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amneal pharmaceuticals llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - 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 use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inha

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xellia pharmaceuticals aps - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 1200 mg in 30 ml - tobramycin for injection, usp is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the pediatric patient and adult caused by p. aeruginosa, e. coli, and klebsiella   spp lower respiratory tract infections caused by p. aeruginosa, klebsiella   spp, enterobacter spp, serratia spp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains) serious central-nervous-system infections (meningitis) caused by susceptible organisms intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella   spp, and enterobacter spp skin, bone, and skin structure infections caused by p. aeruginosa , proteus spp, e. coli , klebsiella spp, enterobacter s pp, and s. aureus complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus spp (indole-positive and indole-negative), e. coli , klebsiella spp, enterobacter spp, serratia spp, s. aureus , p

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sandoz inc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with p. 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). tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

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teva pharmaceuticals usa, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - 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 tobramy

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

akorn - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - 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 tobramy

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

xgen pharmaceuticals djb, inc. - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 1.2 g in 30 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa, e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginosa, klebsiella sp, enterobacter sp, serratia sp, e. coli, and s. aureus (penicillinase and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa, proteus sp, e. coli, klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa, proteus sp (indole-positive and indole-negative), e. coli, klebsiella sp, enterobacter sp, serratia s

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

genericus, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 300 mg in 5 ml - tobramycin inhalation solution pak (co-packaging of tobramycin inhalation solution and pari lc plus reusable nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with p. aeruginosa . safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with 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 [warnings and precautions (5.5)] . although there are no available data on tobramycin inhalation solution pak use in pregnant women 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 be minimal [see clinical pharmacology (12.3)] . there are risks to the mother associated with cystic fibrosis in pregnancy (see clinical considerations) . in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; 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 defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk cystic fibrosis may increase the risk for preterm delivery. data animal data no reproductive toxicity studies have been conducted with tobramycin inhalation solution. however, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes. subcutaneous doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin. risk summary there are no data on the presence of tobramycin inhalation solution in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. however, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see clinical pharmacology (12.3)] . tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin inhalation solution pak and any potential adverse effects on the breastfed infant from tobramycin inhalation solution pak or from the underlying maternal condition. clinical considerations tobramycin may cause intestinal flora alteration. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the safety and efficacy of tobramycin inhalation solution have not been studied in pediatric patients under 6 years of age. clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. 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, it may be useful to monitor renal function [see warnings and precautions (5.3)]. instructions for use tobramycin inhalation solution pak (tobramycin inhalation solution), for oral inhalation follow the instructions below for using tobramycin inhalation solution pak which contains tobramycin inhalation solution and the pari lc plus reusable nebulizer (pari lc plus). if you have any questions, ask your healthcare provider or pharmacist. each tobramycin inhalation solution pak carton (28-day supply) contains 56 tobramycin inhalation solution ampules packed in 14 foil pouches that each contain 4 single- use tobramycin inhalation solution ampules. you will need the following supplies (see figure a): - 1 tobramycin inhalation solution ampule - pari lc plus reusable nebulizer - devilbiss pulmo-aide (pulmo-aide) air compressor - tubing to connect the nebulizer and compressor - clean, lint-free towel - nose clip (optional, not pictured) note: read the instructions for use that come with your pari lc plus reusable nebulizer and devilbiss pulmo-aide air compressor for detailed instructions on how to use and care for your nebulizer and air compressor before you use it. do not mix the medicine in tobramycin inhalation solution pak with other medicines in your