Indications 

Tobi Podhaler Capsules is a prescription inhaled medication used for the management of respiratory infections in individuals with cystic fibrosis. It is an antibiotic that targets the bacteria called Pseudomonas aeruginosa, commonly found in the lungs of cystic fibrosis patients. Tobi Podhaler is indicated for suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older.  

Tobi Podhaler contains the active ingredient tobramycin, which is an antibiotic. When inhaled, it reaches the lungs and targets the bacteria that cause respiratory infections in individuals with cystic fibrosis. It helps to reduce the growth of bacteria and manage the symptoms of lung infections. 

Use and Dosage 

Tobi Podhaler contains 28 mg of Tobramycin Inhalation Powder per capsule. One treatment cycle consists of 28 days on and 28 days off treatment. Each dose of 4 capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart. The powder from all 4 capsules must be inhaled to receive the full dose of 112 mg. Inhale 2 times from each capsule in order to empty it. 

To use Tobi Podhaler Capsules, follow these general steps: 

1. Remove the device from its case and open it by twisting the cap counterclockwise. Do not remove the capsule from the blister card until you are ready to use it. 
2. Hold the base of the Podhaler device upright and lift the mouthpiece cover. Then, peel back the foil to expose the blister containing the capsule. Push the capsule through the foil into the chamber of the Podhaler device. 
3. Close the mouthpiece cover by pressing it firmly until you hear a click. This will pierce the capsule and make it ready for inhalation. 
4. Breathe out fully, away from the device. Place your lips tightly around the mouthpiece and breathe in deeply and forcefully through your mouth. This will release the medication from the capsule and deliver it to your lungs. Remove the device from your mouth and hold your breath for a few seconds before exhaling. 
5. Open the mouthpiece cover to check if the capsule is empty. If there is any powder left, repeat the inhalation step. Once the capsule is empty, discard it and close the mouthpiece cover. 

Do not swallow the TOBI Podhaler capsules, as the powder in the capsule is for inhalation only. Each capsule should only be removed from the blister immediately before use and should be stored in the blister.  

Side Effects 

Common Side Effects 

• Changes in voice 
• Cough 
• Headache 
• Painful breathing or chest pain 
• Shortness of breath 
• Sore throat 

Serious Side Effects

• Balance problems 
• Chest tightness 
• Coughing 
• Difficulty breathing 
• Hearing problems 
• Hives 
• Hoarse voice 
• Little or no urination 
• Muscle weakness 
• New or worsening breathing problems 
• Ringing in your ears 
• Severe dizziness 
• Shortness of breath 
• Spinning sensation 
• Swelling in your feet or ankles 
• Swelling of your face lips tongue or throat 
• Tiredness 
• Trouble breathing 
• Weak or shallow breathing 
• Wheezing 
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights 
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out 
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. 

Cautions 

• Bronchospasm has been reported with inhalation of TOBI Podhaler. If you experience severe breathing problems or bronchospasm, seek medical attention immediately. 
• Some individuals may be allergic to tobramycin or other ingredients in Tobi Podhaler Capsules. If you experience symptoms such as rash, itching, swelling, dizziness, or difficulty breathing, stop using the medication and consult a healthcare professional. 
• Tobi Podhaler may interact with other medications. Inform your healthcare provider about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements, to avoid potential interactions. 
• Use caution when prescribing Tobi Podhaler to patients with pre-existing conditions such as kidney problems, hearing loss, or muscle weakness. Adjustments to the dosage or alternative treatments may be necessary. 
• Tobi Podhaler should be used with caution during pregnancy and breastfeeding. Consult with a healthcare professional to weigh the potential risks and benefits before using the medication. 
• Follow the proper storage and disposal instructions for Tobi Podhaler. Store the capsules in a dry place at room temperature, away from heat and direct light. Dispose of any unused or expired medication as directed by your healthcare professional. 
• Prolonged or repeated use of Tobi Podhaler may increase the risk of developing infections that are resistant to tobramycin or other antibiotics. This can make future infections more difficult to treat. 
• Regular monitoring of lung function is important when using Tobi Podhaler. Your healthcare provider may perform tests like spirometry to assess your lung function and determine the medication’s effectiveness. 
• Patients with cystic fibrosis may be at an increased risk of developing cystic fibrosis-related diabetes. Tobi Podhaler may affect blood sugar levels in some individuals. Regular monitoring of blood glucose levels may be necessary. 
• Tobi Podhaler may cause hearing and balance problems in some individuals. If you experience hearing loss, ringing in the ears (tinnitus), or problems with balance, notify your healthcare provider.