CARDENE IV Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Baxter Healthcare Corporation

Λέξεις κλειδιά

43066-016 43066-009

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1. Indications and Usage

1.1 Hypertension Cardene I.V. (nicardipine hydrochloride) Premixed Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

<u>Injection:</u> 200 mL nicardipine (0.1 mg/mL) in either dextrose (4.8%) or sodium chloride (0.86%) as a clear, colorless solution, ready-to-use, iso-osmotic solution in a single use GALAXY container ...

4. Contraindications

4.1 Advanced Aortic Stenosis Cardene I.V. Premixed Injection is contraindicated in patients with advanced aortic stenosis because part of the effect of Cardene I.V. Premixed Injection is secondary to reduced ...

5. Warnings and Precautions

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 ...

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 ...

6.2. Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. ...

7. Drug Interactions

7.1 Beta-Blockers In most patients, Cardene I.V. Premixed Injection can safely be used concomitantly with beta blockers. However, titrate slowly when using Cardene I.V. Premixed Injection in combination ...

8.1. Pregnancy

Pregnancy Category C. There are no adequate and well-controlled studies of nicardipine use in pregnant women. However, limited human data in pregnant women with preeclampsia or pre-term labor are available. ...

8.3. Nursing 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 ...

8.4. Pediatric Use

Safety and efficacy in patients under the age of 18 have not been established.

8.5. Geriatric Use

The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (>65 years) and young healthy adults. Clinical studies of nicardipine did not include sufficient numbers of ...

10. Overdosage

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 ...

11. Description

Cardene (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Cardene I.V. Premixed Injection for intravenous administration contains 20 mg (0.1 ...

12.1. Mechanism 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 ...

12.2. Pharmacodynamics

Hemodynamics Cardene I.V. produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered Cardene I.V., the degree of vasodilation and the resultant decrease ...

12.3. Pharmacokinetics

Distribution Rapid dose-related increases in nicardipine plasma concentrations are seen during the first two hours after the start of an infusion of Cardene I.V. Plasma concentrations increase at a much ...

13. Nonclinical Toxicology

13.3 Reproductive and Developmental Toxicology Embryotoxicity, but no teratogenicity, was seen at intravenous doses of 10 mg nicardipine/kg/day in rats and 1 mg/kg/day in rabbits. These doses in the rat ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15, or 45 mg/kg/day) for two years showed a dose-dependent increase in thyroid hyperplasia and ...

14. Clinical Studies

Effects In Hypertension In patients with mild to moderate chronic stable essential hypertension, Cardene I.V. (0.5 to 4 mg/hr) produced dose-dependent decreases in blood pressure. At the end of a 48-hour ...

16.1. How Supplied

Cardene I.V. Premixed Injection is supplied as a single-use, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride ...

16.2. Storage and Handling

Store at controlled room temperature 20º to 25ºC (68º to 77ºF), refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to ...