Cardene In Saline (nicardipine in sodium chloride, iso-osmotic)

Nicardipine is commercially available as nicardipine hydrochloride; dosage is expressed in terms of the salt.

Nicardipine hydrochloride is usually administered orally, but may be administered by IV infusion for the short-term treatment of hypertension when oral administration is not feasible or desired. For prolonged control of blood pressure, patients should be transferred to oral therapy as soon as their clinical condition permits. Some experts state that nicardipine hydrochloride may be administered as an IV bolus+ or infusion in children and adolescents with acute severe hypertension and life-threatening symptoms.

No dosing information is available for this tab.

No dosing information is available for this tab.

Nicardipine is a substrate of cytochrome P-450 (CYP) isoenzyme 3A4, 2C8, and 2D6. Nicardipine inhibits CYP3A4, 2D6, 2C8, and 2C19. Nicardipine does not induce or inhibit its own metabolism.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to nicardipine or any ingredient in the formulation.

*Advanced aortic stenosis, since reduction in diastolic pressure may worsen myocardial oxygen balance.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions to oral nicardipine are pedal edema (7.1%, dose-related), dizziness (6.9%), headache (6.4%), asthenia (5.8%), flushing (5.6%), increased angina (5.6%, dose-related), palpitations (3.3%), and nausea (1.9%).

The most common adverse reactions to IV nicardipine are headache (13 -15%), hypotension (5 -6%), tachycardia (4%), and nausea/vomiting (4 -5%).

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Although safety and efficacy of oral or IV nicardipine remain to be established in pediatric patients younger than 18 years of age, some experts have recommended IV pediatric dosages+ for severe hypertension based on clinical experience.

Nicardipine hydrochloride has been shown to be embryocidal in pregnant rabbits when given at an oral daily dose of 150 mg/kg during organogenesis but not at a daily dose of 50 mg/kg (8 times the maximum recommended human dosage). There was no evidence of embryotoxicity or teratogenicity when nicardipine hydrochloride was administered IV at dosages up to 5 mg/kg daily in pregnant rats or up to 0.5 mg/kg daily in pregnant rabbits. Embryolethality was observed at IV dosages of 10 mg/kg daily (equivalent to a human IV dosage of 1.6 mg/kg daily) in rats and 1 mg/kg daily (equivalent to a human IV dosage of 0.32 mg/kg daily) in rabbits, but there was no evidence of teratogenicity at these dosages. No adverse effects on the fetus were observed when New Zealand albino rabbits received nicardipine hydrochloride dosages up to 100 mg/kg daily during organogenesis. Pregnant rats receiving oral nicardipine hydrochloride at dosages up to 100 mg/kg daily (50 times the maximum recommended human dosage) did not exhibit evidence of embryolethality or teratogenicity but did exhibit evidence of dystocia, reduced birthweights, reduced neonatal survival, and reduced neonatal weight gain.

There are no adequate and well-controlled studies using nicardipine in pregnant women. Hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, and flushing have been reported in pregnant women who were treated with IV nicardipine for hypertension during pregnancy. Fetal effects ranged from transient fetal heart rate decelerations to no adverse events; neonatal effects ranged from hypotension to no adverse events. Adverse events in women treated with IV nicardipine during pre-term labor include pulmonary edema, dyspnea, hypoxia, hypotension, tachycardia, headache, and phlebitis at the site of injection; neonatal adverse events include acidosis (pH<7.25).

Nicardipine crosses the placenta, but fetal plasma concentrations are only approximately 10% of concurrent maternal plasma concentrations.

Nicardipine should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Nicardipine is distributed into milk in high concentrations in rats and minimally excreted into human milk. In a small number of women receiving nicardipine postpartum, infants received an average of 0.073 and 0.14% of the weight-adjusted maternal dose following oral and IV nicardipine administration, respectively. In another small study of women receiving immediate postpartum IV nicardipine for the treatment of preeclampsia, the maximum dose in the breastfed neonate was estimated to be <0.3 mcg daily or 0.004-0.015% of the therapeutic dose in a 1 kg neonate.

Some manufacturers recommend against breastfeeding while receiving nicardipine, while others recommend to consider the possibility of infant exposure from breastfeeding.

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 of concomitant disease or other drug therapy.

When nicardipine hydrochloride was administered at doses of 10, 20, and 30 mg three times daily, plasma drug concentrations in elderly hypertensive subjects were similar to plasma concentrations in healthy young adult subjects suggesting that the pharmacokinetics of nicardipine hydrochloride are similar in young and elderly hypertensive patients. Clinical studies of nicardipine did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients. While other clinical experience generally has not revealed age-related differences in pharmacokinetics, response, or tolerance, drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The frequencies of pedal edema may be higher in geriatric patients than in younger adults, while the frequencies of flushing and headache may be lower. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly should be considered.