Salmeterol Fluticasone Inhaled

Salmeterol/Fluticasone Inhaled is a prescription medicine used to treat the symptoms of asthma and chronic obstructive pulmonary disease (COPD).

• Salmeterol/Fluticasone inhaled is available under the following different brand names: Advair Diskus, Advair HFA, AirDuo RespiClick, Wixela Inhub, AirDuo Digihaler

Adult and pediatric dosage

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

Asthma

Adult dosage

• Inhaled powder (Advair Diskus or generic): 1 actuation orally every 12 hours; not to exceed 1 actuation of 50 mcg/500 mcg every 12hours; do not use with a spacer
• Inhaled powder (AirDuo RespiClick, AirDuo Digihaler): 1 actuation orally every 12 hours; not to exceed 1 actuation of 14 mcg/232 mcg every 12 hours; do not use with a spacer or volume holding chamber
• Inhaled aerosol (Advair HFA): 2 actuation orally every 12 hours; not to exceed 2 actuation of 21 mcg/230 mcg every 12hours

Pediatric dosage

Inhaled powder (Advair Diskus)

• Children below 4 years: Safety and efficacy not established
• Children between 4-11 years: 1 actuation of 50 mcg/100 mcg orally every 12 hours
• Children above 12 years: 1 actuation orally every 12 hours (initial dose determined by asthma severity); not to exceed 1 actuation of 50 mcg/500 mcg every 12 hours

Inhaled powder (AirDuo RespiClick, AirDuo Digihaler)

• Children below 12 years: Safety and efficacy not established
• Children above 12 years: 1 actuation orally every 12 hours; not to exceed 1 actuation of 14 mcg/232 mcg every 12 hours

Inhaled aerosol (Advair HFA)

• Children below 12 years: Safety and efficacy not established
• Children above 12 years: 2 actuation orally every 12 hours (initial dose determined by asthma severity); not to exceed 2 actuation of 21 mcg/230 mcg every 12 hours

Chronic Obstructive Pulmonary Disease

Adult dosage

• Inhaled powder (Advair Diskus or generic): 1 actuation of 50 mcg/250 mcg orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Salmeterol/Fluticasone inhaled include:

• headache,
• muscle pain,
• bone pain
• back pain,
• nausea,
• vomiting,
• thrush,
• throat irritation,
• ongoing cough,
• hoarseness or deepened voice, 
• cold symptoms (stuffy nose, sneezing, sore throat)
• fever,
• ear pain or full feeling,
• trouble hearing,
• drainage from the ear, and
• fussiness

Serious side effects of Salmeterol/Fluticasone inhaled include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• wheezing,
• choking,
• breathing problems after using the medication,
• chills,
• cough with mucus,
• feeling short of breath,
• chest pain,
• fast or irregular heartbeats,
• pounding in the neck or ears,
• tremors,
• nervousness,
• blurred vision,
• tunnel vision,
• eye pain,
• seeing halos around lights,
• sores or white patches in the mouth or throat,
• trouble swallowing,
• increased thirst,
• increased urination,
• dry mouth,
• fruity breath odor,
• leg cramps,
• constipation,
• fluttering in the chest,
• numbness or tingling,
• muscle weakness or limp feeling,
• worsening tiredness or weakness, and
• lightheadedness

Rare side effects of Salmeterol/Fluticasone inhaled include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Salmeterol/Fluticasone inhaled has severe interactions with the following drugs:
  • darunavir
  • fosamprenavir
  • indinavir
  • lefamulin
  • lopinavir
  • nelfinavir
  • ritonavir
• Salmeterol/Fluticasone inhaled has serious interactions with at least 35 other drugs.
• Salmeterol/Fluticasone inhaled has moderate interactions with at least 298 other drugs.
• Salmeterol/Fluticasone inhaled has minor interactions with at least 16 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• 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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Salmeterol/Fluticasone inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Salmeterol/Fluticasone inhaled?”

