Fluticasone/salmeterol

Fluticasone/salmeterol
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

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Black Box Warning

WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete Boxed 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. Data from a large placebo-controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths 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. Therefore, when treating patients with asthma, physicians should 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.

Overview

Fluticasone/salmeterol is a corticosteroid, beta2-adrenergic agonist that is FDA approved for the treatment of asthma, maintenance treatment of chronic obstructive pulmonary disease (COPD). There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, oral candidiasis, musculoskeletal pain, dizziness, bronchitis, cough, difficulty speaking, hoarse, pharyngitis, throat irritation, upper respiratory tract infection, viral lower respiratory tract infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fluticasone + salmeterol 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 + salmeterol is not recommended as some patients are more likely to experience adverse effects with higher doses of fluticasone + salmeterol. Patients using fluticasone + salmeterol should not use additional LABA for any reason.

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Asthma: 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.
• The recommended starting dosages for fluticasone + salmeterol for patients aged 12 years and older are based upon patients’ asthma severity.
• The maximum recommended dosage is fluticasone + salmeterol 500/50 twice daily.
• Improvement in asthma control following inhaled administration of fluticasone + salmeterol 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 + salmeterol 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 + salmeterol with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

Chronic Obstructive Pulmonary Disease

• The recommended dosage for patients with COPD is 1 inhalation of fluticasone + salmeterol 250/50 twice daily, approximately 12 hours apart.
• If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone/salmeterol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone/salmeterol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

=Asthma: Pediatric Patients Aged 4 to 11 Years

For patients with asthma aged 4 to 11 years who are not controlled on an inhaled corticosteroid, the dosage is 1 inhalation of fluticasone + salmeterol 100/50 twice daily, approximately 12 hours apart.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone/salmeterol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone/salmeterol in pediatric patients.

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

Warnings

WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete Boxed 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. Data from a large placebo-controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths 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. Therefore, when treating patients with asthma, physicians should 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.

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Postmarketing Experience

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Drug Interactions

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Drug 2

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Drug 3

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Drug 4

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Drug 5

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

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Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

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Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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• Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

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Chronic Overdose

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Management

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Pharmacology

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Fluticasone/salmeterol
Combination of
Fluticasone	Glucocorticoid
Salmeterol	Long-Acting Beta2 Agonist
Identifiers
CAS number	?
ATC code	?
PubChem	?
Therapeutic considerations
Pregnancy cat.	?
Legal status	P(UK)
Routes	?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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Condition 2

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Condition 3

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How Supplied

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Storage

There is limited information regarding Fluticasone/salmeterol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Fluticasone/salmeterol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fluticasone/salmeterol Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.