Indications and Usage
KITABIS PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.
Dosage and Administration
- KITABIS PAK is a co-packaging of tobramycin inhalation solution with a PARI LC PLUS® Reusable Nebulizer.
- Administer tobramycin inhalation solution as one single–use ampule (300 mg/5 mL) twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.
- Dosage is not adjusted by weight.
- Take doses as close to 12 hours apart as possible; but not less than 6 hours apart.
- Administer each 300 mg dose using the PARI LC PLUS Reusable Nebulizer and DeVilbiss® Pulmo-Aide® compressor.
Dosage Forms and Strengths
Inhalation solution: 300 mg in a single-use 5 mL ampule.
Known hypersensitivity to any aminoglycoside.
Warnings and Precautions
- Bronchospasm: Can occur with inhalation of tobramycin inhalation solution. Treat as medically appropriate, if it occurs.
- Ototoxicity: Tinnitus and hearing loss have been reported in patients receiving tobramycin inhalation solution. . If noted, manage as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
- Nephrotoxicity: Has been associated with aminoglycosides as a class. If nephrotoxicity develops, manage the patient as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
- Neuromuscular Disorders: Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary.
The most common adverse reactions (> 5%) in patients treated with tobramycin inhalation solution were cough, pharyngitis, and increased sputum.
To report SUSPECTED ADVERSE REACTIONS, contact PARI at 1-844 KITABIS (1-844-548-2247) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Concurrent and/or sequential use with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided.
- Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity.
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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