fluticasone propionate and salmeterol 50 ug; 500 ug Powder
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta2-Adrenergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of fluticasone and salmeterol (Advair® Diskus, Advair® HFA, AirDuo® Respiclick) is used to treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma. The combination of fluticasone and salmeterol (Advair® Diskus) is also used to prevent and treat wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). The combination of fluticasone and salmeterol (Advair® Diskus) is used in adults and children 4 yea...
Read the full MedlinePlus article ↗- No — and this is really important. This inhaler is a long-term controller, not a rescue inhaler. It won't work fast enough in an emergency. If you're having a sudden attack, use yo...
- Can I use this inhaler when I'm having an asthma attack right now?
- The corticosteroid (fluticasone) can settle in your mouth and throat and encourage a fungal infection called oral thrush — you'd notice it as white patches or soreness. Rinsing wit...
- Why do I need to rinse my mouth after using this inhaler?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.649 | $98.96 / 60 powders |
| Medicaid paysCMS SDUD · 12 mo | $1.99 | $119.64 / 60 powders |
| Medicare drug plans payPart D · Q2 2026 | $2.27 | $136.36 / 60 powders |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| fluticasone propionate and salmeterol 50 ug/1; 500 ugthis 00054-0328-56 | Hikma | 1 pouch | $1.649 | AB | Availability likely | — |
| fluticasone propionate and salmeterol 500 ug/1; 50 ug 00093-7516-31 | Teva | 1 pouch | $1.649 | AB | Availability likely | — |
| Wixela Inhub 500 ug/1; 50 ug 00378-9322-32 | Mylan | 1 inhaler | $1.649 | AB | Availability likely | — |
| Fluticasone Propionate and Salmeterol DISKUS 500 ug/1; 50 ug 66993-0586-97 | Prasco | 1 inhaler | $1.649 | AB | Availability likely | — |
| Advair Diskus 50 ug/1; 500 ug 00173-0697-00 | GlaxoSmithKline | 1 inhaler | $4.227 | AB | Availability likely | +156% |
| Advair Diskus 50 ug/1; 500 ug 50090-0732-00 | A-S | 1 inhaler | — | AB | FDA listed | — |
| Fluticasone Propionate and Salmeterol DISKUS 500 ug/1; 50 ug 50090-4214-00 | A-S | 1 inhaler | — | AB | FDA listed | — |
| Advair Diskus 50 ug/1; 500 ug 50090-4505-00 | A-S | 1 inhaler | — | AB | FDA listed | — |
| Fluticasone Propionate and Salmeterol DISKUS 500 ug/1; 50 ug 70518-4348-00 | REMEDYREPACK | 1 inhaler | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00054-0328-56 You're viewing this | 1 POUCH in 1 CARTON (0054-0328-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER | 2023-12-19 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important Limitation of Use: Not indicated for relief of acute bronchospasm.
( 1.1 , 1.2 )
1.1Treatment of Asthma Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalation powder should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.
1.2Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg over fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg has not been demonstrated.
Important Limitation of Use Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Fluticasone propionate and salmeterol inhalation powder should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of fluticasone propionate and salmeterol inhalation powder is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol.
Patients using fluticasone propionate and salmeterol inhalation powder should not use additional LABA for any reason [see Warnings and Precautions ( 5.3 , 5.12 )] . • For oral inhalation only. ( 2 ) • Treatment of Asthma in Patients Aged 12 Years and Older: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, or fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg twice daily. Starting dosage is based on asthma severity.
( 2.1 ) • Treatment of Asthma in Patients Aged 4 to 11 Years: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg twice daily. ( 2.1 ) • Maintenance Treatment of COPD: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily. ( 2.2 )
2.1Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Adult and Adolescent Patients Aged 12 Years and Older For patients aged 12 years and older, the dosage is 1 inhalation twice daily, approximately 12 hours apart. When choosing the starting dosage strength of fluticasone propionate and salmeterol inhalation powder, consider the patients’ disease severity, based on their previous asthma therapy, including the ICS dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation.
