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baxter healthcare corporation - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin in dextrose injection is indicated for the treatment of respiratory tract infections due to streptococcus pneumoniae, staphylococcus aureus and streptococcus pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . limitations of use injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin in dextrose injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available. cefazolin in dextrose injection is indicated for the treatment of urinary tract infections due to escherichia coli, and proteus mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of skin and skin structure infections due to s. aureus , s. pyogenes , and streptococcus agalactiae in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of biliary infections due to e. coli , various isolates of streptococci, p. mirabilis, and s. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of bone and joint infections due to s. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of genital infections due to e. coli, and p. mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)]. cefazolin in dextrose injection is indicated for the treatment of septicemia due to s. pneumoniae, s. aureus , p. mirabilis, and e. coli in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)] . cefazolin in dextrose injection is indicated for the treatment of endocarditis due to s. aureus and s. pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.2, 2.4 and 2.5) and use in specific populations (8.4)]. cefazolin in dextrose injection is indicated is indicated for perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved [see dosage and administration (2.1, 2.3, 2.4, 2.5) and use in specific populations (8.4)]. the perioperative use of cefazolin in dextrose injection is indicated in adult and pediatric patients (aged 10 to 17 years old) surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin in dextrose injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin in dextrose injection and other antibacterial drugs, cefazolin in dextrose 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 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. cefazolin in dextrose injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactams [see warnings and precautions (5.1) ]. risk summary available data from published prospective cohort studies, case series and case reports over several decades with cephalosporin use, including cefazolin, in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. cefazolin crosses the placenta. animal reproduction studies with rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (mrhd) did not demonstrate adverse developmental outcomes. in rats subcutaneously administered cefazolin prior to delivery and throughout lactation, there were no adverse effects on offspring at a dose approximately 2 times the mrhd (see 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. data human data while available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data reproduction studies have been performed in rats, mice and rabbits administered cefazolin during organogenesis at doses of 2000, 4000 and 240 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose on a body surface area comparison). there was no evidence of any adverse effects on embryofetal development due to cefazolin. in a peri‑postnatal study in rats, cefazolin administered subcutaneously up to 1200 mg/kg/day (approximately 2 times the mrhd based on body surface area comparison) to pregnant dams prior to delivery and through lactation caused no adverse effects on offspring. risk summary data from published literature report that cefazolin is present in human milk, but is not expected to accumulate in a breastfed infant. there are no data on the effects of cefazolin 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 cefazolin in dextrose injection and any potential adverse effects on the breastfed child from cefazolin in dextrose injection or from the mother’s underlying condition. cefazolin in dextrose injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis in pediatric patients for whom appropriate dosing with this formulation can be achieved and for perioperative prophylaxis in pediatric patients aged 10 to 17 years old [see indications and usage (1.1 to 1.8)] . safety and effectiveness of cefazolin in dextrose injection in premature infants and neonates have not been established and is not recommended for use in this age group of pediatric patients. dosing for cefazolin in pediatric patients younger than one month old has not been established. because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of cefazolin in dextrose injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of cefazolin in dextrose injection that does not equal 1 gram or 2 grams is required and an alternative formulation of cefazolin should be considered [see dosage and administration (2.2, 2,3, 2.4 and 2.5)] . the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have not been established in pediatric patients younger than 10 years old. the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have been established in pediatric patients aged 10 to 17 years old. use of cefazolin in dextrose injection in these age groups is supported by evidence from adults with additional safety and pharmacokinetic data in pediatric patients aged 10 to 17 years old. safety and pharmacokinetics were evaluated in two multicenter, non-comparative studies (study 1 and study 2). these studies were conducted to assess the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin in dextrose injection for perioperative prophylaxis in pediatric patients. study 1 evaluated the safety and pharmacokinetics of 1 g of cefazolin for injection in pediatric patients aged 10 to 17 years old scheduled for surgery with a weight of at least 25 kg but less than 60 kg and, 2 g in pediatric patients with a weight of at least 60 kg. study 2 evaluated 1 g of cefazolin for injection in pediatric patients aged 10 to 12 years old scheduled for surgery with a weight of at least 25 kg but less than 50 kg and, 2 g in pediatric patients with a weight of at least 50 kg to less than 85 kg [see dosage and administration (2.3), adverse reactions (6.1) and clinical pharmacology (12.3)] . the safety and effectiveness of cefazolin in dextrose injection for perioperative prophylaxis have not been established in pediatric patients younger than 10 years old. of the 920 subjects who received cefazolin in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. 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. 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 [see dosage and administration (2.3) and warnings and precautions (5.2) ]. when cefazolin in dextrose injection is administered to adult and pediatric patients with low urinary output because of impaired renal function (creatinine clearance less than 55 ml/min and 70 ml/min for adults and pediatric patients, respectively), lower daily dosage is required [see dosage and administration (2.4) and warnings and precautions (5.2) ].

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

anudha limited, tanzania - patient monitor -

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

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

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

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

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

celgene corporation - idecabtagene vicleucel (unii: 8px1x7ug4d) (idecabtagene vicleucel - unii:8px1x7ug4d) - abecma is a b-cell maturation antigen (bcma)-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 monoclonal antibody. none. risk summary there are no available data with abecma use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with abecma to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if abecma has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. therefore, abecma is not recommended for women who are pregnant, and pregnancy after abecma infusion should be discussed with the treating physician. assess immunoglobulin levels in newborns of mothers treated with abecma. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. risk summary there is no information regarding the presence of abecma in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for abecma and any potential adverse effects on the breastfed infant from abecma or from the underlying maternal condition. pregnancy testing pregnancy status of sexually active females with reproductive potential should be verified via pregnancy testing prior to starting treatment with abecma. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with abecma. infertility there are no data on the effect of abecma on fertility. the safety and efficacy of abecma in patients under 18 years of age have not been established. in the clinical trial of abecma, 45 (35%) of the 127 patients in the karmma study were 65 years of age or older and 4/127 (3%) patients were 75 years of age or older. all five cases of grade 3 neurotoxicity occurred in patients ≥65 years of age (66 to 74 years). no clinically important differences in effectiveness of abecma were observed between these patients and patients younger than 65 years of age.

