Dosing & Uses
Dosage Forms & Strengths
solution for nebulization
- 300mg/4mL ampule (Bethkis)
- 300mg/5mL ampule (TOBI, Kitabis Pak)
- NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)
powder for inhalation
- 28mg/capsule
Pseudomonas aeruginosa Infection
Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis
Nebulizer: 300 mg inhaled orally via nebulizer BID
Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID
Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle
Dosing Considerations
Safety and efficacy not established in the following patients
- Age <6 years
- FEV1 <25% or >80% predicted
- Colonized with Burkholderia cepacia
Bronchiectasis (Orphan)
TOBI: Orphan designation for treatment of bronchiectasis patients infected with Pseudomonas aeruginosa
Orphan sponsor
- Novartis Pharmaceuticals Corp; Drug Regulatory Affairs; One Health Plaza; East Hanover, NJ 07936-1080
Dosage Forms & Strengths
solution for nebulization
- 300mg/4mL ampule (Bethkis)
- 300mg/5mL ampule (TOBI, Kitabis Pak)
- NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)
powder for inhalation
- 28mg/capsule
Pseudomonas aeruginosa Infection
Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis
<6 years: Safety and efficacy not established
≥6 years
- Nebulizer: 300 mg inhaled orally via nebulizer BID
- Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID
- Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle
Dosing Considerations
Safety and efficacy not established in the following patients
- Age <6 years
- FEV1 <25% or >80% predicted
- Colonized with Burkholderia cepacia
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (88)
- abobotulinumtoxinA
tobramycin inhaled increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- agalsidase beta
tobramycin inhaled and agalsidase beta both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- amikacin
tobramycin inhaled and amikacin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- amphotericin B cholesteryl sulfate
tobramycin inhaled and amphotericin B cholesteryl sulfate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- amphotericin B deoxycholate
tobramycin inhaled and amphotericin B deoxycholate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- amphotericin B liposomal
tobramycin inhaled and amphotericin B liposomal both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- amphotericin B phospholipid complex
tobramycin inhaled and amphotericin B phospholipid complex both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- artemether
tobramycin inhaled and artemether both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- aspirin
tobramycin inhaled and aspirin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- aspirin/citric acid/sodium bicarbonate
tobramycin inhaled and aspirin/citric acid/sodium bicarbonate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- atracurium
tobramycin inhaled increases effects of atracurium by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- azithromycin
tobramycin inhaled and azithromycin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- bismuth subsalicylate
tobramycin inhaled and bismuth subsalicylate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- bumetanide
tobramycin inhaled, bumetanide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent use if possible; theorized mechanisms include rapid injection of loop diuretics, existing renal impairment, or volume depletion leading to increased aminoglycoside concentration within the nephron.
- carboplatin
tobramycin inhaled and carboplatin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- celecoxib
tobramycin inhaled and celecoxib both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- chloroquine
tobramycin inhaled and chloroquine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- choline magnesium trisalicylate
tobramycin inhaled and choline magnesium trisalicylate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- cidofovir
tobramycin inhaled and cidofovir both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ciprofloxacin
tobramycin inhaled and ciprofloxacin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- cisatracurium
tobramycin inhaled increases effects of cisatracurium by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- cisplatin
tobramycin inhaled and cisplatin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- cysteamine
tobramycin inhaled and cysteamine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- cytarabine
tobramycin inhaled and cytarabine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- deferasirox
tobramycin inhaled and deferasirox both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- deferoxamine
tobramycin inhaled and deferoxamine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- diflunisal
tobramycin inhaled and diflunisal both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- eflornithine
tobramycin inhaled and eflornithine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- erythromycin lactobionate
tobramycin inhaled and erythromycin lactobionate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ethacrynic acid
tobramycin inhaled, ethacrynic acid. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent use if possible; theorized mechanisms include rapid injection of loop diuretics, existing renal impairment, or volume depletion leading to increased aminoglycoside concentration within the nephron.
