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Nicardipine: Pediatric drug information

Nicardipine: Pediatric drug information
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For additional information see "Nicardipine: Drug information" and "Nicardipine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Cardene IV
Therapeutic Category
  • Antianginal Agent;
  • Antihypertensive Agent;
  • Calcium Channel Blocker;
  • Calcium Channel Blocker, Dihydropyridine
Dosing: Neonatal
Hypertension

Hypertension: Limited data available: Preterm and term neonates: Continuous IV infusion: Initial: 0.5 mcg/kg/minute; dosing range: 0.5 to 2 mcg/kg/minute (Ref).

Dosing: Pediatric
Hypertension, acute severe with life-threatening symptoms

Hypertension , acute severe with life-threatening symptoms: Limited data available:

Infants, Children, and Adolescents: IV: Bolus dose (optional): Initial: 30 mcg/kg, maximum dose: 2 mg/dose; followed by continuous IV infusion: Initial: 0.5 to 1 mcg/kg/minute; titrate dose to achieve goal blood pressure; rate of infusion may be increased every 15 to 30 minutes; maximum dose: 4 to 5 mcg/kg/minute (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

IV: Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; based on experience in adult patients, titrate slowly with careful monitoring; dosage adjustment may be necessary.

Dosing: Liver Impairment: Pediatric

IV: Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, nicardipine is extensively metabolized by the liver. Based on experience in adult patients, consider titrating slowly with monitoring; dosage adjustment may be necessary.

Dosing: Adult

(For additional information see "Nicardipine: Drug information")

Acute aortic syndromes/acute aortic dissection

Acute aortic syndromes/acute aortic dissection (adjunctive agent) (off-label use):

Note: Manage patients on an emergency basis (including operative assessment) by first controlling pain with IV opioids and heart rate (target 60 to 80 beats per minute) with a parenteral beta blocker (eg, esmolol) while targeting systolic BP of ≤120 mm Hg (or lowest tolerated pressure without compromising perfusion). If systolic BP remains elevated after heart rate is controlled at 60 to 80 beats per minute with beta-blockade, may consider adding a vasodilator (eg, nicardipine) (Ref).

Continuous IV infusion: Initial: 5 mg/hour; titrate by 2.5 mg/hour at 5- to 15-minute intervals to achieve target blood pressure; maximum dose: 15 mg/hour. Invasive blood pressure monitoring, preferably via arterial line, in a critical care unit is recommended for appropriate dose titration (Ref).

Acute ischemic stroke, BP management with reperfusion therapy

Acute ischemic stroke, BP management with reperfusion therapy (off-label use):

Note: Prior to reperfusion therapy (thrombolytic and/or mechanical thrombectomy), maintain a target BP of ≤185/110 mm Hg. If BP remains >185/110 mm Hg, do not administer thrombolytic. During and 24 hours after start of thrombolytic therapy, maintain a target BP of ≤180/105 mm Hg; if hypertension is refractory or diastolic BP >140 mm Hg, consider alternative therapy (Ref).

Continuous IV infusion: Initial: 5 mg/hour; titrate by 2.5 mg/hour at 5- to 15-minute intervals (maximum dose: 15 mg/hour) (Ref).

Angina, chronic stable

Angina, chronic stable:

Note: A beta-blocker is the preferred initial therapy; if there are ongoing symptoms on beta-blocker therapy, a dihydropyridine calcium channel blocker may be added; nicardipine may also be used as an alternative therapy if there are contraindications or unacceptable adverse effects with beta-blockade (Ref).

Oral: 20 mg 3 times daily; usual dosage: 20 to 40 mg 3 times daily (allow ≥3 days between dose increases).

Hypertension

Hypertension: Oral: Initial: 20 mg 3 times daily; usual dosage: 20 to 40 mg 3 times daily (allow ≥3 days between dose increases).

