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TOBRAMYCIN INHALATION is a brand name for Tobramycin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TOBRAMYCIN INHALATION SOLUTION USP (tobramycin inhalation solution) is indicated for: • the management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Demonstration of safety and efficacy of tobramycin inhalation solution is limited to clinical trial data obtained…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TOBRAMYCIN INHALATION SOLUTION USP (Tobramycin Inhalation Solution) should be administered by oral inhalation and using a hand- held PARI LC PLUSTM reusable nebulizer with a DeVilbiss Pulmo-Aide® compressor.
TOBRAMYCIN INHALATION SOLUTION USP is not for subcutaneous, intravenous or intrathecal administration. • The dose of TOBRAMYCIN INHALATION SOLUTION USP is the same for all patients within the approved age range regardless of age or weight.
• Safety and efficacy have not been demonstrated in patients with Forced Expiratory Volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia. 2 Recommended Dose and Dosage Adjustment • The recommended dosage for both adults and pediatric patients 6 years of age and older is one single-use ampoule (300 mg) administered twice a day (BID) for 28 days.
The doses should be taken as close to 12 hours apart as possible; they should not be taken less than six hours apart. TOBRAMYCIN INHALATION SOLUTION USP is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBRAMYCIN INHALATION SOLUTION USP therapy for the next 28 days, and then resume therapy for the next 28 day on / 28 day off cycle.
Dosage is not adjusted by weight. All patients should be administered 300 mg BID. • Dosing in special populations o Pediatrics (< 6 years of age) TOBRAMYCIN INHALATION SOLUTION USP is not indicated for use in this age group. Safety, efficacy and pharmacokinetic studies have not been conducted in patients under the age of 6 years.
o Geriatrics (≥ 65 years of age) Use of tobramycin inhalation solution has not been studied in geriatric patients. o Patients with renal impairment Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin.
A dosing recommendation cannot be supported (see 7 WARNINGS AND PRECAUTIONS, Renal: Nephrotoxicity). o Patients with hepatic impairment Use of tobramycin inhalation solution has not been studied in patients with hepatic impairment. o Patients after organ transplantation Use of tobramycin inhalation solution has not been studied in patients after organ transplantation.
4 Administration TOBRAMYCIN INHALATION SOLUTION USP is supplied as a single-use ampoule and is administered by inhalation. TOBRAMYCIN INHALATION SOLUTION USP is not for subcutaneous, intravenous or intrathecal administration. TOBRAMYCIN INHALATION SOLUTION USP is administered using a hand-held PARI LC PLUSTM reusable nebulizer with a DeVilbiss Pulmo-Aide® compressor over a 15 minute period on average.
). If a patient reports tinnitus or hearing loss during TOBRAMYCIN INHALATION SOLUTION USP therapy, the physician should refer them for audiological assessment. If ototoxicity occurs in a patient receiving TOBRAMYCIN INHALATION SOLUTION USP, tobramycin therapy should be discontinued until serum concentrations fall below 2 mcg/mL (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests: Serum Concentrations).
1555A>G variant. These patients may be at increased risk for ototoxicity. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
Gastrointestinal • Clostridium difficile-Associated Disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including tobramycin. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. TOBRAMYCIN INHALATION SOLUTION USP (tobramycin) Page 9 of 45 Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile.
Clostridium difficile produces toxins A and B, which contribute to the development of CDAD. CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated.
, Ear/Nose/Throat: Ototoxicity 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................
4 Administration ....................................................................................................... 5 Missed Dose ..........................................................................................................
6 5 OVERDOSAGE............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS ...................................................................................
TOBRAMYCIN INHALATION SOLUTION USP is contraindicated in: • patients with a known hypersensitivity to any aminoglycoside or who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. TOBRAMYCIN INHALATION SOLUTION USP (tobramycin) Page 5 of 45
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tobramycin in Canada.
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TOBRAMYCIN INHALATION SOLUTION USP 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. TOBRAMYCIN INHALATION SOLUTION USP should not be diluted or mixed with dornase alfa in the nebulizer.
TOBRAMYCIN INHALATION SOLUTION USP must be kept out of the sight and reach of children other than when administered therapeutically under appropriate adult supervision. During clinical studies, patients on multiple therapies were instructed to take them first, followed by TOBRAMYCIN INHALATION SOLUTION USP.