- fenoprofen
tobramycin inhaled and fenoprofen both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- flucytosine
tobramycin inhaled and flucytosine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- fludarabine
tobramycin inhaled and fludarabine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- furosemide
tobramycin inhaled, furosemide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent use if possible; theorized mechanisms include rapid injection of loop diuretics, existing renal impairment, or volume depletion leading to increased aminoglycoside concentration within the nephron.
- gentamicin
tobramycin inhaled and gentamicin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- hydroxychloroquine sulfate
tobramycin inhaled and hydroxychloroquine sulfate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ibuprofen
tobramycin inhaled and ibuprofen both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ibuprofen IV
tobramycin inhaled and ibuprofen IV both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- incobotulinumtoxinA
tobramycin inhaled increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- interferon alfa 2b
tobramycin inhaled and interferon alfa 2b both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- interferon beta 1a
tobramycin inhaled and interferon beta 1a both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- isotretinoin
tobramycin inhaled and isotretinoin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- itraconazole
tobramycin inhaled and itraconazole both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ketorolac
tobramycin inhaled and ketorolac both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- magnesium salicylate
tobramycin inhaled and magnesium salicylate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- mannitol
tobramycin inhaled, mannitol. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent use if possible; mannitol may alter serum/tissue levels of aminoglycosides .
- meclofenamate
tobramycin inhaled and meclofenamate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- mefenamic acid
tobramycin inhaled and mefenamic acid both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- methazolamide
tobramycin inhaled and methazolamide both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- minocycline
tobramycin inhaled and minocycline both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- naproxen
tobramycin inhaled and naproxen both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- neomycin PO
tobramycin inhaled and neomycin PO both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- onabotulinumtoxinA
tobramycin inhaled increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- oxaliplatin
tobramycin inhaled and oxaliplatin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity.
- oxaprozin
tobramycin inhaled and oxaprozin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- pancuronium
tobramycin inhaled increases effects of pancuronium by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- paromomycin
tobramycin inhaled and paromomycin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- pentostatin
tobramycin inhaled and pentostatin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- piroxicam
tobramycin inhaled and piroxicam both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- prabotulinumtoxinA
tobramycin inhaled increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- quinidine
tobramycin inhaled and quinidine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- quinine
tobramycin inhaled and quinine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- ribavirin
tobramycin inhaled and ribavirin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- rimabotulinumtoxinB
tobramycin inhaled increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- rocuronium
tobramycin inhaled increases effects of rocuronium by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- rubella vaccine
tobramycin inhaled and rubella vaccine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- salsalate
tobramycin inhaled and salsalate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- sildenafil
tobramycin inhaled and sildenafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- sodium benzoate
tobramycin inhaled and sodium benzoate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of tobramycin inhaled by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of tobramycin inhaled by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- streptomycin
tobramycin inhaled and streptomycin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- succinylcholine
tobramycin inhaled increases effects of succinylcholine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- sulfasalazine
tobramycin inhaled and sulfasalazine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- sulindac
tobramycin inhaled and sulindac both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- tadalafil
tobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- topiramate
tobramycin inhaled and topiramate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- torsemide
tobramycin inhaled, torsemide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent use if possible; theorized mechanisms include rapid injection of loop diuretics, existing renal impairment, or volume depletion leading to increased aminoglycoside concentration within the nephron.