Hypertensive emergency

Hypertensive emergency:

Note : In general, reduce mean arterial blood pressure gradually by ~10% to 20% over the first hour, then by an additional 5% to 15% over the next 23 hours, unless there is a compelling indication (eg, acute aortic dissection, severe preeclampsia, eclampsia) for more rapid blood pressure and heart rate control. Invasive blood pressure monitoring is recommended for appropriate dose titration (Ref).

Continuous IV infusion: Initial: 5 mg/hour; titrate by 2.5 mg/hour at 5- to 15-minute intervals to achieve target blood pressure; maximum dose: 15 mg/hour (Ref).

Hypertensive emergency in pregnancy or postpartum

Hypertensive emergency in pregnancy or postpartum (including acute-onset severe hypertension in preeclampsia/eclampsia) (off-label use) (alternative agent):

Note: For acute-onset, severe, persistent hypertension (eg, systolic BP ≥160 mm Hg or diastolic BP ≥110 mm Hg) (Ref). Nicardipine may be considered in patients with persistently high BP despite administration of first-line agents (eg, labetalol, hydralazine, nifedipine) (Ref).

Continuous IV infusion: Initial: 5 mg/hour; titrate by 0.5 to 1 mg/hour at 15-minute intervals to achieve target BP; maximum dose: 15 mg/hour (Ref).

Intracerebral hemorrhage, acute, BP management

Intracerebral hemorrhage, acute, BP management (off-label use):

Note: For use in patients with mild to moderate intracerebral hemorrhage with a presenting systolic BP ≥150 mm Hg; acute lowering to <130 mm Hg is potentially harmful (Ref).

Continuous IV infusion: Initial: 5 mg/hour; titrate by 2.5 mg/hour at 5- to 15-minute intervals to target systolic BP (maximum dose: 15 mg/hour) (Ref).

Subarachnoid hemorrhage, acute, BP management

Subarachnoid hemorrhage, acute, BP management (off-label use):

Note: Optimal therapy is not well established. Cautious use of antihypertensive therapy to decrease the risk of rebleeding, while avoiding hypotension and blood pressure variability, may be appropriate in some patients presenting with severe hypertension (Ref).

Continuous IV infusion: Initiate 5 mg/hour; titrate by 2.5 mg/hour at 5- to 15-minute intervals to goal target systolic BP or mean arterial pressure (maximum dose: 15 mg/hour) (Ref).

Substitution for oral therapy (approximate equivalents):

20 mg every 8 hours oral, equivalent to 0.5 mg/hour IV infusion.

30 mg every 8 hours oral, equivalent to 1.2 mg/hour IV infusion.

40 mg every 8 hours oral, equivalent to 2.2 mg/hour IV infusion.

Conversion to oral antihypertensive agent: Initiate oral antihypertensive at the same time that IV nicardipine is discontinued; if transitioning to oral nicardipine, start oral nicardipine 1 hour prior to IV discontinuation.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Oral: Initial: 20 mg 3 times daily; titrate slowly.

IV: There are no specific dosage adjustments provided in the manufacturer's labeling; titrate slowly with careful monitoring; dosage adjustment may be necessary.

Dosing: Liver Impairment: Adult

Oral: Initial: 20 mg twice daily; titrate slowly.

IV: There are no specific dosage adjustments provided in the manufacturer's labeling; titrate slowly with monitoring; dosage adjustment may be necessary.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Flushing (6% to 10%), pedal edema (dose related; 7% to 8%), exacerbation of angina pectoris (dose related; 6%), hypotension (IV 6%), palpitations (3% to 4%), tachycardia (1% to 4%), chest pain (IV 1%), extrasystoles (IV 1%), hemopericardium (IV 1%), hypertension (IV 1%), supraventricular tachycardia (IV 1%), edema (≤1%)

Central nervous system: Headache (6% to 15%), dizziness (4% to 7%), hypoesthesia (1%), intracranial hemorrhage (1%), pain (1%), somnolence (1%)

Dermatologic: Diaphoresis (1%), skin rash (≤1%)

