What is Kitabis Pak?
Kitabis Pak is a co-packaging of Tobramycin Inhalation Solution (drug) and PARI LC PLUS® Reusable Nebulizer (device) in a patient convenience kit. Kitabis Pak contains a prescription antibacterial medicine called tobramycin (an aminoglycoside) used to treat adults and children 6 years of age and older with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa.
How should I use Kitabis Pak?
Kitabis Pak is an inhaled antibiotic that is designed to be nebulized and delivered directly to the lungs. Use Kitabis Pak exactly as instructed by your healthcare provider. Ask your healthcare provider or pharmacist if you are not sure.
The usual dose of Kitabis Pak for adults and children over 6 years of age is:
- 1 ampule of Tobramycin Inhalation Solution inhaled by mouth in the morning and 1 ampule in the evening using your PARI LC PLUS Reusable Nebulizer with DeVilbiss Pulmo-Aide air compressor.
- Each dose of Kitabis Pak should take about 15 minutes to nebulize.
- Each dose of Kitabis Pak should be used as close to 12 hours apart as possible.
- Do not use your doses of Kitabis Pak less than 6 hours apart.
- After using Kitabis Pak for 28 days, you should stop using it for 28 days. It is important that you keep to the 28-day on, 28-day off cycle.
Using the FDA-Approved Device
To ensure that you receive the benefits of the Tobramycin Inhalation Solution included in Kitabis Pak, it is important that you use only the equipment or device approved for delivery of Tobramycin Inhalation Solution. The PARI LC PLUS nebulizer and the Devilbiss® Pulmo-Aide® 5650D (Pulmo-Aide®) compressor are the only FDA-approved devices for the administration of nebulized tobramycin.
Because of its unique drug + device design, your Kitabis Pak prescription already includes the PARI LC PLUS. If you already have a Devilbiss Pulmo-Aide compressor for other medications, then you can use it with Kitabis Pak, too. If you don’t, PARI will ensure you can get it using the PARI PROVIDE Compressor Access Program.
Read More About Taking Kitabis Pak...
Kitabis Pak (co-packaging of tobramycin inhalation solution and a PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Important Safety Information
Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycocide antibiotic.
Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems including ringing or other noises in your ears, dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you inhale Kitabis Pak, inform your health care provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if Kitabis Pak will pass into breast milk.
Tell your health care provider about all the medicines you take. Taking Kitabis Pak with certain other medications can cause serious side effects. If you are taking Kitabis Pak, you should discuss with your health care provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or diuretics (water pills) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.
Kitabis Pak can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your health care provider right away of you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing or chest tightness. Your health care provider may do a blood test and urine test to check how your kidneys are working while you are taking Kitabis Pak.
The most common side effects of Kitabis Pak include cough, sore throat, productive cough, shortness of breath, coughing up blood, worsening of lung problems or cystic fibrosis, changes in your voice (hoarseness), altered taste, and rash. Tell your health care provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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