- tretinoin
tobramycin inhaled and tretinoin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- vancomycin
tobramycin inhaled and vancomycin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- vardenafil
tobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- varenicline
tobramycin inhaled and varenicline both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- vecuronium
tobramycin inhaled increases effects of vecuronium by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- verteporfin
tobramycin inhaled and verteporfin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- vincristine
tobramycin inhaled and vincristine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- vinorelbine
tobramycin inhaled and vinorelbine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- voclosporin
voclosporin, tobramycin inhaled. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- zidovudine
tobramycin inhaled and zidovudine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
Minor (1)
- entecavir
tobramycin inhaled, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
Adverse Effects
>10%
Voice alteration (12.8%)
1-10%
Myalgia (4.7%)
Laryngitis (4.3%)
Tinnitus (3%)
Epistaxis (3%)
Postmarketing Reports
General disorders: Malaise
Ear and labyrinth disorders: Hearing loss
Skin and subcutaneous tissue disorders: Hypersensitivity, pruritus, urticaria, rash
Nervous system disorders: Aphonia, dysgeusia
Respiratory, thoracic, and mediastinal disorders: Bronchospasm, oropharyngeal pain, sputum discolored
Decreased appetite
Warnings
Contraindications
Hypersensitivity
Cautions
Known or suspected renal, auditory, vestibular, or neuromuscular dysfunction
Carefully monitor if on concomitant parenteral antimicrobials#aminoglycosides; therapy should be monitored as clinically appropriate for toxicities associated with antimicrobials#aminoglycosides as a class; serum tobramycin levels should be monitored
Nephrotoxicity not observed in clinical trials, but has been associated with antimicrobials#aminoglycosides as a class; patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs should have serum concentrations of tobramycin and laboratory measurements of renal function obtained at discretion of treating physician; if nephrotoxicity develops, patient should be managed as medically appropriate, including potentially discontinuing therapy
May exacerbate muscular disorders (eg, myasthenia gravis, Parkinson disease); therapy may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function; neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease
Bronchospasm can occur; prolonged respiratory paralysis may occur in patients receiving concomitant neuromuscular blocking agents; if neuromuscular blockade occurs, it may be reversed by administration of calcium salts but mechanical assistance may be necessary; bronchospasm that occurs during therapy should be treated as medically appropriate
Ototoxicity
- Ototoxicity may occur in some patients even when their aminoglycoside serum levels are within recommended range
- Postmarketing experience, patients receiving therapy have reported hearing loss; vestibular toxicity may be manifested by vertigo, ataxia, or dizziness; patients with known or suspected auditory or vestibular dysfunction should be closely monitored when receiving therapy; monitoring might include obtaining audiometric evaluations and serum tobramycin levels;
- Mitochondrial DNA variants are present in <1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as severity of ototoxicity is unknown
- 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 antimicrobials#aminoglycosides unless increased risk of permanent hearing loss is outweighed by severity of infection and lack of safe and effective alternative therapies
Pregnancy & Lactation
Pregnancy
Aminoglycosides can cause fetal harm; antimicrobials#aminoglycosides cross the placenta; published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman; although there are no available data on ophthalmic use of tobramycin in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal
There are risks to mother associated with cystic fibrosis in pregnancy; in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies; advise pregnant women of potential risk to a fetus
Cystic fibrosis may increase risk for preterm delivery
Animal data
- No reproduction toxicology studies have been conducted in animals; however, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes
- Doses of tobramycin greater than or equal to 40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes; ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin
Lactation
There are no data on presence of drug in either human or animal milk, the effects on breastfed infant, or effects on milk production; limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk; however, systemic absorption of tobramycin following inhaled administration is expected to be minimal; therapy may cause alteration in intestinal flora of breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Therapy may cause intestinal flora alteration; advise a woman to monitor breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash)
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Aminoglycoside that acts by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death
In vitro activity against wide range of gram-negative organisms including Pseudomonas aeruginosa
Absorption
Sputum Concentration (10 min post dose): 1154 mcg/g (range: 39-8085 mcg/g)
Serum Concentration (1 hr post dose): 0.95 mcg/mL (single dose); 1.05 mcg/mL (after 20 weeks of therapy)
Elimination
Half-life: 2 hr (IV)
Excretion: Unabsorbed drug eliminated primarily in expectorated sputum
