Verenigde Staten - Engels - NLM (National Library of Medicine)

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin for injection is indicated for the treatment of septicemia caused by susceptible isolates of p. aeruginosa, e. coli, and klebsiella spp., in adult and pediatric patients. tobramycin for injection is indicated for the treatment of lower respiratory tract infections caused by susceptible isolates of p. aeruginosa, klebsiella spp., enterobacter spp., serratia spp., e. coli, and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bacterial meningitis caused by susceptible bacteria in adult and pediatric patients. tobramycin for injection is indicated for the treatment of intra-abdominal infections, including peritonitis, caused by susceptible isolates of e. coli, klebsiella spp., and enterobacter spp. in adult and pediatric patients. tobramycin for injection is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bone infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients tobramycin for injection is indicated for the treatment of complicated urinary tract infections caused by susceptible isolates of p. aeruginosa, proteus spp., (indole-positive and indole-negative), e. coli, klebsiella spp., enterobacter spp., serratia spp., s. aureus, providencia spp., and citrobacter spp. in adult and pediatric patients to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin for injection and other antibacterial drugs, tobramycin 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 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. tobramycin for injection is contraindicated in patients with a history of hypersensitivity to tobramycin or any other aminoglycoside [see warnings and precautions (5.4)] . risk summary aminoglycosides, including tobramycin for injection, can cause fetal harm when administered to a pregnant woman. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.3)]. in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes at doses up to 3.2 times and 1.3 times the maximum recommended clinical dose based on body surface area; however, ototoxicity was not evaluated in the offspring from these studies (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, 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 subcutaneous administration of tobramycin at doses of up to 100 mg/kg/day (rat) or 20 mg/kg/day (rabbit) during organogenesis was not associated with adverse developmental outcomes. these doses are 3.2 and 1.3 times the maximum recommended clinical daily dose of 5 mg/kg based on body surface area. doses of tobramycin ≥40 mg/kg/day were maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin. risk summary limited published data with tobramycin for injection in lactating women indicate that tobramycin is present in human milk. there are no data on the effects of tobramycin for injection on milk production. tobramycin may cause alteration in the intestinal flora of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin for injection and any potential adverse effects on the breastfed infant from tobramycin for injection or from the underlying maternal condition. use tobramycin for injection with caution in premature infants and neonates because of their renal immaturity and the resulting prolongation of serum half-life. for pediatric dosing information [see dosage and administration (2.3)]. similar to adults, monitor renal function and serum tobramycin concentrations in pediatric patients receiving tobramycin for injection. elderly patients may be at a higher risk of developing nephrotoxicity and ototoxicity while receiving tobramycin for injection [see warnings and precautions (5.1)]. tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function and serum tobramycin levels [see dosage and administration (2.6) and warnings and precautions (5.1)]. the dosage schedule of tobramycin for injection should be adjusted according to the degree of renal impairment and serum concentration [see dosage and administration (2.6)]. in patients undergoing hemodialysis, 25% to 70% of the administered dose may be removed, depending on the duration and type of dialysis.

Verenigde Staten - Engels - NLM (National Library of Medicine)

