Why is this drug prescribed? Return to top
Budesonide, the active ingredient in Pulmicort Respules, is an anti-inflammatory steroid medication. Inhaled on a regular basis, Pulmicort helps prevent asthma attacks. Pulmicort Respules are prescribed for children 12 months to 8 years of age. They are given by nebulizer (a device that produces a fine spray). Adults and children over 6 can use another form of budesonide, Pulmicort Turbuhaler, that's taken with an inhaler. Both types of Pulmicort are preventive medicines. They will not relieve an acute or life-threatening episode of asthma.
Most important fact about this drug Return to top
Because steroids can suppress the immune system, children taking Pulmicort may become more susceptible to infections, and their infections could be more severe. Be careful to protect the child from exposure to infectious diseases such as chickenpox and measles. If the youngster is exposed, contact your doctor immediately.
How should you take this medication? Return to top
Use Pulmicort Respules exactly as directed. The effectiveness of this medication depends on its regular use. Your doctor will prescribe the lowest effective dose. Do not use more or less medication than the amount prescribed. When starting therapy, carefully read the instructions that come with the medication. The child's asthma symptoms may begin to improve in 2 to 8 days, although you may not see the maximum benefit for 4 to 6 weeks. If symptoms do not improve or get worse, contact your doctor. Pulmicort Respules contain a liquid suspension of budesonide for administration with a jet nebulizer connected to a mouthpiece or facemask. Do not use an ultrasonic nebulizer, and do not mix Pulmicort with other medications. Gently shake the Respule in a circular motion before use. Avoid exposing the eyes to the medication. To decrease the risk of developing a fungus infection in the mouth, have the child rinse with water, without swallowing, after each dose. Wash the child's face after using the facemask. --If you miss a dose... Give it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to the regular schedule. Do not give 2 doses at once. --Storage instructions... Store Pulmicort Respules upright at room temperature. Do not refrigerate or freeze. When you open the aluminum foil envelope containing the Respules, record the date on the back of the envelope. Keep unused Respules in the envelope protected from light. Use any individually opened Respules promptly. You should discard any unused Respules two weeks after opening the envelope.
What side effects may occur? Return to top
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Pulmicort. - More common side effects may include:
Abdominal pain, conjunctivitis (pinkeye), cough, diarrhea, ear infection or inflammation, fever, fungal infection in mouth, headache, nasal or sinus inflammation, nosebleed, pain, rash, respiratory infection, stomach or intestinal inflammation, throat inflammation, viral infection, vomiting, wheezing
- Less common side effects may include:
Allergic reaction, bleeding under skin, chest pain, earache, eczema, emotional changeability, fatigue, flu-like symptoms, fracture, growth suppression, herpes simplex, infection, itching, loss of appetite, muscle pain, noisy breathing, outer ear infection, restlessness, skin inflammation, voice alteration
- Rare side effects may include:
Abnormal thinking, aggressiveness, anxiety, bone disorders, depression, difficulty breathing, irritability, osteoporosis
Why should this drug not be prescribed? Return to top
If the child is allergic to budesonide, this drug cannot be used. In addition, Pulmicort cannot be used to treat severe asthma attacks.
Special warnings about this medication Return to top
If the youngster is switching to Pulmicort from an oral steroid medication, the doctor will be careful to reduce the oral dosage very gradually. Taking oral steroids suppresses the natural production of steroids by the adrenal gland, and it takes months for production to return to normal after the oral steroids are stopped. In the meantime, the body will be unusually vulnerable to stress. There have been reports of death during and immediately after transfer from oral steroids to inhaled steroids, so your doctor will monitor the child carefully during this period. People who have been taking high doses of oral steroids for an extended period of time are especially prone to problems, particularly when the oral steroids have been almost completely stopped. At that point, any stress from trauma, surgery, or infection (especially stomach or intestinal inflammation) is more likely to trigger adverse events. If the child experiences a period of stress or a severe asthma attack during the switch to Pulmicort, begin giving the oral medication again (in large doses) and contact your doctor immediately. The child should carry a medical identification card indicating that he or she may need additional medication during periods of stress or a severe asthma attack. Transfer from oral steroids to Pulmicort may unmask allergic conditions previously controlled by the oral drugs, such as nasal inflammation, conjunctivitis (pinkeye), and eczema. Transfer from oral steroids may also be accompanied by withdrawal symptoms, including joint or muscle pain, fatigue, and depression, even while Pulmicort is improving the child's asthma symptoms. Like other inhaled asthma medications, Pulmicort occasionally triggers an asthma attack. If this occurs, immediately administer a fast-acting inhaled bronchodilator, stop using Pulmicort, and contact your doctor. The youngster will need to switch to a different asthma medication. Also alert your doctor immediately if the usual doses of the child's fast-acting bronchodilator no longer work. Oral steroids may be needed for a while. Steroid medications can stunt growth in children and teenagers. Your doctor will prescribe the lowest effective dose of Pulmicort in order to minimize this problem, and will monitor the child's growth carefully. While using this medication, some people develop fungal infections in the mouth and throat. If this occurs, the doctor can prescribe antifungal medication while the child continues to use Pulmicort. Individuals with tuberculosis, ocular herpes simplex, or any untreated fungal, bacterial, viral, or parasitic infection should use inhaled steroids with caution. Caution is also in order if the child has liver disease. In rare instances, inhaled steroids have been known to cause glaucoma (increased pressure in the eye) and cataracts.
Possible food and drug interactions when taking this medication Return to top
If Pulmicort is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining Pulmicort with ketoconazole (Nizoral).
Special information if you are pregnant or breastfeeding Return to top
This medication is not intended for women of child-bearing age, but you should know that budesonide is recommended during pregnancy only if clearly needed. In addition, steroids makes their way into breast milk and are not recommended for nursing mothers.
Recommended dosage Return to top
CHILDREN 12 MONTHS TO 8 YEARS OF AGE
The usual dosage depends on the child's previous treatments for asthma. If fast-acting bronchodilators alone have been used previously, the usual starting dose is 0.5 milligrams daily. (A dose of 0.25 milligrams taken once daily may be prescribed if the child has failed to respond to non-steroidal therapy.) The maximum long-term dosage is 0.5 milligrams daily. If inhaled steroids have been used previously, the usual starting dose is 0.5 milligrams. The maximum long-term dosage is 1 milligram daily. If oral steroids have been used previously, the usual starting dose is 1 milligram. The maximum long-term dosage is also 1 milligram daily. The daily dosage may be taken in a single dose or divided into 2 doses if once-daily treatment does not adequately control asthma symptoms. Once asthma symptoms are controlled, the dose may be gradually lowered. Children already taking oral steroids will continue to do so while starting therapy with Pulmicort Respules. After one week, the doctor will lower the dose of the oral steroids, then gradually lower it further at one- or two-week intervals.
Overdosage Return to top
Excessive doses of steroid medications taken for long periods can stunt growth or cause a condition called Cushing's syndrome. Symptoms of this condition include weight gain, a "moon face," muscle wasting, weakness, and poor wound healing. If you think a problem is developing, check with your doctor immediately. Return to top
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