tobramycin

Generic Name: tobramycin (inhalation) (toe bra MY sin)
Brand Name: Tobi

What is tobramycin?

Tobramycin is an antibiotic. It fights bacteria in the body.

Tobramycin inhalation is inhaled into the lungs using a nebulizer. Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis.

Tobramycin may also be used for purposes other than those listed here.

What is the most important information I should know about tobramycin?

Notify your doctor immediately if you develop ringing in the ears, dizziness, or changes in hearing during treatment with tobramycin.

Slideshow: Top Prevention Tips: Springtime Allergies

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

What should I discuss with my healthcare provider before using tobramycin?

Do not use tobramycin without first talking to your doctor if you have had an allergic reaction to an aminoglycoside antibiotic such as tobramycin (Nebcin, Tobi), gentamicin (Garamycin, others), amikacin (Amikin), kanamycin (Kantrex), streptomycin, paromomycin, or neomycin.

Talk to your doctor before using tobramycin if you have

• hearing problems;

• a neuromuscular disease such as myasthenia gravis or Parkinson's disease; or

• kidney disease.

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tobramycin is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Tobramycin is known to cause deafness in the baby when taken during pregnancy. Do not use tobramycin without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether tobramycin passes into breast milk. Do not use tobramycin without first talking to your doctor if you are breast-feeding a baby.

How should I use tobramycin?

Use tobramycin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Tobramycin is inhaled into the lungs with the use of a nebulizer. Do not swallow the solution by mouth.

Wash your hands with soap and water before preparing each treatment.

To use tobramycin inhalation:

• Set up the nebulizer as directed.

• Open one ampule of tobramycin solution for inhalation and squeeze the contents of the ampule into the nebulizer cup. Replace the nebulizer top.

• Turn on the compressor. Check for a steady mist from the mouthpiece. If there is no mist, check all tubing connections and make sure the compressor is working.

• Sit or stand in a position that will allow you to breathe normally. Place the mouthpiece of the nebulizer between your teeth and above your tongue and breathe normally only through your mouth. A noseclip may help you to breathe only through your mouth during a treatment. Continue breathing through the mouthpiece until all of the medicine is gone and no more mist is being produced. You may hear a sputtering sound when the nebulizer cup is empty. The entire treatment should take approximately 15 minutes to complete.

• If you are interrupted or need to cough or rest during a treatment, turn the compressor off to save the medication. Turn the compressor back on when you are ready to resume treatment.

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

If you are using several respiratory medications, the recommended order is bronchodilator first, followed by chest physiotherapy, then other inhaled medications, followed by tobramycin.

Do not use tobramycin that is cloudy or that has particles in it. Tobramycin stored at room temperature may become a darker color of yellow. This does not indicate any change in quality of the medication.

Do not mix tobramycin with dornase alfa (Pulmozyme) or any other medications in the nebulizer.

Do not use tobramycin in bigger doses or more often than prescribed.

Use all of the tobramycin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

Store tobramycin in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). If refrigeration is not available (e.g., when traveling), tobramycin may be stored at room temperature (77 degrees Fahrenheit/25 degrees Celsius) for up to 28 days. Avoid exposing ampules of tobramycin to direct light. Do not use tobramycin beyond the expiration date printed on the ampule.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is less than six hours until the next scheduled dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a tobramycin overdose may include dizziness, ringing in the ears, loss of hearing, difficulty or decreased breathing, and weakness.

What should I avoid while using tobramycin?

Do not mix tobramycin with dornase alfa (Pulmozyme) in the nebulizer.

Tobramycin side effects

If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• ringing in the ears or changes in hearing;

• dizziness;

• new or worsening respiratory problems or difficulty breathing;

• muscle weakness; or

• a rash.

If you experience any of the following less serious side effects, continue using tobramycin and talk to your doctor:

• changes in voice; or

• unpleasant taste or odor of the medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: tobramycin side effects (in more detail)

Tobramycin Dosing Information

Usual Adult Dose for Bacteremia:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Intraabdominal Infection:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Osteomyelitis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Pneumonia:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Pyelonephritis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Skin or Soft Tissue Infection:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Bacterial Infection:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Sepsis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Burns - External:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

In patients with extensive burns, altered pharmacokinetics may result in reduced serum levels of aminoglycosides. In such patients treated with tobramycin, measurement of serum levels is recommended as a basis for dosage adjustment.

(Not approved by FDA)

2 to 2.5 mg/kg loading dose, followed by 1.7 to 2 mg/kg IV every 8 hours has been recommended

Usual Adult Dose for Cystic Fibrosis:

IV: 5 to 10 mg/kg/day IV in 2 to 4 divided doses or 10 to 15 mg/kg/day IV in 3 to 4 divided doses; alternatively, 7 to 15 mg/kg IV every 24 hours has been used

In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum concentration of aminoglycosides. In such patients treated with tobramycin, measurement of serum levels is recommended as a basis for dosage adjustment. In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested only as a guide by the manufacturer. The serum levels of tobramycin should be measured directly during treatment due to a wide interpatient variability.

