NICARDIPINE HYDROCHLORIDE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Hikma Pharmaceuticals USA Inc.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6)]. Do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. 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. There are limited human data in pregnant women with pre-eclampsia and preterm labor. In animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. Therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproduction studies conducted in rats and rabbits, increased embryolethality oc

Dettagli prodotto:

Nicardipine Hydrochloride Injection is available in packages as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NICARDIPINE
HYDROCHLORIDE INJECTION RX ONLY
PREMIERPRORX®
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NICARDIPINE
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR NICARDIPINE
HYDROCHLORIDE.
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)
DOSAGE AND ADMINISTRATION
Individualize dosage based upon the severity of hypertension and
response of the patient during dosing
(2.1).
Single dose vials must be diluted before use (2.2).
When substituting for oral nicardipine therapy, use the intravenous
infusion rate as follows (2.3):
ORAL NICARDIPINE
DOSE
EQUIVALENT IV
INFUSION RATE
20 mg q8h
0.5 mg/hr
30 mg q8h
1.2 mg/hr
40 mg q8h
2.2 mg/hr
In a drug-free patient, initiate therapy at 5 mg/hr. Increase the
infusion rate by 2.5 mg/hr to a
maximum of 15 mg/hr until desired blood pressure reduction is
achieved. For a gradual blood pressure
reduction the rate can be increased every 15 minutes, for a rapid
reduction, every 5 minutes (2.4).
If hypotension or tachycardia ensues, discontinue the infusion. After
stabilized, patient can be restarted
at low doses such as 3 to 5 mg/hr (2.5).
DOSAGE FORMS AND STRENGTHS
25 mg/10 mL (2.5 mg/mL) single-dose vial (3)
CONTRAINDICATIONS
Do not use in patients with advanced aortic stenosis (4.1).
WARNINGS AND PRECAUTIONS
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. Avoid
intraarterial administration or
extravasation (5.7).
To minimize the risk of peripheral venous irritation, change the site
of infusion of nicardipine every 12
hours (5.7).
Nicardipine is not a beta-blocker and theref