cardene in 0.86% sodium chloride in plastic container
Pharmaranks rates Cardene in 0.86% Sodium Chloride in Plastic Container 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cardene in 0.86% Sodium Chloride in Plastic Container (Nicardipine Hydrochloride) is a dihydropyridine calcium channel blocker used to treat Variant Angina Pectoris, Hypertension, Stable Angina.
Nicardipine Hydrochloride · by Chiesi
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Nicardipine Hydrochloride
- Drug class
- Dihydropyridine Calcium Channel Blocker
- Form
- Injectable
- Strength
- Nicardipine Hydrochloride 20MG/200ML (0.1MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- variant angina pectoris, hypertension, stable angina
- Manufacturer
- Chiesi
- What the pharmacy pays
- ~$41.18 for 30 — not your price
- FDA application
- NDA019734
What is Cardene in 0.86% Sodium Chloride in Plastic Container?
From the FDA label: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 169 o C. 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…
How to use
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…
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…
Warnings
Important safety information
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.
Who should not take Cardene in 0.86% Sodium Chloride in Plastic Container
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.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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.
Drug class
How this class works, per Calcium Channel Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Cardene in 0.86% Sodium Chloride in Plastic Container ranks — best-rated dihydropyridine calcium channel blocker for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Cardene in 0.86% Sodium Chloride in Plastic Container treat?
- Cardene in 0.86% Sodium Chloride in Plastic Container (Nicardipine Hydrochloride) may be used to treat variant angina pectoris, hypertension, stable angina, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cardene in 0.86% Sodium Chloride in Plastic Container work?
- Cardene in 0.86% Sodium Chloride in Plastic Container is a dihydropyridine calcium channel blocker. Dihydropyridine calcium channel blockers stop calcium from entering the muscle cells in your blood vessel walls. With less calcium, those muscles relax and the vessels widen, which lowers blood pressure and eases the heart's workload.
- How is Cardene in 0.86% Sodium Chloride in Plastic Container rated?
- pharmaranks gives Cardene in 0.86% Sodium Chloride in Plastic Container a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Cardene in 0.86% Sodium Chloride in Plastic Container cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $41.18 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Nymalize — about $37.38 on the same basis.
- Is there a coupon or discount for Cardene in 0.86% Sodium Chloride in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cardene in 0.86% Sodium Chloride in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cardene in 0.86% Sodium Chloride in Plastic Container?
- Cardene in 0.86% Sodium Chloride in Plastic Container is marketed by Chiesi. You can see Chiesi's full profile, rating, and other products on pharmaranks.
- Is Cardene in 0.86% Sodium Chloride in Plastic Container a brand-name or generic drug?
- Cardene in 0.86% Sodium Chloride in Plastic Container is a brand-name product with the active ingredient Nicardipine Hydrochloride.
- Is Cardene in 0.86% Sodium Chloride in Plastic Container available over the counter?
- No. Cardene in 0.86% Sodium Chloride in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cardene in 0.86% Sodium Chloride in Plastic Container come in?
- Cardene in 0.86% Sodium Chloride in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Cardene in 0.86% Sodium Chloride in Plastic Container?
- Cardene in 0.86% Sodium Chloride in Plastic Container is classified as dihydropyridine calcium channel blocker, per the FDA's Established Pharmacologic Class.
- Is Cardene in 0.86% Sodium Chloride in Plastic Container FDA-registered?
- Cardene in 0.86% Sodium Chloride in Plastic Container is on record with the U.S. FDA under application number NDA019734. You can verify this on its official FDA label.
- Has Cardene in 0.86% Sodium Chloride in Plastic Container been recalled by the FDA?
- Cardene in 0.86% Sodium Chloride in Plastic Container has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cardene in 0.86% Sodium Chloride in Plastic Container safe?
- There's no single safe-or-not verdict. pharmaranks gives Cardene in 0.86% Sodium Chloride in Plastic Container a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cardene in 0.86% Sodium Chloride in Plastic Container?
- Cardene in 0.86% Sodium Chloride in Plastic Container's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cardene in 0.86% sodium chloride in plastic container
70/100