The maximum recommended dosage is fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg twice daily. Improvement in asthma control following inhaled administration of fluticasone propionate and salmeterol inhalation powder can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of fluticasone propionate and salmeterol inhalation powder with a higher strength may provide additional improvement in asthma control. If a previously effective dosage regimen fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of fluticasone propionate and salmeterol inhalation powder with a higher strength, adding additional ICS, initiating oral corticosteroids) should be considered.
Pediatric Patients Aged 4 to 11 Years For patients with asthma aged 4 to 11 years who are not controlled on an ICS, the dosage is 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg twice daily, approximately 12 hours apart.
2.2Chronic Obstructive Pulmonary Disease The recommended dosage for patients with COPD is 1 inhalation of fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily, approximately 12 hours apart. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Inhalation Powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains a combination of fluticasone propionate 100, 250, or 500 mcg and salmeterol 50 mcg per blister. Inhalation Powder: Inhaler containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as a powder formulation for oral inhalation. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of fluticasone propionate and salmeterol inhalation powder 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 Precautions ( 5.11 ), Adverse Reactions ( 6.3 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.
( 4 ) • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 risk. ( 5.4 ) • Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
( 5.5 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
( 5.6 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to fluticasone propionate and salmeterol inhalation powder. ( 5.7 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.
If such changes occur, discontinue fluticasone propionate and salmeterol inhalation powder slowly. ( 5.8 ) • If paradoxical bronchospasm occurs, discontinue fluticasone propionate and salmeterol inhalation powder and institute alternative therapy. ( 5.10 ) • Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation.
( 5.12 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.13 ) • Monitor growth of pediatric patients. ( 5.14 ) • Glaucoma and cataracts may occur with long-term use of inhaled corticosteroids.
Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone propionate and salmeterol inhalation powder long term. ( 5.15 ) • Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. ( 5.16 , 5.18 ) • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
( 5.17 )
5.1Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of LABA as monotherapy (without 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-related hospitalization in pediatric and adolescent patients. 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 (see Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists) . Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists Four (4) large, 26-week, randomized, double-blind, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed-dose combination with ICS compared with ICS alone in subjects with asthma.
Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder [ see Clinical Studies ( 14.1 ) ], 1 trial compared mometasone furoate/formoterol with mometasone furoate, and 1 trial compared budesonide/formoterol with budesonide. The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 ( 5.6 )] • Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.8 )] • Reduction in bone mineral density [see Warnings and Precautions ( 5.13 )] • Growth effects [see Warnings and Precautions ( 5.14 )] • Glaucoma and cataracts [see Warnings and Precautions ( 5.15 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most common adverse reactions (incidence greater than or equal to 3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. ( 6.1 ) • COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience in Asthma Adult and Adolescent Subjects Aged 12 Years and Older The incidence of adverse reactions associated with fluticasone propionate and salmeterol inhalation powder in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 2). A total of 705 adult and adolescent subjects (349 females and 356 males) previously treated with salmeterol or ICS were treated twice daily with fluticasone propionate and salmeterol inhalation powder (100 mcg/50 mcg or 250 mcg/50 mcg doses), fluticasone propionate inhalation powder (100- or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo.
