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hf acquisition co llc, dba healthfirst - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients. acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease [see warnings and precautions (5.1)]. 8.1 pregnancy 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 1,430 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. 8.2 lactation risk summary there is no information regarding the presence of acetaminophen 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 and any potential adverse effects on the breastfed infant from acetaminophen or from the underlying maternal condition. 8.3 females and males of reproductive potential 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)]. 8.4 pediatric use treatment of acute pain the safety and effectiveness of acetaminophen 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 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 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 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 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. 8.5 geriatric use of the total number of subjects in clinical studies of acetaminophen, 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. 8.6 patients with hepatic impairment 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. 8.7 patients with renal impairment 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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medical purchasing solutions, llc - 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 n

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medical purchasing solutions, llc - 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 n

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medical purchasing solutions, llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively

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hf acquisition co llc, dba healthfirst - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [w-p-w] and lown-ganong- levine [l-g-l] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white (w-p-w) and lown-ganong-levine (l-g-l) syndromes). in controlled studies in the united states, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutt

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hf acquisition co llc, dba healthfirst - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [w-p-w] and lown-ganong- levine [l-g-l] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white (w-p-w) and lown-ganong-levine (l-g-l) syndromes). in controlled studies in the united states, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutt

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nucare pharmaceuticals,inc. - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - a. intravenous or intramuscular administration . when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. endocrine disorders . primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or

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asclemed usa, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 30 mg in 1 ml - bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see dosage and administration (2.2)]. limitations of use not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see dosage and administration (2.2), contraindications (4), warnings and precautions (5.1, 5.4, 5.5, 5.7, 5.9)] . bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated in: - obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death. - intravenous regional anesthesia (bier block) [see warnings and precautions (5.7)]. - patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. risk summary bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated for obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death [see contraindications (4), warnings and precautions (5.1)]. there are no available data on use of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (mrhd) on a body surface area (bsa) basis. based on animal data, advise pregnant women of the potential risks to a fetus (see data). local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)]. the incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus, and neonate involve alterations of the cns, peripheral vascular tone, and cardiac function. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. the supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. elevating the patient's legs will also help prevent decreases in blood pressure. the fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. labor or delivery epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. the use of obstetrical anesthesia may increase the need for forceps assistance. the use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. this has not been reported with bupivacaine. it is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. to do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. data animal data bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). the high doses are comparable to the daily mrhd of 400 mg/day on a mg/m 2 bsa basis. no embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal no observed adverse effect level representing approximately 0.3 times the mrhd on a bsa basis. in a rat pre-and post-natal developmental study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg, decreased pup survival was observed at the high dose. the high dose is comparable to the daily mrhd of 400 mg/day on a bsa basis. risk summary lactation studies have not been conducted with bupivacaine. bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection should be administered to lactating women only if clearly indicated. studies assessing the effects of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in breastfed children have not been performed. studies to assess the effect of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is approved for use in adults. administration of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pediatric patients younger than 12 years is not recommended. continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities. patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. in clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see clinical pharmacology (12.3)]. this product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. elderly patients may require lower doses of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection, especially with repeat doses [see warnings and precautions (5.10)] . bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. this should be considered when selecting the bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection dosage [see use in specific populations (8.5)] . carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ).  acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. ( see also boxed warning) ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings –  anaphylactoid reactions , and precautions – pre-existing asthma ). ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings for correction of volume depletion). ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine is contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.  ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content. lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. purpose: - first aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. - for preparation of the skin prior to surgery. - helps reduce bacteria that can potentially cause skin infections. - as a first aid antiseptic for more than 1 week. - in the eyes. - over large areas of the body. - deep puncture wounds - animal bites - serious burns - if irritation and redness develop - if condition persists for more than 72 hours, consult a physician. for use as an - first aid antiseptic - pre-operative skin preperation antiseptic for first aid to decrease germs in - minor cuts - scrapes - burns for preparation of the skin prior to injection

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hf acquisition co llc, dba healthfirst - esmolol hydrochloride (unii: v05260lc8d) (esmolol - unii:mdy902uxsr) - 1.1 supraventricular tachycardia or noncompensatory sinus tachycardia esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. esmolol hydrochloride injection is intended for short-term use. 1.2 intraoperative and postoperative tachycardia and hypertension esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. use of esmolol hydrochloride injection to prevent such events is not recommended. esmolol hydrochloride injection is contraindicated in patients with: severe sinus bradycardia: may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions (5.2)]. heart block greater than first degree: second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions (5.2)]. sick sinus syndrome: may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions (5.2)]. decompensated heart failure: may worsen heart failure. cardiogenic shock: may precipitate further cardiovascular collapse and cause cardiac arrest. iv administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and esmolol hydrochloride in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving esmolol hydrochloride and intravenous verapamil. pulmonary hypertension: may precipitate cardiorespiratory compromise. hypersensitivity reactions, including anaphylaxis, to esmolol or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible). 8.1 pregnancy pregnancy category c. esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). there are no adequate and well-controlled studies in pregnant women. esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. teratogenicity studies in rats at intravenous dosages of esmolol hydrochloride up to 3000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. in rabbits, intravenous dosages up to 1000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions. 8.2 labor and delivery although there are no adequate and well-controlled studies in pregnant women, use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 nursing mothers it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from esmolol hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 pediatric use the safety and effectiveness of esmolol hydrochloride in pediatric patients have not been established. 8.5 geriatric use clinical studies of esmolol hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they responded 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 usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy. 8.6 hepatic impairment no special precautions are necessary in patients with hepatic impairment because esmolol hydrochloride is metabolized by red-blood cell esterases [see clinical pharmacology (12.3)]. 8.7 renal impairment no dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours. there is no information on the tolerability of maintenance infusions of esmolol using rates in excess of 150 mcg/kg or maintained longer than 4 hours [see clinical pharmacology (12.3)].

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advanced rx pharmacy of tennessee, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. for each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1, 2.2) limitations of use not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9) bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each