Kitabis Pak (inhalation)

Kitabis Pak is an antibiotic that you inhale into your lungs with a nebulizer. This inhalation medicine is used to treat lung infections in patients who have cystic fibrosis.

Kitabis Pak is for adults and children who are at least 6 years old.

Kitabis Pak may also be used for reasons that are not listed in this medication guide.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and all medicines you are taking.

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

Tell your doctor if you have ever had:

• hearing problems;
• breathing problems (cough, wheezing, chest tightness);
• dizzy spells;
• a neuromuscular disease such as myasthenia gravis or Parkinson's disease; or
• kidney disease.

It is not known whether Kitabis Pak will harm an unborn baby. However, a medicine similar to this medicine caused irreversible hearing damage in babies whose mothers took that medicine during pregnancy.

Tell your doctor if you are pregnant or plan to become pregnant. Having cystic fibrosis during pregnancy may increase the risk of premature birth. The benefit of treating cystic fibrosis may outweigh any risks to the baby.

If you breastfeed while using Kitabis Pak, watch the baby for signs of diarrhea, blood in the stools, or a fungal diaper rash with white patches on the skin.

Kitabis Pak is not approved for use by anyone younger than 6 years old.

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

Kitabis Pak may cause serious side effects. Call your doctor right away if you have:

• new or worsening breathing problems, such as wheezing, cough, chest tightness, or trouble breathing;
• hearing problems, ringing in your ears;
• hoarse voice;
• severe dizziness, spinning sensation, balance issues;
• weak or shallow breathing;
• muscle weakness; or
• kidney problems—little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of Kitabis Pak may include:

• cough, sore throat, hoarse voice;
• feeling short of breath;
• noisy breathing;
• worsening of lung problems or cystic fibrosis;
• coughing up mucus or blood;
• changed sense of taste;
• fever;
• headache; or
• rash.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Use only the inhaler device provided with your medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Kitabis Pak is given in a treatment cycle of 28 days on and 28 days off. Follow your doctor's dosing instructions very carefully. Keep using this medicine on this schedule, even if you feel fine.

Use your doses at regular intervals of 12 hours apart but not less than 6 hours apart.

If you use other inhaled medicines, or if you perform chest physiotherapy to remove mucus from the lungs, use these other treatments first before using your Kitabis Pak dose.

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

Store Kitabis Pak ampules in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius).

If refrigeration is not available, store the ampules at cool room temperature for up to 28 days. Protect from light. The solution may become darker in color at room temperature, but this should not affect the quality of the medicine.

Store Tobi Podhaler capsules in their original blister pack at room temperature away from moisture and heat. Remove a Tobi Podhaler capsule from the blister pack only when you are ready to load it into your inhaler device.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

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

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

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects.

Tell your doctor about all your other medicines, especially:

• urea;
• a diuretic or "water pill"—furosemide, Lasix, ethacrynic acid, and others;
• Kitabis Pak or similar medicines (taken by mouth or injected)—amikacin, kanamycin, neomycin, paromomycin, plazomicin, streptomycin; or
• other medicine that may harm your kidneys, hearing, or nervous system—certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

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