Albuterol (al-BUE-ter-ol), Budesonide (bue-DES-oh-nide)

Treats or prevents symptoms of asthma and prevents asthma attacks.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Aerosol

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You will use this medicine with a device called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your caregiver will show you how to use your inhaler and the spacer (if needed). Do not use more medicine or use it more often than instructed.
• Prime the inhaler before using it for the first time. Shake the inhaler and spray the medicine into the air away from your face. Do this 4 times. You will need to re-prime the inhaler after each cleaning and if you have not used it for 7 days or longer, or if you have dropped it. Re-prime the inhaler by shaking and spraying it into the air away from your face 2 times.
• Shake the inhaler well just before each use. Avoid spraying this medicine into your eyes.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
• Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
• Immediately repeat these steps for the second puff, starting with shaking the inhaler.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.
• Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not use soap and do not dry with towel or tissue. Do not let the canister get wet.
• Throw away this medicine 12 months after opening the foil pouch, when the dose counter reaches "0", whichever comes first.
• Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
• Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how albuterol/budesonide works. Tell your doctor if you are using any of the following:
  • Digoxin
  • Blood pressure medicine (including beta-blocker medicine)
  • Diuretic (water pill)
  • Medicine for depression (including an MAO inhibitor or TCA within the past 2 weeks)
  • Medicine to treat HIV or AIDS (including atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat infection (including clarithromycin, ketoconazole, telithromycin)
  • Medicine to treat seizures
  • Other inhaled or asthma medicines

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart or blood vessel disease (including high blood pressure, heart rhythm problems), diabetes, any kind of infection (including tuberculosis or herpes infection of the eye), weak immune system, eye problems (including cataracts or glaucoma), thyroid problems, seizures, or a history of osteoporosis. Tell your doctor if you have ever been exposed to chickenpox or measles.
• This medicine may cause the following problems:
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • Heart rhythm problems
  • Hypokalemia (low potassium in the blood)
  • Increased risk of infection, including fungus infection in the mouth (thrush)
  • Adrenal gland problems
  • Low bone mineral density
  • Eye or vision problems, including glaucoma or cataracts
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Dry mouth, increased thirst, muscle cramps
• Eye pain or vision changes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures, tremors, nervousness, shaking

If you notice these less serious side effects, talk with your doctor:

• Sores or white patches in your mouth or throat, pain when eating or swallowing

If you notice other side effects that you think are caused by this medicine, tell your doctor

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