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|Budesonide Spray

Budesonide Spray

Budesonide Spray is used for:

Treating nasal allergy symptoms, including runny nose, nasal congestion, and sneezing. It may also be used for other conditions as determined by your doctor.

Budesonide Spray is a corticosteroid. It works by shrinking swollen and inflamed nasal tissue and by blocking the action of certain cells and chemicals of the immune system.

Do NOT use Budesonide Spray if:

• you are allergic to any ingredient in Budesonide Spray
• you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Budesonide Spray:

Some medical conditions may interact with Budesonide Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a bacterial, viral, fungal, or parasitic infection; chickenpox; tuberculosis; a positive tuberculosis (TB) skin test; measles; diarrhea; nasal ulcer, surgery, or trauma; or herpes infection in the eye; or if you have had a recent vaccine

Some MEDICINES MAY INTERACT with Budesonide Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Budesonide Spray"s effectiveness
• Clarithromycin, imidazoles (eg, ketoconazole), mifepristone, or steroidal contraceptives (eg, birth control pills) because side effects, such as adrenal suppression effects, may occur
• Mifepristone, ritodrine, or live vaccines because the risk of their side effects may be increased by Budesonide Spray
• Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Budesonide Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Budesonide Spray:

Use Budesonide Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Budesonide Spray is for use in the nose.
• Shake well before each use.
• Before using this medicine for the first time, gently shake the container and prime the pump 8 times.
• Clear your nose before using Budesonide Spray. You may sniff gently to distribute the medicine into your nose, but do not breathe deeply.
• If Budesonide Spray is used daily, the pump does not need to be reprimed. If it not used for 2 consecutive days, reprime it with 1 spray or until a fine spray mist appears.
• If Budesonide Spray is not used for more than 14 days, rinse the applicator and reprime it with 2 sprays or until a fine spray appears.
• Use Budesonide Spray on a regular schedule to get the most benefit from it.
• Continue to use Budesonide Spray even if you feel well. Do not miss any doses.
• Throw the bottle away after 120 sprays following the priming of the bottle. The correct amount of medication in each spray cannot be ensured after a certain number of uses. Do not transfer any remaining suspension to another bottle.
• If you miss a dose of Budesonide Spray, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Budesonide Spray.

Important safety information:

• Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Spray. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
• Avoid spraying in the eyes.
• Always have a spare inhaler available in case the unit malfunctions or is empty.
• Symptoms can start to improve as soon as 10 hours after you start using Budesonide Spray, and should improve within a few days. If symptoms do not improve within 2 weeks, or if the condition worsens, contact your health care provider.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Budesonide Spray.
• Budesonide Spray should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide Spray while you are pregnant. It is not known if Budesonide Spray is found in breast milk. If you are or will be breast-feeding while you use Budesonide Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Budesonide Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste; coughing; headache; hoarseness; nasal irritation or dryness; nausea; sore throat; tightness in the lungs.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuing nose discomfort; increased pressure in the eye; infection (fever, chills, sore throat); nosebleeds or soreness; pounding in the chest.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include body discomfort; depression; difficulty breathing; dizziness; exhaustion; fainting; joint pain; loss of appetite; muscle aches; nausea.

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in an upright position. Store away from heat, moisture, and light. Do not freeze. Keep Budesonide Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Budesonide Spray, please talk with your doctor, pharmacist, or other health care provider.
• Budesonide Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Budesonide Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.