Medicine guide

Cardene Iv

.2 mg/mL · Injection, Solution

Prescription only
Dihydropyridine Calcium Channel Blocker

Active substance: Nicardipine Hydrochloride
Used in: Heart, blood pressure and circulation
Made by: Baxter Healthcare Corporation
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-03-27

This product has an FDA recall

Class II Ongoing · 2026-08-06 — CGMP DeviationsUsing the product could cause temporary or medically reversible harm.

A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls

What it is

Dihydropyridine Calcium Channel Blocker

Used for

• CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension in

Do not take it if

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

All warnings ↓

Good to know

Prescription only

44other products contain Nicardipine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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) ] .

From the official label · 2026-03-27 · DailyMed

How it works

From this product’s own US prescribing label.

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.

How the body breaks it down

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-27

Do not take it if

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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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. 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) ] 2.2 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. 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) ] . CARDENE I.V. is available as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required. Inspect CARDENE I.V. 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. is normally a clear, colorless to yellow solution. Do not combine CARDENE I.V. 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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 ) 5.1 Exacerbation 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. 5.2 Exacerbation 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. 5.3 Increased 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. 5.4 Prolonged 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. 5.5 Local 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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 during organogenesis, at doses up to 16 times the oral MRHD based on body surface area (mg/m2) (100 mg/kg/day).
While significant maternal mortality occurred, no adverse effects on the fetus were observed.
Pregnant rats received oral nicardipine from day 6 through day 15 of gestation at doses up to 8 times the oral MRHD based on body surface area (mg/m2) (100 mg/kg/day).
There was no evidence of embryolethality or teratogenicity; however, dystocia, reduced birth weights, reduced neonatal survival, and reduced neonatal weight gain were noted.
IN SPECIFIC POPULATIONS
Pregnancy:
Based on animal data may cause embryofetal harm. ( 8.1 ) 8.1 Pregnancy 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 during organogenesis, at doses up to 16 times the oral MRHD based on body surface area (mg/m2) (100 mg/kg/day). While significant maternal mortality occurred, no adverse effects on the fetus were observed. Pregnant rats received oral nicardipine from day 6 through day 15 of gestation at doses up to 8 times the oral MRHD based on body surface area (mg/m2) (100 mg/kg/day). There was no evidence of embryolethality or teratogenicity; however, dystocia, reduced birth weights, reduced neonatal survival, and reduced neonatal weight gain were noted. 8.2 Lactation Risk Summary Nicardipine is present in human milk in low amounts. In two published clinical studies in which 18 infants were exposed to nicardipine through breast milk in the postpartum period, the calculated daily infant dose was less than 0.3 mcg. In one study, there were no adverse neonatal outcomes attributed to maternal treatment with nicardipine in breastfed infants (see Data). There are no available data on the effect of nicardipine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CARDENE I.V. and any potential adverse effects on the breastfed infant from CARDENE I.V. or from the underlying maternal condition. Data In a study of 11 women who received oral nicardipine 4 to 14 days postpartum, 4 women received immediate-release nicardipine 40 to 80 mg daily, 6 received sustained-release nicardipine 100 to 150 mg daily, and one received intravenous nicardipine 120 mg daily. The peak milk concentration was 7.3 mcg/L (range 1.9-18.8), and the mean milk concentration was 4.4 mcg/L (range 1.3-13.8). Infants received an average of 0.073% of the weight-adjusted maternal oral dose and 0.14% of the weight-adjusted maternal intravenous dose. In another study of seven women who received intravenous nicardipine for an average of 1.9 days in the immediate postpartum period as therapy for preeclampsia, 34 milk samples were obtained at unspecified times and nicardipine was undetectable (<5 mcg/L) in 82% of the samples. Four women who received 1 to 6.5 mg/hour of nicardipine had 6 milk samples with detectable nicardipine levels (range 5.1 to 18.5 mcg/L). The highest concentration of 18.5 mcg/L was found in a woman who received 5.5 mg/hour of nicardipine. The estimated maximum dose in a breastfed infant was < 0.3 mcg daily or between 0.015 to 0.004% of the therapeutic dose in a 1 kg infant. 8.4 Pediatric Use The safety and effectiveness of CARDENE I.V. have not been established in pediatric patients. 8.5 Geriatric 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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 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. 7.5 In 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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of CARDENE I.V. have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

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.

Quoted from the official label, section “Geriatric Use”.

Side effects

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 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.
6.2 Postmarketing 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).

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 How 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
Storage 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.

Quoted from the official label, section “How Supplied”.

What is in it

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,
0.01 M 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (6)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 6 of 6

Details

Made by	Baxter Healthcare Corporation
Active substance	Nicardipine Hydrochloride
Used in	Heart, blood pressure and circulation
Strength	.2 mg/mL
Form	Injection, Solution
Route	Intravenous
Packs	10 BAG in 1 CARTON / 200 mL in 1 BAG
NDC	43066-016
NDC	43066-024

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection, Solution3 products
- .1 mg/mL
- .2 mg/mL
- 2.5 mg/10mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Nicardipine Hydrochloride