The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group. Table 2: Adverse Reactions with Fluticasone Propionate and Salmeterol Inhalation Powder with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma Adverse Event Fluticasone Propionate and Salmeterol Inhalation Powder 100 mcg/50 mcg (n = 92) % Fluticasone Propionate and Salmeterol Inhalation Powder 250 mcg/50 mcg (n = 84) % Fluticasone Propionate 100 mcg (n = 90) % Fluticasone Propionate 250 mcg (n = 84) % Salmeterol 50 mcg (n = 180) % Placebo (n = 175) % Ear, Nose, and Throat Upper Respiratory Tract Infection 27 21 29 25 19 14 Pharyngitis 13 10 7 12 8 6 Upper Respiratory Inflammation 7 6 7 8 8 5 Sinusitis 4 5 6 1 3 4 Hoarseness/Dysphonia 5 2 2 4 <1 <1 Oral Candidiasis 1 4 2 2 0 0 Lower Respiratory Viral respiratory infections 4 4 4 10 6 3 Bronchitis 2 8 1 2 2 2 Cough 3 6 0 0 3 2 Neurology Headaches 12 13 14 8 10 7 Gastrointestinal Nausea and Vomiting 4 6 3 4 1 1 Gastrointestinal Discomfort and Pain 4 1 0 2 1 1 Diarrhea 4 2 2 2 1 1 Viral Gastrointestinal Infections 3 0 3 1 2 2 Non-site Specific Candidiasis Unspecified Site 3 0 1 4 0 1 Musculoskeletal Musculoskeletal Pain 4 2 1 5 3 3 The types of adverse reactions and events reported in Trial 3, a 28-week, non-U.S. clinical trial in 503 subjects previously treated with ICS who were treated twice daily with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, fluticasone propionate inhalation powder 500 mcg and salmeterol inhalation powder 50 mcg used concurrently, or fluticasone propionate inhalation powder 500 mcg, were similar to those reported in Table 2.
Additional Adverse Reactions Othe…
🔄 Drug Interactions ▾
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 propionate and salmeterol inhalation powder. • Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir, ketoconazole): Use not recommended.
May increase risk of systemic corticosteroid and cardiovascular effects. ( 7.1 ) • Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system.
( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) • Diuretics: Use with caution.
Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 )
7.1Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of fluticasone propionate and salmeterol inhalation powder, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with fluticasone propionate and salmeterol inhalation powder is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur.
Ritonavir Fluticasone Propionate: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology ( 12.3 )] . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.
Ketoconazole Fluticasone Propionate: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol. Salmeterol: In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and C max increased 1.4-fold).
Three (3) subjects were withdrawn due to beta 2 -agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration.
7.2Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Fluticasone propionate and salmeterol inhalation powder should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol, a component of fluticasone propionate and salmeterol inhalation powder, on the vascular system may be potentiated by these agents.
7.3Beta-adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as salmeterol, a component of fluticasone propionate and salmeterol inhalation powder, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not no…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Monitor patients for signs of increased drug exposure. ( 8.6 )
8.1Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate and salmeterol inhalation powder or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. There are clinical considerations with the use of fluticasone propionate and salmeterol inhalation powder in pregnant women ( see Clinical Considerations ). In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis (see Data ).
However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis (see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 50 times the MRHDID on an AUC basis.
These adverse effects generally occurred at large multiples of the MRHDID when salmeterol was administered by the oral route to achieve high systemic exposures. No such effects occurred at an oral salmeterol dose approximately 20 times the MRHDID (see Data ). The estimated risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma.
Labor and Delivery: There are no human studies evaluating the effects of fluticasone propionate and salmeterol inhalation powder during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of fluticasone propionate and salmeterol inhalation powder during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. Data Human Data: Fluticasone Propionate: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.
Animal Data: Fluticasone Propionate and Salmeterol: In an embryofetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,000; 30/0; 10/100; 30/1,000; and 100/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects. Omphalocele, increased embryofetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses in the presence of maternal toxicity when combining fluticasone propionate at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and salmeterol at a dose approximately 970 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 10,000 mcg/kg/day).
The rat no observed adverse effect level (NOAEL) was observed when combining fluticasone propionate at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis at a maternal subcu…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate and salmeterol inhalation powder or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. There are clinical considerations with the use of fluticasone propionate and salmeterol inhalation powder in pregnant women ( see Clinical Considerations ). In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis (see Data ).
However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis (see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 50 times the MRHDID on an AUC basis.
These adverse effects generally occurred at large multiples of the MRHDID when salmeterol was administered by the oral route to achieve high systemic exposures. No such effects occurred at an oral salmeterol dose approximately 20 times the MRHDID (see Data ). The estimated risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma.
Labor and Delivery: There are no human studies evaluating the effects of fluticasone propionate and salmeterol inhalation powder during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of fluticasone propionate and salmeterol inhalation powder during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. Data Human Data: Fluticasone Propionate: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.
