Tobramycin Inhalation

TOBRAMYCIN INHALATION- tobramycin solution
Prasco, LLC

1 INDICATIONS AND USAGE

Tobramycin Inhalation Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [s ee Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

Tobramycin Inhalation Solution is for oral inhalation only [see Dosage and Administration (2.2)]. The recommended dosage of Tobramycin Inhalation Solution for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart.

The 300 mg/4 mL dose of Tobramycin Inhalation Solution is the same for patients regardless of age or weight. Tobramycin Inhalation Solution has not been studied in patients less than six years old.

If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose. If less than 6 hours remain before the next dose, wait until their next scheduled dose.

2.2 Administration Instructions

Tobramycin Inhalation Solution is administered by oral inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute. Tobramycin Inhalation Solution should not be diluted or mixed with dornase alfa or other medications in the nebulizer. Tobramycin Inhalation Solution is not for subcutaneous, intravenous, or intrathecal administration.

Further patient instructions on how to administer Tobramycin Inhalation Solution are provided in the Patient’s Instructions for Use [see Patient Counseling Information ( 17)].

Tobramycin Inhalation Solution should not be used if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days.

3 DOSAGE FORMS AND STRENGTHS

Tobramycin Inhalation Solution is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous inhalational solution for nebulization in single-use 4 mL ampule containing 300 mg of tobramycin.

4 CONTRAINDICATIONS

Tobramycin Inhalation Solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

5 WARNINGS AND PRECAUTIONS

5.1 Ototoxicity

Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected auditory or vestibular dysfunction.

Findings related to ototoxicity as measured by audiometric evaluations and auditory adverse event reports were similar between Tobramycin Inhalation Solution and placebo in controlled clinical trials. Hearing loss was reported in two (1.1%) Tobramycin Inhalation Solution-treated patients and in one (0.9%) placebo-treated patient during clinical studies. Additionally, dizziness and vertigo, both of which may be manifestations of vestibular forms Tobramycin Inhalation Solution of ototoxicity, were observed in similar numbers of Tobramycin Inhalation Solution- and placebo-treated patients. Dizziness occurred in two (1.1%) Tobramycin Inhalation Solution-treated patients and one (0.9%) placebo-treated patient and vertigo occurred in two (1.1%) Tobramycin Inhalation Solution-treated patients versus no placebo patients in clinical studies. None of the Tobramycin Inhalation Solution patients discontinued their therapy due to hearing loss, dizziness or vertigo.

Tinnitus may be a sentinel symptom of ototoxicity. No reports of tinnitus occurred in patients during clinical studies with Tobramycin Inhalation Solution, but because it has been observed with inhaled tobramycin solutions [see Adverse Reactions (6.2)] , onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Patients with known or suspected auditory or vestibular dysfunction should be closely monitored when taking Tobramycin Inhalation Solution. Monitoring may include obtaining audiometric evaluations and serum tobramycin levels. If ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing Tobramycin Inhalation Solution.

5.2 Nephrotoxicity

Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected renal dysfunction.

Nephrotoxicity was not seen during Tobramycin Inhalation Solution clinical studies 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 at the discretion of the treating physician. If nephrotoxicity develops, the patient should be managed as medically appropriate, including potentially discontinuing Tobramycin Inhalation Solution until serum concentrations fall below 2 mcg/mL.

Twenty-six (14%) Tobramycin Inhalation Solution patients and 15 (13%) placebo patients had increases in serum creatinine of at least 50% over baseline. Follow-up values were obtained for 17 of the 26 Tobramycin Inhalation Solution patients, all of which decreased to serum creatinine values that were within normal laboratory ranges. Patients who experience an increase in serum creatinine during treatment with Tobramycin Inhalation Solution should have their renal function closely monitored.

5.3 Neuromuscular Disorders

Tobramycin Inhalation Solution should be used cautiously in patients with muscular 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 paralysis may also occur in patients receiving concomitant neuromuscular blocking agents. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary.

5.4 Bronchospasm

Bronchospasm has been reported with inhalation of tobramycin. In clinical studies with Tobramycin Inhalation Solution, bronchospasm was observed in one (0.5%) Tobramycin Inhalation Solution-treated patient and in no placebo-treated patients. Wheezing occurred in ten (5%) Tobramycin Inhalation Solution-treated patients and four (4%) placebo-treated patients. Bronchospasm and wheezing should be treated as medically appropriate.

5.5 Laboratory Tests

Audiograms

Clinical studies of inhaled tobramycin solutions did not identify hearing loss using audiometric tests which evaluated hearing up to 8000 Hz. Physicians should consider an audiogram for patients who show any evidence of auditory dysfunction, or who are at increased risk for auditory dysfunction. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.

Serum Concentrations

In patients with normal renal function treated with Tobramycin Inhalation Solution, serum tobramycin concentrations range from approximately 0.06-1.89 mcg/mL one hour after dose administration and do not require routine monitoring. Serum concentrations of tobramycin in patients with renal dysfunction or patients treated with concomitant parenteral tobramycin should be monitored at the discretion of the treating physician [see Clinical Pharmacology (12.3)].

The serum concentration of tobramycin should only be monitored through venipuncture and not finger prick blood sampling. Contamination of the skin of the fingers with tobramycin may lead to falsely increased measurements of serum levels of the drug. This contamination cannot be completely avoided by hand washing before testing.

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