A-Z Drug Facts > Fluticasone Propionate/Salmeterol

Fluticasone Propionate / Salmeterol

Pronunciation: (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

Advair Inhalation Aerosol (Canada)

Pharmacology

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Fluticasone

Inhibits multiple cell types (eg, mast cells) and mediator production or secretion (eg, histamine) involved in the asthmatic response.

Salmeterol

Produces bronchodilation by relaxing bronchial smooth muscle through beta ₂ -receptor stimulation.

Indications and Usage

Advair Diskus

Long-term maintenance treatment of asthma in patients 4 yr of age and older.

Advair Diskus 250/50

Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; reduce exacerbations of COPD in patients with a history of exacerbations.

Advair HFA

Long-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; severe hypersensitivity to milk proteins ( Advair Diskus ).

Dosage and Administration

Advair Diskus is available in 3 strengths, containing fluticasone propionate 100, 250, and 500 mcg, each in combination with salmeterol 50 mcg.

Asthma
Adults and Adolescents 12 yr of age and older

Inhalation

Advair Diskus

1 inhalation twice daily (morning and evening, approximately 12 h apart). For patients not currently on inhaled corticosteroids whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, or patients inadequately controlled on an inhaled corticosteroid, the recommended starting dosage is fluticasone/salmeterol 100/50 or 250/50 twice daily (max, 500/50 twice daily). For patients who do not respond adequately to the starting dosage after 2 wk of therapy, 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 options (eg, replacing current strength with a higher strength, initiating oral corticosteroids or adding additional inhaled corticosteroids) should be considered.

Children 4 to 11 yr of age (symptomatic on inhaled corticosteroids)

Inhalation

Advair Diskus

1 inhalation of fluticasone/salmeterol 100/50 twice daily (morning and evening, approximately 12 h apart).

COPD
Adults

Inhalation 1 inhalation (250/50 mcg) twice daily (morning and evening, approximately 12 h apart).

Advair HFA

Advair 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 older

Inhalation 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, 2 inhalations twice daily, depending on the current daily dose of the concomitant inhaled corticosteroid (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 Diskus

Store 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 HFA

Store 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.

CYP3A4 strong inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)

Fluticasone plasma levels may be elevated and increased cardiovascular effects may occur; coadministration with fluticasone is not recommended.

Long-acting beta ₂ -agonists

Because 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

Arrhythmias, MI, migraine, tachycardia (1% to 3%); extrasystoles, hypertension, pallor, ventricular tachycardia (postmarketing).

CNS

Headache (21%); dizziness (5%); intoxication and hangover, malaise and fatigue (3%); sleep disorders (1% to 3%); aggression, agitation, anxiety, behavioral changes including hyperactivity and irritability (primarily in children), depression, paresthesia, restlessness (postmarketing).

Dermatologic

Dermatitis, dermatosis, eczema (1% to 3%); contact dermatitis, contusions, ecchymosis, photodermatitis, pruritus (postmarketing).

EENT

Pharyngitis (13%); throat irritation (9%); ear, nose, and throat infections, throat irritation (8%); dysphonia, nasal congestion, nasopharyngitis (5%); oral candidiasis (4%); allergic eye disorder, ear signs and symptoms, epistaxis, eye edema, eye swelling, laryngitis, nasal blockage, nose dryness, postnasal drip/rhinorrhea, unspecified oropharyngeal plaques (1% to 3%); aphonia, cataracts, earache, facial and oropharyngeal edema, glaucoma, paranasal sinus pain, rhinitis, throat soreness and irritation, tonsillitis (postmarketing).

GI

Oral and throat candidiasis (10%); nausea/vomiting (6%); nausea (greater than 5%); diarrhea, GI discomfort and pain, viral GI infection (4%); GI signs and symptoms (3%); abdominal discomfort and pain, constipation, dental discomfort and pain, disorder of hard tissue of teeth, GI gaseous symptoms, GI infection, hemorrhoids, hyposalivation, oral abnormalities (1% to 3%); abdominal pain, dyspepsia, xerostomia (postmarketing).

