Tobramycin Inhalation

Tobramycin Inhalation is an FDA-registered drug product whose active ingredient is TOBRAMYCIN INHALATION. It is labelled by Prasco, LLC taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 66993-195, application NDA201820, label effective 20230224. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TOBRAMYCIN INHALATION are most often described in connection with: tobramycin inhalation, management cystic, fibrosis patients, pseudomonas aeruginosa, age six, fev less, burkholderia cepacia, solution indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )] . Tobramycin Inhalation Solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia . ( 1 )

2 DOSAGE AND ADMINISTRATION For oral inhalation only ( 2.1 ) Administer the entire contents of one ampule twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. ( 2.1 ) 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.

4 CONTRAINDICATIONS Tobramycin Inhalation Solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Tobramycin Inhalation Solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )

6 ADVERSE REACTIONS Common adverse reactions (more than 5%) occurring more frequently in Tobramycin Inhalation Solution patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Tobramycin Inhalation Solution in two placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving Tobramycin Inhalation Solution ranged in age from 6 to 31 years. In Study 1, an eight week study, 29 patients received Tobramycin Inhalation Solution versus 30 patients who received placebo for a total of four weeks on drug and four weeks off drug. All patients were ≤ 30 years of age (mean age 12.6 years) and 46% were females. 52.5% of patients were 6 to 12 years of age while 30.5% of patients were 13-17 years old. Only 16.5% of patients were adults (> 17 years old). Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa while 20.3% of patients were initially or intermittently colonized with Pseudomonas aeruginosa during the study. More patients in the placebo group discontinued/dropped out of Study 1 than in the Tobramycin Inhalation Solution group (23% [7/30] vs 3.4% [1/29], respectively). Five patients in the placebo group compared to none in the Tobramycin Inhalation Solution group discontinued/dropped out because of treatment-emergent adverse events (TEAEs) such as pulmonary exacerbations and respiratory disorders. In Study 2, a 24 week study, 161 patients received Tobramycin Inhalation Solution versus 85 patients who received placebo in alternating four week on-off cycles for three cycles. All patients were ≤ 46 years of age (mean age 14.8 years) and 45% were females. 41% of patients were 6-12 years old while 29% of patients were 13-17 years old. Only 30% were adults (>17 years). Eighty-seven percent (87%) of patients were chronically colonized with P. aeruginosa . Only 13% were either initially or intermittently colonized with P. aeruginosa during the study. More patients in the placebo group discontinued/dropped out of Study 2 than in the Tobramycin Inhalation Solution group (9.4% [8/85] vs 4.3% [7/161], respectively). Of these, 3 patients in the Tobramycin Inhalation Solution group (1.9%) compared to 2 patients in the placebo group (2.4%) withdrew due to a TEAE. The most common TEAEs causing patients to discontinue from the study drug are respiratory, thoracic, and mediastinal disorders. The most common adverse experiences reported were respiratory disorders, consistent with the underlying disease in the patient population being evaluated and these were similarly distributed between both Tobramycin Inhalation Solution- and placebo-treated patients. The following adverse reactions were reported in at least 5% of Tobramycin Inhalation Solution-treated patients and at rates ≥ 2% more common compared to the placebo-treated patients: decreased forced expiratory volume, rales, red blood cell sedimentation rate increased, and dysphonia ( Table 1 ). Table 1: Patients with Selected Treatment-Emergent Adverse Reactions Occurring in ≥ 2% of Tobramycin Inhalation Solution Patients Adverse Reactions Tobramycin Inhalation Solution N=190 (%) Placebo N=115 (%) Forced expiratory volume decreased 59 (31%) 33 (29%) Rales 36 (19%) 18 (16%) Red blood cell sedimentation rate increased 16 (8%) 6 (5%) Dysphonia 11 (6%) 2 (2%) Wheezing 10 (5%) 4 (4%) Epistaxis 6 (3%) 0 Pharyngolaryngeal pain 5 (3%) 2 (2%) Bronchitis 5 (3%) 1 (1%) Tonsillitis 4 (2%) 0 Diarrhea 3 (2%) 1 (1%) Eosinophilia 3 (2%) 0 Immunoglobulins increased 3 (2%) 0 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tobramycin inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ear and labyrinth disorders: Hearing loss, Tinnitus [see Warnings and Precautions ( 5.1 )] Skin and subcutaneous tissue disorders : Hypersensitivity, pruritus, urticaria, rash Nervous system disorders : Aphonia, dysgeusia Respiratory, thoracic, and mediastinal disorders: Bronchospasm [see Warnings and Precautions ( 5.4 )] , oropharyngeal pain Metabolism and Nutrition Disorders: Decreased appetite

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Tobramycin Inhalation used for?
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 FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )] . Tobramycin Inhalation …

Who makes Tobramycin Inhalation?
Prasco, LLC is the labeler of record for Tobramycin Inhalation.

What form does Tobramycin Inhalation come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Tobramycin Inhalation prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Tobramycin Inhalation been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.