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FLUTICASONE-SALMETEROL (fluticasone propionate/salmeterol xinafoate)
- Maintenance therapy for asthma
- Prevention of bronchospasm with chronic bronchitis
- Bronchospasm prevention with COPD
- Prevention of bronchospasms with emphysema
- Wixela Inhub Powder For Inhalation
- Fluticasone Propionate-salmeterol Inhalation Powder Blister
- Advair Diskus Powder For Inhalation
- By Indication
100 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
250 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
500 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
fluticasone 100 mcg-salmeterol 50 mcg/dose blistr powdr for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
fluticasone 250 mcg-salmeterol 50 mcg/dose blistr powdr for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
fluticasone 500 mcg-salmeterol 50 mcg/dose blistr powdr for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
100 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
250 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
500 mcg-50 mcg/dose powder for inhalation
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
Maintenance therapy for asthma
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
Prevention of bronchospasm with chronic bronchitis
- Inhale 1 puff by inhalation route 2 times per day in the morning and evening approximately 12 hours apart
- natalizumab
- Tysabri
Contraindicated
- amiodarone
- amiodarone in dextrose,iso-osm
- amoxicil-clarithromy-lansopraz
- artemether-lumefantrine
- atazanavir
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- boceprevir
- bromocriptine
- cabergoline
- Cafergot
- clarithromycin
- Coartem
- Compound 347
- Cordarone
- Crixivan
- Cycloset
- D.h.e.45
- dihydroergotamine
- disopyramide
- dronedarone
- droperidol
- elvitegr-cobicist-emtric-tenof
- enflurane
- ergoloid
- Ergomar
- ergotamine tartrate
- ergotamine-caffeine
- Forane
- fosamprenavir
- Geodon
- Incivek
- indinavir
- Invirase
- isoflurane
- itraconazole
- Kaletra
- Ketek
- ketoconazole
- Korlym
- Lexiva
- lopinavir-ritonavir
- methylergonovine
- Mifeprex
- mifepristone
- Migergot
- Migranal
- Multaq
- nefazodone
- nelfinavir
- Nexterone
- Norpace
- Norpace Cr
- Norvir
- Norvir Soft Gelatin
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- Orap
- Pacerone
- Parlodel
- pimozide
- Prevpac
- Reyataz
- ritonavir
- saquinavir mesylate
- sevoflurane
- Sojourn
- Sporanox
- Sporanox Pulsepak
- Stribild
- telaprevir
- telithromycin
- Terrell
- thioridazine
- Ultane
- Victrelis
- Viracept
- ziprasidone HCl
- ziprasidone mesylate
Severe
Moderate
- Ablavar
- alfuzosin
- Anzemet
- Apokyn
- apomorphine
- arsenic trioxide
- Avelox
- Avelox Abc Pack
- Avelox In Nacl (iso-osmotic)
- bedaquiline
- Betapace
- Betapace Af
- Caprelsa
- Celexa
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- citalopram
- clozapine
- Clozaril
- Complera
- crizotinib
- dasatinib
- Diskets
- dofetilide
- dolasetron
- Dolophine
- Edurant
- emtricitab-rilpivirine-tenofov
- eribulin
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- escitalopram oxalate
- ezogabine
- Fareston
- Fazaclo
- gadofosveset trisodium
- Halaven
- Haldol
- Haldol Decanoate
- haloperidol
- haloperidol decanoate
- haloperidol lactate
- Invega
- Invega Sustenna
- Istodax
- lapatinib
- Levaquin
- Levaquin In 5 % Dextrose
- levofloxacin
- levofloxacin in D5W
- Lexapro
- methadone
- Methadone Intensol
- Methadose
- moxifloxacin
- moxifloxacin in NaCl (iso-osm)
- Nexavar
- nilotinib
- norfloxacin
- Noroxin
- Noxafil
- ofloxacin
- ondansetron
- ondansetron HCl
- ondansetron HCl (PF)
- paliperidone
- paliperidone palmitate
- pasireotide
- pazopanib
- posaconazole
- Potiga
- propafenone
- Qualaquin
- quetiapine
- quinine sulfate
- rilpivirine
- romidepsin
- Rythmol
- Seroquel
- Seroquel Xr
- Signifor
- Sirturo
- sorafenib
