Fluticasone Propionate / Salmeterol
Pronouncation: (floo-TIK-a-SONE PROE-pee-oh-nate/sal-ME-ter-ol)Class: Respiratory inhalant combination
Trade Names:
Advair Diskus
- Powder for inhalation fluticasone propionate 100 mcg/salmeterol 50 mcg
- Powder for inhalation fluticasone propionate 250 mcg/salmeterol 50 mcg
- Powder for inhalation fluticasone propionate 500 mcg/salmeterol 50 mcg
Trade Names:
Advair HFA
- Aerosol spray for inhalation fluticasone propionate 45 mcg/salmeterol 21 mcg
- Aerosol spray for inhalation fluticasone propionate 115 mcg/salmeterol 21 mcg
- Aerosol spray for inhalation fluticasone propionate 230 mcg/salmeterol 21 mcg
Pharmacology
Feedback for Fluticasone Propionate/Salmeterol
Compare with other drugs.
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Inhibits multiple cell types (eg, mast cells) and mediator production or secretion (eg, histamine) involved in the asthmatic response.
SalmeterolProduces bronchodilation by relaxing bronchial smooth muscle through beta 2 -receptor stimulation.
Pharmacokinetics
Absorption
Peak plasma levels of fluticasone are achieved in 1 to 2 h, and those of salmeterol are achieved in about 5 min.
Elimination
The terminal t ½ of fluticasone averaged 5.33 to 7.65 h when administered as Advair Diskus .
Special Populations
Gender and ageNo difference in pharmacokinetics was seen for gender, and no difference was seen in drug exposure when adults, adolescents, and children 4 yr of age and older were compared.
Indications and Usage
Advair DiskusLong-term maintenance treatment of asthma in patients 4 yr of age and older; COPD associated with chronic bronchitis.
Advair HFALong-term maintenance treatment of asthma in patients 12 yr of age and older.
Contraindications
Primary treatment of status asthmaticus or other acute episodes of asthma or COPD in which intensive measures are required; hypersensitivity to any component of the product.
Dosage and Administration
Advair DiskusAdvair Diskus is available in 3 strengths, containing fluticasone propionate 100, 250, and 500 mcg, each in combination with salmeterol 50 mcg.
Adults and Children 12 yr of age and olderInhalation 1 inhalation twice daily (morning and evening, approximately 12 h apart). For patients not currently on an inhaled corticosteroid, the recommended starting dose is fluticasone/salmeterol 100/50 mcg or 250/50 mcg twice daily. For patients on an inhaled corticosteroid, the recommended starting dose of fluticasone/salmeterol varies from 100/50 mcg to 500/50 mcg twice daily, depending on the concomitant inhaled corticosteroid and the dose. Consult the Advair Diskus package insert.
Children 4 to 11 yr of age (symptomatic on inhaled corticosteroids)Inhalation 100/50 mcg twice daily (morning and evening, approximately 12 h apart).
COPD Associated with Chronic Bronchitis AdultsInhalation 1 inhalation (250/50 mcg) twice daily (morning and evening, approximately 12 h apart).
Advair HFAAdvair HFA is available in 3 strengths, containing fluticasone propionate 45, 115, and 230 mcg, each in combination with salmeterol 21 mcg.
Adults and Children 12 yr of age and olderInhalation 2 inhalations twice daily (morning and evening, approximately 12 h apart). For patients not currently on inhaled corticosteroids, the recommended starting dosage is 2 inhalations of fluticasone/salmeterol 45/21 mcg or 115/21 mcg twice daily (max, 2 inhalations of fluticasone/salmeterol 230/21 mcg twice daily). For patients on an inhaled corticosteroid, the recommended starting dose of fluticasone/salmeterol varies from 45/21 mcg to 230/21 mcg, two inhalations twice daily, depending on the concomitant inhaled corticosteroid and the dose (consult the Advair HFA package insert).
General Advice
- If patient is also receiving short-acting bronchodilator by inhalation, administer bronchodilator 5 min before fluticasone/salmeterol to enhance penetration of latter drugs into bronchial tree.
- Have patient rinse mouth with water without swallowing after inhalation is complete.
- Advair HFA
- Prime aerosol inhalation before using the first time by releasing 4 test sprays into the air away from face, shaking canister well for 5 sec before each spray.
- If inhaler has not been used for more than 4 wk or if it is dropped, prime inhaler again by shaking well before each spray and releasing 2 test sprays away from the face.
- Shake inhaler well for 5 sec before using.
Storage/Stability
Advair DiskusStore delivery device at controlled room temperature (68° to 77°F) in a dry place away from direct heat or sunlight. Discard delivery device 30 days after removing from foil pouch or after every blister has been used and dose indicator reads “0.”
Advair HFAStore at 59° to 86°F. Store with mouthpiece down. Use at room temperature.
Drug Interactions
Beta-adrenergic blocking agents (eg, propranolol)May block the pulmonary effect of salmeterol.
