverse events included pulmonary edema, dyspnea, hypoxia, hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, flushing, and phlebitis at site of injection. Fetal/neonatal adverse events included transient fetal heart rate decelerations, hypotension and acidosis (pH<7.25) ( see Clinical Considerations ). In animal reproductive and developmental toxicity studies in which nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis, increased embryolethality, but no teratogenicity occurred at a dose 0.27 times and 0.05 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively.
No embryotoxicity occurred in offspring of pregnant rats administered oral doses of nicardipine 8 times the oral MRHD, but did occur in offspring of pregnant rabbits with oral doses at 24 times the oral MRHD ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and stillbirth.
Pregnant women with hypertension should be carefully monitored and managed accordingly. Maternal Adverse Reactions Hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, and flushing have been reported in pregnant women who were treated with intravenous nicardipine for hypertension during pregnancy. Adverse events in women treated with intravenous nicardipine during pre-term labor include pulmonary edema, dyspnea, hypoxia, hypotension, tachycardia, headache, and phlebitis at site of injection.
Manage the patient accordingly. Fetal/Neonatal Adverse Reactions Nicardipine crosses the placenta. Transient fetal heart rate decelerations have been reported.
Hypotension and acidosis (pH<7.25) have also been reported in neonates. The relationship to the use of nicardipine is not clear. If fetal heart rate decelerations, or neonatal hypotension or acidosis occur, manage accordingly.
Data Animal Data In embryofetal toxicity studies, no embryotoxicity or teratogenicity was seen when nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.14 times the MRHD based on body surface area (mg/m 2 ) (5 mg/kg/day in rats) and 0.03 times the MRHD based on body surface area (mg/m 2 ) (0.5 mg/kg/day in rabbits). Embryolethality, but no teratogenicity was seen at 0.27 times the MRHD based on body surface area (mg/m 2 ) (10 mg/kg/day) in rats and at 0.05 times the MRHD based on body surface are (mg/m 2 ) (1 mg/kg/day) in rabbits.
In other animal studies, pregnant Japanese White rabbits received oral nicardipine during organogenesis, at doses 8 and 24 times the oral MRHD based on body surface area (mg/m2) (50 and 150 mg/kg/day). Embryolethality occurred at the high dose along with signs of maternal toxici… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published literature (clinical trials and case series) over decades of use of intravenous nicardipine during pregnancy have not identified a drug-associated risk of major birth defects or miscarriage. However, nicardipine is predominantly used in pregnancy after 20 gestational weeks. Use of nicardipine in women with preeclampsia or pre-term labor is associated with maternal and fetal/neonatal adverse events.
Maternal adverse events included pulmonary edema, dyspnea, hypoxia, hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, flushing, and phlebitis at site of injection. Fetal/neonatal adverse events included transient fetal heart rate decelerations, hypotension and acidosis (pH<7.25) ( see Clinical Considerations ). In animal reproductive and developmental toxicity studies in which nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis, increased embryolethality, but no teratogenicity occurred at a dose 0.27 times and 0.05 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively.
No embryotoxicity occurred in offspring of pregnant rats administered oral doses of nicardipine 8 times the oral MRHD, but did occur in offspring of pregnant rabbits with oral doses at 24 times the oral MRHD ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and stillbirth.
Pregnant women with hypertension should be carefully monitored and managed accordingly. Maternal Adverse Reactions Hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, and flushing have been reported in pregnant women who were treated with intravenous nicardipine for hypertension during pregnancy. Adverse events in women treated with intravenous nicardipine during pre-term labor include pulmonary edema, dyspnea, hypoxia, hypotension, tachycardia, headache, and phlebitis at site of injection.
Manage the patient accordingly. Fetal/Neonatal Adverse Reactions Nicardipine crosses the placenta. Transient fetal heart rate decelerations have been reported.
Hypotension and acidosis (pH<7.25) have also been reported in neonates. The relationship to the use of nicardipine is not clear. If fetal heart rate decelerations, or neonatal hypotension or acidosis occur, manage accordingly.