Genitourinary

Menstruation symptoms (5%); bacterial reproductive infections, urinary infection (1% to 3%); dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis (postmarketing).

Hematologic-Lymphatic

Eosinophilic conditions (postmarketing).

Hepatic

Abnormal LFT (postmarketing).

Hypersensitivity

Allergies and allergic reactions (1% to 3%); immediate and delayed hypersensitivity reactions including angioedema, bronchospasm, and rash (rare); anaphylactic reaction, immediate and delayed hypersensitivity reaction (postmarketing).

Metabolic-Nutritional

Weight gain (1% to 3%); Cushing syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, hyperglycemia, osteoporosis (postmarketing).

Musculoskeletal

Musculoskeletal pain (9%); back pain (more than 5%); muscle pain (4%); muscle cramps and spasms, muscle injuries (3%); arthralgia, articular rheumatism, bone and skeletal pain, musculoskeletal inflammation (1% to 3%); cramps, myositis, osteoporosis (postmarketing).

Respiratory

Upper respiratory tract infection (27%); bronchitis (8%); pneumonia, upper respiratory tract inflammation (7%); cough, viral respiratory infections (6%); hoarseness/dysphonia, lower respiratory viral infection, sinusitis (5%); lower respiratory hemorrhage, lower respiratory infection, lower respiratory signs and symptoms (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 choking and stridor, wheezing (postmarketing).

Miscellaneous

Fever (4%); pain (3%); bacterial infections, candidiasis, congestion, inflammation, poisoning and toxicity, postoperative complications, pressure-induced disorder, soft tissue injuries, viral infections, wounds and lacerations (1% to 3%).

Precautions

Warnings Salmeterol 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.

Monitor Frequently 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

Fluticasone

Undetermined; however, other corticosteroids are excreted in breast milk.

Salmeterol

Undetermined.

Children

Advair Diskus

Safety and efficacy not established in children with asthma younger than 4 yr of age.

Advair HFA

Safety 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.

Renal Function

Pharmacokinetic studies have not been conducted.

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, convulsive disorders, or preexisting diabetes mellitus.

Adrenal suppression

Hypothalamic-pituitary-adrenal suppression may occur.

Bone mineral density (BMD)

Ensure BMD is assessed prior to starting therapy and periodically thereafter in patients with risk factors for decreased BMD being treated for COPD. Be prepared to introduce therapy to treat or prevent osteoporosis if indicated.

CNS effects

Excessive beta-adrenergic stimulation has been associated with dizziness, fatigue, headache, insomnia, malaise, nervousness, and tremor.

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.

Hyperglycemia

Clinically important changes in blood glucose may occur.

Hypokalemia

May occur as a result of intracellular shunting from administration of salmeterol.

Increased use

If therapy becomes less effective, this may be a marker of destabilization of asthma, which requires reevaluation.

Immunosuppression

Patients receiving immunosuppressive therapy may be more susceptible to infection than healthy persons.

Local effects

Localized infections of the mouth and pharynx with Candida albicans has been reported.

Ophthalmic effects

Glaucoma, increased IOP, and cataracts have been reported with long-term administration of fluticasone

Paradoxical bronchospasm

May occur and be life-threatening.

Pneumonia

Consider the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.

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.

Systemic corticosteroids

Transfer patients from systemically active corticosteroids to the less systemically available inhaled corticosteroids with particular care because death caused by adrenal insufficiency has occurred in asthmatic patients during and after transfer.

Upper airway symptoms

Laryngeal spasm, irritation, or swelling (eg, choking, stridor) may occur.

Overdosage

Symptoms

Fluticasone

Hypercorticism.

Salmeterol

Excessive 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 BMD may need to be monitored.
• Advise patient that medication should never be administered with a spacer device.
• Caution patient not to exceed prescribed dose of 1 inhalation 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 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 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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