Bethkis

Bethkis is a prescription medication used for people with cystic fibrosis with long-lasting lung infections caused by certain bacteria. Tobramycin, the active ingredient in Bethkis, belongs to a group of medicines called aminoglycoside antibiotics. These work by killing the bacteria causing the infections.

This medication comes in a solution to be inhaled using PARI LC PLUS reusable nebulizer and the PARI VIOS air compressor. It is inhaled twice daily, with twelve hours between doses. After 28 days the medication is stopped for 28 days, and then restarted.

Common side effects of Bethkis include worsening of lung problems or cystic fibrosis, noisy breathing (rales), and abnormal red blood cell activity.

Bethkis is a prescription medication used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cornerstone Therapeutics, Inc.

Serious side effects have been reported with Bethkis. See the "Drug Precautions" section.

Common side effects of Bethkis include the following:

• worsening of lung problems or cystic fibrosis
• noisy breathing (rales)
• abnormal red blood cell activity
• changes in your voice (hoarseness)

This is not a complete list of Bethkis side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that may harm your nervous system, kidneys, or hearing
• diuretics (water pills) such as ethacrynic acid (Edecrin), furosemide (Lasix), and mannitol
• urea

This is not a complete list of Bethkis drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Bethkis including the following:

• ototoxicity (hearing loss or ringing in the ears). 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.
• nephrotoxicity (worsening kidney problems). Your healthcare provider may do a blood test or 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).
• bronchospasm (severe breathing problems). Tell your healthcare provider right away if you experience shortness of breath with wheezing, coughing, and chest tightness.
• Tobramycin is in a class of drugs which may cause harm to an unborn baby.

Do not take Bethkis if you are allergic to Bethkis or to any of its ingredients or to any other aminoglycoside.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bethkis, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Bethkis, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Bethkis or to any of its ingredients
• 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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bethkis falls into category D. It has been shown that use of Bethkis in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Bethkis crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Bethkis.

Take Bethkis exactly as prescribed.

Bethkis comes in a solution to be inhaled using PARI LC PLUS reusable nebulizer and the PARI VIOS air compressor. It is inhaled twice daily, with twelve hours between doses. After 28 days the medication is stopped for 28 days, and then restarted.

You should not take your dose of Bethkis less than 6 hours apart.

Each dose of Bethkis should take about 15 minutes to finish.

Do not mix Bethkis with 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 miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Bethkis at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Bethkis is one ampule inhaled by mouth in the morning and one ampule 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 be taken as close to 12 hours apart as possible.

If you take too much Bethkis, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Bethkis in the refrigerator until needed.
• Bethkis may be stored at room temperature 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 this and all medicines out of reach of children.