Data Animal Data In embryofetal toxicity studies, no embryotoxicity or teratogenicity was seen when nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.14 times the MRHD based on body surface area (mg/m 2 ) (5 mg/kg/day in rats) and 0.03 times the MRHD based on body surface area (mg/m 2 ) (0.5 mg/kg/day in rabbits). Embryolethality, but no teratogenicity was seen at 0.27 times the MRHD based on body surface area (mg/m 2 ) (10 mg/kg/day) in rats and at 0.05 times the MRHD based on body surface are (mg/m 2 ) (1 mg/kg/day) in rabbits.
In other animal studies, pregnant Japanese White rabbits received oral nicardipine during organogenesis, at doses 8 and 24 times the oral MRHD based on body surface area (mg/m2) (50 and 150 mg/kg/day). Embryolethality occurred at the high dose along with signs of maternal toxicity (marked maternal weight gain suppression). New Zealand albino rabbits received oral nicardipine d… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CARDENE I.V. have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (>65 years) and young healthy adults. Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, use low initial doses in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of immediate-release oral nicardipine, and another patient, 2160 mg of the sustained-release formulation of nicardipine. Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion and slurred speech.
All symptoms resolved without sequelae. An overdosage occurred in a one year old child who ingested half of the powder in a 30 mg nicardipine standard capsule. The child remained asymptomatic.
Based on results obtained in laboratory animals, lethal overdose may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine. For treatment of overdosage, implement standard measures including monitoring of cardiac and respiratory functions.
Position the patient so as to avoid cerebral anoxia. Use vasopressors for patients exhibiting profound hypotension.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Nicardipine inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle.
In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.
12.2Pharmacodynamics Hemodynamics CARDENE I.V. produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered CARDENE I.V., the degree of vasodilation and the resultant decrease in blood pressure were more prominent in hypertensive patients than in normotensive volunteers. Administration of CARDENE I.V. to normotensive volunteers at dosages of 0.25 to 3 mg/hr for eight hours produced changes of <5 mmHg in systolic blood pressure and <3 mmHg in diastolic blood pressure.
An increase in heart rate is a normal response to vasodilation and decrease in blood pressure; in some patients these increases in heart rate may be pronounced. In placebo-controlled trials, the mean increases in heart rate were 7 ± 1 bpm in postoperative patients and 8 ± 1 bpm in patients with severe hypertension at the end of the maintenance period. Hemodynamic studies following intravenous dosing in patients with coronary artery disease and normal or moderately abnormal left ventricular function have shown significant increases in ejection fraction and cardiac output with no significant change, or a small decrease, in left ventricular end-diastolic pressure (LVEDP).
There is evidence that CARDENE I.V. increases blood flow. Coronary dilatation induced by CARDENE I.V. improves perfusion and aerobic metabolism in areas with chronic ischemia, resulting in reduced lactate production and augmented oxygen consumption. In patients with coronary artery disease, CARDENE I.V., administered after beta-blockade, significantly improved systolic and diastolic left ventricular function.
In congestive heart failure patients with impaired left ventricular function, CARDENE I.V. increased cardiac output both at rest and during exercise. Decreases in left ventricular end-diastolic pressure were also observed. However, in some patients with severe left ventricular dysfunction, it may have a negative inotropic effect and could lead to worsened failure [see Warnings and Precautions (5.2)]. “Coronary steal” has not been observed during treatment with CARDENE I.V.
(Coronary steal is the detrimental redistribution of coronary blood flow in patients with coronary artery disease from underperfused areas toward better perfused areas.) CARDENE I.V. has been shown to improve systolic shortening in both normal and hypokinetic segments of myocardial muscle. Radionuclide angiography has confirmed that wall motion remained improved during increased oxygen demand. (Occasional patients have developed increased angina upon receiving oral nicardipine.
Whether this represents coronary steal in these patients, or is the result of increased heart rate and decreased diastolic pressure, is not clear.) In patients with coronary artery disease, CARDENE I.V. improves left ventricular diastolic distensibility during the early filling phase, probably due to a faster rate of myocardial relaxation in previously underperfused areas. There is little or no effect on normal myocardium, suggesting the improvement is mainly by indirect mechanisms such as afterload reduction and reduced ischemia.
