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(tobramycin) Inhalation Solution
Read this Patient Information before you start taking BETHKIS and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is BETHKIS?
BETHKIS is a prescription medicine used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. BETHKIS contains an antibacterial medicine called tobramycin (an aminoglycoside).
It is not known if BETHKIS is safe and effective:
- in children under 6 years of age
- in people who have decreased lung volume or an FEV1 less than 40% of predicted
- in people who are colonized with a bacterium called Burkholderia cepacia
- when used for more than 3 cycles
Who should not take BETHKIS?
Do not take BETHKIS if you are allergic to tobramycin, any of the ingredients in BETHKIS, or to any other aminoglycoside antibacterial.
What should I tell my healthcare provider before taking BETHKIS?
Before you take BETHKIS, tell your healthcare provider if you:
- have or have had hearing problems (including noises in your ears)
- have dizziness
- have or have had kidney problems
- have or have had problems with muscle weakness such as myasthenia gravis or Parkinson's disease
- have or have had breathing problems such as wheezing, coughing, or chest tightness
- have had an organ transplant
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if BETHKIS passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking BETHKIS with certain other medicines can cause serious side effects.
If you are taking BETHKIS, you should discuss with your healthcare provider if you should take:
- other medicines that may harm your nervous system, kidneys, or hearing
- “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take BETHKIS?
- See the step-by-step Instructions for Use at the end of this Patient Information leaflet about the right way to take BETHKIS.
- Take BETHKIS exactly as your healthcare provider tells you to. Ask your healthcare provider or pharmacist if you are not sure.
- The usual dose of BETHKIS for adults and children over 6
years of age is:
- 1 ampule of BETHKIS inhaled by mouth in the morning and 1 ampule of BETHKIS inhaled by mouth in the evening using your hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios air compressor.
- Each dose of BETHKIS should take about 15 minutes to finish.
- Each dose of BETHKIS should be taken as close to 12 hours apart as possible.
- You should not take your dose of BETHKIS less than 6 hours apart.
- After taking BETHKIS for 28 days, you should stop taking it and wait 28 days. After you have stopped taking BETHKIS for 28 days, you should start taking BETHKIS again for 28 days. It is important that you keep to the 28-day on, 28-day off cycle.
- Do not mix BETHKIS with dornase alfa (Pulmozyme) in your nebulizer.
- If you are taking other medicines inhaled through your mouth (bronchodilators), you should take them before you take BETHKIS.
- If you take too much BETHKIS, tell your healthcare provider right away.
What are the possible side effects of BETHKIS?
BETHKIS 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 hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance
- worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking BETHKIS.
- worsening muscle weakness. BETHKIS can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease).
- Tobramycin is in a class of drugs which may cause harm to an unborn baby.
- severe breathing problems (bronchospasm). Tell your
healthcare provider right away if you get any of these symptoms of bronchospasm
while taking BETHKIS:
- shortness of breath with wheezing
- coughing and chest tightness
The most common side effects of BETHKIS include:
- worsening of lung problems or cystic fibrosis
- noisy breathing (rales)
- abnormal red blood cell activity
- changes in your voice (hoarseness)
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects of BETHKIS. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of BETHKIS.
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use BETHKIS for a condition for which it was not prescribed. Do not give BETHKIS to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about BETHKIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BETHKIS that is written for health professionals.
For more information, call 1-888-661-9260.
What are the ingredients in BETHKIS?
Active ingredient: tobramycin
Inactive ingredients: sodium chloride, sulfuric acid, and sodium hydroxide (for pH adjustment)
Instructions for Use
(tobramycin inhalation solution)
Follow the instructions below for taking BETHKIS. If you have any questions, ask your healthcare provider or pharmacist.
BETHKIS is available as a 28-day supply containing 56 ampules including 14 foil pouches and as a 14-day supply containing 28 ampules including 7 foil pouches. Each foil pouch contains 4 BETHKIS ampules.
