Tobramycin

Drug overview for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Generic name: tobramycin in 0.225 % sodium chloride (TOE-bra-MYE-sin)
Drug class: Inhaled Aminoglycosides
Therapeutic class: Respiratory Therapy Agents

Aminoglycosides are antibiotics that generally are active against many aerobic gram-negative bacteria and some aerobic gram-positive bacteria and principally are used for serious infections.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride) have been approved by the FDA:

Indications:
Respiratory cystic fibrosis with Pseudomonas aeruginosa colonization
Synergy for P. aeruginosa infection in cystic fibrosis

Professional Synonyms:
None.

The following dosing information is available for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Dosing
Administration
TOBRAMYCIN
TOBRAMYCIN

Aminoglycoside dosage should be individualized taking into consideration the patient's pretreatment body weight, renal status, serum concentrations of the drug, severity of the infection, and susceptibility of the causative organism. Because of the potential toxicity of aminoglycosides, fixed-dosage recommendations that are not based on patient weight or serum drug concentrations are not advised.

In patients with impaired renal function, doses and/or frequency of administration of aminoglycosides must be modified in response to serum concentrations of the drugs and the degree of renal impairment. Various formulae, tables, nomograms, and computer-assisted programs based on serum creatinine or creatinine clearance have been used to aid in dosage adjustment in patients with renal impairment. One frequently used method that has been recommended for determining dosage of amikacin, gentamicin, kanamycin, or tobramycin in patients with renal impairment is the method of Sarubbi and Hull, which is based on corrected creatinine clearance.

(See Table.) However, even when one of these methods is used, peak and trough serum aminoglycoside concentrations should be monitored, especially in patients with changing renal function. These dosage calculation methods should not be used in patients undergoing hemodialysis or peritoneal dialysis; supplemental doses of aminoglycosides may be required after dialysis.

Amikacin, gentamicin, kanamycin, and tobramycin are administered by IM injection or IV infusion. IV administration generally is recommended in patients with life-threatening infections, septicemia, shock, severe hypotension, congestive heart failure, hematologic disorders, severe burns, or reduced muscle mass. Streptomycin is administered by IM injection, but also has been given by IV infusion+.

Neomycin and paromomycin are administered orally. Although kanamycin also has been administered orally, an oral dosage form is no longer commercially available in the US. Tobramycin solution for oral inhalation is administered via a nebulizer.

Tobramycin+, kanamycin, and gentamicin+ also have been administered by oral inhalation as aerosols prepared extemporaneously from parenteral preparations of the drugs. Amikacin, gentamicin, and tobramycin have been administered intrathecally+ or intraventricularly+ for the treatment of CNS infections. Intraventricular administration of aminoglycosides usually is preferred to intrathecal administration, especially in cases of ventriculitis, to ensure adequate drug concentrations throughout the CSF.

Although some aminoglycosides (e.g., kanamycin, neomycin) have been administered by intraperitoneal instillation or local irrigation (abscess cavities, pleural space, peritoneal and ventricular cavities), there is an increased risk of toxicity with these routes. (See Other Precautions under Cautions: Precautions and Contraindications.) Aminoglycosides should not be admixed with other drugs or infused simultaneously through the same tubing with other drugs.

Dosing information for TOBRAMYCIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
TOBRAMYCIN 300 MG/5 ML AMPULE	Maintenance	Adults inhale 5 milliliters (300 mg) via nebulizer by inhalation route every 12 hours

Generic dosing information for TOBRAMYCIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
TOBRAMYCIN 300 MG/5 ML AMPULE	Maintenance	Adults inhale 5 milliliters (300 mg) via nebulizer by inhalation route every12 hours

The following drug interaction information is available for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Contraindicated
Severe
Moderate

There are 2 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)	VIVOTIF
Selected Nephrotoxic Agents/Bacitracin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3) CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3) PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1) PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3) DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3)	BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC

Drug Interaction

Drug Names

Live Typhoid Vaccine/Antimicrobials

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)

CLINICAL EFFECTS: Vaccination may be ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)

DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

VIVOTIF

Selected Nephrotoxic Agents/Bacitracin

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3)

CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3)

PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1)

PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3)

DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3)

BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Misc Antibiotics/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents. CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression.	ANECTINE, ATRACURIUM BESYLATE, BOTOX, BOTOX COSMETIC, CISATRACURIUM BESYLATE, DAXXIFY, DYSPORT, JEUVEAU, MYOBLOC, NIMBEX, QUELICIN, ROCURONIUM BROMIDE, SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE-NACL, VECURONIUM BROMIDE, VECURONIUM BROMIDE-WATER, XEOMIN
Anesthetics/Aminoglycosides SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neuromuscular blocking activity of aminoglycosides results from a decreased sensitivity at the postjunctional membrane and interfere with transmitter release.(1) These actions produce a synergistic effect with anesthetic agents that produce neuromuscular blockade.(2,3) Some anesthetics cause renal failure due to release of fluoride ion. Aminoglycosides cause nephrotoxicity when high doses are given.(4,5) CLINICAL EFFECTS: Increased neuromuscular blockade activity, profound sedation, respiratory depression, coma, and/or death. Circulatory collapse may also occur secondary to the neuromuscular blockade.(6-10) Decreased urinary output and increased BUN and serum creatinine may indicate renal impairment. PREDISPOSING FACTORS: Patients in respiratory distress, history of renal impairment and high doses of aminoglycosides and anesthetics. PATIENT MANAGEMENT: Monitor neuromuscular blockade with train-of-four stimulus. Monitor vital signs, and respiratory rate. Intravenous neostigmine (0.2 to 2.5 mg), calcium (1 G), and possibly sodium bicarbonate (dose not reported) may be beneficial in reversal of neuromuscular blockade and respiratory depression.(6-10) Supportive care and ventilation should be utilized until the neuromuscular blockade is resolved. Volume replacement may be necessary for circulatory collapse.(6-10) Monitor BUN, serum creatinine, and urinary output and adjust aminoglycoside and anesthetic doses according to renal function. DISCUSSION: Aminoglycosides including kanamycin(6,11), streptomycin(6,13), amikacin(13), gentamicin(7,13-15), neomycin, and tobramycin(13) have been documented to have neuromuscular blocking activity. There is no documentation with netilmicin and paromomycin, though it is assumed that they produce the same effects as the other members of this class. Neomycin has been shown to interact with cyclopropane(8,9), halothane(6), methoxyflurane(6), and nitrous oxide(6). Enflurane, ethylene, and isoflurane share similar properties to the previous inhalation anesthetics and would likely interact with neomycin. Kanamycin(6,11) and streptomycin (6,12) are known to interact with ether. Gentamicin has been reported to potentiate atracurium.(16) Therefore it is hypothesized that all aminoglycosides interact with the inhaled anesthetics. One study evaluating gentamicin and halothane in animals did not exhibit a decrease in muscle strength.(17) Aminoglycosides have been proven to be nephrotoxic at high doses. Anesthetics containing fluoride also produce renal dysfunction. Nephrotoxicity occurred more often when gentamicin or tobramycin were given with enflurane than when enflurane was given alone or in patients who received nitrous oxide and opioid anesthesia.(4)	DESFLURANE, FORANE, ISOFLURANE, SUPRANE, TERRELL
Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.	VOWST
Cyclosporine/Aminoglycosides SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Cyclosporine and aminoglycosides can both cause nephrotoxicity. Concurrent administration may result in an additive or synergistic risk of nephrotoxicity.(1-3) CLINICAL EFFECTS: Concurrent use of cyclosporine with aminoglycosides may result in a higher risk of renal dysfunction, including structural kidney damage.(1-3) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include pre-existing renal impairment, older age, higher doses or longer treatment duration of either drug, and dehydration.(1-3) PATIENT MANAGEMENT: Avoid the concurrent use of cyclosporine and aminoglycosides whenever possible.(2,3) If concurrent use cannot be avoided, it should be undertaken with great caution. Minimize the cyclosporine dose and monitor renal function carefully. Frequent dose adjustment may be indicated. If renal function deteriorates, the aminoglycoside may need to be decreased or discontinued.(1-4) DISCUSSION: Coadministration of cyclosporine with other drugs that may impair renal function, like aminoglycosides, may cause additive or synergistic impairment of renal function. A meta-analysis of 30 studies that evaluated the correlation and risk factors between cyclosporine and kidney injury in allogeneic hematopoietic stem cell transplant (allo-HSCT) patients included 7 studies that examined the role of the combination with other drugs in the development of nephrotoxicity. Coadministration of aminoglycosides and amphotericin B were independent risk factors for acute or chronic kidney diseases related to cyclosporine in allo-HSCT patients.(5)	CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE
Selected Nephrotoxic Agents/Polymyxin B SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Polymyxin B can cause nephrotoxicity with a slight degree of tubular damage. Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) CLINICAL EFFECTS: Concurrent use of polymyxin B with other nephrotoxic agents may result in additive nephrotoxic effects. Polymyxin B nephrotoxicity is characterized by albuminuria, cellular casts, azotemia, diminished urine output, elevated BUN and rising blood levels usually after about 4 days of therapy.(1,2) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses and longer duration of therapy of polymyxin B and exposure to multiple nephrotoxins.(2) PATIENT MANAGEMENT: Concurrent or sequential use of potentially nephrotoxic agents with polymyxin B should be avoided. If concurrent use is necessary, it should be undertaken with great caution. Check renal function at baseline and monitor renal function and polymyxin B blood levels frequently during therapy.(1) DISCUSSION: Polymyxin B is associated with high rates of nephrotoxicity. Concurrent use with other nephrotoxins may increase the risk of nephrotoxicity.	POLYMYXIN B SULFATE

