Nicardipine Hydrochloride .2 mg/mL Injection
Other active recalls for Nicardipine Hydrochloride (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Nicardipine is a calcium channel blocker — a type of blood pressure medication. The oral capsules treat two things: high blood pressure and chronic stable angina, which is chest pa...
- It can, yes — dizziness, headaches, and flushing are among the more common side effects, since the medication works by widening blood vessels. Most people find these effects mild a...
- Will nicardipine make me dizzy or give me headaches?
- That depends on which medications. A few important ones to know about: if you take cyclosporine or tacrolimus (common transplant drugs), nicardipine can raise those drug levels sig...
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.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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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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.
2 inactive ingredients listed in the exact product block matched to this NDC.
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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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 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/mL 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/mLthis 65145-0198-10 | Caplin | 10 pouches | — | 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 | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65145-0198-01 | 1 BAG in 1 POUCH (65145-198-01) / 200 mL in 1 BAG | 2025-11-04 | Active |
| 65145-0198-10 You're viewing this | 10 POUCH in 1 CASE (65145-198-10) / 1 BAG in 1 POUCH (65145-198-01) / 200 mL in 1 BAG | 2026-06-25 | Active |
Pack size FAQ
What quantity is in NDC 65145-0198-10?
What NDC number is used to bill for this package of Nicardipine Hydrochloride .2 mg/mL Injection?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Nicardipine hydrochloride in 0.9% sodium chloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible.
1.1Hypertension Nicardipine hydrochloride in 0.9% sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6) ] .
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION • Individualize dosage based upon the severity of hypertension and response of the patient during dosing ( 2.1 ). • When substituting for oral nicardipine therapy, use the intravenous infusion rate as follows ( 2.3 ): Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg every 8 hours 0.5 mg/hr 30 mg every 8 hours 1.2 mg/hr 40 mg every 8 hours 2.2 mg/hr • In a drug-free patient, initiate therapy at 5 mg/hr. Increase the infusion rate by 2.5 mg/hr to a maximum of 15 mg/hr until desired blood pressure reduction is achieved.
For a gradual blood pressure reduction the rate can be increased every 15 minutes, for a rapid reduction, every 5 minutes ( 2.4 ). • If hypotension or tachycardia ensues, discontinue the infusion. After stabilized, patient can be restarted at low doses such as 3 mg/hr to 5 mg/hr ( 2.5 ).
2.1General Information Individualize dosing based on the severity of hypertension and the response of the patient during dosing. Monitor blood pressure and heart rate both during and after the infusion to avoid tachycardia or too rapid or excessive reduction in either systolic or diastolic blood pressure. Administer nicardipine hydrochloride in 0.9% sodium chloride injection by slow continuous infusion by a central line or through a large peripheral vein.
Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.7) ] .
2.2Inspection and Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if particulate matter, precipitate, or crystallization is present, or if the container appears damaged. Single Dose Containers Dilution is not required for nicardipine hydrochloride in 0.9% sodium chloride injection.
Check the container for minute leaks prior to use; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Do not combine nicardipine hydrochloride in 0.9% sodium chloride injection with any product in the same intravenous line or premixed container.
Do not add supplementary medication to the bag. Protect from light until ready to use. Do not use plastic containers in series connections.
Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete. Discard Unused Portion 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.
2.3Dosage 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 Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg every 8 hours 0.5 mg/hr 30 mg every 8 hours 1.2 mg/hr 40 mg every 8 hours 2.2 mg/hr
2.4Dosage for Initiation of Therapy in a Drug-Free Patient The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride in 0.9% sodium chloride injection is administered by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes.
It reaches about 50% of its ultimate decrease in about 45 minutes. When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 minutes plus/minus 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for many hours. Titration For a gradual reduction in blood pressure, initiate therapy at a rate of 5 mg/hr.
If desired blood pressure reduction is not achieved at this dose, increase the infusion…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Nicardipine hydrochloride in 0.9% sodium chloride injection is a clear, colorless to yellow solution and is available in the following presentations: 20 mg nicardipine hydrochloride in 200 mL 0.9% sodium chloride injection (0.1 mg/mL) in a single dose container 40 mg nicardipine hydrochloride in 200 mL 0.9% sodium chloride injection (0.2 mg/mL) in a single container • 20 mg nicardipine hydrochloride in 200 mL 0.9% sodium chloride injection (0.1 mg/mL) in a single dose container • 40 mg nicardipine hydrochloride in 200 mL 0.9% sodium chloride injection (0.2 mg/mL) in a single container
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Do not use in patients with advanced aortic stenosis ( 4.1 ).
4.1Advanced Aortic Stenosis Do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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. Avoid intraarterial administration or extravasation ( 5.7 ). To minimize the risk of peripheral venous irritation, change the site of infusion of nicardipine every 12 hours ( 5.7 ).
Nicardipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal. Withdraw beta-blockers gradually ( 5.8 ). Closely monitor response in patients with angina ( 5.3 ), congestive heart failure ( 5.4 ), impaired hepatic function ( 5.5 ), portal hypertension ( 5.5 ), and renal impairment ( 5.6 ) and pheochromocytoma ( 5.9 ).
5.1Excessive Pharmacologic Effects In administrating nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage.
5.2Rapid Decreases in Blood Pressure No clinical events have been reported suggestive of a too rapid decrease in blood pressure with nicardipine. However, as with any antihypertensive agent, blood pressure lowering should be accomplished over as long a time as is compatible with the patient's clinical status.
5.3Use in Patients with Angina Increases in frequency, duration, or severity of angina have been seen in chronic oral therapy with nicardipine capsules. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with nicardipine. The mechanism of this effect has not been established.
5.4Use in Patients with Congestive Heart Failure Nicardipine reduced afterload without impairing myocardial contractility in preliminary hemodynamic studies of CHF patients. However, in vitro and in some patients, a negative inotropic effect has been observed. Therefore, monitor vital signs carefully when using nicardipine, particularly in combination with a beta-blocker, in patients with CHF or significant left ventricular dysfunction.
5.5Use in Patients with Impaired Hepatic Function Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor response. Nicardipine administered intravenously increased hepatic venous pressure gradient by 4 mmHg in cirrhotic patients at high doses (5 mg/20 min) in one study. Use caution in patients with portal hypertension.
5.6Use in Patients with Impaired Renal Function When nicardipine was given to mild-to-moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher AUC was observed. These results are consistent with those seen after oral administration of nicardipine. Careful dose titration is advised when treating patients with more than mild renal impairment.
5.7Intravenous Infusion Site To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the rare 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, consider changing the site of the drug infusion every 12 hours.
5.8Beta-Blocker Withdrawal Nicardipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal. Withdraw beta-blockers gradually.
5.9Use in Patients with Pheochromocytoma Only limited clinical experience exists in use of nicardipine for patients with hypertension from pheochromocytoma.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are headache (13%), hypotension (5%), tachycardia (4%) and nausea/vomiting (4%) ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles at 1-866-978-6111 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Adverse Reactions Observed in Clinical Trials 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. Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine. Adverse experiences were generally not serious and most were expected consequences of vasodilation.
Adverse reactions occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia. Adverse reactions that occurred more often on nicardipine than on placebo by at least 2% were headache (13%) and nausea/vomiting (4%).
The following adverse reactions have been reported in clinical trials or in the literature during 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.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Cimetidine increases nicardipine plasma levels ( 7.3 ). Nicardipine may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended when co-administering nicardipine ( 7.5 , 7.6 )
7.1Antihypertensive Agents Since nicardipine hydrochloride injection may be administered to patients already being treated with other medications, including other antihypertensive agents, careful monitoring of these patients is necessary to detect and to treat promptly any undesired effects from concomitant administration.
7.2Beta-Blockers In most patients, nicardipine hydrochloride injection can safely be used concomitantly with beta-blockers. However, monitor response carefully when combining nicardipine hydrochloride injection with a beta-blocker in the treatment of congestive heart failure patients [see Warnings and Precautions (5.4) ] .
7.3Cimetidine Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration. Carefully monitor patients receiving the two drugs concomitantly. Data with other histamine-2 antagonists are not available.
7.4Digoxin Studies have shown that oral nicardipine usually does not alter digoxin plasma concentrations.
7.5Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Monitor closely plasma concentrations of cyclosporine during nicardipine hydrochloride injection administration, and adjust the dose of cyclosporine accordingly.
7.6Tacrolimus 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 nicardipine administration, and adjust the dose of tacrolimus accordingly.
7.7In 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 fetal harm ( 8.1 ). Nursing Mothers: It is recommended that women who wish to breastfeed should not be given this drug ( 8.3 ). Safety and efficacy in patients under the age of 18 have not been established ( 8.4 ).
8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of nicardipine use in pregnant women. There are limited human data in pregnant women with pre-eclampsia and preterm labor.
In animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. Therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproduction studies conducted in rats and rabbits, increased embryolethality occurred when nicardipine was administered intravenously at doses equivalent to human intravenous doses of 1.6 (rats) and 0.32 mg/kg/day (rabbits).
Increased embryolethality was also observed when nicardipine was administered orally to pregnant rabbits at a dose equivalent to a human oral dose of about 48 mg/kg/day (a dose 24 times the maximum recommended human oral dose and one associated with marked maternal body weight gain suppression). At a lower oral dose, equivalent to a human dose of about 32 mg/kg/day (16 times the maximum recommended human oral dose), in a different strain of rabbit, there were no adverse effects on the fetus, though there was increased maternal mortality.
