Levalbuterol and Tobramycin Sulfate

• Generic Name: levalbuterol
• Dosage Forms: inhalation solution
• Other Brand Names: Xopenex, Xopenex Concentrate, Xopenex HFA

Levalbuterol is a short-acting bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Levalbuterol inhalation is used to treat or prevent asthma attacks in adults and children who are at least 4 years old.

Levalbuterol inhalation may also be used for purposes not listed in this medication guide.

• Generic Name: tobramycin
• Dosage Forms: n.a.
• Other Brand Names: Bethkis, Kitabis Pak, Tobi, TOBI Podhaler

Treatment of serious bone and joint infections caused by susceptible Staphylococcus aureus, Enterobacter, Escherichia coli, Klebsiella, Proteus, or Pseudomonas aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible Enterobacter, E. coli, or Klebsiella. Used as an adjunct to other appropriate anti-infectives.

Treatment of CNS infections (meningitis) caused by susceptible gram-negative bacteria.

Aminoglycosides should not be used alone for treatment of meningitis; usually used as an adjunct to other anti-infectives in initial treatment. Used in conjunction with ampicillin for initial empiric treatment of neonatal Streptococcus agalactiae (group B streptococci) meningitis or for Listeria monocytogenes meningitis.

Treatment of serious respiratory tract infections caused by susceptible S. aureus, Enterobacter, E. coli, Klebsiella, Serratia, or Ps. aeruginosa. Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of nosocomial pneumonia.

Administered by oral inhalation via nebulization for management of bronchopulmonary Ps. aeruginosa infections in cystic fibrosis patients ≥6 years of age. Safety and efficacy not established in pediatric patients < 6 years of age, in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% of the predicted value, or in patients colonized with Burkholderia cepacia (formerly Ps. cepacia).

Treatment of septicemia caused by susceptible E. coli, Klebsiella, or Ps. aeruginosa.

Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of life-threatening septicemia.

Treatment of serious skin and skin structure infections caused by susceptible S. aureus, Enterobacter, E. coli, Klebsiella, Proteus, or Ps. aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Treatment of serious complicated and recurrent UTIs caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Providencia, Serratia, or Ps. aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Not indicated for uncomplicated UTIs unless causative organism is resistant to other less-toxic alternatives.

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients. Used in conjunction with an appropriate antipseudomonal cephalosporin (e.g., ceftazidime, ceftriaxone), extended-spectrum penicillin (e.g., ticarcillin, piperacillin and tazobactam, ticarcillin and clavulanate), or carbapenem (e.g., imipenem, meropenem).

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients. Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.