Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV)
Hospira, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension. LEVOPHED should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If LEVOPHED is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis. LEVOPHED should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) u
LEVOPHED (norepinephrine bitartrate) injection, USP, contains the equivalent of 1 mg base of LEVOPHED per 1 mL (4 mg/4 mL). Supplied as: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from light. Regitine, trademark, CIBA Pharmaceuticals Company. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1152-3.0 Revised: 06/2018
New Drug Application
LEVOPHED- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE HOSPIRA, INC. ---------- LEVOPHED™ NOREPINEPHRINE BITARTRATE INJECTION, USP Rx only DESCRIPTION Norepinephrine (sometimes referred to as _l-arterenol/Levarterenol_ or_ l-norepinephrine_) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula: LEVOPHED is supplied in sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 0.2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the vials has been displaced by nitrogen gas. CLINICAL PHARMACOLOGY LEVOPHED functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action). INDICATIONS AND USAGE For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension. CONTRAINDICATIONS LEVOPHED should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If LEVOPHED is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic bloo Przeczytaj cały dokument