CARDENE I.V. has no negative effect on myocardial relaxation at therapeutic doses. The clinical benefits of these properties have not yet been demonstrated. Electrophysiologic Effects In general, no detrimental effects on the cardiac conduction system have been seen w… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nicardipine inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle.
In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied CARDENE I.V. is supplied as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) nicardipine hydrochloride in sodium chloride. Pack Size Diluent NDC Number 10 bags, each containing 20 mg in 200 mL (0.1mg/mL) 0.86% Sodium Chloride NDC 43066-009-10 10 bags, each containing 40 mg in 200 mL (0.2mg/mL) 0.83% Sodium Chloride NDC 43066-016-10
16.2Storage and Handling Store at controlled room temperature 20º to 25ºC (68º to 77ºF), refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use. Discard unused portion.
📋 Description ▾
11 DESCRIPTION CARDENE I.V. (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). CARDENE I.V. for intravenous administration contains 20 mg (0.1 mg/mL) of nicardipine hydrochloride per 200 mL in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) of nicardipine hydrochloride per 200 mL in sodium chloride.
Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169ºC. It is freely soluble in chloroform, methanol, and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water,
0.01M potassium dihydrogen phosphate, acetone, and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether, and hexane. It has a molecular weight of 515.99. CARDENE I.V. is available as a ready-to-use sterile, non-pyrogenic, clear, colorless to yellow, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) or 40 mg (0.2 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride.
Nicardipine Hydrochloride in 4.8% Dextrose Injection 20 mg in 200 mL (0.1 mg/mL) Each mL contains 0.1 mg nicardipine hydrochloride, 48 mg dextrose hydrous, USP, 0.0192 mg citric acid, anhydrous, USP, and 1.92 mg sorbitol, NF. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL (0.1 mg/mL) Each mL contains 0.1 mg nicardipine hydrochloride, 8.6 mg sodium chloride, USP, 0.0192 mg citric acid, anhydrous, USP, and 1.92 mg sorbitol, NF.
Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) Each mL contains 0.2 mg nicardipine hydrochloride, 8.3 mg sodium chloride, USP, 0.0384 mg citric acid, anhydrous, USP, and 3.84 mg sorbitol, NF. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7.
The GALAXY container is fabricated from multilayered plastic. Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
Cardene Structural Formula
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Distribution Rapid dose-related increases in nicardipine plasma concentrations are seen during the first two hours after the start of an infusion of CARDENE I.V. Plasma concentrations increase at a much slower rate after the first few hours, and approach steady state at 24 to 48 hours. The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (>65 years) and young healthy adults.
On termination of the infusion, nicardipine concentrations decrease rapidly, with at least a 50% decrease during the first two hours post-infusion. The effects of nicardipine on blood pressure significantly correlate with plasma concentrations. Nicardipine is highly protein bound (>95%) in human plasma over a wide concentration range.
Following infusion, nicardipine plasma concentrations decline tri-exponentially, with a rapid early distribution phase (α-half-life of 2.7 minutes), an intermediate phase (β-half-life of 44.8 minutes), and a slow terminal phase (γ-half-life of 14.4 hours) that can only be detected after long-term infusions. Total plasma clearance (Cl) is
0.4L/hr•kg, and the apparent volume of distribution (V d ) using a non-compartment model is
8.3L/kg. The pharmacokinetics of CARDENE I.V. are linear over the dosage range of 0.5 to 40 mg/hr. Metabolism and Excretion CARDENE I.V. has been shown to be rapidly and extensively metabolized by the hepatic cytochrome P450 enzymes, CYP2C8, 2D6, and 3A4.
Nicardipine does not induce or inhibit its own metabolism, however, nicardipine has been shown to inhibit certain cytochrome P450 enzymes (including CYP3A4, CYP2D6, CYP2C8, and CYP2C19). Inhibition of these enzymes may result in increased plasma levels of certain drugs, including cyclosporine and tacrolimus (7.3, 7.4). The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.
