NICARDIPINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

NICARDIPINE HYDROCHLORIDE (UNII: K5BC5011K3) (NICARDIPINE - UNII:CZ5312222S)

Commercializzato da:

Civica, Inc.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

niCARdipine Hydrochloride Injection, USP is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.  For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)] . Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload.  Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. 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. In animal studies, no embryotoxicity occurred in rats with oral doses 8 times the maximum recommended human dose (MRHD) based on body surface area (mg/m2 ), but did occur in rabbits with oral doses

Dettagli prodotto:

niCARdipine Hydrochloride Injection, USP is available in packages of 10 vials of 10 mL as follows:  25 mg/10 mL (2.5 mg/mL), NDC 72572-470-10 Store at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature. Freezing does not adversely affect the product, but avoid exposure to elevated temperatures.  Protect from light.  Store vials in carton until used. Mfd for: Civica, Inc. Lehi, Utah  84043 Mfd by: American Regent, Inc. New Albany, OH  43054 RQ1092-A

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION,
SOLUTION
CIVICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NICARDIPINE HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NICARDIPINE HYDROCHLORIDE
INJECTION.
NICARDIPINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
niCARdipine hydrochloride injection is a calcium channel blocker
indicated for the short-term treatment of
hypertension when oral therapy is not feasible. (1.1)
DOSAGE AND ADMINISTRATION
For Intravenous Use. (2.1)
DILUTION IS REQUIRED. (2.3)
When substituting for oral nicardipine therapy, use the intravenous
infusion rate from the table below (2.1):
ORAL NICARDIPINE DOSE
EQUIVALENT INTRAVENOUS INFUSION RATE
(0.1 MG/ML)
20 mg q8h
0.5 mg/hr = 5 mL/hr
30 mg q8h
1.2 mg/hr = 12 mL/hr
40 mg q8h
2.2 mg/hr = 22 mL/hr
In a patient not receiving oral nicardipine, initiate therapy at 50
mL/hr (5 mg/hr) 0.1 mg/mL solution. Increase the
infusion rate by 25 mL/hr every 5 minutes (for rapid titration) to 15
minutes (for gradual titration) up to a maximum of
150 mL/hr until desired blood pressure reduction is achieved. (2.1)
If unacceptable hypotension or tachycardia occurs, discontinue the
infusion. When blood pressure and heart rate
stabilize, restart the infusion at low doses such as 30 to 50 mL/hr.
(2.2)
DOSAGE FORMS AND STRENGTHS
niCARdipine hydrochloride injection is supplied in a vial containing
25 mg of nicardipine hydrochloride in 10 mL (2.5
mg/mL) for intravenous infusion. (3)
CONTRAINDICATIONS
Do not use in patients with advanced aortic stenosis. (4.1).
WARNINGS AND PRECAUTIONS
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 car