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:

Sun Pharmaceutical Industries, 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 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 at 24

Dettagli prodotto:

Nicardipine hydrochloride injection is available in packages of 10 ampuls of 10 mL as follows: 25 mg/10 mL (2.5 mg/mL)                             NDC 47335-882-44 Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature]. Freezing does not adversely affect the product, but avoid exposure to elevated temperatures. Protect from light. Store ampuls in carton until used. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India. PJPI0551 ISS. 02/2021

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

NICARDIPINE HYDROCHLORIDE - NICARDIPINE HYDROCHLORIDE INJECTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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 I.V. 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 an ampul 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
extr