Nicardipine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Nicardipine is a Calcium Channel Blocker that is FDA approved for the {{{indicationType}}} of short-term treatment of hypertension when oral therapy is not feasible or not desirable. Common adverse reactions include Hypotension, Peripheral edema, Tachyarrhythmia, Nausea, Vomiting, Headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Hypertension
- Dosing information (capsule)
- The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response.
- Initial dosage: 20 mg PO tid.
- Dosage range: 20 mg - 40 mg PO tid. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy. (See PRECAUTIONS, Blood Pressure; INDICATIONS AND USAGE; CLINICAL PHARMACOLOGY, Effects in Hypertension.)
- At least 3 days should be allowed before increasing the nicardipine dose to ensure achievement of steady-state plasma drug concentrations.
- Dosing information (Injection)
- Dosage as a Substitute for Oral Nicardipine Therapy
- The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:
- Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine
- Initiate dosage: 25 mL/hr (5.0 mg/hr).
- If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved.
- Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 mL/hr (3 mg/hr).
- Drug Discontinuation and Transition to an Oral Antihypertensive Agent
- Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.
- If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.
- If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.
- Special Populations
- Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function
Angina
- Dosing information (Capsule only)
- Initial dosage: 20 mg PO tie.
- Dosage range: 20 mg to 40 mg PO tie. At least 3 days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady-state plasma drug concentrations.
- Concomitant Use With Other Antianginal Agents
- 1.Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine therapy.
- 2.Prophylactic Nitrate Therapy–Nicardipine may be safely coadministered with short- and long-acting nitrates.
- 3.Beta-blockers–(See PRECAUTIONS, Drug Interactions.)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nicardipine sandbox in adult patients.
Non–Guideline-Supported Use
Electroconvulsive therapy
- Dosing information
- Not applicable 9702620
Migraine
- Dosing information
- 20 mg PO tid1468086
- 20 mg PO bid2245455
Subarachnoid hemorrhage - Vasospasm
- Dosing information
- 0.15 mg/kg/hr 8450326
- 0.83 mg/mL 17494654
- 2 mg in 10 mL Intrathecal 7709781
- 4 mg bid19139684
Variant angina
- Dosing information
- Intracoronary： 0.4 mg2744905
- Intracoronary：40-160 mg/day 3927691
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nicardipine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nicardipine sandbox in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicardipine sandbox in pediatric patients.
Contraindications
There is limited information regarding Nicardipine Contraindications in the drug label.
Warnings
There is limited information regarding Nicardipine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Nicardipine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Nicardipine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nicardipine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nicardipine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nicardipine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nicardipine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nicardipine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nicardipine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nicardipine in geriatric settings.
Gender
There is no FDA guidance on the use of Nicardipine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nicardipine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nicardipine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nicardipine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nicardipine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nicardipine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Nicardipine Administration in the drug label.
Monitoring
There is limited information regarding Nicardipine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Nicardipine and IV administrations.
Overdosage
There is limited information regarding Nicardipine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nicardipine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nicardipine Mechanism of Action in the drug label.
Structure
There is limited information regarding Nicardipine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Nicardipine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Nicardipine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Nicardipine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nicardipine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Nicardipine How Supplied in the drug label.
Storage
There is limited information regarding Nicardipine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Nicardipine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nicardipine sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Nicardipine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Nicardipine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.