pharmacopeia
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/api/v1/drug/tobramycin

Boxed warning

Patients treated with Tobramycin Injection and other aminoglycosides should be under close clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth-nerve impairment and nephrotoxicity may develop, primarily in patients having pre-existing renal damage and in those with normal renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Protein Synthesis Inhibitors.

Protein Synthesis

Indications

Sourced from openFDA
  • Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E.

Contraindications

Sourced from openFDA
  • A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.contraindicated

Dosage & administration

Sourced from openFDA

Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. This insert is for a Pharmacy Bulk Package and is intended for preparing I.V. admixtures only. Dosage recommendations for intramuscular use are for informational purposes only. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see WARNINGS box and PRECAUTIONS ). Administration for Patients with Normal Renal Function— Adults with Serious Infections : 3 mg/kg/day in 3 equal doses every 8 hours (see Table 3). Adults with Life-Threatening Infections : Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see WARNINGS box and PRECAUTIONS ).

Warnings & precautions

Sourced from openFDA

See WARNINGS box above. This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson Syndrome have been reported rarely in patients on tobramycin therapy. Although rare, fatalities have been reported (see CONTRAINDICATIONS ). If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tobramycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Adverse reactions

Sourced from openFDA

Neurotoxicity — Adverse effects on both the vestibular and auditory branches of the eighth nerve have been noted, especially in patients receiving high doses or prolonged therapy, in those given previous courses of therapy with an ototoxin, and in cases of dehydration. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss. Hearing loss is usually irreversible and is manifested initially by diminution of high-tone acuity. Tobramycin and gentamicin sulfates closely parallel each other in regard to ototoxic potential. Nephrotoxicity — Renal function changes, as shown by rising BUN, NPN, and serum creatinine and by oliguria, cylindruria, and increased proteinuria, have been reported, especially in patients with a history of renal impairment who are treated for longer periods or with higher doses than those recommended. Adverse renal effects can occur in patients with initially normal renal function. Clinical studies and studies in experimental animals have been conducted to compare the nephrotoxic potential of tobramycin and gentamicin. In some of the clinical studies and in the animal studies, tobramycin caused nephrotoxicity significantly less frequently than gentamicin. In some other clinical studies, no significant difference in the incidence of nephrotoxicity between tobramycin and gentamicin was found.

Overdosage

Sourced from openFDA

Signs and Symptoms— The severity of the signs and symptoms following a tobramycin overdose are dependent on the dose administered, the patient’s renal function, state of hydration, and age and whether or not other medications with similar toxicities are being administered concurrently. Toxicity may occur in patients treated more than 10 days, in adults given more than 5 mg/kg/day, children given more than 7.5 mg/kg/day, or patients with reduced renal function whose dose has not been appropriately adjusted. Nephrotoxicity following the parenteral administration of an aminoglycoside is most closely related to the area under the curve of the serum concentration versus time graph. Nephrotoxicity is more likely if trough blood concentrations fail to fall below 2 mcg/mL and is also proportional to the average blood concentration. Patients who are elderly, have abnormal renal function, are receiving other nephrotoxic drugs, or are volume depleted are at greater risk for developing acute tubular necrosis. Auditory and vestibular toxicities have been associated with aminoglycoside overdose.

Approval history

Sourced from openFDA
  • Nov 25, 1981NDANDA050555Novartis
  • Aug 18, 1988NDANDA050592Sandoz
  • Sep 28, 1988NDANDA050616Novartis
  • Dec 22, 1997NDANDA050753Viatris
  • Jul 13, 2004NDANDA050789Fresenius Kabi Usa
  • Dec 14, 2004NDANDA050804Bausch And Lomb
  • Feb 13, 2009NDANDA050818Harrow Eye
  • Oct 12, 2012NDANDA201820Chiesi

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Tobramycin, Solution, 300 mg/4 mL (NDC 0093-3750-28)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Tobramycin, Solution, 300 mg/4 mL (NDC 0093-3750-63)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Tobramycin, Solution, 300 mg/5 mL (NDC 0093-4085-63)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
27,627 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use2,2068.0%
  2. 2Death1,7596.4%
  3. 3Pneumonia1,5925.8%
  4. 4Infective Pulmonary Exacerbation Of Cystic Fibrosis1,5815.7%
  5. 5Dyspnoea1,5295.5%
  6. 6Cough1,3514.9%
  7. 7Cystic Fibrosis1,2884.7%
  8. 8Drug Ineffective1,0743.9%
  9. 9Condition Aggravated1,0593.8%
  10. 10Hospitalisation1,0523.8%
  11. 11Infection9123.3%
  12. 12Acute Kidney Injury7912.9%
  13. 13Fatigue7802.8%
  14. 14Pyrexia7712.8%
  15. 15Malaise7412.7%

Literature

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Recent PubMed references pinned to Tobramycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 186 ClinicalTrials.gov registrations naming Tobramycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Tobramycin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Tobramycin work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What is Tobramycin used for?
According to FDA labeling, Tobramycin carries indications including: Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tobramycin?
Tobramycin is classified as Antibiotics, Other aminoglycosides, Aminoglycoside Antibacterial, Protein Synthesis Inhibitors, Cell Membrane Alteration, Decreased Protein Synthesis.
What are the brand names for Tobramycin?
Tobramycin is marketed under brand names including Bethkis, Kitabis, Tobi, Tobradex, Tobrex, Zylet.
What are the contraindications for Tobramycin?
Tobramycin labeling lists contraindications including: A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.. Always consult the full prescribing information and a clinician.
Note. Data for tobramycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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