This product is taken via Podhaler®.
Why is it prescribed?
Inhaled tobramycin sulfate can prevent worsening of and maintain stable status of patients with cystic fibrosis and chronic lung infections.
- Tobi® Podhaler contains an antibiotic called tobramycin sulfate. When the capsules are inhaled using the Podhaler device, the antibiotic goes into the lungs and clears up the infection that is making breathing more difficult.
- The Tobi® Podhaler treats a bacteria that commonly infects the lungs of patients with Cystic Fibrosis. Because this bacteria can damage the lungs, it is important that it is treated.
- If you are using other inhalers as well, it is important to wait at least 15 minutes after using them before using your Tobi® Podhaler. Tobi® Podhaler should always be the last inhaler used.
- Each Tobi® Podhaler contains enough medicine for 7 days. After the 7 days have been completed, the Podhaler should be discarded and a fresh one started.
Instructions for use and handling
- Each weekly box contains seven blister strips (corresponding to the seven days of the week) and each blister strip contains eight capsules (corresponding to a daily dose: 4 capsules to be taken in the morning and 4 capsules to be taken in the evening).
- The capsules must always be stored in the blister strip, and only removed immediately before use. Allow the device and capsules to reach room temperature before use. Each inhaler and its case are used for seven days and then discarded and replaced.
Preparation for use:
1. Wash and fully dry your hands.
2. Just before use, remove the inhaler from its case by holding the base and twisting off the top of the case in a counter-clockwise direction. Set the top of the case aside. Briefly inspect the inhaler to make sure it is not damaged or dirty, and then stand it in the base of the case.
3. Holding the body of the inhaler, unscrew and remove the mouthpiece from the inhaler body. Set the mouthpiece aside on a clean, dry surface.
4. Separate the 4 morning capsules and the 4 evening capsule on the blister strip. Peel back the foil from the blister strip to reveal one capsule and remove it from the card.
5. Immediately insert the capsule into the inhaler chamber. Replace the mouthpiece and screw it on firmly until it stops. Do not overtighten.
6. To puncture capsule, hold the inhaler with the mouthpiece down, press the blue button firmly with your thumb as far as it will go, then release the button. The medication is now ready for inhalation. It is important for the patient to understand that the hypromellose (HPMC) capsule might fragment and small pieces might reach the mouth or throat during inhalation. It is not harmful if these pieces are swallowed or inhaled. The tendency for this to happen is minimized by not piercing the capsule more than once.
7. Fully exhale away from the inhaler. Position the inhaler with the mouthpiece facing towards you.
8. Place mouth over the mouthpiece creating a tight seal with your lips. Inhale the powder deeply with a single continuous inhalation.
9. Remove inhaler from mouth, and hold breath for a count of approximately 5 seconds, then exhale normally away from the inhaler.
10. After a few normal breaths, perform a second inhalation from the same capsule, repeating steps 7–9 above.
Check and continue
11. Unscrew the mouthpiece and remove the ‘empty’ or ‘used’ capsule from the chamber.
12. Inspect the used capsule. It should appear punctured and empty. If it is empty, discard the capsule.
- If the capsule is punctured but still contains some powder, place it back into the chamber with the punctured side of the capsule inserted first, replace the mouthpiece and take another two inhalations from the capsule (repeat step 5, then steps 7–12, do not repuncture the capsule). Reinspect capsule.
- If the capsule appears to be unpunctured, place it back into the chamber, replace the mouthpiece, press the button firmly as far as it goes and take another two inhalations from the capsule (repeat steps 5–11). After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again (repeat steps 3 and 5–12).
13. Repeat, starting at step 4, for the remaining three capsules of the dose.
14. Replace the mouthpiece and screw it on firmly until it stops. When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth. The inhaler should never be washed with water.
15. Place inhaler back in storage case and close tightly. Store at room temperature away from moisture.
See other products used in the treatment of •cystic fibrosis •
Tobi® Podhaler is not to be used in children under the age of 6 years old.
The recommended dosage is 4 capsules taken by inhalation twice daily for 28 days. Tobi® Podhaler is taken in alternating cycles of 28 days on the drug followed by 28 days off of the drug.
Tobramycin is an aminoglycoside antibiotic. It is used in the management of cystic fibrosis patients with chronic lung infections.
The most common side effects of inhaled tobramycin include:
- worsening of lung problems or cystic fibrosis
- productive cough
- shortness of breath
- sore throat
- changes in your voice (hoarseness)
- coughing up blood
- altered taste
Inhaled tobramycin can cause serious side effects, including:
- hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears such as ringing or hissing. Tell your healthcare provider if you develop vertigo, difficulty with balance or dizziness.
- worsening kidney problems (nephrotoxicity) - especially in people with known or suspected kidney problems.
- worsening muscle weakness - in people who already have problems with muscle weakness
- severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm:
- shortness of breath with wheezing
- coughing and chest tightness
Do not use if allergic to aminoglycosides.
Tell your doctor before using inhaled tobramycin if you have:
Unusual difficulty in breathing with wheezing or coughing or chest tightness
Blood in your sputum (the substance you cough up)
Muscle weakness that lasts or becomes worse with time.
You should not take the following medicines while you are taking inhaled tobramycin:
Furosemide or ethacrynic acid
Urea or intravenous mannitol
Other medicines which may harm your kidneys or hearing
Use in pregnancy: Use only if risk outweighs benefit. Consult your docotor or pharmacist before use.
Use in breastfeeding: Use only if risk outweighs benefit. Consult your docotor or pharmacist before use.