Supplies you will need to take BETHKIS (See Figure A):
- 1 ampule of BETHKIS
- PARI LC PLUS reusable nebulizer
- PARI Vios compressor
- tubing to connect the nebulizer and compressor
- clean paper or cloth towels
- nose clips (optional)
BETHKIS is used only in a PARI LC PLUS re-usable Nebulizer connected to a PARI LC PLUS Vios air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in BETHKIS.
Do not mix BETHKIS with other medicines in your nebulizer.
BETHKIS comes in a sealed foil pouch. Do not open a sealed pouch until you are ready to use a dose of BETHKIS. After opening the pouch, unused ready-to-use ampules should be returned to, and stored in, the pouch.
- Put your PARI LC PLUS Reusable Nebulizer Top and Bottom (Nebulizer Cup) Assembly, Inspiratory Valve Cap, Mouthpiece with Valve, and Tubing on a clean and dry surface.
- Wash your hands with soap and water.
Preparing your BETHKIS dose:
Step 1: Open foil pouch. (See Figure B)
Step 2: Separate 1 ampule by gently pulling apart at the bottom tabs (See Figure C) and use it right away.
Step 3: Hold the bottom tab on the BETHKIS ampule with 1 hand (See Figure D). With your other hand, hold the top of the ampule and twist off the top of the ampule (See Figure D).
- Do not squeeze the ampule until you are ready to squeeze all the medicine into the Nebulizer Cup.
Step 4: Hold the Nebulizer Cup and twist off the Nebulizer Cup Top in a counter-clockwise direction (See Figure E). Set the Top aside on a clean, dry surface.
Step 5: Squeeze all of the medicine from the ampule into the Nebulizer Cup (See Figure F).
Step 6: Line up the semi-circle on the Nebulizer Cup Top with the Nebulizer Cup Outlet and twist on the Nebulizer Cup Top in a clock-wise direction until it is tight. (See Figure G).
Step 7: Push the mouthpiece straight onto the Nebulizer Cup Outlet (See Figure H).
Step 8: Firmly push the Inspiratory Valve Cap straight down onto the Nebulizer Cup Top (See Figure I). The Inspiratory Valve Cap should fit tightly.
Step 9: Connect 1 end of the tubing to the compressor air outlet. The tubing should fit tightly (See Figure J).
Step 10: Plug your compressor plug into an electrical outlet (See Figure K).
Step 11: Hold the Nebulizer Cup upright and firmly push the free end of the tubing straight up onto the Air Intake on the bottom of the Nebulizer Cup (See Figure L). Make sure to keep the Nebulizer Cup upright.
Giving your BETHKIS dose:
Step 12: Turn on the compressor (Figure M) and check the Mouthpiece. You should see a steady mist coming from the Mouthpiece (Figure N).
- If you do not see a steady mist coming from the mouthpiece, check all tubing connections and make sure that the compressor is working the right way.
Step 13: Sit or stand in a comfortable, upright position that will let you breathe normally. Place the Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure O).
- Nose clips may help you breathe only through your mouth and not through your nose.
Step 14: Keep breathing in your BETHKIS dose for at least 15 minutes. You will know that you have received your full dose of medicine when you hear a “spitting noise” coming from the Mouthpiece for at least 1 minute and the Nebulizer Cup is empty.
After your BETHKIS Dose:
Step 15: Clean and disinfect your nebulizer (see manufacturer's instructions).
Care and Use of Your PARI Vios®Compressor
Follow the manufacturer's instructions for care and use of your compressor.
How should I store BETHKIS?
- Store BETHKIS in the refrigerator at 36°F to 46°F (2°C to 8°C) until needed.
- BETHKIS may be stored at room temperature between 66°F to 77°F (20°C to 25°C) for up to 28 days.
- Do not use BETHKIS after the expiration date printed on the ampule.
- Keep BETHKIS ampules in the foil pouch and away from light.
- Keep BETHKIS and all medications out of the reach of children.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 5/2/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Bethkis Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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