WIXELA INHUB

AbsorptionFluticasone Propionate Healthy Subjects Fluticasone propionate acts locally in the lung; therefore, plasma levels do not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. In contrast, the majority of the fluticasone propionate delivered to the lung is systemically...

14.1 Asthma Adult and Adolescent Subjects Aged 12 Years and Older In clinical trials comparing fluticasone propionate and salmeterol inhalation powder with its individual components, improvements in most efficacy endpoints were greater with fluticasone propionate and salmeterol inhalation powder than with the use of either fluticasone propionate or salmeterol alone. In addition, clinical trials showed similar results between fluticasone propionate and salmeterol inhalation powder and the concurrent use of fluticasone propionate plus salmeterol at corresponding doses from separate inhalers. Tri...

Use of LABA may result in the following:

• Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ]
• Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ] Systemic and local corticosteroid use may result in the following:
• Candida albicans infection [see Warnings and Precautions (5.4) ]
• Pneumonia in patients with COPD [see Warnings and Precautions (5.5) ]
• Immunosuppression [see Warnings and Precautions (5....

The use of Wixela Inhub ® is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2) ] .
• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precau...

• LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 )
• Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. ( 5.2 )
• Do not use in combination with an additional medicine containing a LABA because of risk of overdose. ( 5.3 )
• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the ri...

7 DRUG INTERACTIONS Fluticasone propionate and salmeterol inhalation powder has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology (12.2) ] . No formal drug interaction trials have been performed with fluticasone pr...