País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
NICARDIPINE HYDROCHLORIDE (UNII: K5BC5011K3) (NICARDIPINE - UNII:CZ5312222S)
West-Ward Pharmaceuticals Corp
NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE 2.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
New Drug Application
NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION WEST-WARD PHARMACEUTICALS CORP ---------- 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 Llegiu el document complet