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

baxter healthcare corporation - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - the injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol injection should not be administered to patients with known or suspected renal pathology. this caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. a much larger amount of polyethylene glycol 300 than is present in recommended doses of methocarbamol injection is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

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

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

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

baxter healthcare corporation - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride injection is indicated for the treatment of adult patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, alcohol, or monothioglycerol. [see warnings and precautions (5.4)] risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data ). there are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. advise pregnant women of the potential risk to a fetus. 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. data animal data bendamustine hydrochloride was intraperitoneally administered once to mice from 210 mg/m2 (approximately 1.8 times the mrhd) during organogenesis and caused an increase in resorptions, skeletal and visceral malformations (exencephaly, cleft palates, accessory rib, and spinal deformities) and decreased fetal body weights. this dose did not appear to be maternally toxic and lower doses were not evaluated. repeat intraperitoneal administration of bendamustine hydrochloride in mice on gestation days 7 to 11 resulted in an increase in resorptions from 75 mg/m2 (approximately 0.6 times the mrhd) and an increase in abnormalities from 112.5 mg/m2 (approximately 0.9 times the mrhd), similar to those seen after a single intraperitoneal administration. bendamustine hydrochloride was intraperitoneally administered once to rats from 120 mg/m2 (approximately the mrhd) on gestation days 4, 7, 9, 11, or 13 and caused embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses. a significant increase in external (effect on tail, head, and herniation of external organs [exomphalos]) and internal (hydronephrosis and hydrocephalus) malformations were seen in dosed rats. risk summary there are no data on the presence of bendamustine hydrochloride or its metabolites in either human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with bendamustine hydrochloride injection, and for 1 week after the last dose. bendamustine hydrochloride injection can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiation of treatment with bendamustine hydrochloride injection. contraception females advise female patients of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility based on findings from clinical studies, bendamustine hydrochloride injection may impair male fertility. impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs. in some instances, spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued. advise patients of the potential risk to their reproductive capacities. based on findings from animal studies, bendamustine hydrochloride injection may impair male fertility due to an increase in morphologically abnormal spermatozoa. the long-term effects of bendamustine hydrochloride injection on male fertility, including the reversibility of adverse effects, have not been studied [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. safety, pharmacokinetics and efficacy were assessed in a single open-label trial (nct01088984) in patients aged 1 to 19 years with relapsed or refractory acute leukemia, including 27 patients with acute lymphocytic leukemia (all) and 16 patients with acute myeloid leukemia (aml). bendamustine hydrochloride was administered as an intravenous infusion over 60 minutes on days 1 and 2 of each 21-day cycle. there was no treatment response (cr+ crp) in any patient. the safety profile in these patients was consistent with that seen in adults, and no new safety signals were identified. the pharmacokinetics of bendamustine in 43 patients, aged 1 to 19 years (median age of 10 years) were within range of values previously observed in adults given the same dose based on body surface area. no overall differences in safety were observed between patients ≥65 years of age and younger patients. efficacy was lower in patients 65 and over with cll receiving bendamustine hydrochloride based upon an overall response rate of 47% for patients 65 and over and 70% for younger patients. progression free survival was also longer in younger patients with cll receiving bendamustine (19 months vs. 12 months). no overall differences in efficacy in patients with non-hodgkin lymphoma were observed between geriatric patients and younger patients. do not use bendamustine hydrochloride injection in patients with creatinine clearance (clcr) < 30 ml/min [see clinical pharmacology (12.3)] . do not use bendamustine hydrochloride injection in patients with ast or alt 2.5-10 × upper limit of normal (uln) and total bilirubin 1.5-3 × uln, or total bilirubin > 3 × uln [see clinical pharmacology (12.3)]

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

baxter healthcare corporation - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin in sodium chloride injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved, 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 in sodium chloride injection is indicated for the treatment of adult patients for whom appropriate dosing can be achieved, with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin in sodium chloride injection is indicated for the treatment of pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved with staphylococcus aureus bloodstream infections (bacteremia). daptomycin in sodium chloride injection is not indicated for the treatment of pneumonia. daptomycin in sodium chloride 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 in sodium chloride 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 in sodium chloride injection and other antibacterial drugs, daptomycin in sodium chloride 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 in sodium chloride 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 in pediatric patients below the age of one year have not been established. avoid use of daptomycin in sodium chloride 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)]. because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of daptomycin in sodium chloride injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of daptomycin in sodium chloride injection is required that does not equal 350 mg, 500 mg, 700 mg or 1,000 mg and an alternative formulation of daptomycin should be considered [see dosage and administration (2.3, 2.5)]. daptomycin in sodium chloride injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. daptomycin in sodium chloride 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 in sodium chloride 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 in sodium chloride 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 in sodium chloride injection in pediatric patients with renal impairment has not been established.

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

baxter healthcare corporation - vasopressin (unii: y4907o6mfd) (vasopressin - unii:y4907o6mfd) - vasopressin in sodium chloride injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. vasopressin in sodium chloride injection is contraindicated in patients with a known allergy or hypersensitivity to 8-l-arginine vasopressin. risk summary there are no available data on vasopressin in sodium chloride injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted. clinical considerations there are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness of vasopressin in sodium chloride injection in pediatric patients with vasodilatory shock have not been established. clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see warnings and precautions (5), adverse reactions (6), and clinical pharmacology (12.3)].