Administration
Administration
For oral inhalation only
Bethkis: Administer using a hand-held PARI LC Plus reusable nebulizer with a APRI Vios Air compressor over ~15 minutes
TOBI: Administer using a hand-held PARI LC Plus reusable nebulizer with a DeVilbiss Pulmo-Aide compressor over ~15 minutes
Kitabis: Administer using PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor over ~15 minutes
TOBI Podhaler: For use with Podhaler device for oral inhalation; do not swallow capsules
Doses should be taken as close to 12 hr apart as possible; and, not less than 6 hr apart
For patients taking several different inhaled medications and/or performing chest physiotherapy, it is recommended that TOBI Podhaler is taken last
Storage
Store ampules refrigerated (2-8ºC [36-46ºF])
Avoid exposure to intense light
May store the ampules foil pouches (opened or unopened) at room temperature (up to 25ºC [77ºF]) for up to 28 days
Unrefrigerated solution may slightly darken beyond its normally light yellow color; however the quality/potency of the solution is maintained for up to 28 days
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Tobrex ophthalmic (eye) - | 0.3 % ointment |  | |
| Tobrex ophthalmic (eye) - | 0.3 % drops |  | |
| tobramycin inhalation - | 300 mg/4 mL nebulizer soln |  | |
| tobramycin inhalation - | 300 mg/4 mL nebulizer soln |  | |
| tobramycin inhalation - | 300 mg/4 mL nebulizer soln |  | |
| tobramycin ophthalmic (eye) - | 0.3 % drops |  | |
| tobramycin ophthalmic (eye) - | 0.3 % drops |  | |
| tobramycin ophthalmic (eye) - | 0.3 % drops |  | |
| tobramycin ophthalmic (eye) - | 0.3 % drops |  | |
| tobramycin ophthalmic (eye) - | 0.3 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tobramycin inhalation
TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION
(TOE-bra-MYE-sin)
COMMON BRAND NAME(S): Tobi Podhaler
USES: This medication is used to treat people with cystic fibrosis who have an ongoing lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs.Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin works by stopping the growth of bacteria, including Pseudomonas aeruginosa, that commonly infect the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.
HOW TO USE: Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using tobramycin and each time you get a refill. Learn how to use the inhaler properly. Children may need help from an adult to use this medication properly. If you have any questions, ask your doctor or pharmacist.Do not swallow these capsules by mouth. Use the special inhaler to inhale the powder in the capsules. Inhale this medication by mouth as directed by your doctor, usually twice daily (12 hours apart). Each dose is usually 4 of the 28-milligram capsules. Inhale 2 times per capsule to make sure you inhale all of the drug. Do not breathe out into the mouthpiece at any time. Each dose takes approximately 2 to 6 minutes.Inhaled tobramycin is usually given for 28 days, followed by a 28-day break when you do not inhale any tobramycin. Then if directed by your doctor, you may start another 28-day course of inhaled tobramycin. Do not use this medication for more than 28 days at a time. Keep track of the days that you use this medication.After each dose, wipe the mouthpiece with a clean, dry cloth. The inhaler should never be washed with water. Keep it dry and store it in its case. Use a new inhaler every week.Do not inhale any other medications at the same time you inhale tobramycin. If you are taking other inhaled medications or doing chest physiotherapy, your doctor will let you know which order you should receive your treatments. Inhaled tobramycin should always be the last treatment.If you are using a quick-relief inhaler (such as salbutamol, albuterol), you should inhale it 15 to 90 minutes before inhaling tobramycin. This will help you inhale and absorb the tobramycin.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Hoarseness, cough, dry mouth, difficulty speaking, change in taste, and changes in voice may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of hearing damage (such as ringing/roaring sounds in the ears, hearing loss, dizziness), signs of kidney problems (such as change in the amount of urine), coughing up blood, chest tightness/wheezing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using tobramycin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: hearing problems (including deafness, decreased hearing), kidney problems, coughing up blood, myasthenia gravis, Parkinson's disease.Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using tobramycin before having any immunizations/vaccinations.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.It is unknown if inhaled tobramycin passes into breast milk. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: botulinum toxin, neostigmine, pyridostigmine.Other medications that may affect hearing or cause kidney damage may increase the risk of hearing loss or kidney problems if taken with tobramycin. Some affected drugs include: amikacin, gentamicin, mannitol, tacrolimus, platinum compounds such as carboplatin/cisplatin, among others.
OVERDOSE: This medication will not work and may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as breathing tests, hearing tests, kidney function, tobramycin levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is less than 6 hours before your next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store this medication at room temperature away from moisture. Keep the capsules stored in the blister package until right before use. Do not store in the bathroom. Keep the inhaler in a tightly closed case when not in use. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