Endocrine & metabolic: Hypokalemia (IV 1%)

Gastrointestinal: Nausea and vomiting (IV 5%), nausea (2%), dyspepsia (≤2%), abdominal pain (IV 1%), xerostomia (≤1%)

Genitourinary: Hematuria (1%)

Local: Injection site reaction (IV 1%), pain at injection site (IV 1%)

Neuromuscular & skeletal: Weakness (4% to 6%), myalgia (1%), paresthesia (1%)

<1%, postmarketing, and/or case reports: Abnormal dreams, abnormal hepatic function tests, abnormal vision, angina pectoris, anxiety, arthralgia, atrial fibrillation (not distinguishable from natural history of atherosclerotic vascular disease), atrioventricular block, atypical chest pain, blurred vision, cerebral ischemia (not distinguishable from natural history of atherosclerotic vascular disease), confusion, conjunctivitis, constipation, deep vein thrombophlebitis, depression, depression of ST segment on ECG, dyspnea, ear disease, ECG abnormal, fever, gingival hyperplasia, heart block (not distinguishable from natural history of atherosclerotic vascular disease), hot flash, hyperkinesia, hypersensitivity reaction, hypertonia, hypophosphatemia, impotence, infection, insomnia, inversion T wave on ECG, malaise, myocardial infarction (chronic therapy; may be due to disease progression), neck pain, nervousness, nocturia, orthostatic hypotension, oxygen saturation decreased (possible pulmonary shunting), parotitis, pericarditis (not distinguishable from natural history of atherosclerotic vascular disease), peripheral vascular disease, psoriasis (Song 2021), respiratory tract disease, rhinitis, sinus node dysfunction (chronic therapy; may be due to disease progression), sinusitis, sore throat, sustained tachycardia, syncope, thrombocytopenia, tinnitus, tremor, urinary frequency, ventricular extrasystoles, ventricular tachycardia, vertigo, vomiting

Contraindications

Hypersensitivity to nicardipine or any component of the formulation; advanced aortic stenosis

Warnings/Precautions

Concerns related to adverse effects:

• Angina/MI: Increased angina (frequency, duration, or severity) and/or MI has occurred. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta blockade.

• Hypotension/syncope: Symptomatic hypotension with or without syncope may rarely occur; blood pressure must be lowered at a rate appropriate for the patient's clinical condition. Avoid systemic hypotension in acute cerebral infarction or hemorrhage. Close monitoring of heart rate and blood pressure, especially during initial therapy and dosage titration, is required.

• Peripheral edema: A common side effect is peripheral edema (dose-dependent); occurs within 2 to 3 weeks of starting therapy.

• Tachycardia: May occur; close monitoring of heart rate is required.

Disease-related concerns:

• Aortic stenosis: Use with caution in patients with mild to moderate aortic stenosis; may reduce coronary perfusion resulting in ischemia. Use is contraindicated in patients with advanced aortic stenosis.

• Heart failure: Use in patients with heart failure (HF) or severe left ventricular dysfunction, particularly with concomitant beta-blockade, may experience worsened symptoms of HF due to mild negative inotropic effects of nicardipine. The ACC/AHA heart failure guidelines recommend to avoid use in patients with heart failure due to lack of benefit and/or worse outcomes with calcium channel blockers in general (FDA 2015).

• Hepatic impairment: Use with caution in patients with hepatic impairment or reduced hepatic blood flow. Consider lower starting dose and closely monitor response.

• Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction: Use with caution in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (AHA/ACC [Ommen 2024]).

• Kidney impairment: Use with caution in patients with kidney impairment. Increase dose cautiously in patients with kidney impairment since clearance of nicardipine is diminished in this population.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Infusion sites: To minimize infusion site reactions, peripheral infusion sites (for IV therapy) should be changed every 12 hours; use of arteries or small peripheral veins should be avoided.