Solution for inhalation:
Initial dose: 300 mg via nebulizer over approximately 15 minutes twice daily (every 12 hours) for 28 days

Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off. If patient is on multiple therapies, the following order of administration is recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, tobramycin solution.

Usual Adult Dose for Endocarditis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

(Not approved by FDA)

A loading dose of 1.5 to 2 mg/kg has been recommended.

American Heart Association, Infectious Diseases Society of America (IDSA) recommendations:
Preferred regimen for infective endocarditis due to Pseudomonas aeruginosa: 8 mg/kg IV or IM once a day

Maintenance of peak levels of 15 to 20 mcg/mL and trough levels of 2 mcg/mL or less is recommended. Tobramycin should be administered in combination with either an extended-spectrum penicillin (e.g., ticarcillin, piperacillin) or ceftazidime or cefepime in full doses. The toxicity associated with this regimen has been reported as low; combination therapy should be given for at least 6 weeks.

Usual Adult Dose for Meningitis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

(Not approved by FDA)

A loading dose of 2 mg/kg has been recommended. Parenteral therapy should be continued for at least 1 week after the patient becomes afebrile and cerebrospinal fluid (CSF) normalizes.

IDSA recommendations:
Parenteral: 5 mg/kg/day IV or IM in 3 divided doses

Intraventricular: 5 to 20 mg intraventricularly (preservative-free formulation) per day
Subsequent doses should be based on the CSF concentration.

Duration of therapy:
Neisseria meningitidis: 7 days
Haemophilus influenzae: 7 days
Streptococcus pneumoniae: 10 to 14 days
Streptococcus agalactiae: 14 to 21 days
Aerobic gram-negative bacilli: 21 days
Listeria monocytogenes: 21 days or longer

These guidelines are not standardized and the duration of therapy should be individualized based on the patient's clinical response. IV antimicrobial therapy is recommended for the duration of therapy to ensure that adequate CSF levels are attained.

Usual Adult Dose for Peritonitis:

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

(Not approved by FDA)

IV: 2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours has been recommended

Intraperitoneal in CAPD patients: 0.6 to 0.75 mg/kg intraperitoneally once a day or 16 to 20 mg per every 2 L dialysate

Usual Adult Dose for Shunt Infection:

(Not approved by FDA)

IDSA recommendations:
5 to 20 mg intraventricularly (preservative-free formulation) up to every 24 hours, in addition to parenteral antibiotic therapy
Subsequent doses should be based on the CSF concentration. Shunt removal is usually necessary to achieve a cure.

Usual Pediatric Dose for Bacterial Infection:

Manufacturer recommendations:
Premature or full-term neonates 1 week of age or less: Up to 4 mg/kg/day may be administered IV or IM in 2 equal doses every 12 hours.

Greater than 1 week of age: 6 to 7.5 mg/kg/day IV or IM in 3 or 4 equally divided doses (2 to 2.5 mg/kg IV or IM every 8 hours or 1.5 to 1.89 mg/kg IV or IM every 6 hours)

American Academy of Pediatrics (AAP) recommendations:
Preterm neonate, less than 1000 g: 3.5 mg/kg IV or IM every 24 hours

Less than 1 week, less than 1200 g: 2.5 mg/kg IV or IM every 18 to 24 hours
Less than 1 week, 1200 g or more: 2.5 mg/kg IV or IM every 12 hours

1 to 4 weeks, less than 1200 g: 2.5 mg/kg IV or IM every 18 to 24 hours
1 to 4 weeks, 1200 to 2000 g: 2.5 mg/kg IV or IM every 8 to 12 hours
1 to 4 weeks, greater than 2000 g: 2.5 mg/kg IV or IM every 8 hours

1 month or older: 1 to 2.5 mg/kg IV or IM every 8 hours for severe infections

The AAP states that tobramycin is not appropriate for the treatment of mild to moderate infections.

Usual Pediatric Dose for Cystic Fibrosis:

Parenteral: 2.5 to 3.3 mg/kg IV or IM every 6 to 8 hours

Solution for Inhalation:
6 years or older:
Initial dose: 300 mg via nebulizer over approximately 15 minutes twice a day (every 12 hours) for 28 days

Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off. If patient is on multiple therapies, the following order of administration is recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, tobramycin solution.

What other drugs will affect tobramycin?

Before using tobramycin, tell your doctor if you are taking:

• furosemide (Lasix);

• ethacryinc acid (Edecrin); or

• mannitol (Osmitrol).

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Do not mix tobramycin with dornase alfa (Pulmozyme) in the nebulizer.

Drugs other than those listed here may also interact with tobramycin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

• Your pharmacist has additional information about tobramycin written for health professionals that you may read.