Animal Data: Fluticasone Propionate and Salmeterol: In an embryofetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,000; 30/0; 10/100; 30/1,000; and 100/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects. Omphalocele, increased embryofetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses in the presence of maternal toxicity when combining fluticasone propionate at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and salmeterol at a dose approximately 970 times the MRHDID (on a mcg/m 2 basis at a maternal oral dose of 10,000 mcg/kg/day).
The rat no observed adverse effect level (NOAEL) was observed when combining fluticasone propionate at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and salmeterol at a dose approximately 100 times the MRHDID (on a mcg/m 2 basis at…
🧒 Pediatric Use ▾
8.4Pediatric Use Use of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older subjects and by safety and efficacy data from a trial of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in children with asthma aged 4 to 11 years [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 )] . The safety and effectiveness of fluticasone propionate and salmeterol inhalation powder in children with asthma younger than 4 years have not been established.
ICS, including fluticasone propionate, a component of fluticasone propionate and salmeterol inhalation powder, may cause a reduction in growth velocity in children and adolescents [see Warnings and Precautions ( 5.14 )] . The growth of pediatric patients receiving orally inhaled corticosteroids, including fluticasone propionate and salmeterol inhalation powder, should be monitored. A 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder (FLOVENT ROTADISK) at 50 and 100 mcg twice daily was conducted in the U.S. in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years.
The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n = 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79).
In children aged 8.5 years, the mean age of children in this trial, the range for expected growth velocity is: boys – 3 rd percentile = 3.8 cm/year, 50 th percentile = 5.4 cm/year, and 97 th percentile = 7.0 cm/year; girls – 3 rd percentile = 4.2 cm/year, 50 th percentile = 5.7 cm/year, and 97 th percentile = 7.3 cm/year. The clinical relevance of these growth data is not certain. If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered.
The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including fluticasone propionate and salmeterol inhalation powder, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see Dosage and Administration ( 2.1 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of fluticasone propionate and salmeterol inhalation powder for asthma did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects with asthma respond differently than younger subjects. Of the total number of subjects in clinical trials receiving fluticasone propionate and salmeterol inhalation powder for COPD, 1,621 were aged 65 years and older and 379 were aged 75 years and older. Subjects with COPD aged 65 years and older had a higher incidence of serious adverse events compared with subjects younger than 65 years.
Although the distribution of adverse events was similar in the 2 age groups, subjects older than 65 years experienced more severe events. In two 1-year trials, the excess risk of pneumonia that was seen in subjects treated with fluticasone propionate and salmeterol inhalation powder compared with those treated with salmeterol was greater in subjects older than 65 years than in subjects younger than 65 years [see Adverse Reactions ( 6.2 )] . As with other products containing beta 2 -agonists, special caution should be observed when using fluticasone propionate and salmeterol inhalation powder in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta 2 -agonists.
Based on available data for fluticasone propionate and salmeterol inhalation powder or its active components, no adjustment of dosage of fluticasone propionate and salmeterol inhalation powder in geriatric patients is warranted. No relationship between fluticasone propionate systemic exposure and age was observed in 57 subjects with COPD (aged 40 to 82 years) given 250 or 500 mcg twice daily.
🆘 Overdosage ▾
10 OVERDOSAGE No human overdosage data has been reported for fluticasone propionate and salmeterol inhalation powder. Fluticasone propionate and salmeterol inhalation powder contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to fluticasone propionate and salmeterol inhalation powder. Treatment of overdosage consists of discontinuation of fluticasone propionate and salmeterol inhalation powder together with institution of appropriate symptomatic and/or supportive therapy.
The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
10.1Fluticasone Propionate Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.8 )] . Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated.
Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
10.2Salmeterol The expected signs and symptoms with overdosage of salmeterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). Overdosage with salmeterol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias.
As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of salmeterol.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Fluticasone Propionate and Salmeterol Inhalation Powder Fluticasone propionate and salmeterol inhalation powder contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to fluticasone propionate and salmeterol inhalation powder. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices.
Fluticasone Propionate Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.
