Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated 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

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections: due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of st

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - before instituting treatment with ceftriaxone for injection, usp, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, usp and other antibacterial drugs, ceftriaxone 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, 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. ceftriaxone for injection, usp is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections caused by streptococcus pneumoniae, staphylococcus aureus, haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, escherichia coli, enterobacter aerogenes, proteus mirabilis or serratia marcescens. acute bacterial otitis media caused by streptococcus pneumoniae, haemophilus influenzae (including beta‑lactamase producing strains) or moraxella catarrhalis (including beta-lactamase producing strains). note: in one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, usp compared to 10 days of oral therapy. in a second study comparable cure rates were observed between single dose of ceftriaxone for injection, usp and the comparator. the potentially lower clinical cure rate of ceftriaxone for injection, usp should be balanced against the potential advantages of parenteral therapy (see clinical studies ). skin and skin structure infections caused by staphylococcus aureus, staphylococcus epidermidis, streptococcus pyogenes , viridans group streptococci, escherichia coli, enterobacter cloacae, klebsiella oxytoca, klebsiella pneumoniae, proteus mirabilis, morganella morganii1 , pseudomonas aeruginosa, serratia marcescens, acinetobacter calcoaceticus, bacteroides fragilis1 or peptostreptococcus species. urinary tract infections (complicated and uncomplicated) caused by escherichia coli, proteus mirabilis, proteus vulgaris, morganella morganii or klebsiella pneumoniae. uncomplicated gonorrhea (cervical/urethral and rectal) caused by neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase‑producing strains of neisseria gonorrhoeae. pelvic inflammatory disease caused by neisseria gonorrhoeae. ceftriaxone for injection, usp, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. bacterial septicemia caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, haemophilus influenzae or klebsiella pneumoniae. bone and joint infections caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, proteus mirabilis, klebsiella pneumoniae or enterobacter species. intra-abdominal infections caused by escherichia coli, klebsiella pneumoniae, bacteroides fragilis, clostridium species (note: most strains of clostridium difficile are resistant) or peptostreptococcus species. meningitis caused by haemophilus influenzae, neisseria meningitidis or streptococcus pneumoniae. ceftriaxone for injection, usp has also been used successfully in a limited number of cases of meningitis and shunt infection caused by staphylococcus epidermidis1 and escherichia coli.1 1 efficacy for this organism in this organ system was studied in fewer than ten infections. the preoperative administration of a single 1 gm dose of ceftriaxone for injection, usp may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). although ceftriaxone for injection, usp has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. when administered prior to surgical procedures for which it is indicated, a single 1 gm dose of ceftriaxone for injection, usp provides protection from most infections due to susceptible organisms throughout the course of the procedure. ceftriaxone is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see warnings – hypersensitivity ). premature neonates: ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age). hyperbilirubinemic neonates: hyperbilirubinemic neonates should not be treated with ceftriaxone. ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients. ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium‑containing iv solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone‑calcium (see clinical pharmacology , warnings and dosage and administration ). cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. in some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. there have been no similar reports in patients other than neonates. intravenous administration of ceftriaxone solutions containing lidocaine is contraindicated. when lidocaine solution is used as a solvent with ceftriaxone for intramuscular injection, exclude all contraindications to lidocaine. refer to the prescribing information of lidocaine.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc - meropenem (unii: fv9j3ju8b1) (meropenem anhydrous - unii:yop6px0bao) - meropenem for injection is indicated for the treatment of complicated skin and skin structure infections (csssi) due to staphylococcus aureus (methicillin-susceptible isolates only), streptococcus pyogenes, streptococcus agalactiae , viridans group streptococci, enterococcus faecalis (vancomycin-susceptible isolates only), pseudomonas aeruginosa, escherichia coli, proteus mirabilis, bacteroides fragilis, and peptostreptococcus species . meropenem for injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, escherichia coli, klebsiella pneumoniae, pseudomonas aeruginosa, bacteroides fragilis, b. thetaiotaomicron, and peptostreptococcus species . meropenem for injection is indicated for the treatment of bacterial meningitis caused by  haemophilus influenzae , neisseria meningitidis and penicillin-susceptible isolates of streptococcus pneumoniae. meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. to reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection and other antibacterial drugs, meropenem for injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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. meropenem is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. risk summary there are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. no fetal toxicity or malformations were observed in pregnant rats and cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (mrhd) based on body surface area comparison, respectively. in rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the mrhd based on body surface area comparison (see data ). the 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. data meropenem administered to pregnant rats during organogenesis (gestation day 6 to gestation day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. the no-observed-adverse-effect-level (noael) for fetal toxicity in this study was considered to be the high dose of 750 mg/kg/day (equivalent to approximately 2.4 times the mrhd of 1 gram every 8 hours based on body surface area comparison). meropenem administered intravenously to pregnant cynomolgus monkeys during organogenesis from day 20 to 50 after mating at doses of 120, 240, and 360 mg/kg/day did not produce maternal or fetal toxicity at the noael dose of 360 mg/kg/day (approximately 2.3 times the mrhd based on body surface area comparison). in a peri-postnatal study in rats described in the published literature 2 , intravenous meropenem was administered to dams from gestation day 17 until lactation day 21 at doses of 240, 500, and 1000 mg/kg/day. there were no adverse effects in the dams and no adverse effects in the first generation offspring (including developmental, behavioral, and functional assessments and reproductive parameters) except that female offspring exhibited lowered body weights which continued during gestation and nursing of the second generation offspring. second generation offspring showed no meropenem-related effects. the noael value was considered to be 1000 mg/kg/day (approximately 3.2 times the mrhd based on body surface area comparisons). risk summary meropenem has been reported to be excreted in human milk. no information is available on the effects of meropenem on the breast-fed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem and any potential adverse effects on the breast-fed child from meropenem or from the underlying maternal conditions. the safety and effectiveness of meropenem have been established for pediatric patients 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for pediatric patients of all ages with complicated intra-abdominal infections. skin and skin structure infections use of meropenem in pediatric patients 3 months of age and older with complicated skin and skin structure infections is supported by evidence from an adequate and well-controlled study in adults and additional data from pediatric pharmacokinetics studies [ see indications and usage (1.3) , dosage and administration (2.3) , adverse reactions (6.1) , clinical pharmacology (12.3),  clinical studies (14.1) ] . intra-abdominal infections use of meropenem in pediatric patients 3 months of age and older with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetics studies and controlled clinical trials in pediatric patients. use of meropenem in pediatric patients less than 3 months of age with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric pharmacokinetic and safety study [ see indications and usage (1.2) , dosage and administration (2.3) , adverse reactions (6.1) , clinical pharmacology (12.3),  clinical studies (14.2) ] . bacterial meningitis use of meropenem in pediatric patients 3 months of age and older with bacterial meningitis is supported by evidence from adequate and well-controlled studies in the pediatric population [ see indications and usage (1.3) , dosage and administration (2.3) , adverse reactions (6.1) , clinical pharmacology (12.3), clinical studies (14.3) ] . of the total number of subjects in clinical studies of meropenem, approximately 1100 (30%) were 65 years of age and older, while 400 (11%) were 75 years and older. additionally, in a study of 511 patients with complicated skin and skin structure infections, 93 (18%) were 65 years of age and older, while 38 (7%) were 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects; spontaneous reports and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. meropenem 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. 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. a pharmacokinetic study with meropenem in elderly patients has shown a reduction in the plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance [ see clinical pharmacology (12.3) ] . dosage adjustment is necessary in patients with creatinine clearance 50 ml/min or less [ see dosage and administration (2.2) , warnings and precautions (5.8) , clinical pharmacology (12.3) ] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, 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%–30% of human intubation dose of 0.6–1.2 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 us 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 (35–166) 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: 22-90 minutes) [see clinical pharmacology (12.3)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see clinical studies (14.1)], liver transplant [see clinical studies (14.2)] , heart transplant [see clinical studies (14.3)] , or lung transplant [see clinical studies (14.4)] in combination with other immunosuppressants . tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. healthcare

