Amikacin Nebulizer Suspension

What is this medication?

AMIKACIN (am i KAY sin) treats infections caused by bacteria. It is prescribed when other medications have not worked well enough. It will not treat colds, the flu, or infections caused by viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ARIKAYCE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Have been told you have an increased likelihood of hearing problems
• Kidney disease
• Lung or breathing disease, such as asthma or COPD
• Myasthenia gravis
• Parkinson disease
• Personal or family history of hearing loss or problems
• An unusual or allergic reaction to amikacin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for inhalation using a nebulizer. Nebulizers make a liquid into an aerosol that you breathe in through your mouth or your mouth and nose and into your lungs. Take it as directed on the prescription label. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• Cisplatin
• Cyclosporine
• Diuretics
• Estrogen or progestin hormones
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Other medications for infection, such as acyclovir, adefovir, amphotericin B, bacitracin, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• Pamidronate
• Zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your care team if you have diarrhea that lasts more than 2 days or if it is severe and watery.

Your hearing may be tested before and during the use of this medication.

Tell your care team right away if you have any change in your hearing.

You should make sure you get enough vitamin B6 and vitamin B12 while you are taking this medication. Discuss the food you eat and the vitamins you take with your care team.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Coughing up blood
• Dry cough, shortness of breath or trouble breathing
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Wheezing or trouble breathing

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in voice, hoarseness
• Cough
• Diarrhea
• Headache
• Nausea
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Refrigeration (preferred): Store in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Get rid of any unused medication after the expiration date.

Room Temperature: This medication may be stored at room temperature for up to 4 weeks. If it is stored at room temperature, get rid of any unused medication after 4 weeks or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.