After coadministration of a radioactive intravenous dose of CARDENE I.V. with an oral 30 mg dose given every 8 hours, 49% of the radioactivity was recovered in the urine and 43% in the feces within 96 hours. None of the dose was recovered as unchanged nicardipine.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Hemodynamics CARDENE I.V. produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered CARDENE I.V., the degree of vasodilation and the resultant decrease in blood pressure were more prominent in hypertensive patients than in normotensive volunteers. Administration of CARDENE I.V. to normotensive volunteers at dosages of 0.25 to 3 mg/hr for eight hours produced changes of <5 mmHg in systolic blood pressure and <3 mmHg in diastolic blood pressure.
An increase in heart rate is a normal response to vasodilation and decrease in blood pressure; in some patients these increases in heart rate may be pronounced. In placebo-controlled trials, the mean increases in heart rate were 7 ± 1 bpm in postoperative patients and 8 ± 1 bpm in patients with severe hypertension at the end of the maintenance period. Hemodynamic studies following intravenous dosing in patients with coronary artery disease and normal or moderately abnormal left ventricular function have shown significant increases in ejection fraction and cardiac output with no significant change, or a small decrease, in left ventricular end-diastolic pressure (LVEDP).
There is evidence that CARDENE I.V. increases blood flow. Coronary dilatation induced by CARDENE I.V. improves perfusion and aerobic metabolism in areas with chronic ischemia, resulting in reduced lactate production and augmented oxygen consumption. In patients with coronary artery disease, CARDENE I.V., administered after beta-blockade, significantly improved systolic and diastolic left ventricular function.
In congestive heart failure patients with impaired left ventricular function, CARDENE I.V. increased cardiac output both at rest and during exercise. Decreases in left ventricular end-diastolic pressure were also observed. However, in some patients with severe left ventricular dysfunction, it may have a negative inotropic effect and could lead to worsened failure [see Warnings and Precautions (5.2)]. “Coronary steal” has not been observed during treatment with CARDENE I.V.
(Coronary steal is the detrimental redistribution of coronary blood flow in patients with coronary artery disease from underperfused areas toward better perfused areas.) CARDENE I.V. has been shown to improve systolic shortening in both normal and hypokinetic segments of myocardial muscle. Radionuclide angiography has confirmed that wall motion remained improved during increased oxygen demand. (Occasional patients have developed increased angina upon receiving oral nicardipine.
Whether this represents coronary steal in these patients, or is the result of increased heart rate and decreased diastolic pressure, is not clear.) In patients with coronary artery disease, CARDENE I.V. improves left ventricular diastolic distensibility during the early filling phase, probably due to a faster rate of myocardial relaxation in previously underperfused areas. There is little or no effect on normal myocardium, suggesting the improvement is mainly by indirect mechanisms such as afterload reduction and reduced ischemia.
CARDENE I.V. has no negative effect on myocardial relaxation at therapeutic doses. The clinical benefits of these properties have not yet been demonstrated. Electrophysiologic Effects In general, no detrimental effects on the cardiac conduction system have been seen with CARDENE I.V.
During acute electrophysiologic studies, it increased heart rate and prolonged the corrected QT interval to a minor degree. It did not affect sinus node recovery or SA conduction times. The PA, AH, and HV intervals* or the functional and effective refractory periods of the atrium were not prolonged.
The relative and effective refractory periods of the His-Purkinje system were slightly shortened. *PA = conduction time from high to low right atrium; AH = conduction time from low right atrium to His bundle deflection, or AV nodal conduction time; HV = conduction time through the His bundle and the bund… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Effects In Hypertension In patients with mild to moderate chronic stable essential hypertension, CARDENE I.V. (0.5 to 4 mg/hr) produced dose-dependent decreases in blood pressure. At the end of a 48-hour infusion at 4 mg/hr, the decreases were 26 mmHg (17%) in systolic blood pressure and 20.7 mmHg (20%) in diastolic blood pressure.
In other settings (e.g., patients with severe or postoperative hypertension), CARDENE I.V. (5 to 15 mg/hr) produced dose-dependent decreases in blood pressure. Higher infusion rates produced therapeutic responses more rapidly.