There are 4 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Tobramycin Inhalation/Selected Diuretics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The combination may have additive or synergistic risks for ototoxicity and/or nephrotoxicity.(1,2) CLINICAL EFFECTS: Concurrent use may result in an increased risk of aminoglycoside toxicity.(1) PREDISPOSING FACTORS: Severe renal impairment, sepsis, or concomitant use of additional ototoxic or nephrotoxic agents may further increase the risk for toxicity. Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at greatly increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.(3) PATIENT MANAGEMENT: Instruct patients to contact their provider for new onset or worsening tinnitus. Tinnitus may be a sentinel symptom of ototoxicity. In clinical trials of tobramycin inhalation 8 patients (3%) receiving tobramycin reported tinnitus while no patients in the placebo group reported this symptom.(1) For renally impaired patients receiving long term tobramycin inhalation therapy, consider measurement of serum tobramycin to assure low systemic levels. The manufacturer of tobramycin for inhalation states that the product should not be administered concurrently with ethacrynic acid, furosemide, intravenous mannitol, or urea.(1) DISCUSSION: Although systemic absorption of inhaled tobramycin is limited, the manufacturer states that because these diuretics may enhance the risk for aminoglycoside toxicity, they should not be administered concurrently with inhaled tobramycin.(1)	EDECRIN, ETHACRYNATE SODIUM, ETHACRYNIC ACID, FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, LASIX, MANNITOL, OSMITROL
Gentamicin, Amikacin, Tobramycin/Amphotericin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive with those of amphotericin. CLINICAL EFFECTS: The concurrent administration of gentamicin, amikacin, or tobramycin with amphotericin may result in additive ototoxic or nephrotoxic effects.(1) PREDISPOSING FACTORS: Preexisting renal impairment, sepsis, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, or concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin appear to increase the risk for nephrotoxicity and ototoxicity.(1-6). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.(7) PATIENT MANAGEMENT: The Australian manufacturer of gentamicin, amikacin, and tobramycin state that the concurrent use of gentamicin, amikacin, or tobramycin and amphotericin should be avoided.(1,4,5) DISCUSSION: The Australian and U.K. manufacturers of gentamicin, amikacin, and tobramycin state that since the ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including amphotericin.(1,3,4,5)	ABELCET, AMBISOME, AMPHOTERICIN B, AMPHOTERICIN B LIPOSOME
Selected Nephrotoxic Agents/Cisplatin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The nephrotoxic effects of aminoglycosides or non-steroidal anti-inflammatory drugs (NSAIDs) may be additive to those of cisplatin. CLINICAL EFFECTS: The concurrent administration of amikacin, gentamicin, tobramycin, or NSAIDs with cisplatin may result in additive nephrotoxic effects.(1,2,5,6) PREDISPOSING FACTORS: Pre-existing renal insufficiency, advanced age, dehydration may increase the risk of nephrotoxicity.(1,5,6) PATIENT MANAGEMENT: The US labeling for aminoglycosides and cisplatin states that the concurrent use of aminoglycosides and cisplatin should be avoided.(1,3,4,6) Inform patients that concurrent cisplatin and aminoglycosides or NSAIDs can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary.(2) DISCUSSION: The US manufacturers of amikacin, gentamicin and tobramycin state that since the nephrotoxic effects of these medications may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including cisplatin.(1,3,6)	CISPLATIN, KEMOPLAT
Gentamicin, Amikacin, Tobramycin/Vancomycin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive with those of vancomycin. CLINICAL EFFECTS: The concurrent administration of gentamicin, amikacin, or tobramycin with vancomycin may result in additive ototoxic or nephrotoxic effects.(1) PREDISPOSING FACTORS: Preexisting renal impairment, sepsis, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, or concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin appear to increase the risk for nephrotoxicity and ototoxicity.(1-5). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides. PATIENT MANAGEMENT: The Australian manufacturer of gentamicin, amikacin, and tobramycin state that the concurrent use of gentamicin, amikacin, or tobramycin and vancomycin should be avoided.(1,4,5) DISCUSSION: The Australian and U.K. manufacturers of gentamicin, amikacin, and tobramycin state that since the ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including vancomycin.(1,3,4,5)	FIRVANQ, VANCOCIN HCL, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W

