No black box warning on record for Tobramycin Inhalation Solution

As of the latest FDA labeling reviewed, Tobramycin Inhalation Solution (TOBRAMYCIN INHALATION SOLUTION) does not carry a black box warning. Standard warnings and precautions still apply — see the full Tobramycin Inhalation Solution medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS 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 ) Nephrotoxicit
5.1 Bronchospasm Bronchospasm can occur with inhalation of tobramycin inhalation solution. In clinical studies with tobramycin inhalation solution, changes in FEV 1 measured after the inhaled dose were similar in tobramycin inhalation solution and placebo groups. Bronchospasm that occurs during the use of tobramycin inhalation solution should be treated as medically appropriate.
5.2 Ototoxicity with use of Tobramycin inhalation solution Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Transient tinnitus occurred in eight tobramycin inhalation solution treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symp
5.3 Nephrotoxicity Nephrotoxicity was not seen during clinical studies with tobramycin inhalation solution but has been associated with aminoglycosides as a class. Patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs along with tobramycin inhalation solution should have serum concentrations of tobramycin and laboratory measurements of renal function obtained a
5.4 Neuromuscular Disorders Aminoglycosides, including tobramycin, may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease. Prolonged respiratory para

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS 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 ) Nephrotoxicit

5.1 Bronchospasm Bronchospasm can occur with inhalation of tobramycin inhalation solution. In clinical studies with tobramycin inhalation solution, changes in FEV 1 measured after the inhaled dose were similar in tobramycin inhalation solution and placebo groups. Bronchospasm that occurs during the use of tobramycin inhalation solution should be treated as medically appropriate.

5.2 Ototoxicity with use of Tobramycin inhalation solution Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Transient tinnitus occurred in eight tobramycin inhalation solution treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symp

5.3 Nephrotoxicity Nephrotoxicity was not seen during clinical studies with tobramycin inhalation solution but has been associated with aminoglycosides as a class. Patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs along with tobramycin inhalation solution should have serum concentrations of tobramycin and laboratory measurements of renal function obtained a

5.4 Neuromuscular Disorders Aminoglycosides, including tobramycin, may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease. Prolonged respiratory para

Tobramycin Inhalation Solution Black Box Warning

No black box warning on record for Tobramycin Inhalation Solution

Other warnings & precautions

Tobramycin Inhalation Solution Black Box Warning

No black box warning on record for Tobramycin Inhalation Solution

Other warnings & precautions