Tobramycin (Oral Inhalation)

(toe bra MYE sin)

• Bethkis
• Kitabis Pak
• Tobi
• Tobi Podhaler
• Tobramycin Pak [DSC]

Non-cystic fibrosis bronchiectasis

According to a national consensus summary and international guidelines, aerosolized tobramycin should not be used for the treatment and prevention of non-cystic fibrosis bronchiectasis. Aerosolized antibiotics may be considered in children and adults who have experienced 3 or more exacerbations requiring antibiotic therapy per year; organism sensitivity should be considered when choosing an antibiotic. The risk of adverse events, cost of therapy, and patient status should be considered prior to initiating aerosolized tobramycin because the efficacy of aerosolized tobramycin in the treatment of non-cystic fibrosis bronchiectasis has not been well documented.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Powder, for inhalation (Tobi Podhaler): Store in original package at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

Solution, for inhalation (Bethkis, Kitabis Pak, Tobi): Store under refrigeration at 2°C to 8°C (36°F to 46°F). May be stored in foil pouch (opened or unopened) at room temperature of 25°C (77°F) for up to 28 days. Protect from light. The colorless to pale yellow solution may darken over time if not stored under refrigeration; however, the color change does not affect product quality. Do not use if solution has been stored at room temperature for >28 days.

Loop Diuretics: May enhance the nephrotoxic effect of Tobramycin (Oral Inhalation). Loop Diuretics may enhance the ototoxic effect of Tobramycin (Oral Inhalation). Monitor therapy

Mannitol (Systemic): May enhance the nephrotoxic effect of Tobramycin (Oral Inhalation). Avoid combination

>10%:

Central nervous system: Voice disorder (4% to 14%), headache (11% to 12%)

Respiratory: Cough (powder: 10% to 48%, solution: 31%), rhinitis (solution: 11% to 35%), pulmonary disease (30% to 34%; includes pulmonary or cystic fibrosis exacerbations), reduced forced expiratory volume (solution: 1% to 31%, powder: 4%), discoloration of sputum (21%), productive cough (18% to 20%), rales (solution: 6% to 19%, powder: 7%), dyspnea (12% to 16%), decreased lung function (7% to 16%), oropharyngeal pain (11% to 14%), hemoptysis (12% to 13%), pharyngolaryngeal pain (powder: 11%, solution: 3%)

Miscellaneous: Fever (12% to 16%)

1% to 10%:

Cardiovascular: Chest discomfort (3% to 7%)

Central nervous system: Malaise (6%)

Dermatologic: Skin rash (2%)

Endocrine: Increased serum glucose (powder: 3%, solution: <1%)

Gastrointestinal: Nausea (8% to 10%), dysgeusia (powder: 4% to 7%, solution: <1%), vomiting (6%), diarrhea (2% to 4%)

Hematologic & oncologic: Increased erythrocyte sedimentation rate (solution: 8%), eosinophilia (solution: 2%), increased serum immunoglobulins (solution: 2%)

Neuromuscular & skeletal: Musculoskeletal chest pain (<1% to 5%), myalgia (solution: ≤5%)

Otic: Hypoacusis (powder: 10%), tinnitus (2% to 3%), deafness (≤1%; including unilateral deafness, reported as mild to moderate hearing loss or increased hearing loss)

Respiratory: Upper respiratory tract infection (7% to 9%), nasal congestion (7% to 8%), wheezing (5% to 7%), throat irritation (2% to 5%), bronchospasm (≤1% to 5%), laryngitis (solution: ≤5%) bronchitis (solution: 3%), epistaxis (2% to 3%), tonsillitis (solution: 2%)

<1% (Limited to important or life-threatening): Aphonia, decreased appetite, hypersensitivity reaction, increased bronchial secretions, pneumonitis, pruritus, pulmonary congestion

The utility of monitoring serum concentrations in patients with renal impairment should be per health care provider discretion; serum concentrations achieved following inhalation are significantly less than those achieved following parenteral therapy in patients with normal renal function. Monitor serum tobramycin concentrations in patients with known or history of auditory dysfunction, renal dysfunction, and/or concomitant use of nephrotoxic drugs. One hour after inhalation, serum concentrations of 1 to 2 mcg/mL have been observed.