Label: NICARDIPINE HYDROCHLORIDE injection

  • NDC Code(s): 69097-007-22, 69097-007-45, 69097-008-22, 69097-008-45
  • Packager: Cipla USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 1, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NICARDIPINE HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for NICARDIPINE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1            Hypertension - Nicardipine hydrochloride in 0.9% sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Information - Individualize dosing based on the severity of hypertension and the response of the patient during dosing. Monitor blood pressure and heart rate both during and after ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Nicardipine hydrochloride in 0.9% sodium chloride injection is available in the following presentations: 20 mg nicardipine hydrochloride in 200 mL 0.9% sodium chloride injection (0.1 mg/mL) in ...
  • 4 CONTRAINDICATIONS
    4.1 Advanced Aortic Stenosis - Do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. Reduction of diastolic pressure in these ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Excessive Pharmacologic Effects - In administrating nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension ...
  • 6 ADVERSE REACTIONS
    6.1 Adverse Reactions Observed in Clinical Trials - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot ...
  • 7 DRUG INTERACTIONS
    7.1 Antihypertensive Agents - Since nicardipine hydrochloride injection may be administered to patients already being treated with other medications, including other antihypertensive agents ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - There are no adequate and well-controlled studies of nicardipine use in pregnant women. There are limited human data in pregnant women with pre-eclampsia and preterm labor. In ...
  • 10 OVERDOSAGE
    Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of nicardipine immediate release capsules, and another patient, 2160 mg of ...
  • 11 DESCRIPTION
    Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International ...
  • 12 CLINICAL PHARMACOLOGY
    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 ...
  • 13 NONCLINICAL TOXICOLOGY
    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 ...
  • 14 CLINICAL STUDIES
    Effects in Hypertension - In patients with mild-to-moderate chronic stable essential hypertension, nicardipine hydrochloride injection (0.5 to 4 mg/hr) produced dose-dependent decreases in blood ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Nicardipine hydrochloride in 0.9% sodium chloride injection is available in packages as follows: NDC - Strength - Packaged - 69097-007-45 - 20 mg in 200 ...
  • PRINCIPAL DISPLAY PANEL-BAG labels
    NDC 69097-007-45Rx Only - USE IMMEDIATELY ONCE REMOVED FROM THE OVERWRAP - niCARdipine Hydrochloride - in 0.9% Sodium Chloride Injection - 20 mg in 200 mL - (0.1 mg/mL) For Intravenous ...
  • INGREDIENTS AND APPEARANCE
    Product Information