KITABIS PAK

AbsorptionTobramycin inhalation solution contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. 1 The bioavailability of tobramycin inhalation solution may vary because of individual differences in nebulizer performance and airway pathology. 2 Following administration of tobramycin inhalation solution, tobramycin remains concentrated primarily in the airways. Sputum Concentrations Ten minutes after inhalation of the first 300 mg dose of tobramycin inhal...

Two identically designed, double-blind, randomized, placebo-controlled, parallel group, 24-week clinical studies (Study 1 and Study 2) at a total of 69 cystic fibrosis centers in the United States were conducted in cystic fibrosis patients with P. aeruginosa with tobramycin inhalation solution. Subjects who were less than 6 years of age, had a baseline creatinine of > 2 mg/dL, or had B. cepacia isolated from sputum were excluded. All subjects had baseline FEV 1 % predicted between 25% and 75%. In these clinical studies, 258 patients received tobramycin inhalation solution therapy on an outpati...

The following serious adverse reactions are described below and elsewhere in the labeling: Bronchospasm [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (> 5%) in patients treated with tobramycin inhalation solution were increased cough, pharyngitis, increased sputum, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact PARI Respi...

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 ).

Bronchospasm: Can occur with inhalation of tobramycin inhalation solution. Treat as medically appropriate, if it occurs ( 5.1 ). Ototoxicity: Tinnitus and hearing loss have been reported in patients receiving tobramycin inhalation solution. If noted, manage as medically appropriate, including potentially discontinuing tobramycin inhalation solution ( 5.2 ). Nephrotoxicity: Has been associated with aminoglycosides as a class. If nephrotoxicity develops, manage the patient as medically appropriate...

7 DRUG INTERACTIONS Concurrent and/or sequential use with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided ( 7.1 ). Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity ( 7.2 ). 7.1 Drugs with Neurotoxic, Nephrotoxic or Ototoxic Potential Concurrent and/or...