5 Missed Dose In case of a missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more to make up for the missed dose.
Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile.
Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases. Immune • Allergic Reactions Severe hypersensitivity (allergic) reactions have been reported following administration of tobramycin for injection to patients.
TOBRAMYCIN INHALATION SOLUTION USP is contraindicated in patients with a known history of hypersensitivity to any aminoglycoside. If an allergic reaction to TOBRAMYCIN INHALATION SOLUTION USP does occur, stop administration of the drug and initiate treatment as appropriate (see 2 CONTRAINDICATIONS).
Monitoring and Laboratory Tests • Audiograms For patients with known or suspected auditory or vestibular dysfunction and those who are at increased risk for auditory dysfunction, it may be necessary to consider audiological assessment before initiating TOBRAMYCIN INHALATION SOLUTION USP therapy.
Tinnitus may be a sentinel symptom of ototoxicity and therefore the onset of this symptom warrants caution. If a patient reports tinnitus or hearing loss during TOBRAMYCIN INHALATION SOLUTION USP therapy, the physician should refer them for audiological assessment.
Clinical studies of 4-6 cycles duration of tobramycin inhalation solution therapy did not identify hearing loss using audiometric tests which used as criteria a bilateral, high frequency decrease of ≥ 15 dB at two consecutive frequencies, evaluating frequencies up to 8000 Hz.
However, tinnitus was documented in a small number of tobramycin inhalation solution patients, and there have been occasional reports of severe hearing loss in post marketing experience where patients received tobramycin inhalation solution in association with previous or concomitant parenteral aminoglycoside use (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
• Serum Concentrations Serum tobramycin concentrations should be monitored in patients with known or suspected auditory or renal dysfunction. Serum concentrations of tobramycin should be monitored in patients receiving concomitant parenteral aminoglycoside therapy.
These patients should be monitored as clinically appropriate, taking into account the risk of cumulative toxicity. If oto- or nephrotoxicity occurs in a patient receiving TOBRAMYCIN INHALATION SOLUTION USP, tobramycin therapy should be discontinued until trough serum concentration falls below 2 mcg/mL.
TOBRAMYCIN INHALATION SOLUTION USP (tobramycin) Page 10 of 45 In patients with normal renal function treated with tobramycin inhalation solution, serum tobramycin concentrations are approximately 1 mcg/mL one hour after dose administration.
Peak serum concentrations greater than 12 mcg/mL and trough serum concentrations > 2 mcg/mL are associated with tobramycin toxicity. All tobramycin treatment should be discontinued if concentrations exceed these levels. 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. • Renal Function Laboratory tests of urine and renal function should be conducted at the discretion of the treating physician.
The clinical studies of tobramycin inhalation solution did not reveal any imbalance in the percentage of patients in the […]
1 Special Populations.............................................................................................. 1 Pregnant Women ............................................................................................ 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
12 8 ADVERSE REACTIONS ................................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................... 5 Post-Market Adverse Reactions ..........................................................................
16 9 DRUG INTERACTIONS ................................................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................
17 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action........................................................................................... 2 Pharmacodynamics .............................................................................................
3 Pharmacokinetics ................................................................................................ 18 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
23 PART II: SCIENTIFIC INFORMATION ........................................................................................ 24 13 PHARMACEUTICAL INFORMATION .............................................................................
24 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ..................................................................................
25 15 MICROBIOLOGY ......................................................................................................... 27 16 NON-CLINICAL TOXICOLOGY ......................................................................................
29 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 33 PATIENT MEDICATION INFORMATION ................................................................................... 34 TOBRAMYCIN INHALATION SOLUTION USP (tobramycin) Page 4 of 45 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TOBRAMYCIN INHALATION SOLUTION USP (tobramycin inhalation solution) is indicated for: • the management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa (P.
aeruginosa) infections. Demonstration of safety and efficacy of tobramycin inhalation solution is limited to clinical trial data obtained over 3 cycles (6 months) of therapy for efficacy and up to 6 cycles (12 months) of therapy for safety.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with Forced Expiratory Volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia. To reduce the development of […]