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Tobramycin
Overview
What is TOBI?
TOBI is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is CHNO and the molecular weight is 467.52. Tobramycin is -3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)--[2,6-diamino-2,3,6-trideoxy-α-D--hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is:
Each single-use 5 mL ampule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.
What does TOBI look like?
What are the available doses of TOBI?
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What should I talk to my health care provider before I take TOBI?
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How should I use TOBI?
TOBI is indicated for the management of cystic fibrosis patients with .
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV) <25% or >75% predicted, or patients colonized with (see CLINICAL STUDIES).
The recommended dosage for both adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered BID for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg BID. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
TOBI is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help the patient breathe through the mouth.
TOBI is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle.
TOBI is supplied as a single-use ampule and is administered by inhalation, using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. TOBI is not for subcutaneous, intravenous or intrathecal administration.
What interacts with TOBI?
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What are the warnings of TOBI?
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What are the precautions of TOBI?
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What are the side effects of TOBI?
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What should I look out for while using TOBI?
TOBI is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI should be apprised of the potential hazard to the fetus.
What might happen if I take too much TOBI?
Signs and symptoms of acute toxicity from overdosage of intravenous (IV) tobramycin might include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. Administration by inhalation results in low systemic bioavailability of tobramycin. Tobramycin is not significantly absorbed following oral administration. Tobramycin serum concentrations may be helpful in monitoring overdosage.
In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.
How should I store and handle TOBI?
TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI 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.TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI 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.TOBI 300 mg is available as follows:NDC 0078-0494-715 mL single-dose ampule (carton of 56)TOBI 300 mg is available as follows:NDC 0078-0494-715 mL single-dose ampule (carton of 56)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
TOBI contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes.The bioavailability of TOBI may vary because of individual differences in nebulizer performance and airway pathology.Following administration of TOBI, tobramycin remains concentrated primarily in the airways.
Sputum Concentrations:
Serum Concentrations:
Elimination:
Non-Clinical Toxicology
TOBI is contraindicated in patients with a known hypersensitivity to any aminoglycoside.Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI should be apprised of the potential hazard to the fetus.
In clinical studies of TOBI, patients taking TOBI concomitantly with dornase alfa (PULMOZYME, Genentech), ß-agonists, inhaled corticosteroids, other anti-pseudomonal antibiotics, or parenteral aminoglycosides demonstrated adverse experience profiles similar to the study population as a whole.
Concurrent and/or sequential use of TOBI with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI has not been evaluated.
NOTE: In addition to information provided below, a Patient Medication Guide providing instructions for proper use of TOBI is contained inside the package.
TOBI was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI 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.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI-treated patients. Thirty-three patients (13%) treated with TOBI complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss. The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI and placebo groups.
Nine (3%) patients in the TOBI group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI group, creatinine decreased at the next visit.
Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in >5% of TOBI patients during the two Phase III studies.
Adverse drug reactions (<5%) occurring more frequently with TOBI in the placebo-controlled studies and assessed as drug-related in ≥1% of patients:
Ear and labyrinth disorders
Tinnitus (3.1%, vs 0% for placebo)
Musculoskeletal and connective tissue disorders
Myalgia (4.7%, vs 2.7% for placebo)
Infections and infestations
Laryngitis (4.3%, vs 3.1% for placebo)
Adverse drug reactions derived from spontaneous reports
The following adverse reactions have been identified during postapproval use of TOBI. 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 (see WARNINGS – Ototoxicity)
Skin and subcutaneous tissue disorders
Hypersensitivity, pruritus, urticaria, rash
Nervous system disorders
Aphonia, dysgeusia
Respiratory, thoracic, and mediastinal disorders
Bronchospasm (see WARNINGS – Bronchospasm), oropharyngeal pain
Metabolism and Nutrition Disorders
Decreased appetite
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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