CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive clinical and safety monograph for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER).
Calcium channel blocker (dihydropyridine type) that inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to vasodilation and decreased myocardial contractility.
| Metabolism | Primarily hepatic via CYP3A4; undergoes extensive first-pass metabolism. Metabolites are inactive. |
| Excretion | Renal: 55-60% as metabolites, <1% unchanged; biliary/fecal: 35-40% |
| Half-life | 2-4 hours (terminal); prolonged in hepatic impairment; clinical context: requires continuous IV infusion for sustained effect |
| Protein binding | >95% bound to albumin, alpha-1-acid glycoprotein, and lipoproteins |
| Volume of Distribution | 0.2-0.6 L/kg; suggests limited tissue distribution; higher in hepatic cirrhosis |
| Bioavailability | IV: 100%; not available orally in this formulation |
| Onset of Action | IV: 1-2 minutes after bolus; continuous infusion achieves effect within 5-10 minutes |
| Duration of Action | IV: 10-30 minutes after bolus; infusion: effect ceases within 15-30 minutes after discontinuation; must be titrated continuously |
| Molecular Weight | 515.54 |
Intravenous: 5 mg/hr initially, titrate by 2.5 mg/hr every 15 minutes based on response; usual maintenance 3-10 mg/hr.
| Dosage form | INJECTABLE |
| Renal impairment | GFR < 30 mL/min: initial dose 2.5 mg/hr; titrate cautiously. No adjustment for GFR ≥ 30. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce initial dose by 50%. Class C: avoid use. |
| Pediatric use | Safety and efficacy not established; no standard dosing recommendations. |
| Geriatric use | Start at lower end of dosing range (2.5-3 mg/hr); titrate slowly due to increased sensitivity. |
| 1st trimester | Use only if potential benefit justifies potential risk to fetus. May cause fetotoxicity and fetal death in animal studies. |
| 2nd trimester | May cause hypotension and fetal hypoxia. Avoid prolonged use near term. |
| 3rd trimester | Risk of neonatal hypotension and electrolyte disturbances. Avoid use in pregnancy. |
Clinical note
Comprehensive clinical and safety monograph for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER).
| Placental transfer | Nicardipine crosses the placenta in humans. |
| Breastfeeding | Nicardipine is excreted in human milk in small amounts. Use with caution; monitor infant for adverse effects. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: No adequate human studies; animal studies show no teratogenic effects at therapeutic doses. Second and third trimesters: Potential for fetal hypoxia, hypotension, and growth restriction due to maternal hypotension; avoid use for tocolysis. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and signs of hypotension; fetal heart rate monitoring for bradycardia or distress; uterine activity if used for preterm labor. |
| Fertility Effects | No adequate human data; animal studies show no impairment of fertility at therapeutic doses. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to nicardipine or any componentAdvanced aortic stenosis
| Precautions | Hypotension and reflex tachycardia may occur, especially in patients on beta-blockers., Use caution in patients with congestive heart failure or impaired ventricular function., May cause worsening of angina on abrupt withdrawal., Hepatic impairment may increase drug levels; dose adjustment may be needed., Peripheral edema is common but not due to fluid retention. |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may increase nicardipine levels. High fat meals can affect absorption, but since this is IV, dietary restrictions primarily relate to dextrose content for diabetics. No other significant food interactions. |
| Clinical Pearls | CARDENE (nicardipine) in 4.8% dextrose is a dihydropyridine calcium channel blocker used for IV treatment of hypertension. It is light-sensitive; protect from light. Titrate dose by 1-2 mg/hour increments every 5 minutes up to target blood pressure. Do not mix with sodium bicarbonate or lactated Ringer's. Use with caution in patients with coronary artery disease due to reflex tachycardia, and in hepatic impairment as metabolism is hepatic. May cause peripheral edema; monitor for worsening heart failure. |
| Patient Advice | This medication is given intravenously to lower blood pressure; you will be closely monitored. · Inform your healthcare provider if you have a history of heart disease, liver problems, or if you are pregnant or breastfeeding. · You may experience headache, dizziness, or flushing; report these if severe. · Avoid alcohol consumption while on this medication as it may increase side effects. · This solution contains dextrose; notify your doctor if you have diabetes or need to restrict sugar intake. |
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