The mean time to therapeutic response for severe hypertension, defined as diastolic blood pressure ≤95 mmHg or ≥25 mmHg decrease and systolic blood pressure ≤160 mmHg, was 77 ± 5.2 minutes. The average maintenance dose was 8 mg/hr. The mean time to therapeutic response for postoperative hypertension, defined as ≥15% reduction in diastolic or systolic blood pressure, was 11.5 ± 0.8 minutes.
The average maintenance dose was 3 mg/hr.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15, or 45 mg/kg/day) for two years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One- and three-month studies in the rat have suggested that these results are linked to a nicardipine-induced reduction in plasma thyroxine (T4) levels with a consequent increase in plasma levels of thyroid stimulating hormone (TSH).
Chronic elevation of TSH is known to cause hyperstimulation of the thyroid. In rats on an iodine deficient diet, nicardipine administration for one month was associated with thyroid hyperplasia that was prevented by T4 supplementation. Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes.
There was no evidence of thyroid pathology in dogs treated with up to 25 mg nicardipine/kg/day for one year and no evidence of effects of nicardipine on thyroid function (plasma T4 and TSH) in man. There was no evidence of a mutagenic potential of nicardipine in a battery of genotoxicity tests conducted on microbial indicator organisms, in micronucleus tests in mice and hamsters, or in a sister chromatid exchange study in hamsters. No impairment of fertility was seen in male or female rats administered nicardipine at oral doses as high as 100 mg/kg/day (about 8 times the oral MRHD based on body surface area (mg/m 2 )).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15, or 45 mg/kg/day) for two years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One- and three-month studies in the rat have suggested that these results are linked to a nicardipine-induced reduction in plasma thyroxine (T4) levels with a consequent increase in plasma levels of thyroid stimulating hormone (TSH).
Chronic elevation of TSH is known to cause hyperstimulation of the thyroid. In rats on an iodine deficient diet, nicardipine administration for one month was associated with thyroid hyperplasia that was prevented by T4 supplementation. Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes.
There was no evidence of thyroid pathology in dogs treated with up to 25 mg nicardipine/kg/day for one year and no evidence of effects of nicardipine on thyroid function (plasma T4 and TSH) in man. There was no evidence of a mutagenic potential of nicardipine in a battery of genotoxicity tests conducted on microbial indicator organisms, in micronucleus tests in mice and hamsters, or in a sister chromatid exchange study in hamsters. No impairment of fertility was seen in male or female rats administered nicardipine at oral doses as high as 100 mg/kg/day (about 8 times the oral MRHD based on body surface area (mg/m 2 )).
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. 40 mg in 200 mL (0.2 mg/mL) GALAXY Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-016-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 0.0384 mg CITRIC ACID ANHYDROUS, USP and 3.84 mg SORBITOL, NF.
HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE : See prescribing information. CAUTIONS : Check for minute leaks by squeezing bag firmly.
If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication.
Must not be used in series connections. STORAGE : Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing.
Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S.
Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Code 2G3444 Baxter Logo Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-34-00-2344 *BAR CODE POSITION ONLY 343066016104 Carton Label CARDENE I.V.
Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE NDC 43066-016-10 Rx only CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. DOUBLE CONCENTRATION: CHECK INFUSION RATE Code 2G3444 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA 40 mg in 200 mL (0.2 mg/mL) STORE IN CARTON UNTIL READY TO USE 1 GALAXY Single Dose Container Discard unused portion CARDENE I.V.
Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) UNVARNISHED AREA FOR LOT AND EXP. UCC/EAN 128 BAR CODE POSITION 1.75” W (excluding quiet zone) 0.5” H (excluding human readable) (01) 00343066016104 Iso-osmotic Sterile, nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 0.0384 mg CITRIC ACID ANHYDROUS, USP and 3.84 mg SORBITOL, NF.
HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE: See prescribing information. CAUTIONS: Check for minute leaks by squeezing bag firmly.
If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication.
Must not be used in series connections. STORAGE: Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing.
Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S.
Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-01-00-1677 CARDENE® I.V.
Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE CARDENE® I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection For Intravenous Infusion Only.
20 mg in 200 mL (0.1 mg/mL) GALAXY Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-009-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.1 mg N… [Excerpted — this section continues on DailyMed.]
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