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Bethkis solution

Generic Name: tobramycin (TOE-bra-MYE-sin)
Brand Name: Examples include Bethkis and Tobi

Bethkis solution is used for:

Treating patients with cystic fibrosis and certain infections (Pseudomonas aeruginosa). It may also be used for other conditions as determined by your doctor.

Bethkis solution is an aminoglycoside antibiotic. It works by killing sensitive bacteria.

Do NOT use Bethkis solution if:

  • you are allergic to any ingredient in Bethkis solution or another aminoglycoside antibiotic (eg, gentamicin)
  • you are taking ethacrynic acid, furosemide, mannitol, or urea
  • you are taking any medicine that may harm your kidneys, nervous system, or hearing. Ask your doctor or pharmacist if you are unsure if any of your medicines might cause these problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bethkis solution:

Some medical conditions may interact with Bethkis solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed) or Parkinson disease
  • if you have hearing problems, nerve problems, kidney problems, or severe or extensive burns, or you are dehydrated

Some MEDICINES MAY INTERACT with Bethkis solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aminoglycosides (eg, gentamicin), cephaloridine, cisplatin, colistin, cyclosporine, fludarabine, loop diuretics (eg, furosemide, ethacrynic acid), mannitol, methoxyflurane, nitrosoureas (eg, carmustine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), polymyxin B, urea, vancomycin, or viomycin because they may increase the risk of Bethkis solution's side effects, including increased risk of kidney or hearing loss
  • Beta-lactam antibiotics (eg, penicillin, imipenem, ceftizoxime) because they may decrease Bethkis solution's effectiveness
  • Nondepolarizing muscle relaxants (eg, atracurium) or succinylcholine because the risk of their side effects may be increased by Bethkis solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bethkis solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bethkis solution:

Use Bethkis solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Bethkis solution. Talk to your pharmacist if you have questions about this information. Read it carefully for instructions on how to prepare Bethkis solution for inhalation, administer it, clean and disinfect your nebulizer, and care for your Pulmo-Aide Compressor. Talk to your pharmacist if you have questions about this information.
  • If you are also using dornase alfa, do not mix Bethkis solution in the same nebulizer as the dornase alfa.
  • If you are taking several inhaled medicines, talk to your doctor about the best order for taking your medicines.
  • Bethkis solution is normally slightly yellow in color and may darken with age if it has been left out of the refrigerator. This will not change the effectiveness of Bethkis solution.
  • Do not use Bethkis solution if it is cloudy or contains particles, or if it has been stored at room temperature for more than 28 days.
  • Bethkis solution is usually used in cycles of 28 days on the medicine, followed by 28 days off the medicine. Follow the dosing schedule given to you by your doctor carefully.
  • Use your doses as close to 12 hours apart as possible.
  • If you miss a dose of Bethkis solution, use it as soon as possible. If it is less than 6 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Bethkis solution.

Important safety information:

  • Bethkis solution only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Drinking extra fluids while you are using Bethkis solution is recommended. Check with your doctor for instructions.
  • If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Bethkis solution, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.
  • Be sure to use Bethkis solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of Bethkis solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Tell your doctor or dentist that you take Bethkis solution before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including kidney function, hearing tests, and tobramycin levels, may be performed while you use Bethkis solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Bethkis solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Bethkis solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bethkis solution while you are pregnant. It is not known if this medicine is found in breast milk after inhalation. Do not breast-feed while taking Bethkis solution.

Possible side effects of Bethkis solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Discolored sputum; voice changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; clumsiness; confusion; decreased hearing or other hearing changes; decreased urination; dizziness or light-headedness; feeling of a whirling motion; fever, chills, or persistent sore throat; hearing loss; hoarseness; loss of coordination; muscle weakness; numbness or tingling; ringing or roaring in the ears; seizures; severe or persistent diarrhea; shortness of breath; stomach pain or cramps; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Bethkis solution:

Store Bethkis solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Bethkis solution may be stored in the foil pouches at room temperature below 77 degrees F (25 degrees C) for up to 28 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bethkis solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Bethkis solution, please talk with your doctor, pharmacist, or other health care provider.
  • Bethkis solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Bethkis solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bethkis solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bethkis solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Bethkis solution.

Issue Date: June 3, 2015