Adverse effects of corticosteroids inhalers

In the laboratory classroom clinical trials in children (Studies 1 and 2), both CONCERTA® once daily and methylphenidate three times daily increased resting pulse by an average of 2 to 6 bpm and produced average increases of systolic and diastolic blood pressure of roughly 1 to 4 mm Hg during the day, relative to placebo. In the placebo-controlled adolescent trial (Study 4), mean increases from baseline in resting pulse rate were observed with CONCERTA® and placebo at the end of the double-blind phase (5 and 3 beats/minute, respectively). Mean increases from baseline in blood pressure at the end of the double-blind phase for CONCERTA® and placebo-treated patients were and mm Hg (systolic) and and mm Hg (diastolic), respectively. In one placebo-controlled study in adults (Study 6), dose-dependent mean increases of to bpm from baseline in standing pulse rate were observed with CONCERTA® at the end of the double-blind treatment vs. an increase of beats/minute with placebo. Mean changes from baseline in standing blood pressure at the end of double-blind treatment ranged from to mm Hg (systolic) and to mm Hg (diastolic) for CONCERTA® and was mm Hg (systolic) and - mm Hg (diastolic) for placebo. In a second placebo-controlled study in adults (Study 5), mean changes from baseline in resting pulse rate were observed for CONCERTA® and placebo at the end of the double-blind treatment ( and - beats/minute, respectively). Mean changes from baseline in blood pressure at the end of the double-blind treatment for CONCERTA® and placebo-treated patients were - and - mm Hg (systolic) and and mm Hg (diastolic), respectively [see WARNINGS AND PRECAUTIONS ].

For additional guidance on the use of Preservation Conditions, consider seeking legal counsel or contact the ACHP. When a federal agency is considering use of a Preservation Condition, the relevant SHPO/THPO may also be a useful source of information on the preservation needs of the property at hand, and also various considerations relevant to the substantive terms of the draft Preservation Condition. The ACHP intends to supplement this guidance with case studies (Appendix II.) and regularly update this guidance as necessary. If you have any suggestions about this guidance, please contact the ACHP at  preservationconditionguidance@ . 

Adverse effects of corticosteroids inhalers

adverse effects of corticosteroids inhalers

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