ADVAIR HFA

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 systemical...

ADVAIR HFA has been studied in subjects with asthma aged 12 years and older. ADVAIR HFA has not been studied in subjects younger than 12 years or in subjects with COPD. In clinical trials comparing ADVAIR HFA with its individual components, improvements in most efficacy endpoints were greater with ADVAIR HFA than with the use of either fluticasone propionate or salmeterol alone. In addition, clinical trials showed comparable results between ADVAIR HFA and ADVAIR DISKUS. 14.1 Trials Comparing ADVAIR HFA with Fluticasone Propionate Alone or Salmeterol Alone Four (4) double-blind, parallel-group ...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)]
• Oropharyngeal candidiasis [see Warnings and Precautions (5.4)]
• Pneumonia in patients with COPD [see Warnings and Precautions (5.5)]
• Immunosuppression and risk of infections [see Warnings and Precautions (5.6)]
• Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8)]
• ...

ADVAIR HFA is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] .
• Hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.11 ), Adverse Reactions ( 6.2 ), Description ( 11 )] .
• Primary treatment of status asthmaticus or acute e...

• LABA monotherapy increases the risk of serious asthma-related events. (5.1)
• Do not initiate in acutely deteriorating asthma or 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 risk. ( 5.4 )
• Increased...

7 DRUG INTERACTIONS ADVAIR HFA has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and nasal corticosteroids, commonly used in patients with asthma without adverse drug reactions [see Clinical Pharmacology (12.2)] . No formal drug interaction trials have been performed with ADVAIR HFA.

• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ket...