Albuterol is a bronchodilator. Budesonide is a steroid.

albuterol and budesonide is for occasional use and is not a maintenance treatment for asthma.

Albuterol and budesonide inhalation is a combination medicine used in adults to treat the symptoms of asthma or to prevent asthma attacks.

Albuterol and budesonide inhalation may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you take oral steroid medicine, do not stop it suddenly. Ask your doctor about tapering your dose.

Albuterol and budesonide inhalation is not a maintenance medicine for asthma. You should continue using your maintenance medicine to control your asthma symptoms. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or stop using asthma medication without your doctor's advice. Tell your doctor if your medicine seems to stop working.

Before your first use, shake the inhaler for 5 seconds and prime it with 4 sprays into the air, away from your face. Prime again with 2 sprays into the air whenever the inhaler has not been used in longer than 7 days, after cleaning, or if it has been dropped.

Rinse your mouth with water after each use of your inhaler to decrease the chance of getting a fungal infection (thrush) in your mouth or throat.

Do not take apart an inhaler device or float the medicine canister in water. Get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill.

You may need medical tests.

Keep the cover on your inhaler when not in use. Store away from open flame or high heat. Do not puncture or burn an empty canister.

Once you have opened a foil pouch, the canister should be used within 12 months or when the dose indicator reaches zero, whichever comes first.

Usual Adult Dose for Asthma:

Albuterol 180 mcg-budesonide 160 mcg oral inhalation as needed
(Administered as 2 actuations of this product)

Maximum dose: 6 doses (12 inhalations) a day

Comments:
-This product delivers a combination of albuterol (90 mcg) and budesonide (80 mcg) with a single actuation.
-Prime the product prior to using it for the first time to ensure appropriate product content in each actuation.
-To prime this product, release 4 sprays into the air away from the face, shaking well before each spray.
-When used in geriatric patients with concomitant cardiovascular disease, use with caution.
-Shake well before using.

Use: For the treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adult patients with asthma.

You should not use albuterol and budesonide if you are allergic to albuterol or budesonide.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;

• convulsions (seizures);

• thyroid disorder;

• diabetes;

• low blood levels of potassium;

• immune system problem;

• tuberculosis;

• breathing problems;

• any type of eye infection;

• glaucoma, cataracts, or other vision problems; or

• liver problem.

Long-term use of steroid medicine can lead to weak bones (osteoporosis). Talk to your doctor about your risk.

It is not known if albuterol and budesonide inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Having asthma during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating asthma may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of albuterol and budesonide on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Albuterol and budesonide inhalation is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use more than 6 doses (12 inhalations) within 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast heartbeats, and feeling shaky or nervous.

Avoid getting albuterol and budesonide in your eyes. If contact does occur, rinse with water.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using albuterol and budesonide inhalation and call your doctor at once if you have trouble breathing, coughing, and wheezing.

Albuterol and budesonide may cause serious side effects. Call your doctor at once if you have:

• heart problems, high blood pressure, or fast heart rate;

• low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• eye problems, such as glaucoma and cataracts; or

• bone problems, such as bone pain.

Common side effects of albuterol and budesonide may include:

• sores or white patches in your mouth or throat, trouble swallowing;

• headache;

• cough; or

• hoarse or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a beta blocker--atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others;

• a diuretic or "water pill";

• isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others;

• nefazodone;

• other inhaled or asthma medication;

• cancer medicine--ceritinib, idelalisib, ribociclib, tucatinib;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;

• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir; or

• a beta blocker--atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others.

Many drugs can affect albuterol and budesonide (inhalation). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.