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1 Indications And Usage Serevent Diskus Is A Laba Indicated For: • Treatment Of Asthma In Patients Aged 4 Years And Older With An Ics. ( 1.1 ) • Prevention Of Exercise-Induced Bronchospasm (Eib) In Patients Aged 4 Years And Older. ( 1.2 ) • Maintenance Treatment Of Bronchospasm Associated With Chronic Obstructive Pulmonary Disease (Copd). ( 1.3 ) Important Limitation Of Use: Not Indicated For Relief Of Acute Bronchospasm. ( 1.1 , 1.3 ) 1.1 Treatment Of Asthma Serevent Diskus Is Indicated For The Treatment Of Asthma And In The Prevention Of Bronchospasm Only As Concomitant Therapy With An Ics In Patients Aged 4 Years And Older With Reversible Obstructive Airway Disease, Including Patients With Symptoms Of Nocturnal Asthma. Laba, Such As Salmeterol, The Active Ingredient In Serevent Diskus, As Monotherapy (Without Ics) Increase The Risk Of Asthma-Related Death [See Warnings And Precautions ( 5.1 )] . Use Of Serevent Diskus For The Treatment Of Asthma Without Concomitant Use Of An Ics Is Contraindicated [See Contraindications ( 4 )] . Use Serevent Diskus Only As Additional Therapy For Patients With Asthma Who Are Currently Taking But Are Inadequately Controlled On An Ics. Do Not Use Serevent Diskus For Patients Whose Asthma Is Adequately Controlled On Low- Or Medium-Dose Ics. Pediatric And Adolescent Patients Available Data From Controlled Clinical Trials Suggest That Laba As Monotherapy Increase The Risk Of Asthma-Related Hospitalization In Pediatric And Adolescent Patients. For Pediatric And Adolescent Patients With Asthma Who Require Addition Of A Laba To An Ics, A Fixed-Dose Combination Product Containing Both An Ics And A Laba Should Ordinarily Be Used To Ensure Adherence With Both Drugs. In Cases Where Use Of A Separate Ics And A Laba Is Clinically Indicated, Appropriate Steps Must Be Taken To Ensure Adherence With Both Treatment Components. If Adherence Cannot Be Assured, A Fixed-Dose Combination Product Containing Both An Ics And A Laba Is Recommended. Important Limitation Of Use Serevent Diskus Is Not Indicated For The Relief Of Acute Bronchospasm. 1.2 Prevention Of Exercise-Induced Bronchospasm Serevent Diskus Is Also Indicated For Prevention Of Exercise-Induced Bronchospasm (Eib) In Patients Aged 4 Years And Older. Use Of Serevent Diskus As A Single Agent For The Prevention Of Eib May Be Clinically Indicated In Patients Who Do Not Have Persistent Asthma. In Patients With Persistent Asthma, Use Of Serevent Diskus For The Prevention Of Eib May Be Clinically Indicated, But The Treatment Of Asthma Should Include An Ics. 1.3 Maintenance Treatment Of Chronic Obstructive Pulmonary Disease Serevent Diskus Is Indicated For The Long-Term Twice-Daily Administration In The Maintenance Treatment Of Bronchospasm Associated With Chronic Obstructive Pulmonary Disease (Copd) (Including Emphysema And Chronic Bronchitis). Important Limitation Of Use Serevent Diskus Is Not Indicated For The Relief Of Acute Bronchospasm.
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