What is Kitabis Pak?
Kitabis Pak contains a prescription medicine and a Pari LC Plus Reusable Nebulizer used to treat adults and children 6 years of age and older with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. Kitabis Pak contains an antibacterial medicine called tobramycin (an aminoglycoside).
It is not known if tobramycin inhalation solution is safe and effective:
- in children under 6 years of age.
- in people who have an FEV1 less than 25% or greater than 75% predicted.
- in people who are colonized with a bacterium called Burkholderia cepacian.
- when used for more than 3 cycles.
Who should not use Kitabis Pak?
Do not use Kitabis Pak if you are allergic to tobramycin, any of the ingredients in Kitabis Pak, or to any other aminoglycoside antibacterial medicine.
What should I tell my healthcare provider before using Kitabis Pak?
Before using Kitabis Pak, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had breathing problems such as wheezing, coughing, or chest tightness.
- have or have had hearing problems (including noises in your ears).
- have dizziness.
- have or have had kidney problems.
- have or have had problems with muscle weakness such as myasthenia gravis or Parkinson's disease.
- are pregnant or plan to become pregnant. Kitabis Pak contains a medicine that may cause harm to your unborn baby. See “What are the possible side effects of Kitabis Pak?” below for more information.
- are breastfeeding or plan to breastfeed. It is not known if the medicine in Kitabis Pak (tobramycin inhalation solution) passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter, vitamins, and herbal supplements.
Using Kitabis Pak with certain other medicines can cause serious side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
If you are using Kitabis Pak, you should discuss with your healthcare provider if you should take:
- other medicines that may harm your nervous system, kidneys, or hearing
- “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol
How should I use Kitabis Pak?
- See the step-by-step Instructions for Use that come with Kitabis Pak about the right way to use Kitabis Pak.
- Use Kitabis Pak exactly as your healthcare provider tells you to. Ask your healthcare provider or pharmacist if you are not sure.
- The usual dose of Kitabis Pak for adults and children 6 years of age and over is:
- 1 ampule of tobramycin inhalation solution inhaled by mouth in the morning and 1 ampule of tobramycin inhalation solution inhaled by mouth in the evening using your PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide air compressor.
- Each dose of Kitabis Pak should take about 15 minutes to finish.
- Each dose of Kitabis Pak should be used as close to 12 hours apart as possible.
- Do not use your dose of Kitabis Pak less than 6 hours apart.
- After using Kitabis Pak for 28 days, you should stop using it for 28 days. After you have stopped using Kitabis Pak for 28 days, you should start using Kitabis Pak again for 28 days. It is important that you keep to the 28-day on, 28-day off cycle.
- Do not mix the medicine in Kitabis Pak with other medicines including dornase alfa in your nebulizer.
- If you are taking other medicines inhaled through your mouth (bronchodilators), your healthcare provider will tell you how to take your medicine the right way.
- If you inhale too much of the medicine in Kitabis Pak, tell your healthcare provider right away.
Kitabis Pak can cause serious side effects, including:
- severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while using Kitabis Pak:
- shortness of breath with wheezing
- coughing and chest tightness
- hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.
- worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are using Kitabis Pak.
- worsening muscle weakness. The medicine in Kitabis Pak (tobramycin inhalation solution) is in a class of medicines that can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease).
- The medicine in Kitabis Pak (tobramycin inhalation solution) is in a class of medicines which may cause harm to an unborn baby.
The most common side effects of Kitabis Pak include:
- sore throat
- productive cough
- shortness of breath
- coughing up blood
- worsening of lung problems or cystic fibrosis
- changes in your voice (hoarseness)
- altered taste
These are not all of the possible side effects of Kitabis Pak. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Kitabis Pak
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Kitabis Pak for a condition for which it was not prescribed. Do not give Kitabis Pak to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Kitabis Pak that is written for health professionals.
How should I store Kitabis Pak?
- Store tobramycin inhalation solution in the refrigerator between 36°F to 46°F (2°C to 8°C) until needed.
- You may store the tobramycin inhalation solution in the foil pouches (opened or unopened) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days.
- Do not use tobramycin inhalation solution after the expiration date stamped on the ampule.
- Keep tobramycin inhalation solution in the foil pouch and out of the light.
- Tobramycin inhalation solution is normally slightly yellow, but may get darker with age if unrefrigerated. The color change does not change how the medicine works.
- Do not use tobramycin inhalation solution if it is cloudy, has particles in the solution, or if it has been stored at room temperature for more than 28 days. Throw the applicable ampule(s) away in your household trash and get a new ampule.
Keep Kitabis PAK and all medicines out of the reach of children.
What are the ingredients in Kitabis Pak?
Active ingredient: tobramycin
Inactive ingredients: sodium chloride in sterile water, sulfuric acid, and sodium hydroxide (for pH adjustment)