Kitabis Pak
- Generic Name: tobramycin inhalation solution for oral inhalation
- Brand Name: Kitabis Pak
Kitabis Pak (Tobramycin Inhalation Solution for Oral Inhalation) side effects drug center
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- increased cough
- sore throat
- productive cough
- shortness of breath
- coughing up blood
- worsening of lung problems associated with cystic fibrosis
- changes in your voice (hoarseness)
- altered taste, and
- rash
- 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 problems;
- 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.
- cough, sore throat, hoarse voice;
- feeling short of breath;
- noisy breathing;
- worsening of lung problems or cystic fibrosis;
- coughing up mucus or blood;
- altered sense of taste;
- fever;
- headache; or
- rash.
- Bronchospasm [see WARNINGS AND PRECAUTIONS]
- Ototoxicity [see WARNINGS AND PRECAUTIONS]
- The most frequent adverse reactions in the tobramycin inhalation arm were cough, pharyngitis, and increased sputum (see Table 1).
- Thirty-three patients (13%) treated with tobramycin inhalation solution complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
- Eight patients from the tobramycin inhalation solution group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the tobramycin inhalation solution treatment regimen, and were not associated with loss of hearing in audiograms.
Kitabis Pak (tobramycin) Inhalation Solution is an antibiotic used for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Common side effects of Kitabis Pak Inhalation Solution include:
The 300 mg/5mL dose of Kitabis Pak inhalation solution is the same for all patients regardless of age or weight. Kitabis Pak may interact with other medicines that may harm your nervous system, kidneys or hearing, or diuretics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plant o become pregnant before using Kitabis Pak. This drug may harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Kitabis Pak (tobramycin) Inhalation Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kitabis Pak (Tobramycin Inhalation Solution for Oral Inhalation)
Kitabis Pak Professional Information
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tobramycin inhalation solution was studied in two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received tobramycin inhalation solution in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks. Adverse reactions reported in these studies are described below:
Table 1 lists the percent of patients with selected adverse reactions that occurred in > 5% of tobramycin inhalation solution patients during the two Phase III studies.
Table 1: Percent of Patients With Selected Adverse
Reactions Occurring in > 5% of Tobramycin Inhalation Solution Patients
| Cough Increased | 46.1 | 47.3 |
| Pharyngitis | 38.0 | 39.3 |
| Sputum Increased | 37.6 | 39.7 |
| Dyspnea | 33.7 | 38.5 |
| Hemoptysis | 19.4 | 23.7 |
| Lung Function Decreased1 | 16.3 | 15.3 |
| Voice Alteration | 12.8 | 6.5 |
| Taste Perversion | 6.6 | 6.9 |
| Rash | 5.4 | 6.1 |
| 1Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration. | ||
Selected adverse reactions that occurred in less than or equal to 5% of patients treated with tobramycin inhalation solution
Ear and Labyrinth Disorders
Tinnitus
Musculoskeletal and Connective Tissue Disorders
Infections and Infestations
Postmarketing Experience
The following adverse reactions have been identified during post approval use of tobramycin inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ear and Labyrinth Disorders
Hearing loss: Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus. [see WARNINGS AND PRECAUTIONS]
Skin and Subcutaneous Tissue Disorders
Hypersensitivity, pruritus, urticaria, rash
Nervous system Disorders
Aphonia, dysgeusia
Respiratory, Thoracic, and Mediastinal Disorders
Bronchospasm [see WARNINGS AND PRECAUTIONS], oropharyngeal pain
Read the entire FDA prescribing information for Kitabis Pak (Tobramycin Inhalation Solution for Oral Inhalation)
&Copy; Kitabis Pak Patient Information is supplied by Cerner Multum, Inc. and Kitabis Pak Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.