Cautions

• Risk of LABAs used as monotherapy
  • Use of LABAs as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death
  • Data from controlled clinical trials also suggest that the use of LABA as monotherapy increases the risk of asthma-related hospitalization in a pediatric and adolescent patient
  • These findings are considered a class effect of LABA monotherapy
  • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
• Dosing frequency should not exceed every 12 hours
• Aerosol is not recommended when the patient is being switched from oral 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 (i.e., 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
• Particular care is needed in switching patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually by reducing daily prednisone dose by 2.5 mg on a weekly basis
• During stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should resume oral corticosteroids immediately
• Risk of paradoxical bronchospasm, which may be life-threatening; discontinue, and treat immediately with inhaled SABA
• Cardiovascular and central nervous system (CNS) effects may occur as consequences of excess beta-adrenergic stimulation; may result in asthma-related death; caution is advised in patients with cardiovascular or convulsive disorders or thyrotoxicosis
• Bone mineral density may decrease after long-term administration of corticosteroids; monitor patients at risk
• Should not be used for relief of acute symptoms, like, rescue therapy for the treatment of acute episodes of bronchospasm; acute symptoms should be treated with inhaled, short-acting beta2-agonist
• May decrease growth velocity in children; monitor
• Risk of cataracts, glaucoma, and increased intraocular pressure
• Rare cases of vasculitis (Churg-Strauss syndrome) or other systemic eosinophilic conditions may occur
• Use caution in patients with diabetes mellitus; beta2 agonists may increase glucose levels
• Use caution in patients with hepatic impairment; may lead to accumulation of fluticasone in plasma; monitor closely; glaucoma: consider eye exams in chronic users
• Use caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation
• Changes in thyroid status may require dosage adjustments; hyperthyroidism may increase corticosteroids clearance while it may decrease in hypothyroidism
• Prolonged corticosteroid use may increase the incidence of secondary infection, mask acute infection, prolong or exacerbate viral infections, or limit response to vaccines
• Corticosteroids may cause psychiatric manifestations, including depression, euphoria, insomnia, mood swings, and personality changes; may also exacerbate preexisting psychiatric conditions
• Laryngeal spasm, irritation, and swelling (choking) may occur
• Risk of transient hypokalemia; supplementation may not be required
• Long-acting beta-agonist (LABA) monotherapy increases the risk of serious asthma-related events
• Not for use in acutely deteriorating asthma or COPD; not for treatment of acute symptoms
• Potential worsening of infections (eg, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex); use caution in patients with these infections
• Should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients receiving therapy should not use another medicine containing a LABA for any reason
• Immunosuppression and risk of infections
  • Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals
  • Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible adolescents or adults using corticosteroids; in such patients who have not had these diseases or who have not been properly immunized, particular care should be taken to avoid exposure
  • How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known
  • The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known; if a patient is exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated
  • If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.)
  • If chickenpox develops, treatment with antiviral agents may be considered; inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
• Transferring patients from systemic corticosteroid therapy
  • Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
  • After withdrawal from systemic corticosteroids, several months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function
  • Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn
  • During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss
  • Although treatment may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does not provide the mineralocorticoid activity that is necessary for coping with these emergencies
  • During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physician for further instruction
  • These patients should also be instructed to carry a medical identification warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack
  • Patients requiring systemic corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to aerosol formulation or inhaler, Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of systemic corticosteroids
  • In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiencies, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension
  • Unmasking of allergic conditions resulting from systemic corticosteroid suppression
  • Transfer of patients from systemic corticosteroid therapy may unmask allergic conditions previously suppressed by systemic corticosteroid therapy (eg, rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions)
  • Corticosteroid withdrawal symptoms
  • During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal (eg, joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function
• Hypercorticism and adrenal suppression
  • Fluticasone propionate, a component of the aerosol and inhaled formulations, will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone
  • Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose
  • A relationship between plasma levels of fluticasone propionate and inhibitory effects on stimulated cortisol production has been shown after 4 weeks of treatment with fluticasone propionate inhalation aerosol
  • Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing the drug combination
  • Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients treated with the combination drug should be observed for any evidence of systemic corticosteroid effects
  • Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response
  • Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects
  • If such effects occur, the dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for the management of asthma symptoms

Pregnancy and Lactation

• There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is an 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; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control of asthma
• Labor and delivery
  • There are no human studies evaluating the effects of therapy during labor and delivery; because of the potential for beta-agonist interference with uterine contractility, use of the drug during labor should be restricted to those patients in whom benefits outweigh the risks
• Lactation
  • There are no available data on the presence of fluticasone propionate or salmeterol in human milk, effects on the breastfed child, or effects on milk production; other corticosteroids have been detected in human milk; however, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or underlying maternal condition
  • Measurable levels of salmeterol and fluticasone were detected in lactating rats treated with each drug