There was no evidence of embryolethality or teratogenicity when pregnant rats were administered nicardipine orally at a dose equivalent to a human oral dose of about 16 mg/kg/day (8 times the MRHD); however, dystocia, reduced birth weight, reduced neonatal survival and reduced neonatal weight gain were reported [see Nonclinical Toxicology (13.3) ] .
8.3Nursing Mothers Nicardipine is minimally excreted into human milk. Among 18 infants exposed to nicardipine through breast milk in the postpartum period, calculated daily infant dose was less than 0.3 mcg and there were no adverse events observed. It is recommended that women who wish to breastfeed should not be given this drug.
In a study of 11 women who received oral nicardipine 4 days to 14 days postpartum, 4 women received immediate-release nicardipine 40 to 80 mg daily, 6 women received sustained-release nicardipine 100 mg to 150 mg daily, and one woman received intravenous nicardipine 120 mg daily. The peak milk concentration was 7.3 mcg/L (range 1.9 to 18.8), and the mean milk concentration was 4.4 mcg/L (range 1.3 to 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 pre-eclampsia, 34 milk samples were obtained at unspecified times and nicardipine was undetectable (less than 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 less than 0.3 mcg daily or 0.015% to 0.004% of the therapeutic dose in a 1 kg infant.
8.4Pediatric Use Safety and efficacy in patients under the age of 18 have not been established.
8.5Geriatric Use The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (greater than 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, dose selection for an elderly patient should be cautious,…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of nicardipine use in pregnant women. There are limited human data in pregnant women with pre-eclampsia and preterm labor.
In animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. Therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproduction studies conducted in rats and rabbits, increased embryolethality occurred when nicardipine was administered intravenously at doses equivalent to human intravenous doses of 1.6 (rats) and 0.32 mg/kg/day (rabbits).
Increased embryolethality was also observed when nicardipine was administered orally to pregnant rabbits at a dose equivalent to a human oral dose of about 48 mg/kg/day (a dose 24 times the maximum recommended human oral dose and one associated with marked maternal body weight gain suppression). At a lower oral dose, equivalent to a human dose of about 32 mg/kg/day (16 times the maximum recommended human oral dose), in a different strain of rabbit, there were no adverse effects on the fetus, though there was increased maternal mortality.
There was no evidence of embryolethality or teratogenicity when pregnant rats were administered nicardipine orally at a dose equivalent to a human oral dose of about 16 mg/kg/day (8 times the MRHD); however, dystocia, reduced birth weight, reduced neonatal survival and reduced neonatal weight gain were reported [see Nonclinical Toxicology (13.3) ] .
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy in patients under the age of 18 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (greater than 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, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and concomitant disease of other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of nicardipine immediate release capsules, 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, standard measures including monitoring of cardiac and respiratory functions should be implemented.
The patient should be positioned to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension.
Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.
🧬 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 Nicardipine produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered nicardipine, the degree of vasodilation and the resultant decrease in blood pressure were more prominent in hypertensive patients than in normotensive volunteers. Administration of nicardipine to normotensive volunteers at dosages of 0.25 to 3 mg/hr for eight hours produced changes of less than 5 mmHg in systolic blood pressure and less than 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 nicardipine increases blood flow. Coronary dilatation induced by nicardipine 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, nicardipine, administered after beta-blockade, significantly improved systolic and diastolic left ventricular function.
In congestive heart failure patients with impaired left ventricular function, nicardipine 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. “Coronary steal” has not been observed during treatment with nicardipine (Coronary steal is the detrimental redistribution of coronary blood flow in patients with coronary artery disease from underperfused areas toward better perfused areas.) Nicardipine 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 nicardipine capsules. 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, nicardipine 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. Nicardipine 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 nicardipine. During ac…
🧬 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 Nicardipine hydrochloride in 0.9% sodium chloride injection is a clear, colorless to yellow solution and is available in packages as follows: NDC Strength Packaged 65145-197-01 20 mg in 200 mL (0.1 mg/mL) 1 single dose container 65145-198-01 40 mg in 200 mL (0.2 mg/mL) 1 single dose container
16.2Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Made in India. Distributed by: Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00006405 November 2025 22201534 nicardipine-caplin-logo
📋 Description ▾
11 DESCRIPTION Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). 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 yellow to pale yellow, odorless, crystalline powder that has a melting point range of 165-170ºC.
It is soluble in methanol, sparingly soluble in ethanol, slightly soluble in acetone, chloroform and water. It has a molecular weight of 515.99. Nicardipine hydrochloride in 0.9% sodium chloride injection is available as a sterile, single-use, ready-to-use, iso-osmotic, clear, colorless to yellow solution for intravenous administration in a 200 mL single dose container.
Each mL contains 0.1 mg or 0.2 mg nicardipine hydrochloride, USP in 9 mg sodium chloride, USP. Hydrochloric acid (q.s.) may have been added to adjust pH to 3 to 5. nicardipine-structure