• Withdrawal: Abrupt withdrawal may cause rebound angina in patients with CAD.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Generic: 20 mg, 30 mg

Solution, Intravenous:

Generic: 20 mg/200 mL in NaCl 0.9% (200 mL); 40 mg/200 mL in NaCl 0.9% (200 mL)

Solution, Intravenous [preservative free]:

Generic: 20 mg/200 mL in NaCl 0.9% (200 mL); 40 mg/200 mL in NaCl 0.9% (200 mL)

Solution, Intravenous, as hydrochloride:

Cardene IV: 20 mg (200 mL); 40 mg (200 mL)

Generic: 2.5 mg/mL (10 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Generic: 2.5 mg/mL (10 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (niCARdipine HCl Oral)

20 mg (per each): $15.49

30 mg (per each): $22.19

Solution (Cardene IV Intravenous)

20 mg/200 mL 0.86% (per mL): $0.30

40 mg/200 mL 0.83% (per mL): $0.48

Solution (niCARdipine HCl in NaCl Intravenous)

20 mg/200 mL 0.9% (per mL): $0.30 - $0.49

40 mg/200 mL 0.9% (per mL): $0.48 - $0.98

Solution (niCARdipine HCl Intravenous)

2.5 mg/mL (per mL): $2.29 - $25.29

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

IV: Administer by slow IV continuous infusion through a central line or large peripheral vein; avoid extravasation. Peripheral infusion sites should be changed every 12 hours to minimize venous irritation.

Vial: Must be diluted prior to administration.

Premixed solutions: No further dilution needed. For single use only; discard any unused portion. Use only if solution is clear; per manufacturer's labeling, do not add nicardipine solution with other medications in the same line or in premixed container.

Administration: Adult

Oral: Administer without regards to meals.

IV:

Administer as a slow continuous infusion via central line or through a large peripheral vein. Peripheral venous irritation may be minimized by changing the site of infusion every 12 hours.

Premixed bags: Do not combine or run in the same line as other medications.

Usual Infusion Concentrations: Pediatric

Note: Premixed solutions available.

IV infusion: 100 mcg/mL, 200 mcg/mL, or 500 mcg/mL.

Storage/Stability

IV:

Premixed bags: Store at 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat. Do not freeze.

Vials: Store at 20°C to 25°C (68°F to 77°F). Protect from light. Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Diluted solution (0.1 mg/mL) in D5W with KCl 40 mEq, D51/2NS, D5NS, D5W, NS, or 1/2NS is stable at room temperature for 24 hours in glass or PVC containers. Stability has also been demonstrated at room temperature at concentrations up to 0.5 mg/mL in PVC containers for 24 hours or in glass containers for up to 7 days (Baaske 1996).

Oral: Store at room temperature. Protect from light.

Use

Oral: Treatment of chronic stable angina and treatment of hypertension (FDA approved in adults).

Parenteral: Short-term treatment of hypertension when oral treatment is not feasible (FDA approved in adults).

Medication Safety Issues
Sound-alike/look-alike issues:

NiCARdipine may be confused with niacinamide, NIFEdipine, niMODipine

Cardene may be confused with Cardizem, Cardura, codeine

Cardene I.V. may be confused with Nexterone

Administration issues:

Significant differences exist between oral and IV dosing. Use caution when converting from one route of administration to another.

International issues:

Cardene [US, Great Britain, Netherlands] may be confused with Cardem brand name for celiprolol [Spain]; Cardin brand name for simvastatin [Poland]

Metabolism/Transport Effects

Substrate of CYP1A2 (Minor), CYP2C8 (Minor), CYP2C9 (Minor), CYP2D6 (Minor), CYP2E1 (Minor), CYP3A4 (Minor), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2D6 (Weak);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Atosiban: Calcium Channel Blockers may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Calcium Salts: May decrease therapeutic effects of Calcium Channel Blockers. Risk C: Monitor

Cimetidine: May increase serum concentration of Calcium Channel Blockers. Risk C: Monitor

CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of NiCARdipine. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of NiCARdipine. Risk C: Monitor

