Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

1. INDICATIONS AND USAGE TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)]. TOBRAMYCIN INHALATION SOLUTION PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa (1).

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Advisory information

contraindications
4. CONTRAINDICATIONS Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside (4).
Adverse reactions
6. ADVERSE REACTIONS 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)] Nephrotoxicity [see Warnings and Precautions (5.3)] The most common adverse reactions (> 5%) in patients treated with tobramycin inhalation solution were cough, pharyngitis, and increased sputum (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Genericus at 1-877-236-7239 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tobramycin inhalation solution was studied in two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received tobramycin inhalation solution in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks. Adverse reactions reported in these studies are described below: The most frequent adverse reactions in the tobramycin inhalation arm were cough, pharyngitis, and increased sputum (see Table 1). Thirty-three patients (13%) treated with tobramycin inhalation solution complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods. Eight patients from the tobramycin inhalation solution group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the tobramycin inhalation solution treatment regimen, and were not associated with loss of hearing in audiograms. Table 1 lists the percent of patients with selected adverse reactions that occurred in >5% of tobramycin inhalation solution patients during the two Phase III studies. Table 1: Percent of Patients With Selected Adverse Reactions Occurring in >5% of Tobramycin Inhalation Solution Patients 1 Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration. Adverse Reaction Tobramycin Inhalation Solution (n=258) % Placebo (n=262) % Cough Increased 46.1 47.3 Pharyngitis 38.0 39.3 Sputum Increased 37.6 39.7 Dyspnea 33.7 38.5 Hemoptysis 19.4 23.7 Lung Function Decreased1 16.3 15.3 Voice Alteration 12.8 6.5 Taste Perversion 6.6 6.9 Rash 5.4 6.1 Following are selected adverse reactions that occurred in less than or equal to 5% of patients treated with tobramycin inhalation solution: Ear and labyrinth disorders Tinnitus Musculoskeletal and connective tissue disorders Myalgia Infections and infestations Laryngitis 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval 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: Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus. [see WARNINGS and Precautions (5.2)] Skin and subcutaneous tissue disorders Hypersensitivity, pruritus, urticaria, rash Nervous system disorders Aphonia, dysgeusia Respiratory, thoracic, and mediastinal disorders Bronchospasm [see Warnings and Precautions (5.1)], oropharyngeal pain

Usage information

Dosing and administration
2. DOSAGE AND ADMINISTRATION TOBRAMYCIN INHALATION SOLUTION PAK is a co-packaging of tobramycin inhalation solution with a PARI LC PLUS® Reusable Nebulizer (2.1). Administer tobramycin inhalation solution as one single–use ampule (300 mg/5 mL) twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug (2.1). Dosage is not adjusted by weight (2.1). Take doses as close to 12 hours apart as possible; but not less than 6 hours apart (2.1) Administer each 300 mg dose using the PARI LC PLUS Reusable Nebulizer and DeVilbiss® PulmoAide® compressor (2.2) 2.1 Dosing Information TOBRAMYCIN INHALATION SOLUTION PAK is a co-packaging of tobramycin inhalation solution ampules with a PARI LC PLUS Reusable Nebulizer. Administer as follows: One single-use ampule (300 mg /5 mL) of tobramycin inhalation solution twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug. The 300 mg/5mL dose of tobramycin inhalation solution is the same for all patients regardless of age or weight. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. 2.2 Administration of Tobramycin Inhalation Solution Each dose of tobramycin inhalation solution is administered by oral inhalation using only the co-packaged PARI LC PLUS Reusable Nebulizer (Model No. 022B81-TA) included in the TOBRAMYCIN INHALATION SOLUTION PAK, along with a DeVilbiss Pulmo-Aide air compressor (Model No. 5650D). Tobramycin inhalation solution is not for subcutaneous, intravenous or intrathecal administration. Prior to administration, read the Patient Information/Instructions for Use for TOBRAMYCIN INHALATION SOLUTION PAK for detailed information on how to use TOBRAMYCIN INHALATION SOLUTION PAK and follow the manufacturer's instructions for use and care of the DeVilbiss Pulmo-Aide air compressor. The entire tobramycin inhalation solution treatment should take approximately 15 minutes to complete. Continue treatment until all the tobramycin inhalation solution has been delivered, and there is no longer any mist being produced. Tobramycin inhalation solution should not be diluted or mixed with other drugs including dornase alfa (Pulmozyme®) in the nebulizer. Instruct patients on multiple therapies to take their medications prior to inhaling the tobramycin inhalation solution, or as directed by their physician. 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.
Use in special populations
8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D [See Warnings and Precautions (5.5)] Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. No adequate and well-controlled studies of tobramycin inhalation solution have been conducted in pregnant women. If tobramycin inhalation solution is used during pregnancy, or if the patient becomes pregnant while taking tobramycin inhalation solution, the patient should be apprised of the potential hazard to the fetus. No reproduction toxicology studies have been conducted with tobramycin inhalation solution. However, subcutaneous administration of tobramycin at doses of 100 or 20 mg/kg/day during organogenesis was not teratogenic in rats or rabbits, respectively. Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of teratogenicity. Ototoxicity was not evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin. 8.3 Nursing Mothers It is not known if tobramycin inhalation solution will reach sufficient concentrations after administration by inhalation to be excreted in human breast milk. Because of the potential for ototoxicity and nephrotoxicity in nursing infants from tobramycin inhalation solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric patients under 6 years of age. 8.5 Geriatric Use Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.3)].
Pregnancy and lactation
8.3 Nursing Mothers It is not known if tobramycin inhalation solution will reach sufficient concentrations after administration by inhalation to be excreted in human breast milk. Because of the potential for ototoxicity and nephrotoxicity in nursing infants from tobramycin inhalation solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

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 sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided if possible. 7.2 Diuretics Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol.

More information

Category Value
Authorisation number NDA205433
Agency product number VZ8RRZ51VK
Orphan designation No
Product NDC 70644-899
Date Last Revised 11-09-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 348719
Storage and handling 16.2 Storage Tobramycin inhalation solution should be stored under refrigeration at 2-8ºC/36-46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. Tobramycin inhalation solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2-8ºC/36-46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF). Tobramycin inhalation solution ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
Marketing authorisation holder Genericus, Inc.