- Sorine
- sotalol
- Sotalol Af
- Sprycel
- Tasigna
- telavancin
- tetrabenazine
- Tikosyn
- toremifene
- Trisenox
- Tykerb
- Uroxatral
- vandetanib
- vemurafenib
- Versacloz
- Vibativ
- Votrient
- Xalkori
- Xenazine
- Zelboraf
- Zofran
- Zofran Odt
- Zuplenz
- Acutely deteriorating asthma
Contraindicated
- Active tuberculosis
- Cardiac arrhythmia
- Chronic myocardial ischemia
- Congenital long QT syndrome
- Hypokalemia
- Ocular herpes simplex
- Parasitic infection
- Prolonged QT interval
Severe
Moderate
- Cataracts
- Diabetes mellitus
- Hypertension
- Hypothalamic-pituitary insufficiency
- Open angle glaucoma
- Oral candidiasis
- Osteopenia
- Osteoporosis
- Seizure disorder
- Thyrotoxicosis
FLUTICASONE-SALMETEROL (fluticasone propionate/salmeterol xinafoate)
- Maintenance therapy for asthma
- Prevention of bronchospasm with chronic bronchitis
- Bronchospasm prevention with COPD
- Prevention of bronchospasms with emphysema
- Bronchitis
- Cough
- Headache disorder
- Myalgias
- Oral candidiasis
- Pharyngeal candidiasis
- Pharyngitis
- Sinusitis
- Upper respiratory infection
More Frequent
Severe
Less Severe
- None
- Cough
- Cramps
- Dizziness
- Influenza
- Nasal congestion
- Nausea
- Nervousness
- Palpitations
- Rhinitis
- Sore throat
- Tachycardia
- Tremor
- Voice change
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Aggressive behavior
- Anaphylaxis
- Angina
- Angioedema
- Asthma exacerbation
- Atrial fibrillation
- Bronchitis
- Cardiac arrhythmia
- Cataracts
- Central serous chorioretinopathy
- Chest pain
- Conjunctivitis
- Edema
- Esophageal candidiasis
- Extrasystoles
- Glaucoma
- Hypercortisolism
- Hyperglycemia
- Hypersensitivity angiitis
- Hypersensitivity drug reaction
- Hypertension
- Hypotension
- Immunosuppression
- Keratitis
- Laryngismus
- Osteopenia
- Osteoporosis
- Paradoxical bronchospasm
- Pneumonia
- Prolonged QT interval
- Seizure disorder
- Sinusitis
- Skin and skin structure infection
- Skin rash
- Stridor
- Upper respiratory infection
- Urinary tract infection
- Urticaria
- Ventricular tachycardia
Less Severe
- Agitation
- Arthralgias
- Blurred vision
- Contact dermatitis
- Dental caries
- Dental discoloration
- Depression
- Diarrhea
- Dizziness
- Dyspepsia
- Dyspnea
- Earache
- Ecchymosis
- Eczema
- Eosinophilia
- Facial edema
- Fatigue
- Fever
- Hyperkinesis
- Insomnia
- Irritability
- Laryngitis
- Malaise
- Muscle rigidity
- Myalgias
- Nausea
- Oral candidiasis
- Paresthesia
- Pruritus of skin
- Rhinitis
- Rhinorrhea
- Skin rash
- Sore throat
- Symptoms of anxiety
- Toothache
- Urticaria
- Viral infection
- Vomiting
- Weight gain
- Xerostomia
Contraindicated
None
Severe Precaution
Fluticasone (Oral Inhal)
Risk of decreased growth velocity. Safety and efficacy not established age < 4 years.
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
Safety & efficacy not established age <4 years. Not for use in acute asthma attack.
- 1 Day – 4 Years
- Risk of decreased growth velocity. Safety and efficacy not established age < 4 years.
- 1 Day – 12 Years
- Risk of decreased growth velocity. Safety and efficacy not established age < 4 years.
Glucocorticoid_LA-Beta Agonist
Risk of decreased growth velocity. Safety and efficacy not established age < 4 years.
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
Safety & efficacy not established age <4 years. Not for use in acute asthma attack.
- 1 Day – 4 Years
- Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
- 1 Day – 12 Years
- Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
Salmeterol
Risk of decreased growth velocity. Safety and efficacy not established age < 4 years.
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
Safety & efficacy not established age <4 years. Not for use in acute asthma attack.
- 1 Day – 4 Years
- Safety & efficacy not established age <4 years. Not for use in acute asthma attack.
