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|Tobi Solution

Tobi Solution

Tobi Solution is used for:

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

Tobi Solution is an aminoglycoside antibiotic. It works by killing sensitive bacteria.

Do NOT use Tobi Solution if:

• you are allergic to any ingredient in Tobi Solution or another aminoglycoside antibiotic (eg, gentamicin)
• you are taking certain diuretics (eg, furosemide, ethacrynic acid), cyclosporine, mannitol, methoxyflurane, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or urea

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

Before using Tobi Solution:

Some medical conditions may interact with Tobi 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 Tobi Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, gentamicin), cephalosporins (eg, ceftizoxime), cephaloridine, cisplatin, colistin, cyclosporine, fludarabine, loop diuretics (eg, furosemide, ethacrynic acid), mannitol, methoxyflurane, nitrosoureas (eg, carmustine), NSAIDs (eg, ibuprofen), polymyxin B, urea, vancomycin, or viomycin because they may increase the risk of Tobi Solution"s side effects, including increased risk of kidney or hearing loss
• Nondepolarizing muscle relaxants (eg, atracurium) or succinylcholine because the risk of their side effects may be increased by Tobi Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tobi 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 Tobi Solution:

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

• An extra patient leaflet is available with Tobi Solution. Talk to your pharmacist if you have questions about this information. Read it carefully for instructions on how to prepare Tobi 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 Tobi 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.
• Tobi Solution may darken with age if it has been left out of the refrigerator. This will not change the effectiveness of Tobi Solution.
• Do not use Tobi Solution if it is cloudy or contains particles.
• Tobi 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 Tobi 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 Tobi Solution.

Important safety information:

• Tobi Solution only works against bacteria; it does not treat viral infections (eg, the common cold).
• Drinking extra fluids while you are using Tobi Solution is recommended. Check with your doctor for instructions.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Be sure to use Tobi 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 Tobi 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 Tobi 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 Tobi Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Tobi 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: Tobi 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 Tobi Solution while you are pregnant. It is not known if Tobi Solution is found in breast milk after inhalation. Do not breast-feed while taking Tobi Solution.

Possible side effects of Tobi 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.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); clumsiness; confusion; decreased hearing; decreased urination; dizziness or lightheadedness; feeling of a whirling motion; fever; hearing loss; loss of coordination; muscle weakness; numbness or tingling; ringing or roaring in the ears; seizures; shortness of breath; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; dizziness; hearing loss; trouble breathing.

Store Tobi Solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Tobi 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 Tobi Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Tobi Solution, please talk with your doctor, pharmacist, or other health care provider.
• Tobi 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.

This information is a summary only. It does not contain all information about Tobi Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.