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tobramycin

Pronunciation

Generic Name: tobramycin (inhalation) (toe bra MY sin)
Brand Name: Bethkis, Tobi, Tobi Podhaler, Tobramycin Sulfate

What is tobramycin?

Tobramycin is an aminoglycoside (ah-meen-oh-GLY-ko-side) antibiotic. Tobramycin fights infections that are caused by bacteria.

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

Tobramycin inhalation may also be used for purposes not listed in this medication guide.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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

You should not use this medication if you are allergic to tobramycin or similar antibiotics (amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin).

To make sure tobramycin is safe for you, tell your doctor if you have:

  • hearing problems;

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

  • kidney disease.

FDA pregnancy category D. Do not use tobramycin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether tobramycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I use tobramycin?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tobramycin is inhaled into the lungs with the use of a nebulizer or an inhaler device. Do not swallow the medicine by mouth.

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

To use the solution with a nebulizer:

  • Open the ampule and empty the medicine into the chamber of the nebulizer. Attach the mouthpiece or face mask, then attach the drug chamber to the compressor.

  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put on the face mask, covering your nose and mouth. Turn on the compressor.

  • Breathe in slowly and evenly until no more mist is formed by the nebulizer and the drug chamber is empty.

  • Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Do not use the solution if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Tobi Podhaler is a powder form of tobramycin that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the end of the Podhaler device will pierce the capsule and release the medicine into the inhaler chamber. Use only the capsules provided with the Tobi Podhaler device.

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

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Tobramycin inhalation will not treat a viral infection such as the common cold or flu.

Store tobramycin solution in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius).

If refrigeration is not available (such as when you are traveling), store the solution at cool room temperature for up to 28 days. Protect from light. Tobramycin solution stored at room temperature may become a darker color of yellow. This does not indicate any change in quality of the medication. Throw away any medicine not used before the expiration date on the label.

Store the tobramycin capsules at room temperature away from moisture and heat. Remove only one capsule at a time and only when you are ready to use it.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

For Tobi Podhaler: Skip the missed dose if your next dose is less than 6 hours away. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using tobramycin?

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

Tobramycin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • hearing problems, ringing in your ears;

  • severe dizziness, spinning sensation, balance problems, feeling like you might pass out;

  • swelling, rapid weight gain, little or no urinating;

  • muscle weakness;

  • coughing up blood; or

  • new or worsening breathing problems.

Common side effects may include:

  • headache;

  • fever, cough, throat pain, hoarse voice; or

  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: 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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

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

Comments:
-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.

Comments:
-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 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; measurement of tobramycin serum levels is recommended as basis for dose adjustment.

Some experts recommend: 2 to 2.5 mg/kg loading dose, followed by 1.7 to 2 mg/kg IV every 8 hours

Usual Adult Dose for Cystic Fibrosis:

Parenteral:
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

Comments:
-In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of tobramycin serum levels is recommended as basis for dose 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 therapy due to wide interpatient variability.

Inhalation:
Inhalation Solution: 300 mg via nebulizer over approximately 15 minutes twice a day
Inhalation Powder: Using the Podhaler(TM) device, inhale the contents of four 28 mg capsules twice a day
Duration of therapy: 28 days

Comments:
-Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.
-Administer in alternating cycles of 28 days on and 28 days off.
-If patient is on multiple therapies, the following order of administration has been recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, inhaled tobramycin.
-Safety and efficacy have not been established in patients colonized with Burkholderia cepacia.
-Bethkis(R): Safety and efficacy have not been established in patients with forced expiratory volume in 1 second (FEV1) less than 40% or greater than 80% predicted.
-TOBI(R): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 75% predicted.
-TOBI(R) Podhaler(TM): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 80% predicted.

Approved indication: The management of cystic fibrosis patients with Pseudomonas aeruginosa

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.

Comments:
-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.
-Some experts recommend a loading dose of 1.5 to 2 mg/kg.

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

Comments:
-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.

Comments:
-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.
-Some experts recommend a loading dose of 2 mg/kg.
-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

Comments:
-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.

Comments:
-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 patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:
IV: 2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours

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

Comments:
-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:
7 days or less, 2000 g or less: 5 mg/kg IV or IM every 48 hours
7 days or less, greater than 2000 g: 4 mg/kg IV or IM every 24 hours
8 to 28 days, 2000 g or less: 4 to 5 mg/kg IV or IM every 24 to 48 hours
8 to 28 days, greater than 2000 g: 4 mg/kg IV or IM every 12 to 24 hours
1 month or older: 1 to 2.5 mg/kg IV or IM every 8 hours for severe infections

Comments (AAP):
-The longer dosing interval may be used in extremely low birth weight (less than 1000 g) neonates until 2 weeks of life.
-Tobramycin is not appropriate for the treatment of mild to moderate infections in patients 1 month or older.
-Measurement of serum levels is recommended in order to individualize and optimize dosing.

Usual Pediatric Dose for Cystic Fibrosis:

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

Comments:
-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 AAP states that higher doses (8 to 10 mg/kg/day) are appropriate for pulmonary exacerbations in patients with cystic fibrosis.
-In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of tobramycin serum levels is recommended as basis for dose adjustment.
-The serum levels of tobramycin should be measured directly during therapy due to wide interpatient variability.

Inhalation:
6 years or older:
Inhalation Solution: 300 mg via nebulizer over approximately 15 minutes twice a day
Inhalation Powder: Using the Podhaler(TM) device, inhale the contents of four 28 mg capsules twice a day
Duration of therapy: 28 days

Comments:
-Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.
-Administer in alternating cycles of 28 days on and 28 days off.
-If patient is on multiple therapies, the following order of administration has been recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, inhaled tobramycin.
-Safety and efficacy have not been established in patients colonized with B cepacia.
-TOBI(R): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 75% predicted.
-Bethkis(R): Safety and efficacy have not been established in patients with FEV1 less than 40% or greater than 80% predicted.
-TOBI(R) Podhaler(TM): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 80% predicted.

Approved indication: The management of cystic fibrosis patients with P aeruginosa

What other drugs will affect tobramycin?

Tobramycin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, diuretics (ethacrynic acid, furosemide), injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

This list is not complete. Other drugs may interact with tobramycin inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about tobramycin inhalation.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2014-03-13, 9:50:19 AM.

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