Inhibitors of CYP-450 3A4 (eg, ketoconazole, ritonavir)Plasma levels of fluticasone may be increased, and plasma cortisol AUC may be reduced. Avoid coadministration of ritonavir, if possible.
Long-acting beta 2 -agonistsBecause this product already contains salmeterol, do not use other long-acting inhaled beta 2 -agonists for prevention of exercise-induced bronchospasm or maintenance treatment of asthma.
Loop diuretics (eg, furosemide), thiazide diuretics (eg, hydrochlorothiazide)ECG changes and hypokalemia may be worsened.
MAOIs (eg, isocarboxazid), tricyclic antidepressants (eg, amitriptyline)Use with extreme caution in patients receiving these agents or within 2 wk of discontinuation.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Arrhythmia, MI, palpitations, syncope, tachycardia (1% to 3%); hypertension, ventricular tachycardia (postmarketing).
CNS
Headache (21%); dizziness (4%); fatigue and malaise, intoxication and hangover (3%); compressed nerve syndrome, hypnagogic effects, migraines, situational disorders, sleep disorders, tremors (1% to 3%); aggression, agitation, anxiety, behavioral changes including hyperactivity and irritability (primarily in children), depression, paresthesia, restlessness (postmarketing).
Dermatologic
Acquired ichthyosis, burns, contusions, dermatitis, dermatosis, disorders of sebum, eczema, hematomas, hives, lacerations, skin flakiness, soft tissue injuries, sweat, urticaria, viral skin infections, wounds (1% to 3%); contact dermatitis, contusions, ecchymosis, photodermatitis, pruritus (postmarketing).
EENT
Pharyngitis (13%); throat irritation (9%); blood in nasal mucosa, conjunctivitis and keratitis, ear, nose, and throat infections, epistaxis (4%); ear signs and symptoms (3%); allergic eye disorder, dry eye, eye edema, eye infections, eye redness, laryngitis, nasal congestion/blockage, nasal dryness, nasal irritation, nasal signs and symptoms, nasal sinus disorders, nose and throat infections, oropharyngeal plaques, rhinitis, rhinorrhea/postnasal drip, sneezing, viral eye infections (1% to 3%); aphonia, cataract, earache, facial and oropharyngeal edema, glaucoma, paranasal sinus pain, throat soreness and irritation, tonsillitis, tracheitis (postmarketing).
GI
Oral and throat candidiasis (10%); diarrhea, GI discomfort and pain (7%); nausea/vomiting (6%); viral GI infection (4%); GI signs and symptoms (3%); abdominal discomfort and pain, appendicitis, candidiasis mouth/throat, constipation, dental discomfort and pain, disorders of the hard tissue of teeth, flatulence, GI disorders, GI infection, hemorrhoids, hyposalivation, oral abnormalities, oral discomfort and pain, oral erythema and rashes, oral lesions, oral ulcerations, unusual taste (1% to 3%); dyspepsia, xerostomia (postmarketing).
Genitourinary
Menstruation symptoms (5%); bacterial reproductive infections, UTIs (1% to 3%); dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis (postmarketing).
Hematologic-Lymphatic
Lymphatic signs and symptoms (1% to 3%); eosinophilic conditions (postmarketing).
Hepatic
Abnormal LFT (1% to 3%).
Metabolic-Nutritional
Hypercorticism, hyperglycemia, hypothyroidism, weight gain (1% to 3%); Cushing syndrome, Cushingoid features, reduction in growth velocity in children and adolescents (postmarketing).
Musculoskeletal
Musculoskeletal pain (9%); muscle cramps and spasms, muscle pain (7%); muscle injuries (3%); arthralgia and articular rheumatism, bone and cartilage disorders, bone and skeletal pain, fractures, muscle injuries, muscle rigidity, musculoskeletal inflammation, stiffness and tightness (1% to 3%); back pain, myositis, osteoporosis (postmarketing).
Respiratory
Upper respiratory tract infection (27%); bronchitis (8%); upper respiratory inflammation (7%); cough, viral respiratory infections (6%); hoarseness/dysphonia, sinusitis (5%); breathing disorders, lower respiratory hemorrhage, lower respiratory infections, lower respiratory signs and symptoms, pneumonia, wheezing (1% to 3%); asthma, asthma exacerbation, chest congestion, chest tightness, dyspnea, immediate bronchospasm, influenza, paradoxical bronchospasm, upper respiratory symptoms of laryngeal spasm, irritation, or swelling including stridor or choking (postmarketing).
Miscellaneous
Fever (5%); candidiasis, chest symptoms, pain (3%); allergies and allergic reactions, bacterial infections, congestion, edema and swelling, fluid retention, inflammation, poisoning and toxicity, postoperative complications, pressure-induced disorder, viral infections, wheezing (1% to 3%); fever, immediate and delayed hypersensitivity reactions including anaphylaxis, pallor (postmarketing).
