Prescribing Information Medication Guide Login
As a component of the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program [see Boxed Warning, Warnings and Precautions (5.1, 5.2), Contraindications (4.1)]. Required components of the Bosentan REMS are: Healthcare professionals who prescribe bosentan must review the ...
Because of the risks of hepatotoxicity and birth defects, TRACLEER is available only through a restricted program called the Bosentan REMS Program. As a component of the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program [seeBOX WARNING,Hepatotoxicity, Embryo-Fetal Toxic...
Available from: https://www.tracleerrems.com/docs/Tracleer_Full_Prescribing_Information.pdf, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf. Barst RJ, Ivy D, Dingemanse J, Widlitz A, Schmitt K, Doran A, et al. Pharmacokinetics, safety, and efficacy of ...
必须在 Tracleer REMS 计划中注册患者(参见完整标签)。上午和下午服用。 ≤12 岁(≥4–8 公斤):每天两次,每次 16 毫克;(>8–16 公斤):每天两次,每次 32 毫克;(>16–24 公斤):每天两次,每次 48 毫克;(>24–40 公斤):每天两次,每次 64 毫克。
必须在 Tracleer REMS 计划中注册患者(参见完整标签)。上午和下午服用。 ≤12 岁(≥4–8 公斤):每天两次,每次 16 毫克;(>8–16 公斤):每天两次,每次 32 毫克;(>16–24 公斤):每天两次,每次 48 毫克;(>24–40 公斤):每天两次,每次 64 毫克。