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Lexette topical foam
通用名称
halobetasol propionate
儿科标签批准日期
2021/8/18 0:00:00
特定指示/秒
Plaque psoriasis in patients 12 years of age and older
标签更改摘要
- Safety and effectiveness for the treatment of stable plaque psoriasis in patients 12 to 17 years is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 patients aged 12 to 17 years. Patients 12 to 17 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks.
- Safety and effectiveness in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.
- Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.
- Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
- Information on adverse reaction, and clinical trial.
- Postmarketing study.