参考資料
英国 Seretide Accuhaler 2015 4 灎 Seretide Evohaler 2015 5 灎
国 販売 承 剤形 含 効能 効果 用法 用
英 国
Seretide Accuhaler
喘息 1999 2 COPD 2003 6
SLM/FP 50µg/100µg 50µg/250µg 50µg/500µg
効能 効果 喘息
慢性閉塞性肺疾患 COPD 用法 用
喘息
成人 び12 以 患者 1回1吸入 1日2回 1回2吸入 1日2回
4 以 児
50/100µg 1回1吸入 1日2回 25/50µg 1回2吸入 1日2回 慢性閉塞性肺疾患 COPD
成人
50/500µg 1回1吸入 1日2回 Seretide
Evohaler SLM/FP
25µg/50µg 25µg/125µg 25µg/250µg
米国 Advair Diskus 2016 4 灎 Advair HFA 2014 11 灎
国 販売 承 剤形 含 効能 効果 用法 用
米 国
Advair Diskus
喘息 2000 8
成人 2004 4
児 COPD 2003 11
FP/SLM 100µg/50µg 250µg/50µg 500µg/50µg
効能 効果 喘息
慢性気管支炎 伴う慢性閉塞性肺疾患 用法 用
喘息
12 以 患者
1回1吸入 1日2回 1回2吸入 1日2回 4～11 児
100/50µg 1回1吸入 1日2回 慢性気管支炎 伴う慢性閉塞性肺疾患 成人
250/50µg 1回1吸入 1日2回 Advair HFA
FP/SLM 45µg/21µg * 115µg/21µg * 230µg/21µg *
*：delivered dose 放出
「 外 け 臨床支援情報 1 妊婦 関す 外情報
邦 使用 注意 妊婦 産婦 授乳婦等 投 記載 以 あ 米FDA 類 異
使用 注意 妊婦 産婦 授乳婦 投
1 妊婦 妊娠 い 可能性 あ 婦人 治療 益性 険性 回 断 場
投 ［β2 剤 び 腎皮質 剤 実験動物 催奇形作用 知 大
郿塩 経口 10mg/kg/日 び ン ン郿 皮
100µg/kg/日 ッ 併用投 催奇形作用 臍 び胎児 育抑 報
告 い ］
2 授乳中 婦人 剤 使用経験 少 い 患者 剤 要性 考慮
授 乳 中 あ い 剤 投 中 ［ 郿 塩 ッ 大
1mg/kg 静脈内投 あ い ン ン郿 10µg/kg ッ 皮 投
乳 中 移行 報告 い ］
類
FDA Pregnancy Category C
Advair Diskus 2016 4 米国添付文書 類
An Australian categorisation of risk of drug use in pregnancy
配 剤 当
Fluticasone B3 Salmeterol B3 2016 7 TGA* Database
*TGA Therapeutic Goods Administration
参考 類 概要
FDA Pregnancy Category
C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
類 An Australian categorisation of risk of drug use in pregnancy
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.
「 児等 関す 記載
邦 使用 注意 児等 投 記載 以 あ 米国 添付文書 び英
国 SPC 異
使用 注意 児等 投
1 全身性 剤 比較 可能性 い 吸入 剤 特 長期間 大 投 場 成
長遅延 あ 長期間投 場 吸入 剤 投 患者 喘息 ン
少用 調節 身長等 経過 観察 十 行う 使用 あ
使用法 指 児等 国内 24逬間 超え 使用経験 い
2 出生体 児 新生児 乳児 4 以 幼児 安全性 確立 い い 使用経験 少 い
出典 記載内容
米国 添付文書 Advair Diskus : 2016 4 灎
8.4 Pediatric Use
Use of ADVAIR DISKUS 100/50 in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older subjects and by safety and efficacy data from a trial of ADVAIR DISKUS 100/50 in children with asthma aged 4 to 11 years.The safety and effectiveness of ADVAIR DISKUS in children with asthma younger than 4 years have not been established.
Inhaled corticosteroids,including fluticasone propionate,a component of ADVAIR DISKUS, may cause a reduction in growth velocity in children and adolescents.The growth of pediatric patients receiving orally inhaled corticosteroids, including ADVAIR DISKUS, should be monitored.
A 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder (FLOVENT® ROTADISK®) at 50 and 100 mcg twice daily was conducted in the US in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years.
The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). In children aged 8.5 years, the mean age of children in this trial, the range for expected growth velocity is: boys – 3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls – 3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. The clinical relevance of these growth data is not certain.
If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including ADVAIR DISKUS, each patient should be titrated to the lowest strength that effectively controls his/her asthma.
英国 SPC Seretide Accuhaler:
2015 4 灎
4.4 Special warnings and precautions for use Paediatric population
Children and adolescents <16years taking high doses of fluticasone propionate (typically ≥ 1000 micrograms/day) may be at particular risk.Systemic effects may occur, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Consideration should be given to referring the child or adolescent to a paediatric respiratory specialist.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained.
備考
そ 他 関連資料 患者用使用説明書〉
患者用使用説明書〉