Precautions
WarningsSalmeterol may increase the risk of asthma-related death. Therefore, prescribe salmeterol or salmeterol-containing products only for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with salmeterol or salmeterol-containing products. |
MonitorFrequently assess patient for response to treatment. Periodically review therapy in patient with COPD associated with chronic bronchitis for periods longer than 6 mo to assess the continuing benefits and potential risks of treatment. Observe patients for evidence of systemic corticosteroid effects. |
Pregnancy
Category C .
Lactation
FluticasoneUndetermined; however, other corticosteroids are excreted in breast milk.
SalmeterolUndetermined.
Children
Advair DiskusSafety and efficacy not established in children with asthma younger than 4 yr of age.
Advair HFASafety and efficacy not established in children younger than 12 yr of age.
Elderly
Use with caution in elderly patients who have concurrent CV disease.
Hypersensitivity
Immediate hypersensitivity reactions may occur.
Hepatic Function
Impairment of liver function may lead to plasma accumulation of the drugs.
Special Risk Patients
Use with caution, if at all, in patients with active or quiescent tuberculosis of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Adrenal suppression
Hypothalamic-pituitary-adrenal suppression may occur.
Bone mineral density (BMD)
Ensure BMD is assessed prior to starting therapy and periodically thereafter in patient with risk factors for decreased BMD being treated for COPD. Be prepared to introduce therapy to treat or prevent osteoporosis if indicated.
CV disorders
Use with caution in patients with CV disease, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Eosinophilic conditions
Rarely, systemic eosinophilic conditions (eg, vasculitis) may occur.
Growth velocity
A reduction of growth velocity in children and adolescents may occur as a result of poorly controlled asthma or from the therapeutic use of corticosteroids, including inhaled corticosteroids.
Immunosuppression
Patients receiving immunosuppressive therapy may be more susceptible to infection than healthy individuals.
Increased use
If therapy becomes less effective, this may be a marker of destabilization of asthma, which requires reevaluation.
Ophthalmic effects
Glaucoma, increased IOP, and cataracts have been reported with long-term administration of fluticasone
Paradoxical bronchospasm
May occur and be life-threatening.
Special warnings
Do not use for transferring patients from systemic corticosteroid therapy; not to be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma; not for use in treating acute asthma symptoms. Do not exceed recommended dose. Do not use in conjunction with an inhaled, long-acting beta-agonist.
Upper airway symptoms
Laryngeal spasm, irritation, or swelling (eg, choking, stridor) may occur.
Overdosage
Symptoms
FluticasoneHypercorticism.
SalmeterolExcessive beta-adrenergic stimulation and/or occurrence or exaggeration of adverse reactions (eg, angina, arrhythmias, dizziness, dry mouth, fatigue, headache, hypertension, hypotension, insomnia, malaise, muscle cramps, nausea, nervousness, palpitation, seizures, tachycardia, tremor), cardiac arrest, death, hyperglycemia, hypokalemia, prolongation of the QTc interval.
Patient Information
- Instruct patient to continue using other medications for asthma or COPD as prescribed by health care provider.
- Advise patient to read the Medication Guide that comes with the product before starting use and each time a refill is obtained.
- Inform patient that the salmeterol ingredient may increase the risk of asthma-related death.
- Caution patient not to stop therapy without health care provider guidance because symptoms may recur.
- Inform patient that long-term use of product may increase risk of some eye problems (eg, cataracts, glaucoma).
- Inform patient at increased risk for decreased BMD that use of product may pose an additional risk and to monitor and, where appropriate, seek treatment for this condition.
- Advise patient that medication should never be administered with a spacer device.
- Caution patient not to exceed prescribed dose of 1ߙinhalation twice daily, morning and evening, and to rinse mouth with water, without swallowing, after each dose.
- Caution patient not to use salmeterol or other long-acting bronchodilators (eg, formoterol) for prevention of exercise-induced asthma or for maintenance treatment of asthma.
- Warn patient that drug is an asthma controller and is not to be used to treat an acute asthma attack. Rescue medication (bronchodilator) must be used to obtain rapid relief of asthma symptoms.
- Explain that effects of drug are not immediate. Benefit requires daily use as instructed and may occur after 30 min but may take 1 wk or longer.
- Advise patient that he or she may or may not feel or taste a dose of medicine during inhalation. Caution patient not to exceed the prescribed dose of 1 inhalation twice daily.
- Advise patient not to increase dose and to inform health care provider if symptoms do not improve or if they worsen, if more short-acting bronchodilator than usual is needed, or if the short-acting bronchodilator appears to become less effective.
- If patient is being converted from oral corticosteroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete. Advise patient to carry medical identification (eg, card, bracelet) indicating that supplemental systemic corticosteroids may be needed during periods of stress or a severe asthma attack.
- Advise patient to carry medical identification (eg, card, bracelet) if experiencing acute severe asthma attacks requiring rapid systemic treatment.
- Advise patient to report the following symptoms to health care provider: chest pain, nervousness, palpitations, persistent cough, rapid heart rate, sore throat or mouth, tremor.
- Advise patient to avoid exposure to chickenpox and measles and to seek medical advice immediately if exposed.
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Asthma -- Maintenance, Chronic Obstructive Pulmonary Disease -- Maintenance
