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caplin steriles limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. teratogenic effects. pregnancy category c pregnancy category c: ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. these doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/ml x 0.05 ml/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis. additionally, when administered to rats after day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. there are no adequate and well-controlled studies in pregnant women. ketorolac tromethamine ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution during late pregnancy should be avoided. because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman. safety and efficacy in pediatric patients below the age of 2 have not been established. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

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armas pharmaceuticals inc. - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone lactate injection is contraindicated in patients who are hypersensitive to it.

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somerset therapeutics, llc - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone lactate injection is contraindicated in patients who are hypersensitive to it.

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baxter healthcare corporation - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. risk summary there are no available human data on use of ropivacaine hydrochloride injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see clinical considerations) . no teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the mrhd of 250 mg for nerve block use, based on body surface area (bsa) comparisons and a 60 kg human weight (see animal data). the estimated background risk of 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. labor or delivery local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12)] . 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 central nervous system, peripheral vascular tone and cardiac function. maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. 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. animal data no malformations were reported in embryo-fetal development toxicity studies conducted in pregnant new zealand white rabbits and sprague-dawley rats. during gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (mrhd) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the mrhd of 250 mg for nerve block use, respectively based on body surface area (bsa) comparisons and a 60 kg human weight). rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the mrhd for epidural use, respectively, and 0.21, 0.43, and 1.0 times the mrhd for nerve block use, respectively, based on bsa comparisons) during gd 6 to 15. no treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. female rats were dosed daily subcutaneously from gd 15 to lactation day 20 at doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the mrhd for epidural use, respectively, and 0.21, 0.43, and 1.0 times the mrhd for nerve block use, respectively), with maternal toxicity exhibited at the high dose. no adverse effects in physical developmental milestones or in behavioral tests were reported in a 2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, and 0.29 times the mrhd for epidural use, respectively, and 0.24, 0.45, and 0.88 times the mrhd for nerve block use, respectively, based on bsa comparisons) for 9 weeks before mating and during mating for males, and for 2 weeks before mating and during mating, pregnancy, and lactation, up to day 42 post coitus for females. significant pup loss was observed in the high dose group during the first 3 days postpartum, from a few hours up to 3 days after delivery compared to the control group, which was considered secondary to impaired maternal care due to maternal toxicity. no differences were observed in litter parameters, or fertility, mean gestation time, or number of live births were observed between the control (saline) and treatment groups [see carcinogenesis, mutagenesis, impairment of fertility (13.1)] . risk summary one publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section. no adverse reactions were reported in the infants. there is no available information on the drug’s effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropivacaine hydrochloride and any potential adverse effects on the breastfed child from ropivacaine hydrochloride or from the underlying maternal condition. the safety and efficacy of ropivacaine hydrochloride in pediatric patients have not been established. of the 2,978 subjects that were administered ropivacaine hydrochloride injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. ropivacaine hydrochloride injection was found to be safe and effective in the patients in these studies. clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. in one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (map) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. this drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see clinical pharmacology (12.3)]. because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations [see warnings and precautions (5.11) ]. this drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see clinical pharmacology (12.3)].

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be pharmaceuticals inc. - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)]. developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m2 ) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms

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lupin pharmaceuticals, inc. - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)]. developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m2 ) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug. teratogenicity was not observed in these animal species. the incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia. however, there are no adequate and well-controlled studies in pregnant women. rocuronium bromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the use of rocuronium bromide in cesarean section has been studied in a limited number of patients [see clinical studies (14.1)] . rocuronium bromide is not recommended for rapid sequence induction in cesarean section patients. the use of rocuronium bromide has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. one of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see dosage and administration (2.6) and clinical studies (14.3)] . rocuronium bromide was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique.  the overall analysis of ecg data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the qtc interval. the data also suggest that rocuronium bromide may increase heart rate. however, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. additionally, when examining plasma levels of rocuronium bromide in correlation to qtc interval prolongation, no relationship was observed [see dosage and administration (2.6), warnings and precautions (5.9) and clinical studies (14.3)].  rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients  recommendations for use in pediatric patients are discussed in other sections [see dosage and administration (2.6) and clinical pharmacology (12.2)] . rocuronium bromide was administered to 140 geriatric patients (65 years or greater) in u.s. clinical trials and 128 geriatric patients in european clinical trials. the observed pharmacokinetic profile for geriatric patients (n=20) was similar to that for other adult surgical patients [see clinical pharmacology (12.3)] . onset time and duration of action were slightly longer for geriatric patients (n=43) in clinical trials. clinical experiences and recommendations for use in geriatric patients are discussed in other sections [see dosage and administration (2.6), warnings and precautions (5.5), clinical pharmacology (12.2), and clinical studies (14.2)] . since rocuronium bromide is primarily excreted by the liver, it should be used with caution in patients with clinically significant hepatic impairment. rocuronium bromide 0.6 mg/kg has been studied in a limited number of patients (n=9) with clinically significant hepatic impairment under steady-state isoflurane anesthesia. after rocuronium bromide 0.6 mg/kg, the median (range) clinical duration of 60 (35 to 166) minutes was moderately prolonged compared to 42 minutes in patients with normal hepatic function. the median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function. four of 8 patients with cirrhosis, who received rocuronium bromide 0.6 mg/kg under opioid/nitrous oxide/oxygen anesthesia, did not achieve complete block. these findings are consistent with the increase in volume of distribution at steady state observed in patients with significant hepatic impairment [see clinical pharmacology (12.3)] . if used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block. duration will be prolonged in these cases. the use of doses higher than 0.6 mg/kg has not been studied [see dosage and administration (2.6)] . due to the limited role of the kidney in the excretion of rocuronium bromide, usual dosing guidelines should be followed. in patients with renal dysfunction, the duration of neuromuscular blockade was not prolonged; however, there was substantial individual variability (range: 22 to 90 minutes) [see clinical pharmacology (12.3)] .

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baxter healthcare corporation - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: 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 flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole – see contraindications and warnings ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including d.c.-cardioversion capability (see adverse reactions , suggested treatment of acute cardiovascular adverse reactions). as familiarity with the patient’s response is gained, use in an office setting may be acceptable. cardioversion has been used safely and effectively after verapamil hydrochloride injection. verapamil hydrochloride injection is contraindicated in:

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be pharmaceuticals inc. - carboprost tromethamine (unii: u4526f86fj) (carboprost - unii:7b5032xt6o) - carboprost tromethamine injection, usp is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. failure of expulsion of the fetus during the course of treatment by another method; 2. premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless con

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armas pharmaceuticals inc. - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g

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northstar rx llc - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g