Fluticasone and salmeterol

Name: Fluticasone and salmeterol

Uses of Fluticasone and Salmeterol

Fluticasone/salmeterol is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD). The condition COPD is a group of lung diseases that includes chronic bronchitis and emphysema.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information

Fluticasone and Salmeterol Brand Names

Fluticasone and Salmeterol may be found in some form under the following brand names:

  • Advair Diskus

  • Advair HFA

  • AirDuo RespiClick

Fluticasone and Salmeterol Drug Class

Fluticasone and Salmeterol is part of the drug class:

  • Inhaled adrenergic and other drugs for obstructive airway diseases

Fluticasone and Salmeterol Dosage

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

The recommended dose of fluticasone/salmeterol Diskus for the treatment of asthma in people 4 years of age and older is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol Diskus for the treatment of COPD in adults is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol HFA for the treatment of asthma in people 12 years of age and older is 2 inhalation twice a day, in the morning and evening, about 12 hours apart.

Fluticasone and Salmeterol FDA Warning

Black Box Warning: Asthma-related death

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in fluticasone/salmeterol, increase the risk of asthma-related death. A US trial showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. 

When treating patients with asthma, only prescribe fluticasone/salmeterol for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue fluticasone/salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use fluticasone/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

 

Fluticasone and salmeterol dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

Fluticasone 250 mcg-salmeterol 50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart

Comments:
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-Fluticasone 250 mcg-salmeterol 50 mcg is the only approved dosage for the treatment of COPD; higher doses are not recommended, as advantage of the higher strength has not been demonstrated.

Uses: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce exacerbations of COPD in patients with a history of exacerbations

Usual Adult Dose for Asthma -- Maintenance:

Inhalation Powder:
-1 inhalation of fluticasone 100 mcg-salmeterol 50 mcg, fluticasone 250 mcg-salmeterol 50 mcg, or fluticasone 500 mcg-salmeterol 50 mcg orally twice a day
-Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:
-2 inhalations of fluticasone 45 mcg-salmeterol 21 mcg, fluticasone 115 mcg-salmeterol 21 mcg, or fluticasone 230 mcg-salmeterol 21 mcg orally twice a day
-Maximum dose: Fluticasone 230 mcg-salmeterol 31 mcg orally twice a day

Comments:
-Inhalations should be administered approximately 12 hours apart.
-Initial dose should be based on the patient's asthma severity.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.
-The inhalation dose can be increased if response does not improve after 2 weeks of therapy.
-If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

Usual Pediatric Dose for Asthma -- Maintenance:

Inhalation Powder:
Less than 4 years: Not recommended.

4 years to 11 years:
-Fluticasone 100 mcg-salmeterol 50 mcg (1 inhalation) orally twice a day

12 years or older:
-1 inhalation of fluticasone 100 mcg-salmeterol 50 mcg, fluticasone 250 mcg-salmeterol 50 mcg, or fluticasone 500 mcg-salmeterol 50 mcg orally twice a day
-Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:
Less than 12 years: Use is not approved.

12 years and older:
-2 inhalations of fluticasone 45 mcg-salmeterol 21 mcg, fluticasone 115 mcg-salmeterol 21 mcg, or fluticasone 230 mcg-salmeterol 21 mcg orally twice a day

Comments:
-Inhalations should be administered approximately 12 hours apart.
-Initial dose should be based on the patient's asthma severity.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.
-The dose can be increased if response does not improve after 2 weeks of therapy.
-If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

Pharmacology

Combination of fluticasone (corticosteroid) and salmeterol (long-acting beta2-agonist) designed to improve pulmonary function and control over what is produced by either agent when used alone. Because fluticasone and salmeterol act locally in the lung, plasma levels do not predict therapeutic effect.

Fluticasone: The mechanism of action for all topical corticosteroids is believed to be a combination of three important properties: Anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions. Fluticasone has extremely potent vasoconstrictive and anti-inflammatory activity.

Salmeterol: Relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, fluticasone and salmeterol are primarily cleared in the liver and may lead to accumulation in patients with hepatic impairment. Use with caution and monitor closely.

Adverse Reactions

>10%:

Central nervous system: Headache (12% to 21%)

Respiratory: Upper respiratory tract infection (16% to 27%), pharyngitis (9% to 13%)

>3% to 10%:

Central nervous system: Dizziness (1% to 4%), pain (1% to 4%)

Gastrointestinal: Nausea (3% to 6%), vomiting (3% to 6%), gastrointestinal infection (≤4%; including viral), diarrhea (2% to 4%), oral candidiasis (1% to 4%)

Neuromuscular & skeletal: Musculoskeletal pain (2% to 7%), myalgia (≤4%)

Respiratory: Throat irritation (7% to 9%), bronchitis (2% to 8%), upper respiratory tract inflammation (4% to 7%), lower respiratory tract infection (1% to 7%; COPD diagnosis and age >65 years increase risk), cough (3% to 6%), sinusitis (4% to 5%), viral respiratory tract infection (3% to 5%), hoarseness (1% to 5%)

1% to 3%:

Cardiovascular: Cardiac arrhythmia, chest symptoms, edema, myocardial infarction, palpitations, syncope, tachycardia

Central nervous system: Migraine, mouth pain, sleep disorder

Dermatologic: Dermatitis, diaphoresis, eczema, exfoliation of skin, urticaria, viral skin infection

Endocrine & metabolic: Fluid retention, hypothyroidism, weight gain

Gastrointestinal: Constipation, dysgeusia, oral mucosa ulcer

Genitourinary: Urinary tract infection

Hematologic & oncologic: Hematoma

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Hypersensitivity reaction

Infection: Candidiasis (≤3%), bacterial infection, viral infection

Neuromuscular & skeletal: Muscle injury (≤3%), arthralgia, bone disease, bone fracture, muscle cramps, muscle rigidity, muscle spasm, ostealgia, rheumatoid arthritis, tremor

Ophthalmic: Conjunctivitis, eye redness, keratitis, xerophthalmia

Respiratory: Chest congestion, ENT infection, epistaxis, laryngitis, lower respiratory signs and symptoms (hemorrhage), nasal signs and symptoms (irritation), rhinitis, rhinorrhea, sneezing

Miscellaneous: Burn, laceration, wound

<1% (Limited to important or life-threatening): Aggressive behavior, atrial fibrillation, cataract, eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), Cushing's syndrome, decreased linear skeletal growth rate, depression, dysmenorrhea, ecchymoses, esophageal candidiasis, exacerbation of asthma (serious and some fatal), glaucoma, hyperactivity, hyperglycemia, hypersensitivity reaction (immediate and delayed), hypertension, hypokalemia, hypothyroidism, influenza, irritability, lassitude, myositis, osteoporosis, pallor, paranasal sinus disease, paresthesia, pelvic inflammatory disease, photodermatitis, skin rash, supraventricular tachycardia, syncope, tracheitis, ventricular tachycardia, vulvovaginitis

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events were observed in animal reproduction studies using this combination. Refer to individual agents.

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