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin for injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus (including methicillin-resistant isolates), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae subsp. equisimilis, and enterococcus faecalis (vancomycin-susceptible isolates only). daptomycin for injection is indicated for the treatment of adult patients with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with staphylococcus aureus bloodstream infections (bacteremia). daptomycin for injection is not indicated for the treatment of pneumonia. daptomycin for injection is not i

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin for injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus (including methicillin-resistant isolates), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae subsp. equisimilis, and enterococcus faecalis (vancomycin-susceptible isolates only). daptomycin for injection is indicated for the treatment of adult patients with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with staphylococcus aureus bloodstream infections (bacteremia). daptomycin for injection is not indicated for the treatment of pneumonia. daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to s. aureus . the clinical trial of daptomycin for injection in adult patients with s. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see clinical studies (14.2)] . daptomycin for injection has not been studied in patients with prosthetic valve endocarditis. daptomycin for injection is not recommended in pediatric patients younger than 1 year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see warnings and precautions (5.7) and nonclinical toxicology (13.2)]. appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection 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 is available, it 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. empiric therapy may be initiated while awaiting test results. daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin [see warnings and precautions (5.1)]. risk summary limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4-times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). no evidence of adverse developmental outcomes was observed. the 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 2-4% and 15-20%, respectively. data animal data in pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. maternal body weight gain was decreased at 75 mg/kg/day. no embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area). in pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. maternal body weight gain and food consumption were decreased at 75 mg/kg/day. no embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area). in a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20. no effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area)1 . risk summary limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose (see data) 2,3,4 . there is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for daptomycin for injection and any potential adverse effects on the breastfed infant from daptomycin for injection or from the underlying maternal condition. the safety and effectiveness of daptomycin for injection in the treatment of csssi and s. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. use of daptomycin for injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and pk studies in pediatric patients with csssi and s. aureus bloodstream infections [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)] . safety and effectiveness of daptomycin for injection in pediatric patients below the age of one year have not been established. avoid use of daptomycin for injection in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see warnings and precautions (5.7) and nonclinical toxicology (13.2)] . daptomycin for injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. daptomycin for injection has not been studied in pediatric patients with other bacterial infections. of the 534 adult patients treated with daptomycin for injection in phase 3 controlled clinical trials of complicated skin and skin structure infections (csssi), 27% were 65 years of age or older and 12% were 75 years of age or older. of the 120 adult patients treated with daptomycin for injection in the phase 3 controlled clinical trial of s. aureus bacteremia/endocarditis, 25% were 65 years of age or older and 16% were 75 years of age or older. in phase 3 adult clinical trials of csssi and s. aureus bacteremia/endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of age. in addition, treatment-emergent adverse events were more common in patients ≥65 years of age than in patients <65 years of age. the exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. however, no adjustment of daptomycin for injection dosage is warranted for elderly patients with creatinine clearance (clcr ) ≥30 ml/min [see dosage and administration (2.6) and clinical pharmacology (12.3)] . daptomycin is eliminated primarily by the kidneys; therefore, a modification of daptomycin for injection dosage interval is recommended for adult patients with clcr <30 ml/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (capd). in adult patients with renal impairment, both renal function and creatine phosphokinase (cpk) should be monitored more frequently than once weekly [see dosage and administration (2.6) , warnings and precautions (5.2, 5.10), and clinical pharmacology (12.3)] . the dosage regimen for daptomycin for injection in pediatric patients with renal impairment has not been established.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - bacitracin (unii: 58h6rwo52i) (bacitracin - unii:58h6rwo52i) - in accordance with the statements in the "warning box" the use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. to reduce the development of drug-resistant bacteria and maintain the effectiveness of bacitracin and other antibacterial drugs, bacitracin 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, 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. this drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

civica, inc. - etomidate (unii: z22628b598) (etomidate - unii:z22628b598) - etomidate injection, usp is indicated by intravenous injection for induction of general anesthesia. when considering use of etomidate, the usefulness of its hemodynamic properties (see clinical pharmacology ) should be weighed against the high frequency of transient skeletal muscle movements (see adverse reactions ). intravenous etomidate is also indicated for supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization. etomidate is contraindicated in patients who have shown hypersensitivity to it.