tobramycin inhaled (Rx)

Brand and Other Names:TOBI, Bethkis, more...TOBI Podhaler, Kitabis Pak
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Dosing & Uses

AdultPediatric

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
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Interactions

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                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.

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                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

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                Warnings

                Contraindications

                Hypersensitivity

                Cautions

                Known or suspected renal, auditory, vestibular, or neuromuscular dysfunction

                Carefully monitor if on concomitant parenteral aminoglycosides; therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class; serum tobramycin levels should be monitored

                Tinnitus occurred in clinical trials of inhaled tobramycin; however, ototoxicity did not occur; 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; if ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing therapy

                Nephrotoxicity not observed in clinical trials, but has been associated with 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

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                Pregnancy & Lactation

                Pregnancy

                Aminoglycosides can cause fetal harm; 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.

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                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

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                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

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                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
                tobramycin inhalation
                -
                300 mg/4 mL nebulizer soln
                tobramycin inhalation
                -
                300 mg/4 mL nebulizer soln
                tobramycin inhalation
                -
                300 mg/4 mL nebulizer soln
                Tobrex ophthalmic (eye)
                -
                0.3 % ointment
                Tobrex ophthalmic (eye)
                -
                0.3 % drops

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Select a drug:
                Patient Education
                tobramycin inhalation

                TOBRAMYCIN SOLUTION - INHALATION

                (TOE-bra-MYE-sin)

                COMMON BRAND NAME(S): Bethkis, Kitabis Pak, Tobi

                USES: This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent 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 inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects 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 provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn and follow all instructions for the use of this medication and the nebulizer. Children may need help from an adult to use this medication properly. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.Use this medication with the nebulizer every 12 hours or as directed by your doctor. Each treatment lasts about 15 minutes. This medicine is usually used for 28 days in a row, followed by 28 days without this medication, repeating the cycle until your doctor directs you to stop.Each ampule of tobramycin is for one-time use. Inspect each ampule before use. Normal solution is slightly yellow and may darken with age. Discard the ampule if the solution is cloudy or has particles in it, or if it has expired or has been stored at room temperature for longer than 28 days. Use all of the contents of the ampule for each dose. Do not mix tobramycin with any other medicines in the nebulizer.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 take 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 and changes in voice may occur. If any of these effects persist or worsen, 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), 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 inhalation solution, 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, myasthenia gravis, Parkinson's disease.Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.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.Other medications that may affect hearing may increase the risk of hearing loss if taken with tobramycin. Some affected drugs include: amikacin, gentamicin, mannitol, among others.

                OVERDOSE: Overdose is unlikely with tobramycin that is inhaled or swallowed. However, 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.Laboratory and/or medical tests (such as breathing tests, hearing tests, kidney function, tobramycin levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store ampules in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Ampules may also be stored at room temperature up to 77 degrees F (25 degrees C) for up to 28 days. Keep all medicines 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, or if it has been stored at room temperature for more than 28 days. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.