No black box warning on record for Fluticasone Propionate And Salmeterol

As of the latest FDA labeling reviewed, Fluticasone Propionate And Salmeterol (FLUTICASONE PROPIONATE AND SALMETEROL) does not carry a black box warning. Standard warnings and precautions still apply — see the full Fluticasone Propionate And Salmeterol medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3 ) Localized infecti
5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of LABA as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)] . Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-relate
5.2 Deterioration of Disease and Acute Episodes Fluticasone Propionate/Salmeterol MDPI should not be initiated in patients during rapidly deteriorating or potentially life‑threatening episodes of asthma. Fluticasone Propionate/Salmeterol MDPI has not been studied in subjects with acutely deteriorating asthma. The initiation of Fluticasone Propionate/Salmeterol MDPI in this setting is not appropria
5.3 Avoid Excessive Use of Fluticasone Propionate/Salmeterol and Avoid Use with Other Long-Acting Beta 2 -Agonists Fluticasone Propionate/Salmeterol MDPI should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported i
5.4 Oropharyngeal Candidiasis In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with Fluticasone Propionate/Salmeterol MDPI. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Fluticasone Propionate/Salmeterol MDPI cont

No black box warning on record for Fluticasone Propionate And Salmeterol

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3 ) Localized infecti

5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of LABA as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)] . Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-relate

5.2 Deterioration of Disease and Acute Episodes Fluticasone Propionate/Salmeterol MDPI should not be initiated in patients during rapidly deteriorating or potentially life‑threatening episodes of asthma. Fluticasone Propionate/Salmeterol MDPI has not been studied in subjects with acutely deteriorating asthma. The initiation of Fluticasone Propionate/Salmeterol MDPI in this setting is not appropria

5.3 Avoid Excessive Use of Fluticasone Propionate/Salmeterol and Avoid Use with Other Long-Acting Beta 2 -Agonists Fluticasone Propionate/Salmeterol MDPI should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported i

5.4 Oropharyngeal Candidiasis In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with Fluticasone Propionate/Salmeterol MDPI. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Fluticasone Propionate/Salmeterol MDPI cont

Fluticasone Propionate And Salmeterol Black Box Warning

No black box warning on record for Fluticasone Propionate And Salmeterol

Other warnings & precautions

Fluticasone Propionate And Salmeterol Black Box Warning

No black box warning on record for Fluticasone Propionate And Salmeterol

Other warnings & precautions