The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Inflammation is also a component in the pathogenesis of COPD. In contrast to asthma, however, the predominant inflammatory cells in COPD include neutrophils, CD8+ T-lymphocytes, and macrophages.
The effects of corticosteroids in the treatment of COPD are not well defined and ICS and fluticasone propionate when used apart from fluticasone propionate and salmeterol inhalation powder are not indicated for the treatment of COPD. Salmeterol Xinafoate Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 -adrenoceptors than albuterol.
Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are also beta 2 -adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 -agonists may have cardiac effects. The pharmacologic effects of beta 2 -adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP).
Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D 2 , from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor– induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.
In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness.
12.2Pharmacodynamics Fluticasone Propionate and Salmeterol Inhalation Powder Healthy Subjects : Cardiovascular Effects: Since systemic pharmacodynamic effects of salmeterol are not normally seen at the therapeutic dose, higher doses were used to produce measurable effects. Four (4) trials were conducted with healthy adult subjects: (1) a single-dose crossover trial using 2 inhalations of fluticasone propionate and salmeterol…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Fluticasone Propionate and Salmeterol Inhalation Powder Fluticasone propionate and salmeterol inhalation powder contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to fluticasone propionate and salmeterol inhalation powder. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices.
Fluticasone Propionate Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.
The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Inflammation is also a component in the pathogenesis of COPD. In contrast to asthma, however, the predominant inflammatory cells in COPD include neutrophils, CD8+ T-lymphocytes, and macrophages.
The effects of corticosteroids in the treatment of COPD are not well defined and ICS and fluticasone propionate when used apart from fluticasone propionate and salmeterol inhalation powder are not indicated for the treatment of COPD. Salmeterol Xinafoate Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 -adrenoceptors than albuterol.
Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are also beta 2 -adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 -agonists may have cardiac effects. The pharmacologic effects of beta 2 -adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP).
Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D 2 , from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor– induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.
In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate and Salmeterol Inhalation Powder, USP 100 mcg/50 mcg is supplied as a disposable gray plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0054-0326-56). 250 mcg/50 mcg is supplied as a disposable gray plastic inhaler containing a foil blister strip with 60 blisters.
The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0054-0327-56). 500 mcg/50 mcg is supplied as a disposable gray plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0054-0328-56).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone propionate and salmeterol inhalation powder should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use.
Discard fluticasone propionate and salmeterol inhalation powder 1 month after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
📋 Description ▾
11 DESCRIPTION Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S- fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure: Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S.
It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta 2 -adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol.
It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α 1 -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure: Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip.
Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds.
In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was
82.4L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of
75.5L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. fluticasone-propionate-chemical.jpg salmeterol-xinafoate-chemical.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Serious Asthma-Related Events Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with fluticasone propionate and salmeterol inhalation powder, there is not a significant increase in the risk of these events.
Not for Acute Symptoms Inform patients that fluticasone propionate and salmeterol inhalation powder is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.
Instruct patients to seek medical attention immediately if they experience any of the following: • Decreasing effectiveness of inhaled, short-acting beta 2 -agonists • Need for more inhalations than usual of inhaled, short-acting beta 2 -agonists • Significant decrease in lung function as outlined by the physician Tell patients they should not stop therapy with fluticasone propionate and salmeterol inhalation powder without physician/provider guidance since symptoms may recur after discontinuation. Do Not Use Additional Long-acting Beta 2 -agonists Instruct patients not to use other LABA for asthma and COPD.
Local Effects Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with fluticasone propionate and salmeterol inhalation powder, but at times therapy with fluticasone propionate and salmeterol inhalation powder may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.
Pneumonia Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia. Immunosuppression Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism and Adrenal Suppression Advise patients that fluticasone propionate and salmeterol inhalation powder may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to fluticasone propionate and salmeterol inhalation powder.
Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of fluticasone propionate and salmeterol inhalation powder. Patients should discontinue fluticasone propionate and salmeterol inhalation powder if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take fluticasone propionate and salmeterol inhalation powder.
Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. Reduced Growth Velocity Inform patients that orally inhaled corticosteroids, incl…