Budesonide and Albuterol Oral Inhalation

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

The combination of budesonide and albuterol comes as an aerosol to inhale by mouth using an inhaler. It is usually taken as 2 puffs as needed to prevent or relieve symptoms. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use budesonide and albuterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Do not use more than 12 puffs in 24 hours.

Budesonide and albuterol controls symptoms of asthma but does not cure them. Do not stop using budesonide and albuterol without talking to your doctor.

Before you use the budesonide and albuterol inhaler the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to demonstrate the proper technique. Practice using the inhaler while in his or her presence.

Stop using the inhaler and throw the inhaler away when the dose counter shows zero.

To use the inhaler, follow these steps:

1. Remove the protective dust cap from the end of the mouthpiece. Check the mouthpiece for dirt or other objects. Be sure that the canister is fully and firmly inserted in the mouthpiece.
2. If you are using the inhaler for the first time or if you have not used the inhaler in more than 7 days, you will need to prime it. To prime the inhaler, shake it well and then press down on the canister 4 times to release 4 test sprays into the air, away from your face. You will also need to re-prime the inhaler if it has been dropped or if it has been cleaned. To re-prime the inhaler, shake it well and then press down on the canister 2 times to release 2 test sprays into the air, away from your face. Be careful not to get budesonide and albuterol in your eyes. Shake the inhaler prior to each test spray.
3. Shake the inhaler well.
4. Breathe out as completely as possible through your mouth.
5. Hold the canister with the mouthpiece on the bottom, facing you and the canister pointing upward. Place the open end of the mouthpiece into your mouth. Close your lips tightly around the mouthpiece.
6. Breathe in slowly and deeply through the mouthpiece. At the same time, press down once on the container to spray the medication into your mouth.
7. When you have breathed in fully, remove the inhaler from your mouth and close your mouth. Try and hold your breath for about 10 seconds, then breathe out gently.
8. To use 2 puffs, immediately repeat steps 3-7.
9. Replace the protective cap on the inhaler.
10. Rinse your mouth with water and spit the water out. Do not swallow the water.
11. Clean your inhaler once a week. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your inhaler.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using budesonide and albuterol oral inhalation,

• tell your doctor and pharmacist if you are allergic to budesonide (Pulmicort, Rhinocort, in Symbicort, others), albuterol (Proair, Proventil, Ventolin, others), any other medications, or any of the ingredients in budesonide and albuterol oral inhalation. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily) and if you have or have ever had an irregular heartbeat, heart disease, high blood pressure, low levels of potassium in your blood, hyperthyroidism (condition in which there is too much thyroid hormone in the body), diabetes, seizures, tuberculosis (TB; a serious lung infection) in your lungs, cataracts (clouding of the lens of the eye), glaucoma (an eye disease) or high pressure in the eye, or liver disease. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface), if you smoke or use tobacco products, or if you are on bedrest or unable to move around.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using budesonide and albuterol oral inhalation, call your doctor.

• tell your doctor if you have never had chicken pox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chicken pox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away.

• you should know that budesonide and albuterol inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, call your doctor right away. Do not use budesonide and albuterol inhalation again unless your doctor tells you that you should.

Unless your doctor tells you otherwise, continue your normal diet.

Budesonide and albuterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• cough
• white patches in the mouth
• hoarseness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• increased difficulty breathing
• fast, pounding, or irregular heartbeat
• chest pain
• rash, hives, or itching
• swelling of the face, throat, tongue, lips, hands, feet, ankles, or lower legs
• difficulty swallowing
• fever, chills, and other signs of infection
• tiredness
• nausea
• vomiting
• weakness
• changes in vision

In rare cases, people who used budesonide for a long time developed glaucoma or cataracts.Talk to your doctor about the risks of using budesonide and albuterol and how often you should have your eyes examined during your treatment.

Budesonide and albuterol may increase your risk of developing osteoporosis (a condition in which the bones become thin and weak and break easily). Talk to your doctor about the risks of using this medication.

Budesonide and albuterol may cause growth retardation in children, Budesonide and albuterol should not be used in children.

Budesonide and albuterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Do not puncture the aerosol canister, and do not discard it in an incinerator or fire.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• seizures
• chest pain
• dizziness
• fast, pounding, or irregular heartbeat
• nervousness
• headache
• shaking of a part of your body that you cannot control
• muscle cramps or weakness
• dry mouth
• nausea
• excessive tiredness
• lack of energy
• difficulty falling asleep or staying asleep

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.