- 1 Day – 12 Years
- Safety & efficacy not established age <4 years. Not for use in acute asthma attack.
Management or Monitoring Precaution
Fluticasone (Oral Inhal)
Growth velocity may be decreased. Monitor growth and use the lowest effective dose. Reports of throat irritation, ear, nose and throat infections.
Risk of decreased growth velocity. Titrate to lowest effective dose and monitor growth
- 4 Years – 18 Years
- Growth velocity may be decreased. Monitor growth and use the lowest effective dose. Reports of throat irritation, ear, nose and throat infections.
- 12 Years – 18 Years
- Growth velocity may be decreased. Monitor growth and use the lowest effective dose. Reports of throat irritation, ear, nose and throat infections.
Fluticasone (Select)
Growth velocity may be decreased. Monitor growth and use the lowest effective dose. Reports of throat irritation, ear, nose and throat infections.
Risk of decreased growth velocity. Titrate to lowest effective dose and monitor growth
- 4 Years – 18 Years
- Risk of decreased growth velocity. Titrate to lowest effective dose and monitor growth
- 12 Years – 18 Years
- Risk of decreased growth velocity. Titrate to lowest effective dose and monitor growth
Fluticasone (inhal)
- Severity Level:
2
- Additional Notes: Current evidence supports use of inhaled corticosteroids for asthma tx in preg
Salmeterol
- Severity Level:
2
- Additional Notes: Limited human data do not suggest a clear association for development toxicity.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Fluticasone (inhal, Nasal)
Systemic products excreted in rats; caution advised with nasal administration
Insufficient human studies data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Systemic products excreted in rats; caution advised with nasal administration |
Salmeterol
Systemic products excreted in rats; caution advised with nasal administration
Insufficient human studies data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human studies data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Fluticasone (inh)
Musculoskeletal-Use with caution in patients with osteoporosis. Decreases in bone mineral density (BMD) has been observed with long-term administration of products containing inhaled corticosteroids.
Cardiovascular-Use caution in severe cardiovascular diseases, particularly coronary insufficiency, since beta-agonists increase heart rate and blood pressure. Endocrine-Use caution in poorly controlled hyperthyroidism or diabetes.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | N | N | Y |
BEERS: N HEDIS: N STOPP: N
Salmeterol
Musculoskeletal-Use with caution in patients with osteoporosis. Decreases in bone mineral density (BMD) has been observed with long-term administration of products containing inhaled corticosteroids.
Cardiovascular-Use caution in severe cardiovascular diseases, particularly coronary insufficiency, since beta-agonists increase heart rate and blood pressure. Endocrine-Use caution in poorly controlled hyperthyroidism or diabetes.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | Y | N | N | Y |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Bronchospasm prevention with COPD | |
| J44 | Other chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
| Prevention of bronchospasm with chronic bronchitis | |
| J41 | Simple and mucopurulent chronic bronchitis |
| J41.0 | Simple chronic bronchitis |
| J41.1 | Mucopurulent chronic bronchitis |
| J41.8 | Mixed simple and mucopurulent chronic bronchitis |
| J42 | Unspecified chronic bronchitis |
| J44 | Other chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| Prevention of bronchospasms with emphysema | |
| J43 | Emphysema |
| J43.0 | Unilateral pulmonary emphysema [macleod's syndrome] |
| J43.1 | Panlobular emphysema |
| J43.2 | Centrilobular emphysema |
| J43.8 | Other emphysema |
| J43.9 | Emphysema, unspecified |
| J44 | Other chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| 0-9 | A-Z |
|---|---|
| J41 | Simple and mucopurulent chronic bronchitis |
| J41.0 | Simple chronic bronchitis |
| J41.1 | Mucopurulent chronic bronchitis |
| J41.8 | Mixed simple and mucopurulent chronic bronchitis |
| J42 | Unspecified chronic bronchitis |
| J43 | Emphysema |
| J43.0 | Unilateral pulmonary emphysema [macleod's syndrome] |
| J43.1 | Panlobular emphysema |
| J43.2 | Centrilobular emphysema |
| J43.8 | Other emphysema |
| J43.9 | Emphysema, unspecified |
| J44 | Other chronic obstructive pulmonary disease |
| J44 | Other chronic obstructive pulmonary disease |
| J44 | Other chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
Formulary Reference Tool