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin for injection is indicated for the treatment of septicemia caused by susceptible isolates of p. aeruginosa, e. coli, and klebsiella spp., in adult and pediatric patients. tobramycin for injection is indicated for the treatment of lower respiratory tract infections caused by susceptible isolates of p. aeruginosa, klebsiella spp., enterobacter spp., serratia spp., e. coli, and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bacterial meningitis caused by susceptible bacteria in adult and pediatric patients. tobramycin for injection is indicated for the treatment of intra-abdominal infections, including peritonitis, caused by susceptible isolates of e. coli, klebsiella spp., and enterobacter spp. in adult and pediatric patients. tobramycin for injection is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients. tobramycin for injection is indicated for the treatment of bone infections caused by susceptible isolates of p. aeruginosa, proteus spp., e. coli, klebsiella spp., enterobacter spp., and s. aureus in adult and pediatric patients tobramycin for injection is indicated for the treatment of complicated urinary tract infections caused by susceptible isolates of p. aeruginosa, proteus spp., (indole-positive and indole-negative), e. coli, klebsiella spp., enterobacter spp., serratia spp., s. aureus, providencia spp., and citrobacter spp. in adult and pediatric patients to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin for injection and other antibacterial drugs, tobramycin 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 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. tobramycin for injection is contraindicated in patients with a history of hypersensitivity to tobramycin or any other aminoglycoside [see warnings and precautions (5.4)] . risk summary aminoglycosides, including tobramycin for injection, can cause fetal harm when administered to a pregnant woman. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.3)]. in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes at doses up to 3.2 times and 1.3 times the maximum recommended clinical dose based on body surface area; however, ototoxicity was not evaluated in the offspring from these studies (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, 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 subcutaneous administration of tobramycin at doses of up to 100 mg/kg/day (rat) or 20 mg/kg/day (rabbit) during organogenesis was not associated with adverse developmental outcomes. these doses are 3.2 and 1.3 times the maximum recommended clinical daily dose of 5 mg/kg based on body surface area. doses of tobramycin ≥40 mg/kg/day were maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin. risk summary limited published data with tobramycin for injection in lactating women indicate that tobramycin is present in human milk. there are no data on the effects of tobramycin for injection on milk production. tobramycin may cause alteration in the intestinal flora of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin for injection and any potential adverse effects on the breastfed infant from tobramycin for injection or from the underlying maternal condition. use tobramycin for injection with caution in premature infants and neonates because of their renal immaturity and the resulting prolongation of serum half-life. for pediatric dosing information [see dosage and administration (2.3)]. similar to adults, monitor renal function and serum tobramycin concentrations in pediatric patients receiving tobramycin for injection. elderly patients may be at a higher risk of developing nephrotoxicity and ototoxicity while receiving tobramycin for injection [see warnings and precautions (5.1)]. tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function and serum tobramycin levels [see dosage and administration (2.6) and warnings and precautions (5.1)]. the dosage schedule of tobramycin for injection should be adjusted according to the degree of renal impairment and serum concentration [see dosage and administration (2.6)]. in patients undergoing hemodialysis, 25% to 70% of the administered dose may be removed, depending on the duration and type of dialysis.

Verenigde Staten - Engels - NLM (National Library of Medicine)

lake erie medical dba quaity care products llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 3 mg in 1 ml - tobramycin ophthalmic solution usp, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution usp, 0.3%. clinical studies have shown tobramycin to be safe and effective for use in children. tobramycin ophthalmic solution usp, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Verenigde Staten - Engels - NLM (National Library of Medicine)

alcon laboratories, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobrex® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobrex (tobramycin ophthalmic ointment) 0.3%. clinical studies have shown tobramycin to be safe and effective for use in children. tobrex (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Verenigde Staten - Engels - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobrex® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobrex (tobramycin ophthalmic ointment) 0.3%. clinical studies have shown tobramycin to be safe and effective for use in children. tobrex (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Verenigde Staten - Engels - NLM (National Library of Medicine)

eyevance pharmaceuticals, llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - tobradex st ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye pathogens: sta

Verenigde Staten - Engels - NLM (National Library of Medicine)

dr. reddy's laboratories inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with pseudomonas aeruginosa.   safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (fev1 ) <25% or >75% predicted, or patients colonized with burkholderia cepacia [see clinical studies (14) ]. tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.5) ]. although there are no available data on tobramycin inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobr

Verenigde Staten - Engels - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with pseudomonas aeruginosa . safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (fev1 ) <25% or >75% predicted, or patients colonized with burkholderia cepacia [see clinical  studies (14)]. tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.5)]. although there are no available data on tobramycin inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of t

Verenigde Staten - Engels - NLM (National Library of Medicine)

northstar rxllc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with pseudomonas aeruginosa.   safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (fev1 ) <25% or >75% predicted, or patients colonized with burkholderia cepacia [see clinical studies (14) ]. tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [ see warnings and precautions (5.5)] . although there are no available data on tobramycin inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tob

Verenigde Staten - Engels - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with pseudomonas aeruginosa . safety and efficacy have not been demonstrated in patients under the age of six years, patients with fev1 less than 40% or greater than 80% predicted, or patients colonized with burkholderia cepacia [see clinical studies (14)] . tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [warnings and precautions (5.6)]. although there are no available data on use of tobramycin inhalation solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to b