Generic name: BUDESONIDE 160ug, FORMOTEROL FUMARATE 4.5ug
Dosage form: aerosol
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SYMBICORT should be administered as 2 inhalations twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information (17.4)].
Prime SYMBICORT before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.
More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of SYMBICORT is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT should not use additional LABA for any reason [see Warnings and Precautions (5.3, 5.12)].
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Adult and Adolescent Patients 12 Years of Age and Older
For patients 12 years of age and older, the dosage is 2 inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5 twice daily.
The recommended starting dosages for SYMBICORT for patients 12 years of age and older are based upon patients' asthma severity.
The maximum recommended dosage in adult and adolescent patients 12 years and older is SYMBICORT 160/4.5, two inhalations twice daily.
Improvement in asthma control following inhaled administration of SYMBICORT can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with SYMBICORT 80/4.5, replacement with SYMBICORT 160/4.5 may provide additional asthma control.
If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of SYMBICORT with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.
Pediatric Patients Aged 6 to less than 12 Years
For patients 6 to less than 12 years of age, the dosage is 2 inhalations of SYMBICORT 80/4.5 twice daily.
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