The following contraindication information is available for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 1 contraindications. Absolute contraindication.

Contraindication List
Mt-RNr1 increased risk of aminoglycoside-induced hearing loss

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Kidney disease with reduction in glomerular filtration rate (GFr)
Myasthenia gravis

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Asthma
Chronic obstructive pulmonary disease
Disorder of the vestibulocochlear nerve
Parkinsonism
Tinnitus
Vertigo

The following adverse reaction information is available for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Aphonia Auditory neurotoxicity Bronchospastic pulmonary disease Nephrotoxicity Neuromuscular blockade Ototoxicity

There are 28 less severe adverse reactions.

More Frequent	Less Frequent
Cough Diarrhea Dysgeusia Dyspnea Fever Headache disorder Hemoptysis Increased sputum Pain in oropharynx Pharyngitis Skin rash Voice change	Laryngitis Myalgia Nausea Non-cardiac chest pain Vomiting Weight loss

Rare/Very Rare
Anorexia Ataxia Dizziness Malaise Pruritus of skin Sputum discoloration Tinnitus Urticaria Vertigo Wheezing

The following precautions are available for TOBRAMYCIN (tobramycin in 0.225 % sodium chloride):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Aminoglycosides can cause fetal harm when administered to pregnant women. Aminoglycosides cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious adverse effects have not been reported in fetuses or neonates whose mothers received other aminoglycosides during pregnancy, the potential for fetal toxicity exists with these antibiotics. If an aminoglycoside is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus.

Small amounts of aminoglycosides are distributed into milk following IM or IV administration. Although it is not known whether neomycin is distributed into human milk following oral administration, it is distributed into cow milk following IM injection. It is not know whether tobramycin is distributed into milk following oral inhalation. Because of the potential for serious adverse reactions to aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.

Respiratory cystic fibrosis p. aeruginosa colonization
B96.5	Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere
E84.0	Cystic fibrosis with pulmonary manifestations
Synergy for p. aeruginosa infection in cystic fibrosis
B96.5	Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere
E84.0	Cystic fibrosis with pulmonary manifestations