Description
Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis. It is breathed into the lungs through the mouth to treat infections caused by the Pseudomonas aeruginosa bacteria.
Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tobramycin inhalation in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of Bethkis® have not been performed in the geriatric population.
Although appropriate studies on the relationship of age to the effects of Tobi® or Tobi® Podhaler™ have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ataluren
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alcuronium
- Aspirin
- Atracurium
- Cholera Vaccine, Live
- Cidofovir
- Cisatracurium
- Colistimethate Sodium
- Cyclosporine
- Decamethonium
- Doxacurium
- Emtricitabine
- Ethacrynic Acid
- Fazadinium
- Foscarnet
- Furosemide
- Gallamine
- Hexafluorenium
- LetibotulinumtoxinA-wlbg
- Lysine
- Mannitol
- Metocurine
- Mivacurium
- Pancuronium
- Pipecuronium
- Rapacuronium
- Rocuronium
- Succinylcholine
- Tacrolimus
- Tenofovir Alafenamide
- Tubocurarine
- Vancomycin
- Vecuronium
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cisplatin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to aminoglycoside antibiotics (eg, amikacin, gentamicin, streptomycin, Garamycin®)—Should not be used in patients with this condition.
- Breathing problems (eg, bronchospasm) or
- Kidney disease or
- Myasthenia gravis (severe muscle weakness) or
- Parkinson's disease or
- Problems with hearing or balance—Use with caution. May make these conditions worse.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions. Ask your doctor if you have any questions.
If you are using the inhalation solution:
- Tobramycin inhalation solution is packaged in small plastic containers called ampules. Each ampule contains one full dose of tobramycin. Do not use an ampule that has already been opened. Also, do not use an ampule of this medicine after the expiration date printed on the package.
- Tobramycin is especially formulated to be used with a PARI LC PLUS™ nebulizer. Tobi® is used together with a DeVilbiss® Pulmo-Aide® compressor, while Bethkis® is used together with a PARI Vios air compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe the spray in through your mouth and into your lungs.
- Use the mouthpiece of the nebulizer to breathe in Bethkis®.
- You will need to use the nebulizer for about 10 to 15 minutes, or until the medicine in the nebulizer cup is gone. You may hear a sputtering sound when the cup is empty.
- Clean all the parts of the nebulizer after each use.
- You may want to rinse your mouth or suck on hard candy if the Tobi® inhalation solution leaves a bad taste in your mouth.
If you are using the inhalation capsule:
- Do not swallow the inhalation capsules.
- This medicine is especially formulated to be used with the Podhaler™ device.
- Store the capsules in the blister pack until you are ready to use them.
- Always use a new Podhaler™ device every 7 days.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece in your mouth with the device upright.
- Breathe in slowly and deeply.
- Hold your breath for about 5 seconds, then breathe out slowly.
- Check if the capsule is empty after inhaling. If some powder remains in the capsule, repeat inhalation until the capsule is empty.
- Wipe the mouthpiece with a clean, dry cloth. Make sure that the Podhaler™ stays dry at all times to work the right way.
If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using tobramycin, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use tobramycin. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with tobramycin. It is recommended that Tobi® Podhaler™ is taken last.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For Pseudomonas lung infections:
- For inhalation dosage form (solution):
- Adults and children 6 years of age and older—One ampule or container with 300 milligrams (mg) of tobramycin 2 times a day for 28 days in the nebulizer. Then, stop using this medicine and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For inhalation dosage form (capsule):
- Adults and children 6 years of age and older—Four capsules with 28 milligrams (mg) of tobramycin 2 times a day for 28 days in the Podhaler™ device. Then, stop using this medicine and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For inhalation dosage form (solution):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Take a dose of Tobi® as soon as you remember. If your next regular dose is in less than 6 hours, skip the missed dose and return to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
If you can't keep the tobramycin inhalation solution in the refrigerator, store the medicine in the foil pouch at room temperature for up to 28 days away from heat or direct light. Do not use the medicine kept at room temperature after 28 days.
Store the Tobi® Podhaler™ capsules at room temperature, away from heat and direct light. Keep the capsules and Podhaler™ device in a dry place.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have dizziness, feeling of fullness in the ears, loss of balance, loss of hearing, ringing or buzzing in the ears, or trouble in hearing. These may be symptoms of a serious hearing or balance problem.
Your doctor may want to test your hearing while you are being treated with tobramycin. Tell your doctor if you already have hearing problems before you are given this medicine.
Using this medicine may cause harm to your kidneys. Check with your doctor right away if you or your child has blood in the urine, change in the frequency of urination, difficulty in breathing, increased thirst, swelling of the feet or lower legs, or weakness.
When you breathe in this medicine, you may have cough or trouble breathing. Call your doctor right away if you have a cough, trouble breathing, or chest tightness after using this medicine.
If any of your medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloody nose
- difficulty with breathing
- discoloration of sputum
- fever
- runny nose
- sneezing
- stuffy nose
- voice changes
Less common
- Black, tarry stools
- chest pain or tightness
- chills
- continuing ringing or buzzing or other unexplained noise in the ears
- feeling of fullness in the ears
- hearing loss
- loss of balance
- loss or change in hearing
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble hearing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Cough
- fast heartbeat
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness or swelling
- mouth or throat pain
- noisy breathing
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- trouble swallowing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blue lips, fingernails, or skin
- dizziness or lightheadedness
- drowsiness
- feeling of constant movement of self or surroundings
- irregular, fast or slow, or shallow breathing
- sensation of spinning
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- general feeling of discomfort or illness
Less common
- Change or loss of taste
- diarrhea
- rash
Less common
- Decreased appetite
- loss of voice
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
