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

eugia us llc - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe) - amphotericin b liposome for injection is indicated for the following: - empirical therapy for presumed fungal infection in febrile, neutropenic patients. - treatment of cryptococcal meningitis in hiv-infected patients (see description of clinical studies ). - treatment of patients with aspergillus species, candida species and/or cryptococcus species infections (see above for the treatment of cryptococcal meningitis) refractory to amphotericin b deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin b deoxycholate. - treatment of visceral leishmaniasis. in immunocompromised patients with visceral leishmaniasis treated with amphotericin b liposome for injection, relapse rates were high following initial clearance of parasites (see description of clinical studies ). see dosage and administration   for recommended doses by indication. eleven clinical studies supporting the efficacy and safety of amphotericin b were conducted. this clinical program include

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

eugia pharma specialities limited - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed  nausea  and  vomiting  associated  with  initial  and  repeat  courses  of  moderately emetogenic cancer chemotherapy (mec). limitations of use - fosaprepitant has not been studied for the treatment of established nausea and vomiting. pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co., inc.’s emend (fosaprepitant) for injection. however, due to merck sharp & dohme corp., a subsidiary of merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. fosaprepitant is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see warnings and precautions (5.2), adverse reactions (6.2)]. - taking pimozide. inhibition of cyp3a4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a cyp3a4 substrate, potentially causing serious or life-threatening reactions, such as qt prolongation, a known adverse reaction of pimozide [see warnings and precautions (5.1)]. risk summary there are insufficient data on use of fosaprepitant in pregnant women to inform a drug associated risk. in animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (auc) approximately equivalent to the exposure at the recommended human dose (rhd) of 150 mg [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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 animal data in embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1,000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits). no embryofetal lethality or malformations were observed at any dose level in either species. the exposures (auc) in pregnant rats at 1,000 mg/kg twice daily and in pregnant rabbits at 25 mg/kg/day were approximately equivalent to the exposure at the rhd of 150 mg. aprepitant crosses the placenta in rats and rabbits. risk summary lactation studies have not been conducted to assess the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. aprepitant is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fosaprepitant and any potential adverse effects on the breastfed infant from fosaprepitant or from the underlying maternal condition. contraception upon administration of fosaprepitant, the efficacy of hormonal contraceptives may be reduced. advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms and spermicides) during treatment with fosaprepitant and for 1 month following the last dose [see drug interactions (7.1), clinical pharmacology (12.3)]. the safety and effectiveness of fosaprepitant for the prevention of nausea and vomiting associated with hec or mec have not been established in patients less than 6 months of age. juvenile animal toxicity data in juvenile dogs treated with fosaprepitant, changes in reproductive organs were observed. in juvenile rats treated with aprepitant, slight changes in sexual maturation were observed without an effect on reproduction. no effects on neurobehavior, sensory and motor function, or learning and memory were observed in rats. in a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 (equivalent to a newborn human) to day 42 (approximately equivalent to a 2 year old human), decreased testicular weight and leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and edema of vaginal tissues were seen in females from 4 mg/kg/day. a study was also conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. rats were treated at oral doses up to the maximum feasible dose of 1,000 mg/kg twice daily from the early postnatal period (postnatal day 10 (equivalent to a newborn human) through postnatal day 58 (approximately equivalent to a 15 year old human)). slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. there were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory. pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co., inc.’s emend (fosaprepitant) for injection. however, due to merck sharp & dohme corp., a subsidiary of merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the 1,649 adult cancer patients treated with intravenous fosaprepitant in hec and mec clinical studies, 27%  were aged  65 and  over,  while  5%  were  aged  75  and  over. other reported clinical experience with fosaprepitant has not identified differences in responses between elderly and younger patients. in general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see clinical pharmacology (12.3)]. the pharmacokinetics of aprepitant in patients with mild and moderate hepatic impairment were similar to those of healthy subjects with normal hepatic function. no dosage adjustment is necessary for patients with mild to moderate hepatic impairment (child-pugh score 5 to 9). there are no clinical or pharmacokinetic data in patients with severe hepatic impairment (child-pugh score greater than 9). therefore, additional monitoring for adverse reactions in these patients may be warranted when fosaprepitant is administered [see clinical pharmacology (12.3)].

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

eugia us llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3,000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2 ). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam and any potential adverse effects on the breastfed child from piperacillin and tazobactam or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see  adverse reactions (6.1) and clinical pharmacology (12.3) ] . use of piperacillin and tazobactam in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions (6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam have not been established in pediatric patients less than 2 months of age [see clinical pharmacology (12) and dosage and administration (2)] . dosage of piperacillin and tazobactam in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age. however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ] . 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. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product. at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium. the geriatric population may respond with a blunted natriuresis to salt loading. this may be clinically important with regard to such diseases as congestive heart failure. this drug is known to be substantially excreted by the kidney, and the risk of toxic 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. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ] . dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3) ] .  as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Canada - English - Health Canada

eugia pharma inc. - naloxone hydrochloride - solution - 4mg - naloxone hydrochloride 4mg

Canada - English - Health Canada

eugia pharma inc. - phenylephrine hydrochloride - solution - 10mg - phenylephrine hydrochloride 10mg

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

eugia us llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 75 mg in 100 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant’s gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions (6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl <50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration (2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.

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

eugia us llc - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - polymyxin b 500000 [usp'u] - acute infections caused by susceptible strains of pseudomonas aeruginosa. polymyxin b sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of ps. aeruginosa . it may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of ps. aeruginosa . it may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: h influenzae , specifically meningeal infections. escherichia coli , specifically urinary tract infections. aerobacter aerogenes , specifically bacteremia. klebsiella pneumoniae , specifically bacteremia. note: in meningeal infections, polymyxin b sulfate should be administered only by the intrathecal route. to reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin b and other antibacterial drugs,

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

auromedics pharma llc - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its ex

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

asclemed usa, inc. - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - intramuscular where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. dermatologic diseases: bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). 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), congenital adrenal hyperplasia, hypercalcemia

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

eugia us llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin 10 g in 100 ml - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ). nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to a methicillin-resistant staphylococcus sp., therapy with nafcillin for injection, usp should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection, usp and other antibacterial drugs, nafcillin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available,