Kitabis Pak

Kitabis Pak is used for the management of cystic fibrosis with Pseudomonas aeruginosa.

Kitabis Pak is a co-packaging of tobramycin inhalation solution and a PARI LC PLUS ® reusable nebulizer. Kitabis Pak also includes DeVilbiss ® Pulmo‐Aide® compressor which is also used when administering the medication.

Tobramycin belongs to a group of drugs called aminoglycosides. These work by killing bacteria that cause infections.

This medication comes as an oral inhalation solution and is taken typically 2 times a day.

Common side effects of include cough, sore throat, and increased sputum (mucus).

Kitabis Pak is a prescription medication used to treat adults and children 6 years of age and older with cystic fibrosis (inherited disease of the mucus and sweat glands) who have a bacterial infection called Pseudomonas aeruginosa.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pari Respiratory Equipment, Inc.

Serious side effects have been reported with Kitabis Pak. See the "Drug Precautions" section.

Common side effects of Kitabis Pak include the following:

• 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
• rash

This is not a complete list of Kitabis Pak side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications that may harm your nervous system, kidneys, or hearing
• diuretics (water pills) such as ethacrynic acid (Edecrin), furosemide (Lasix), mannitol
• urea

This is not a complete list of Kitabis Pak drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Kitabis Pak including the following:

• bronchospasm (severe breathing problems). Tell your healthcare provider right away if you experience shortness of breath with wheezing, cough, and chest tightness.
• ototoxicity (hearing loss or ringing in the ears). 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.
• nephrotoxicity (worsening of kidney problems). 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. This medication may 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) may cause harm to an unborn baby.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kitabis Pak, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Kitabis Pak, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Kitabis Pak or to any of its ingredients
• 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
• have or have had breathing problems such as wheezing, coughing, or chest tightness
• have had an organ transplant
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Kitabis Pak falls into category D. It has been shown that use of Kitabis Pak in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Kitabis Pak crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kitabis Pak.

Take Kitabis Pak exactly as prescribed.

Kitabis Pak comes as an oral inhalation solution and is taken twice a day.

Each dose of Kitabis Pak should take about 15 minutes to finish.

Do not mix the medicine in Kitabis Pak with other medicines including Pulmozyme 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 miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Kitabis Pak at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Kitabis Pak is one ampule of tobramycin inhalation solution inhaled by mouth in the morning and 1 ampule of tobramycin 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 be used as close to 12 hours apart as possible. Do not use your dose of Kitabis Pak less than 6 hours apart.

If you take too much Kitabis Pak, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store tobramycin solution in the refrigerator until needed.
• You may store tobramycin inhalation solution in the foil pouches (opened or unopened) at room temperature 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 light.
• 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.
• Keep this and all medicines out of reach of children.