Patients being treated with PULMICORT RESPULES should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For instructions on the proper use of PULMICORT RESPULES and to attain the maximum improvement in asthma symptoms, the patient or the parent/guardian of the patient should receive, read, and follow the accompanying patient information and instructions carefully.

• Patients should take PULMICORT RESPULES at regular intervals once or twice a day as directed, since its effectiveness depends on regular use. The patient should not alter the prescribed dosage unless advised to do so by the physician.
• The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES should be administered separately in the nebulizer.
• PULMICORT RESPULES is not a bronchodilator, and its use is not intended to treat acute life-threatening episodes of asthma.
• PULMICORT RESPULES should be administered with a jet nebulizer connected to a compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication (see DOSAGE AND ADMINISTRATION).
• Ultrasonic nebulizers are not suitable for the adequate administration of PULMICORT RESPULES and, therefore, are not recommended (see DOSAGE AND ADMINISTRATION).
• Rinsing the mouth with water after each treatment may decrease the risk of development of local candidiasis. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.
• Improvement in asthma control following treatment with PULMICORT RESPULES can occur within 2-8 days of beginning treatment, although maximum benefit may not be achieved for 4-6 weeks after starting treatment. If the asthma symptoms do not improve in that time frame, or if the condition worsens, the patient or the patient's parent/guardian should be instructed not to increase the dosage, but to contact the physician.
• Patients should not stop the use of PULMICORT RESPULES abruptly without consulting with their prescribing physician.
• Patients whose chronic systemic corticosteroids have been reduced or withdrawn should be instructed to carry a warning card indicating that they may need supplemental systemic corticosteroids during periods of stress or an asthma attack that does not respond to bronchodilators.
• As always, care should be taken to avoid exposure to persons with chicken pox and measles. If exposure to such a person occurs, and the child has not had chicken pox or been properly vaccinated, a physician should be consulted without delay (see WARNINGS, and PRECAUTIONS, Pediatric Use).
• Long-term use of inhaled corticosteroids, including budesonide, may increase the risk of some eye problems (cataracts or glaucoma). Regular eye examinations should be considered.
• Patients or their parents/guardians considering use of PULMICORT RESPULES should consult with their physician if they are allergic to budesonide or any other orally inhaled corticosteroid.
• Physicians should be informed of other medications patients are taking as PULMICORT RESPULES may not be suitable in some circumstances and the physician may wish to use a different medicine.
• PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) and protected from light. PULMICORT RESPULES should not be refrigerated or frozen.
• When an aluminum foil envelope has been opened, the shelf life of the unused RESPULES ampules is two weeks when protected from light. The date the envelope was opened should be recorded on the back of the envelope in the space provided.
• After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the envelope to protect them from light. Any individually opened RESPULES ampules must be used promptly.
• For proper usage of PULMICORT RESPULES and to attain maximum improvement, the accompanying Patient's Instructions for Use should be read and followed.

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