本邦における使用上の注意 「妊婦、産婦、授乳婦等への投与」 の項の記載は以下のとおりであり、米国 における記載、オーストラリア分類とは異なる。
【使用上の注意】「妊婦、産婦、授乳婦等への投与」
(1) 妊婦又は妊娠している可能性のある婦人には、治療上の有益性が危険性を上回ると判断される 場合にのみ投与すること。［ラットを用いた器官形成期毒性試験では、ブデソニド/ホルモテロール フマル酸塩水和物として12/0.66μg /kg以上を吸入投与したときに、着床後胚損失率の増加、及び 催奇形性作用が認められている。］
(2) 授乳中の婦人に対しては、治療上の有益性が危険性を上回ると判断される場合にのみ投与する こと。［ブデソニドはヒト乳汁に移行するが、乳児の血液中には検出されないことが報告されている。
ホルモテロールはラット乳汁への移行が報告されている。］
出典 記載内容
米国の添付文書
（2017年12 月）
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy
Risk Summary(一部抜粋)
There are no adequate and well-controlled studies of SYMBICORT or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal risk
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. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.
8.2 Lactation Risk Summary
There are no available data on the effects of SYMBICORT, budesonide or formoterol fumarate on the breastfed child or on milk production. Budesonide, like other inhaled corticosteroids, is present in human milk. There are no available data on the presence of formoterol fumarate in human milk. Formoterol fumarate is present in rat milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SYMBICORT and any potential adverse effects on the breastfed infant from SYMBICORT or from the underlying maternal condition.
分類 オーストラリアの分類：
Australian categorisation system for prescribing medicines in pregnancy
B3
(オーストラリアの添付文書 2017年12月)
【参考】 分類の概要
オーストラリアの分類：Australian categorisation system for prescribing medicines in pregnancy Category B3
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
(2) 小児等への投与に関する海外情報
本邦における使用上の注意 「小児等への投与」の項の記載は以下のとおりであり、スウェーデン/英国及 び米国とは異なる。
【使用上の注意】「小児等への投与」
低出生体重児、新生児、乳児、幼児又は小児に対する安全性は確立していない（国内での使用経験 がない）。
出典 記載内容
スウェーデンの SmPC*
160/4.5μg製剤
（2018年4月）
英国のSmPC*
200/6μg製剤
（2018年4月）
Asthma
A. Symbicort maintenance therapy Recommended doses:
Adolescents (12 – 17 years): 1-2 inhalations twice daily.
Children (6 years and older): A lower strength is available for children 6-11 years.
Children (under 6 years): As only limited data are available, Symbicort is not recommended for children younger than 6 years.
B. Symbicort maintenance and reliever therapy Recommended doses:
Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.
Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
Children under 12 years:
Symbicort maintenance and reliever therapy is not recommended for children.
米国の添付文書
（2017年12月）
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 or level of control of asthma symptoms, and risk of exacerbations on current inhaled corticosteroids.
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.
*Summary of Product Characteristics