Consumer Drug Information

Pulmicort Respules Suspension

Generic Name: Budesonide Inhalation Suspension (byoo-DESS-oh-nide)
Brand Name: Pulmicort Respules

Use caution if you switch from an oral steroid (eg, prednisone) to Pulmicort Respules Suspension. 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.

Pulmicort Respules Suspension is used for:

Long-term treatment of asthma and prevention of asthma in children 1 to 8 years of age. It is not used to relieve an asthma attack. It may also be used for other conditions as determined by your doctor.

Pulmicort Respules Suspension is an inhaled corticosteroid. It works by decreasing the irritation and swelling of the breathing tubes (bronchioles) of the lung to control or prevent asthma symptoms.

Do NOT use Pulmicort Respules Suspension if:

you are allergic to any ingredient in Pulmicort Respules Suspension
you are having an asthma attack
you are taking mifepristone

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

Before using Pulmicort Respules Suspension:

Some medical conditions may interact with Pulmicort Respules Suspension. 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 glaucoma; cataracts; a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chicken pox; or shingles
if you have had a positive TB skin test or have recently been vaccinated

Some MEDICINES MAY INTERACT with Pulmicort Respules Suspension. 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 Pulmicort Respules Suspension's effectiveness
Clarithromycin, steroidal contraceptives (eg, birth control pills), or imidazole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Pulmicort Respules Suspension's side effects
Ritodrine or live vaccines because the risk of their side effects may be increased by Pulmicort Respules Suspension
Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Pulmicort Respules Suspension
Mifepristone because risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pulmicort Respules Suspension 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 Pulmicort Respules Suspension:

Use Pulmicort Respules Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Do not mix Pulmicort Respules Suspension with other medicines in the nebulizer.
Pulmicort Respules Suspension is to be used in a nebulizer or a respirator. Do not use Pulmicort Respules Suspension in an ultrasonic nebulizer.
Open the aluminum foil envelope and remove 1 ampule. Record the date on which you open the foil on the back of the envelope. Once the foil is open, the unused ampules should be used within 2 weeks.
Gently shake the ampules, and then squeeze the contents into the nebulizer. Connect the nebulizer to the air pump and begin treatment as directed. Breathe calmly and evenly. When there is no more mist in the nebulizer chamber, the treatment is complete.
Rinse the mouth with water (without swallowing) after each treatment to help prevent mouth infections. Make sure to wash the face after using a face mask. Rinse well and dry.
Once an ampule is opened, use the medicine immediately or discard.
Improvement may be seen within 2 to 8 days after beginning treatment, although the full benefit may not been seen for 4 to 6 weeks after starting treatment. If the asthma symptoms do not improve in 4 to 6 weeks, contact your health care provider.
After use, wash the reservoir of the nebulizer, mouthpiece, and mask according to the manufacturer's directions.
If you miss a dose of Pulmicort Respules Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pulmicort Respules Suspension.

Important safety information:

It may take several days for Pulmicort Respules Suspension to work. Do not stop using Pulmicort Respules Suspension without checking with your doctor.
Pulmicort Respules Suspension will not stop an asthma attack. Always carry appropriate medicine (eg, bronchodilator inhaler) in case you have an asthma attack. Contact your doctor immediately if your bronchodilator does not help you to breathe normally.
Tell your doctor or dentist that you take Pulmicort Respules Suspension before you receive any medical or dental care, emergency care, or surgery.
Carry an ID card at all times that says you take Pulmicort Respules Suspension.
Use caution if you switch from an oral steroid (eg, prednisone) to Pulmicort Respules Suspension. 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.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Pulmicort Respules Suspension. Talk with your doctor before you receive any vaccine.
Lab tests, including adrenal function assessment, may be performed while you use Pulmicort Respules Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Pulmicort Respules Suspension.
Pulmicort Respules Suspension should not be used in CHILDREN younger than 12 months 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 Pulmicort Respules Suspension while you are pregnant. It is unknown if Pulmicort Respules Suspension is found in breast milk. If you are or will be breast-feeding while you use Pulmicort Respules Suspension, check with your doctor. Discuss any possible risks to your baby.

If symptoms of WITHDRAWAL occur when switching from an oral medicine to an inhaled one (muscle and joint pain, exhaustion, depression), contact your health care provider at once.

Possible side effects of Pulmicort Respules Suspension:

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:

Coughing; diarrhea; nosebleed; rash; redness of the eyes; runny nose; stomach pain; stomach problems; throat irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; ear infection; fainting; increased wheezing; infection (fever, chills, sore throat); irritability; mental/mood changes; personality change; severe dizziness; sinus infection; sudden weight loss; tightness in the lungs; unusual weakness; vomiting; white patches in the mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Proper storage of Pulmicort Respules Suspension:

Store Pulmicort Respules Suspension at controlled room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and direct sunlight. Replace the cover after each use. Do not puncture, break, or burn the canister even if it appears to be empty. Do not store in the bathroom. Keep Pulmicort Respules Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Pulmicort Respules Suspension, please talk with your doctor, pharmacist, or other health care provider.
Pulmicort Respules Suspension 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 Pulmicort Respules Suspension. 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.

Issue Date: December 3, 2008

Database Edition 08.4.1.003