Dantrolene: May increase hyperkalemic effects of Calcium Channel Blockers. Dantrolene may increase negative inotropic effects of Calcium Channel Blockers. Risk X: Avoid

Dapoxetine: May increase orthostatic hypotensive effects of Calcium Channel Blockers. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Grapefruit Juice: May increase serum concentration of NiCARdipine. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Inhalational Anesthetics: May increase hypotensive effects of Calcium Channel Blockers. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Levoketoconazole: NiCARdipine may increase QTc-prolonging effects of Levoketoconazole. Risk X: Avoid

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Magnesium Sulfate: May increase adverse/toxic effects of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor

Melatonin: May decrease antihypertensive effects of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Sincalide: Drugs that Affect Gallbladder Function may decrease therapeutic effects of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider Therapy Modification

SUNItinib: NiCARdipine may increase serum concentration of SUNItinib. Risk C: Monitor

Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Thioridazine: CYP2D6 Inhibitors (Weak) may increase serum concentration of Thioridazine. Management: Consider avoiding concomitant use of thioridazine and weak CYP2D6 inhibitors. If combined, monitor closely for QTc interval prolongation and arrhythmias. Some weak CYP2D6 inhibitors list use with thioridazine as a contraindication. Risk D: Consider Therapy Modification

Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor

Food Interactions

Serum concentrations/toxicity of nicardipine may be increased by grapefruit juice. Management: Monitor for excessive hemodynamic (ie, blood pressure, heart rate) response to nicardipine in patients who consume grapefruit juice.

Reproductive Considerations

Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be continued in patients trying to conceive. Nicardipine is not considered a preferred agent for use in pregnant patients; consider transitioning to a preferred agent in patients planning to become pregnant (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019).

Pregnancy Considerations

Nicardipine has limited placental transfer following maternal oral and IV administration (Bartels 2007; Carbonne 1993; Matsumura 2014).

Nicardipine has been shown to decrease maternal blood pressure without significant changes on placental perfusion or fetal hemodynamics (Cornette 2016). Although effective for the treatment of hypertension in pregnancy, nicardipine may have an increased risk of adverse maternal events (eg, headache, nausea, tachycardia) in comparison to other agents (Nooij 2014). Cases of acute pulmonary edema have been reported following use as a tocolytic (Melis 2015).

Chronic maternal hypertension is also associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019).

Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of chronic hypertension during pregnancy is initiated during pregnancy, agents other than nicardipine may be preferred (ACOG 2019; ESC [Cífková 2020]; ESC [Regitz-Zagrosek 2018], SOGC [Magee 2022]). Nicardipine may be used as an alternative agent for the treatment of acute-onset, severe hypertension in patients who are pregnant (ACOG 2019; ESC [Cífková 2020]).

Monitoring Parameters

Blood pressure (continuously for IV infusion), heart rate, liver and kidney function, infusion site for extravasation.

Mechanism of Action

Inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: IV: Within minutes (constant infusion); Oral: 0.5 to 2 hours.

Peak effect: Oral: 1 to 2 hours; IV continuous infusion: 50% of the maximum effect is seen by 45 minutes.

Duration:

IV: ≤8 hours; upon discontinuation of continuous infusion, a 50% decrease in effect is seen in ~30 minutes with gradual discontinuing antihypertensive effects for ~50 hours.

Oral: ≤8 hours.

Absorption: Oral: ~100%, but large first-pass effect.

Distribution: Vd: 8.3 L/kg.

Protein binding: >95%.

Metabolism: Hepatic; extensive first-pass effect (saturable); major pathway is via cytochrome P450 isoenzyme CYP3A4, 2C8, and 2D6.

Bioavailability: Oral: ~35%.

Half-life elimination: Follows dose-dependent (nonlinear) pharmacokinetics; “apparent” or calculated half-life is dependent upon serum concentrations.

Oral: Half-life over the first 8 hours is 2 to 4 hours; terminal half-life: 8.6 hours.

