Pup survival was decreased from birth to postpartum day 26 at doses 110 times the MRHDID and higher (on a mcg/mThere are no available data on the effects of Symbicort, budesonide or formoterol fumarate on the breastfed child or on milk production. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in COPD and asthma.Studies in asthmatic patients have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects over a wide range of doses of budesonide. After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. You will breathe-in (inhale) the medicine. At run-in, the mean post-bronchodilator % predicted normal FEVIn Study 3, subjects treated with Symbicort 160/4.5, two inhalations twice daily had a significantly lower annual rate of moderate/severe COPD exacerbations compared with formoterol 4.5 mcg with a reduction of 26% (95% CI: 9%, 39%). In these trials, the patients on Symbicort had a mean age of 38 years and were predominantly Caucasian (82%).The incidence of common adverse events in Table 2 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with 2 inhalations of Symbicort 80/4.5 or Symbicort 160/4.5 twice daily. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The selection of the formoterol dose is supported by a randomized, single dose, placebo-controlled, active-controlled (Foradil Aerolizer 12 mcg), 5-way cross-over study in which doses of 2.25, 4.5 and 9 mcg formoterol were administered in combination with budesonide in 54 pediatric patients 6 to less than 12 years of age with asthma. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. If you have any questions, ask your doctor or pharmacist.Clean the white mouthpiece of your Symbicort inhaler every 7 days. Symbicort 160/4.5 is the only strength indicated for the treatment of COPD.Symbicort should be administered as 2 inhalations twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only. Adult and Adolescent Patients 12 Years of Age and OlderSalmeterol Multicenter Asthma Research Trial (SMART)Adult and Adolescent Patients 12 Years of Age and OlderLong-term safety - asthma clinical trials in patients 12 years and olderMusculoskeletal, connective tissue, and bone disorders:Disease-Associated Maternal and/or Embryo/Fetal riskFigure 1 Mean Percent Change From Baseline in Pre-dose FEVFigure 2 Mean Percent Change From Baseline in Pre-dose FEVOnset and Duration of Action and Progression of Improvement in Asthma ControlPatients with asthma 6 to less than 12 years of ageFigure 5 Change From Baseline in Clinic-Measured 1-hour Post-dose FEV1 over 12 Weeks (Efficacy and Safety Study in Patients 6 to less than 12 years of age).Figure 6 Mean Percent Change From Baseline in Pre-dose FEVFigure 7 Mean Percent Change From Baseline in 1-hour Post-dose FEVRate ratio Symbicort 160/4.5 vs. Formoterol 4.5 mcg(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg)(budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg)Symbicort is not used to relieve sudden breathing problemsBefore you use Symbicort, tell your healthcare provider about all of your medical conditions, including if you:See the step-by-step instructions for using Symbicort at the end of this Patient Information leaflet.While you are using Symbicort 2 times each day, do not use other medicines that contain a LABA for any reason.

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