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baxter healthcare corporation - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - 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. norepinephrine bitartrate injection, usp 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 norepinephrine bitartrate injection, usp 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. norepinephrine bitartrate injection, usp 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) unless, in the opinion of the attending physician, the administration of norepinephrine bitartrate injection, usp is necessary as a life-saving procedure. cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. hence, the use of norepinephrine bitartrate injection, usp during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. the same type of cardiac arrhythmias may result from the use of norepinephrine bitartrate injection, usp in patients with profound hypoxia or hypercarbia.

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations) . in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxim

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection, usp is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data) . increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2

United States - English - NLM (National Library of Medicine)

cantrell drug company - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine 16 ug in 1 ml

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cardinal health - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate 1 mg in 1 ml

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hf acquisition co llc, dba healthfirst - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection, usp is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. 8.1 pregnancy risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations below). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data below). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see data below). the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15−20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. data animal data a study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. decreases in fetal oxygenation, urine and lung liquid flow were also observed. norepinephrine administration to pregnant rats on gestation day 16 or 17 resulted in cataract production in rat fetuses. in hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from gestation day 7-10). 8.2 lactation risk summary there are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of norepinephrine bitartrate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. avoid administration of norepinephrine bitartrate injection into the veins in the leg in elderly patients [see warnings and precautions (5.1)].

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deseret biologicals, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - for temporary relief of symptoms related to norepinephrine sensitivity including rashes, hives, premenstrual syndrome, and headache.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to norepinephrine sensitivity including rashes, hives, premenstrual syndrome, and headache.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

United States - English - NLM (National Library of Medicine)

energique, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - may temporarily relieve symptoms associated with reactions to norepinephrine.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve symptoms associated with reactions to norepinephrine.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

United States - English - NLM (National Library of Medicine)

energique, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - may temporarily relieve symptoms associated with reactions to norepinephrine.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve symptoms associated with reactions to norepinephrine.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

United States - English - NLM (National Library of Medicine)

hospira, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine 1 mg in 1 ml - 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