IV: After IV infusion, serum concentrations decrease tri-exponentially; alpha half-life: 3 minutes; beta half-life: 45 minutes; terminal half-life: 14 hours (Note: Terminal half-life can only be seen after long-term infusions).

Time to peak, serum: Oral: 30 to 120 minutes (mean: 1 hour).

Excretion: Urine (oral: 60% as metabolites; IV: 49% as metabolites; <1% as unchanged drug); feces (oral: 35%; IV: 43%).

Clearance: Decreased in patients with hepatic impairment; may be decreased in patients with kidney impairment.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function:

IV: Significantly lower systemic clearance and higher AUC in patients with mild to moderate kidney impairment.

Oral: Cmax and AUC were ~2-fold higher in patients with mild kidney impairment.

Hepatic function impairment: In patients with severe hepatic impairment, plasma concentrations were elevated and the half-life was prolonged.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BE) Belgium: Nicardipine | Rydene;
  • (BF) Burkina Faso: Loxen;
  • (CH) Switzerland: Nicardipin labatec;
  • (CI) Côte d'Ivoire: Loxen;
  • (CN) China: BEI ER PING | Dan yi | Ka rong | Ka shu tai | Pei er | Perdipine | Xin shu li da;
  • (EG) Egypt: Micard | Pelcard;
  • (ES) Spain: Nerdipina;
  • (FR) France: Loxen | Loxen L P | Nicardipine Aguettant | Nicardipine Arrow | Nicardipine Dci;
  • (GB) United Kingdom: Cardene | Nicardipine | Nicardipine kent;
  • (HK) Hong Kong: Nicardipine Aguettant;
  • (ID) Indonesia: Blistra | Carsive | Dipitenz | Loxen | Nicardipine | Nicardipine HCL | Nidaven | Perdipine | Tensilo | Verdif;
  • (IE) Ireland: Cardene;
  • (IT) Italy: Bionicard | Cardioten | Neucor | Nicant | Nicardal | Nicardipina | Nicardipina dorom | Nicardipina drm | Nicarpin | Nicaven | Perdipina | Ranvil | Vasodin;
  • (JP) Japan: Apodipine | Aprovan | Aprovan kobayashi | Aprovan teisan | Carbadin la | Cepadipin | Isedipeal | Kenicalnon | Nicadirus l | Nicarpine sawai | Nicodel | Nisutadil | Palpedinon | Paltidel l | Perdipine | Radistmin | Radistmin taiyo | Salipex la | Salipex nichiiko;
  • (KR) Korea, Republic of: Binicapin | Dong a perdipine | Dongkoo nicardipine hcl | Nicarpin | Perdipine;
  • (KW) Kuwait: Nicardipine;
  • (LB) Lebanon: Loxen;
  • (LU) Luxembourg: Rydene;
  • (MA) Morocco: Loxen | Vasodin;
  • (MY) Malaysia: Cardepine | Nicardipine | Vasonase;
  • (NL) Netherlands: Cardene;
  • (PH) Philippines: Cardepine | Cardilon | Cardimed | Nicard | Nicardilex | Nicardin | Nicaright | Nicarpin | Nicarpine | Noticanz;
  • (PL) Poland: Antagonil | Cardene;
  • (PR) Puerto Rico: Cardene | Nicardipine HCL;
  • (PT) Portugal: Loxen;
  • (QA) Qatar: Cardene;
  • (RO) Romania: Nicardipine Aguettant;
  • (SE) Sweden: Cardene | Cardene SR;
  • (SG) Singapore: Cardibloc;
  • (TH) Thailand: Benicardine | Binicapin | Cardepine | Holdipine | Nicardipine | Nidepine;
  • (TN) Tunisia: Loxen | Nicardipine | Nicardipine medis | Vasodin;
  • (TR) Turkey: Ninax;
  • (TW) Taiwan: Holdipine premixed | Nicardipine | Nicarpine | Perdipine
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