nebulizer. the medicine in tobramycin inhalation solution pak (tobramycin inhalation solution) comes in a sealed foil pouch. do not open a sealed pouch until you are ready to use a dose. after opening the pouch, unopened ampules should be returned to and stored in the pouch. getting ready: - open the pari lc plus package. place the pari lc plus parts including top and bottom (nebulizer cup) assembly, inspiratory valve cap, mouthpiece with valve, and tubing on a clean, dry surface or towel (see figure b). preparing your tobramycin inhalation solution pak dose: step 1: wash your hands with soap and water (see figure c). step 2: open the foil pouch (see figure d). step 3: separate 1 ampule by gently pulling apart starting at the top of the ampules and continue down to the bottom tabs (see figure e) and use it right away. step 4: hold the bottom tab on the tobramycin inhalation solution pak ampule with 1 hand (see figure f). with your other hand, hold the top of the ampule and twist off the top of the ampule (see figure f). - do not squeeze the ampule until you are ready to squeeze all of the medicine into the nebulizer cup. step 5: hold the nebulizer cup and twist off the nebulizer insert or top in a counter-clockwise direction (see figure g). set the top aside on a clean, dry, surface. step 6: squeeze all the medicine from the ampule into the nebulizer cup (see figure h). step 7: replace the nebulizer insert. line up the semi-circle on the nebulizer insert with the nebulizer outlet and twist on the nebulizer insert in a clockwise direction until it is tight and the alignment rings are lined up (see figure i). step 8: push the mouthpiece straight onto the nebulizer cup (see figure j). step 9: firmly push the inspiratory valve cap straight down onto the nebulizer cup top (see figure k). the inspiratory valve cap should fit tightly. step 10: connect 1 end of the tubing to the compressor air outlet (see figure l). the tubing should fit tightly. step 11: plug your compressor into an electrical outlet (see figure m). step 12: hold the nebulizer cup upright and firmly push the free end of the tubing straight up onto the air intake on the bottom of the nebulizer cup (see figure n). make sure to keep the nebulizer cup upright. giving your tobramycin inhalation solution pak dose: step 13: turn on the compressor (see figure o). you should see a steady mist coming from the mouthpiece (see figure p). step 14: sit or stand in a comfortable, upright position that will allow you to breathe normally. place the mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (see figure q). - nose clips may help you breathe only through your mouth and not through your nose. step 15: keep breathing in your tobramycin inhalation solution pak dose for at least 15 minutes. you will know that you have received your full dose of medicine when you hear a “sputtering noise” coming from the mouthpiece for at least 1 minute and the nebulizer cup is empty. after your tobramycin inhalation solution pak dose: step 16: clean and disinfect your nebulizer (see manufacturer's instructions for use). care and use of your devilbiss pulmo-aide compressor: follow the manufacturer's instructions for care and use of your compressor. how should i store tobramycin inhalation solution pak? - store tobramycin inhalation solution in the refrigerator between 36°f to 46°f (2°c to 8°c) until needed. - you may store the tobramycin inhalation solution in the foil pouches (opened or unopened) at room temperature between 68°f to 77°f (20°c to 25°c) for up to 28 days. - do not use tobramycin inhalation solution after the expiration date stamped on the ampule. - keep tobramycin inhalation solution in the foil pouch and out of the light. - tobramycin inhalation solution is normally slightly yellow, but may get darker with age if unrefrigerated. the color change does not change how the medicine works. - do not use tobramycin inhalation solution if it is cloudy, has particles in the solution, or if it has been stored at room temperature for more than 28 days. throw the applicable ampule(s) away in your household trash and get a new ampule. keep tobramycin inhalation solution pak and all medicines out of the reach of children. this patient information and instructions for use have been approved by the u.s. food and drug administration.         revised: date additional information pari lc plus® reusable nebulizer: 1-800-327-8632 devilbiss® pulmo-aide® air compressor: 1-800-338-1988 tobramycin inhalation solution pak: 1-877-236-7239 manufactured by: catalent pharma solutions, llc woodstock, il 60098 distributed by: genericus, inc., glen allen, 23060 va 899d9999 rev. b 11/2019 © 2016-2019 pulmoflow, inc. all rights reserved.

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

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginos a, klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacter sp. aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. the decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the warnings box above. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. a hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. a history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.

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teva parenteral medicines, inc. - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginosa , klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacte

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

baxter healthcare corporation - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginosa , klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus . complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole- positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , provi