NICARDIPINE HYDROCHLORIDE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

West-Ward Pharmaceuticals Corp

INN (nume internaţional):

NICARDIPINE HYDROCHLORIDE

Compoziție:

NICARDIPINE HYDROCHLORIDE 2.5 mg in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION
WEST-WARD PHARMACEUTICALS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NICARDIPINE
HYDROCHLORIDE INJECTION RX ONLY
NOVAPLUS®
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
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 04/2016
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
DO SE
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)
20 mg in 200 mL (0.1 mg/mL) flexible container (3)
40 mg in 200 mL (0.2 mg/mL) flexible container (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