Salmeterol/Fluticasone inhaled

DEA Class;  Rx

Common Brand Names; Advair Diskus, Advair HFA, AirDuo RespiClick, Wixela Inhub, AirDuo Digihaler

  • Respiratory Inhalant Combos; 
  • COPD Agents

Inhaled combination product of a corticosteroid (fluticasone) and a long-acting beta agonist (LABA) (salmeterol)
Used for maintenance treatment of asthma in adult and pediatric patients 4 years and older
Also used in adults for the maintenance treatment of COPD and to reduce COPD exacerbations

For asthma maintenance treatment.
For the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).

Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures

Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients

  • Upper respiratory tract infection (21-27%)
  • Headache (12-21%)
  • Pharyngitis (10-13%)
  • Candidiasis, nonspecific site (0-10%)
  • Throat irritation (7-9%)
  • Musculoskeletal pain (2-9%)
  • Bronchitis (2-8%)
  • Upper respiratory inflammation (4-7%)
  • Viral respiratory infections (4-6%)
  • Nausea or vomiting (4-6%)
  • Cough (3-6%)
  • Sinusitis (4-5%)
  • Hoarseness or dysphonia (2-5%)
  • Fever (3-4%)
  • Diarrhea (2-4%)
  • Gastrointestinal (GI) discomfort or pain (1-4%)
  • Oral candidiasis (1-4%)
  • Muscle cramps or spasms (3%)
  • Malaise or fatigue (2-3%)
  • Viral GI infections (0-3%)

Use of LABAs as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death

Dosing frequency should not exceed q12hr

Aerosol not recommended when patient is being switched from PO to inhaled corticosteroids

Risk of localized Candida albicans infections in mouth and pharynx in some patients; when such an infection develops, it should be treated with appropriate local or systemic (ie, oral) antifungal therapy while treatment continues, but at times therapy may need to be interrupted; mouth must be rinsed after dosing to reduce risk

Monitor COPD patients for signs and symptoms of pneumonia and lung infection

Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate

There are no available data on presence of fluticasone propionate or salmeterol in human milk, effects on breastfed child, or effects on milk production

Maximum recommended asthma dosages are for patients not currently receiving an inhaled corticosteroid.

Adults

1 inhalation of Advair Diskus or Wixela Inhub 500/50 twice daily for asthma; 1 inhalation of Advair Diskus or Wixela Inhub 250/50 twice daily for COPD; 2 inhalations of Advair HFA 230/21 twice daily for asthma; 1 inhalation of Airduo Respiclick or Airduo Digihaler 232/14 twice daily for asthma.

Geriatric

1 inhalation of Advair Diskus or Wixela Inhub 500/50 twice daily for asthma; 1 inhalation of Advair Diskus or Wixela Inhub 250/50 twice daily for COPD; 2 inhalations of Advair HFA 230/21 twice daily for asthma; 1 inhalation of Airduo Respiclick or Airduo Digihaler 232/14 twice daily for asthma.

Adolescents

1 inhalation of Advair Diskus or Wixela Inhub 500/50 twice daily for asthma; 1 inhalation of Advair Diskus or Wixela Inhub 250/50 twice daily for COPD; 2 inhalations of Advair HFA 230/21 twice daily for asthma; 1 inhalation of Airduo Respiclick or Airduo Digihaler 232/14 twice daily for asthma.

Children

12 years and older: 1 inhalation of Advair Diskus or Wixela Inhub 500/50 twice daily for asthma; 2 inhalations of Advair HFA 230/21 twice daily for asthma; 1 inhalation of Airduo Respiclick or Airduo Digihaler 232/14 twice daily for asthma.
4 to 11 years: 1 inhalation of Advair Diskus or Wixela Inhub 100/50 twice daily for asthma. Safety and efficacy of Advair HFA, Airduo Digihaler, and Airduo Respiclick have not been established.
Less than 4 years: Safety and efficacy have not been established.

Salmeterol/fluticasone propionate inhaled

powder for inhalation (Wixela Inhub or Advair Diskus)

  • (50mcg/100mcg)/actuation
  • (50mcg/250mcg)/actuation
  • (50mcg/500mcg)/actuation

powder for inhalation (AirDuo RespiClick,AirDuo Digihaler)

  • (14mcg/55mcg)/actuation
  • (14mcg/113mcg)/actuation
  • (14mcg/232mcg)/actuation

aerosol for inhalation (Advair HFA)

  • (21mcg/45mcg)/actuation
  • (21mcg/115mcg)/actuation
  • (21mcg/230mcg)/actuation

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