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TEVA-TOBRAMYCIN 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: TEVA-TOBRAMYCIN (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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TEVA-TOBRAMYCIN should be administered by oral inhalation and using a hand-held PARI LC PLUSTM reusable nebulizer with a DeVilbiss Pulmo-Aide® compressor. TEVA-TOBRAMYCIN is not for subcutaneous, intravenous or intrathecal administration.
• The dose of TEVA-TOBRAMYCIN 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.
TEVA-TOBRAMYCIN is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop TEVA-TOBRAMYCIN 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 • Pediatrics (< 6 years of age) TEVA-TOBRAMYCIN 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 of age) Use of tobramycin inhalation solution has not been studied in geriatric patients. TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 6 of 49 • 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). • Patients with hepatic impairment Use of tobramycin inhalation solution has not been studied in patients with hepatic impairment. • Patients after organ transplantation Use of tobramycin inhalation solution has not been studied in patients after organ transplantation.
4 Administration TEVA-TOBRAMYCIN is supplied as a single-use ampoule and is administered by inhalation. TEVA- TOBRAMYCIN is not for subcutaneous, intravenous or intrathecal administration. TEVA-TOBRAMYCIN is administered using a hand-held PARI LC PLUSTM reusable nebulizer with a DeVilbiss Pulmo-Aide® compressor over a 15 minute period on average.
). TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 9 of 49 If a patient reports tinnitus or hearing loss during TEVA-TOBRAMYCIN therapy, the physician should refer them for audiological assessment. If ototoxicity occurs in a patient receiving TEVA- TOBRAMYCIN, 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. 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. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
, Renal: Nephrotoxicity). • Patients with hepatic impairment Use of tobramycin inhalation solution has not been studied in patients with hepatic impairment. • Patients after organ transplantation Use of tobramycin inhalation solution has not been studied in patients after organ transplantation.
4 Administration TEVA-TOBRAMYCIN is supplied as a single-use ampoule and is administered by inhalation. TEVA- TOBRAMYCIN is not for subcutaneous, intravenous or intrathecal administration. TEVA-TOBRAMYCIN is administered using a hand-held PARI LC PLUSTM reusable nebulizer with a DeVilbiss Pulmo-Aide® compressor over a 15 minute period on average.
TEVA-TOBRAMYCIN 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. TEVA-TOBRAMYCIN should not be diluted or mixed with dornase alfa (PULMOZYME®) in the nebulizer.
TEVA-TOBRAMYCIN 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.
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.
TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 7 of 49 5 OVERDOSAGE 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 overdose. Acute toxicity should be treated with immediate withdrawal of TEVA-TOBRAMYCIN, and baseline tests of renal function should be undertaken.
TEVA-TOBRAMYCIN is contraindicated in:
TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 5 of 49 • 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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TEVA-TOBRAMYCIN 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. TEVA-TOBRAMYCIN should not be diluted or mixed with dornase alfa (PULMOZYME®) in the nebulizer.
TEVA-TOBRAMYCIN 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.
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.
TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 7 of 49
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.
TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 10 of 49 Immune • Allergic Reactions Severe hypersensitivity (allergic) reactions have been reported following administration of tobramycin for injection to patients. TEVA-TOBRAMYCIN is contraindicated in patients with a known history of hypersensitivity to any aminoglycoside.
If an allergic reaction to TEVA-TOBRAMYCIN 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 TEVA-TOBRAMYCIN 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 TEVA-TOBRAMYCIN 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 TEVA-TOBRAMYCIN, tobramycin therapy should be discontinued until trough serum concentration falls below 2 mcg/mL.
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 TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 11 of 49 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 tobramycin inhalation solution and placebo groups who experienced […]
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.
Hemodialysis may be helpful in removing tobramycin from the body. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Inhalation Solution, 60 mg/mL tobramycin (as sulfate), nitrogen, sodium chloride, sodium hydroxide, sulfuric acid and water for injection Composition TEVA-TOBRAMYCIN 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. 25 mg sodium chloride in sterile water for injection.
0, forming the sulfate salt of tobramycin in solution. Nitrogen is used for sparging. The formulation contains no preservatives. Availability of Dosage Forms TEVA-TOBRAMYCIN is supplied in single-use, low-density polyethylene plastic 5 mL ampoules.
TEVA-TOBRAMYCIN is packaged in boxes of 56 ampoules (14 foil pouches, each containing 4 ampoules). TEVA-TOBRAMYCIN (Tobramycin Inhalation Solution) Page 8 of 49 7 WARNINGS AND PRECAUTIONS General Caution should be exercised when prescribing TEVA-TOBRAMYCIN to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Concurrent and/or sequential use of TEVA-TOBRAMYCIN with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided (see 9 DRUG INTERACTIONS).
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.
1 Pregnant Women). 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 TEVA-TOBRAMYCIN 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 TEVA-TOBRAMYCIN therapy. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with aminoglycosides.
Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Tinnitus is a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. In clinical studies, transient tinnitus occurred in eight tobramycin inhalation solution treated patients versus no placebo patients.
In post marketing experience, severe hearing loss has been reported in some patients who received tobramycin inhalation solution therapy in association with either previous or concomitant parenteral aminoglycoside use (see