Pulmicort Flexhaler - FDA prescribing information, side effects and uses. Generic Name: budesonide. Dosage Form: inhalation powder. Indications and Usage for Pulmicort Flexhaler. Treatment of Asthma. Pulmicort Flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
Limitations of Use: •Pulmicort Flexhaler is NOT indicated for the relief of acute bronchospasm. Pulmicort Flexhaler Dosage and Administration.
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Pulmicort Flexhaler should be administered twice daily by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information (1.
Patients should be instructed to prime Pulmicort Flexhaler prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used. The safety and efficacy of Pulmicort Flexhaler when administered in excess of recommended doses have not been established. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.
The peak expiratory flow rate (PEFR, also known as a peak flow) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full.
For patients who do not respond adequately to the starting dose after 1- 2 weeks of therapy with Pulmicort Flexhaler, increasing the dose may provide additional asthma control. Asthma. If asthma symptoms arise in the period between doses, an inhaled, short- acting beta. Patients 1. 8 Years of Age and Older: For patients 1. In some adult patients, a starting dose of 1. The maximum dosage should not exceed 7. Patients 6 to 1. 7 Years of Age: The recommended starting dosage is 1.
In some pediatric patients, a starting dose of 3. The maximum dosage should not exceed 3. For all patients, it is desirable to titrate to the lowest effective dose after adequate asthma stability is achieved. Peak Flow Rate Adults. Improvement in asthma control following inhaled administration of budesonide can occur within 2. Individual patients will experience a variable onset and degree of symptom relief. If a previously effective dosage regimen of Pulmicort Flexhaler fails to provide adequate control of asthma, the therapeutic regimen should be re- evaluated and additional therapeutic options (e.
Pulmicort Flexhaler with the higher strength or initiating oral corticosteroids) should be considered. Dosage Forms and Strengths. Pulmicort Flexhaler is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 9. Each inhaler contains 6. Contraindications.
The use of Pulmicort Flexhaler is contraindicated in the following conditions: •Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.•Severe hypersensitivity to milk proteins or any ingredients of Pulmicort Flexhaler [see Warnings and Precautions (5. Description (1. 1)]. Warnings and Precautions. Local Effects. In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with Pulmicort Flexhaler. When such an infection develops, it should be treated with appropriate local or systemic (i. Pulmicort Flexhaler continues, but at times, therapy with Pulmicort Flexhaler may need to be interrupted. Patients should rinse the mouth after inhalation of Pulmicort Flexhaler.
Deterioration of Asthma or Acute Episodes. Pulmicort Flexhaler is not a bronchodilator and is not indicated for the rapid relief of bronchospasm or other acute episodes of asthma. Patients should be instructed to contact their physician immediately if episodes of asthma not responsive to their usual doses of bronchodilators occur during the course of treatment with Pulmicort Flexhaler. During such episodes, patients may require therapy with oral corticosteroids. An inhaled short acting beta. Pulmicort Flexhaler, should be used to relieve acute symptoms such as shortness of breath. Asperger Syndrome Adults Checklist. When prescribing Pulmicort Flexhaler, the physician must also provide the patient with an inhaled, short- acting beta.
Pulmicort Flexhaler. Hypersensitivity Reactions Including Anaphylaxis. Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of Pulmicort Flexhaler. Discontinue Pulmicort Flexhaler if such reactions occur [see Contraindications (4), Adverse Reactions (6)]. Pulmicort Flexhaler contains small amounts of lactose, which contains trace levels of milk proteins. It is possible that cough, wheezing, or bronchospasm may occur in patients who have a severe milk protein allergy [see Contraindications (4), Adverse Reactions (6.
Immunosuppression. Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.
In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.
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