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TOBI PODHALER is a brand name for Tobramycin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TOBI PODHALER (Tobramycin Inhalation Powder) is indicated for: • the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Safety and efficacy have not been demonstrated in patients with FEV1 (Forced Expiratory Volume in 1 second) <…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TOBI PODHALER (Tobramycin Inhalation Powder) should only be administered by the oral inhalation route and only using the PODHALER device. It must not be administered by any other TOBI® PODHALER®, tobramycin Product Monograph Page 5 of 46 route or using any other inhaler.
TOBI PODHALER capsules must not be swallowed. Do not administer other drugs with the PODHALER. • The dose of TOBI PODHALER 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 FEV1 (Forced Expiratory Volume in 1 second) < 25% or > 80% predicted, or patients colonized with Burkholderia cepacia.
2 Recommended Dose and Dosage Adjustment • The recommended dosage is the content of four capsules (4 x 28 mg = 112 mg tobramycin) administered twice daily for 28 days. TOBI PODHALER is taken in alternating cycles of 28 days on drug followed by 28 days off drug.
Each dose of four capsules should be inhaled as closely as possible to 12 hours apart and not less than six hours apart. • Dosing in special populations • Pediatrics (< 6 years of age): TOBI PODHALER 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. • Geriatrics (≥ 65 years): There are insufficient safety, efficacy and pharmacokinetic data in this population to recommend for or against dose adjustment.
Renal function in elderly patients should be taken into account while using TOBI PODHALER. • Patients with hepatic impairment: No studies have been performed in patients with hepatic impairment. As tobramycin is not metabolized, the effect of hepatic impairment on the exposure to tobramycin is not expected.
• Patients with renal impairment: Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more were not included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI PODHALER.
Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect exposure to tobramycin. Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected renal dysfunction.
). If a patient reports tinnitus or hearing loss during TOBI PODHALER therapy, the physician should refer TOBI® PODHALER®, tobramycin Product Monograph Page 8 of 46 them for audiological assessment. If ototoxicity occurs in a patient receiving TOBI PODHALER, all tobramycin therapy should be discontinued until trough serum concentrations fall below 2 μg/mL (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
In post marketing experience, severe hearing loss has been reported in some patients who received TOBI (Tobramycin Solution for Inhalation) therapy in association with either previous or concomitant parenteral aminoglycoside use. 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. 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.
General TOBI PODHALER (Tobramycin Inhalation Powder) is administered only by the oral inhalation route and only with the PODHALER device. It must not be administered by any other route or with any other device. TOBI PODHALER capsules must not be swallowed.
The use of TOBI PODHALER has not been studied in patients after organ transplantation. Caution should be exercised when TOBI PODHALER is prescribed to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Systemic exposure with inhaled antibiotics is generally minimal. Concurrent and/or sequential use of TOBI PODHALER with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. If parenteral aminoglycoside therapy is needed, patients should be monitored as clinically appropriate (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests and 9 DRUG INTERACTIONS).
The prevalence of P. aeruginosa infection in cystic fibrosis patients increases with age. P. aeruginosa infection has been associated with poorer clinical outcomes, including more rapid decline in pulmonary function and higher mortality rates in CF patients.
Driving and Operating Machinery Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Ear/Nose/Throat • Ototoxicity Caution should be exercised when TOBI PODHALER is prescribed to patients with known or suspected auditory or vestibular dysfunction.
In these patients and those who are at increased risk for auditory dysfunction, it may be necessary to consider audiological assessment before initiating TOBI PODHALER therapy. Ototoxicity, manifested as both auditory toxicity (hearing loss, tinnitus) and vestibular toxicity, has been reported with aminoglycosides.
Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness. Tinnitus can have several causes but is a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Hearing loss and tinnitus were reported by patients in the TOBI PODHALER clinical trials (see
• TOBI PODHALER (Tobramycin Inhalation Powder) is contraindicated in patients with a known hypersensitivity to aminoglycosides or who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or any components of the capsule or the container.
For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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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No studies have been conducted in patients requiring hemodialysis. • Patients after organ transplant: There are no data for the use of TOBI PODHALER in patients after organ transplant. No recommendation for or against dose adjustment can be made for patients after organ transplant.
4 Administration TOBI PODHALER is administered only by the oral inhalation route and only using the PODHALER device. It must not be administered by any other route or using any other inhaler. TOBI PODHALER capsules must not be swallowed.
To ensure proper administration of the drug, the physician or other health professional should show the patient how to operate the PODHALER inhalation device (see 12 SPECIAL HANDLING INSTRUCTIONS). Where patients are using a short-acting bronchodilator, it should be inhaled 15-90 minutes prior to TOBI PODHALER treatment.
The order of chest physiotherapy and other inhaled therapies should TOBI® PODHALER®, tobramycin Product Monograph Page 6 of 46 follow the physician’s recommendation. TOBI PODHALER should always be taken last. 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 capsules to make up for the missed dose.
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. 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.
Hepatic/Biliary/Pancreatic • Patients with hepatic impairment No studies have been performed in patients with hepatic impairment. As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Immune • Allergic Reactions TOBI® PODHALER®, tobramycin Product Monograph Page 9 of 46 Severe hypersensitivity (allergic) reactions have been reported following administration of tobramycin for injection to patients. TOBI PODHALER is contraindicated in patients with a known history of hypersensitivity to any aminoglycoside.
If an allergic reaction to TOBI PODHALER does occur, stop administration of the drug and initiate treatment as appropriate (see 2 CONTRAINDICATIONS). Monitoring and Laboratory Tests Laboratory tests of urine and renal function should be conducted at the discretion of the treating physician.
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 TOBI PODHALER, tobramycin therapy should be discontinued until trough serum concentration falls below 2 μg/mL.
Serum tobramycin concentrations are approximately 1 to 2 μg/mL one hour after TOBI PODHALER administration. Peak serum concentrations greater than 12 μg/mL and trough serum concentrations > 2 μg/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. 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 TOBI PODHALER therapy.
If a patient reports tinnitus or hearing loss during TOBI PODHALER therapy, the physician should refer them for audiological assessment. Neurologic • Neuromuscular dysfunction Caution should be exercised when TOBI PODHALER is prescribed to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson’s disease.
Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Renal • Nephrotoxicity Caution should be exercised when TOBI PODHALER is prescribed to patients with known or suspected renal dysfunction and serum concentrations of tobramycin should be monitored (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Nephrotoxicity has been reported with the use of parenteral aminoglycosides. Nephrotoxicity was not observed […]