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baxter healthcare corporation - icodextrin (unii: 2nx48z0a9g) (icodextrin - unii:2nx48z0a9g), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium lactate (unii: tu7hw0w0qt) (sodium cation - unii:lyr4m0nh37, lactic acid - unii:33x04xa5at), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838, chloride ion - unii:q32zn48698) - icodextrin 7.5 g in 100 ml - extraneal (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (capd) or automated peritoneal dialysis (apd) for the management of end-stage renal disease. extraneal is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (pet) [see clinical pharmacology (12), clinical studies (14)]. extraneal is contraindicated in patients with a known allergy to cornstarch or icodextrin. extraneal is contraindicated in patients with maltose or isomaltose intolerance and in patients with glycogen storage disease. extraneal is contraindicated in patients with severe lactic acidosis. extraneal contains lactate which may contribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated with hyperventilation, lethargy, hypot

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baxter healthcare corporation - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine 100 mg in 100 ml - dobutamine hydrochloride in 5% dextrose injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-amp-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. in controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-amp-dependent inotropes were consistently associated with increased risks of hospitalization and death. patients with nyha class iv symptoms appeared to be at particular risk. dobutamine hy

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baxter healthcare corporation - nalmefene hydrochloride (unii: k7k69qc05x) (nalmefene - unii:tov02tdp9i) - injection, solution - 1 mg in 1 ml - revex is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. revex is indicated in the management of known or suspected opioid overdose. revex is contraindicated in patients with a known hypersensitivity to the product. revex is an opioid antagonist with no agonist activity. it has no demonstrated abuse potential, is not addictive, and is not a controlled substance.

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baxter healthcare corporation - sodium chloride (unii: 451w47iq8x) (sodium chloride - unii:451w47iq8x) - injection, solution - 3% and 5% sodium chloride injection, usp is indicated as a source of water and electrolytes. none known

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baxter healthcare corporation - vasopressin (unii: y4907o6mfd) (vasopressin - unii:y4907o6mfd) - vasopressin in sodium chloride injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. vasopressin in sodium chloride injection is contraindicated in patients with a known allergy or hypersensitivity to 8-l-arginine vasopressin. risk summary there are no available data on vasopressin in sodium chloride injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted. clinical considerations there are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness of vasopressin in sodium chloride injection in pediatric patients with vasodilatory shock have not been established. clinical studies of vasopressin 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 [see warnings and precautions (5), adverse reactions (6), and clinical pharmacology (12.3)].

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baxter healthcare corporation - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. naloxone hydrochloride injection is also indicated for diagnosis of suspected or known acute opioid overdosage. naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology; adjunctive use in septic shock ). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride has not been reported. tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur.

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baxter healthcare corporation - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen injection is indicated for acetaminophen injection is contraindicated: risk summary published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and birth defects, miscarriage, or adverse maternal or fetal outcomes [see data] . animal reproduction studies have not been conducted with iv acetaminophen. reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen. treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (mhdd) showed evidence of fetotoxicity and increases in bone variations in the fetuses. in another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the mhdd. in mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported. in mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring and reduced birth weight in the next generation. in rats, female fertility was decreased following in utero exposure to acetaminophen [see data] . the estimated background risk of major birth defects and miscarriages 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data the results from a large population-based prospective cohort, including data from 26,424 women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children. the rate of congenital malformations (4.3%) was similar to the rate in the general population. a population-based, case-control study from the national birth defects prevention study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group. other epidemiological data showed similar results. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including recall bias. animal data studies in pregnant rats that received oral acetaminophen during organogenesis at doses up to 0.85 times the maximum human daily dose (mhdd = 4 grams/day, based on a body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes). offspring had no evidence of external, visceral, or skeletal malformations. when pregnant rats received oral acetaminophen throughout gestation at doses of 1.2 times the mhdd (based on a body surface area comparison), areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses. these effects did not occur in animals that received oral acetaminophen at doses 0.3 times the mhdd, based on a body surface area comparison. in a continuous breeding study, pregnant mice received 0.25, 0.5, or 1.0% acetaminophen via the diet (357, 715, or 1430 mg/kg/day). these doses are approximately 0.43, 0.87, and 1.7 times the mhdd, respectively, based on a body surface area comparison. a dose related reduction in body weights of fourth and fifth litter offspring of the treated mating pair occurred during lactation and post-weaning at all doses. animals in the high dose group had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next generation pups. risk summary there is no information regarding the presence of acetaminophen injection in human milk, the effects on the breastfed infant, or the effects on milk production. however, limited published studies report that acetaminophen passes rapidly into human milk with similar levels in the milk and plasma. average and maximum neonatal doses of 1% and 2%, respectively, of the weight-adjusted maternal dose are reported after a single oral administration of 1 gram apap. there is one well-documented report of a rash in a breast-fed infant that resolved when the mother stopped acetaminophen use and recurred when she resumed acetaminophen use. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for acetaminophen injection and any potential adverse effects on the breastfed infant from acetaminophen injection or from the underlying maternal condition. based on animal data use of acetaminophen may cause reduced fertility in males and females of reproductive potential. it is not known whether these effects on fertility are reversible. published animal studies reported that oral acetaminophen treatment of male animals at doses that are 1.2 times the mhdd and greater (based on a body surface area comparison) result in decreased testicular weights, reduced spermatogenesis, and reduced fertility. in female animals given the same doses, reduced implantation sites were reported. additional published animal studies indicate that acetaminophen exposure in utero adversely impacts reproductive capacity of both male and female offspring at clinically relevant exposures [see nonclinical toxicology (13.1)] . treatment of acute pain the safety and effectiveness of acetaminophen injection for the treatment of acute pain in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of acetaminophen injection in adults and safety and pharmacokinetic data from adult and 483 pediatric patients across all age groups [see dosage and administration (2.3) and pharmacokinetics (12.3)] . the effectiveness of acetaminophen injection for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established. in patients younger than 2 years, efficacy was not demonstrated in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. no difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. treatment of fever the safety and effectiveness of acetaminophen injection for the treatment of fever in pediatric patients, including premature neonates born at ≥ 32 weeks gestational age is supported by adequate and well-controlled studies of acetaminophen injection in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates ≥ 32 weeks gestational age. of the total number of subjects in clinical studies of acetaminophen injection, 15% were age 65 and over, while 5% were age 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease [see warnings and precautions (5.1) and clinical pharmacology (12)] . a reduced total daily dose of acetaminophen may be warranted. in cases of severe renal impairment (creatinine clearance ≤ 30 ml/min), longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.

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baxter healthcare corporation - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. naloxone hydrochloride injection is also indicated for diagnosis of suspected or known acute opioid overdosage. naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology; adjunctive use in septic shock ). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride has not been reported. tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur.

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

baxter healthcare corporation - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension. labetalol hydrochloride injection is contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see warnings ). beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

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baxter healthcare corporation - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 7.5 mg in 1 ml - bupivacaine hydrochloride in 8.25% dextrose injection spinal is indicated for the production of subarachnoid block (spinal anesthesia). standard text books should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. bupivacaine hydrochloride in 8.25% dextrose injection spinal is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. the following conditions preclude the use of spinal anesthesia: