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salmeterol/fluticasone inhaled (Rx)Brand and Other Names:Advair Diskus, Advair HFA

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

salmeterol/fluticasone inhaled

powder for inhalation

  • (50mcg/100mcg)/actuation
  • (50mcg/250mcg)/actuation
  • (50mcg/500mcg)/actuation

aerosol for inhalation

  • (21mcg/45mcg)/actuation
  • (21mcg/115mcg)/actuation
  • (21mcg/230mcg)/actuation
more...

Asthma

Inhaled powder: 1 actuation PO q12hr (initial dose determined by asthma severity); not to exceed 1 actuation of 50 mcg/500 mcg q12hr

Inhaled aerosol: 2 actuations PO q12hr (initial dose determined by asthma severity); not to exceed 2 actuations of 21 mcg/230 mcg q12hr

Chronic Obstructive Pulmonary Disease

Inhaled powder: 1 actuation of 50 mcg/250 mcg PO q12hr

Exophthalmos (Orphan)

Treatment of symptomatic exophthalmos associated with thyroid-related eye disease

Orphan sponsor

  • Lithera, Inc, 9191 Towne Center Drive, San Diego, CA 92122

Dosing Considerations

Inhaled powder: If dyspnea occurs between doses, chronic obstructive pulmonary disease (COPD) patients may take inhaled short-acting beta agonist (SABA) for immediate relief

Dosage Forms & Strengths

salmeterol/fluticasone inhaled

powder for inhalation

  • (50mcg/100mcg)/actuation
  • (50mcg/250mcg)/actuation
  • (50mcg/500mcg)/actuation

aerosol for inhalation

  • (21mcg/45mcg)/actuation
  • (21mcg/115mcg)/actuation
  • (21mcg/230mcg)/actuation
more...

Asthma

Inhaled powder

  • <4 years: Safety and efficacy not established
  • 4-12 years: 1 actuation of 50 mcg/100 mcg PO q12hr
  • ≥12 years: 1 actuation PO q12hr (initial dose determined by asthma severity); not to exceed 1 actuation of 50 mcg/500 mcg q12hr

Inhaled aerosol

  • <12 years: Safety and efficacy not established
  • ≥12 years: 2 actuations PO q12hr (initial dose determined by asthma severity); not to exceed 2 actuations of 21 mcg/230 mcg q12hr
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Interactions

Interaction Checker

salmeterol/fluticasone inhaled and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory tract infection (21-27%)

            Headache (12-21%)

            Pharyngitis (10-13%)

            1-10%

            Candidiasis, nonspecific site (0-10%)

            Throat irritation (7-9%)

            Musculoskeletal pain (2-9%)

            Bronchitis (2-8%)

            Upper respiratory inflammation (4-7%)

            Viral respiratory infections (4-6%)

            Nausea or vomiting (4-6%)

            Cough (3-6%)

            Sinusitis (4-5%)

            Hoarseness or dysphonia (2-5%)

            Fever (3-4%)

            Diarrhea (2-4%)

            Gastrointestinal (GI) discomfort or pain (1-4%)

            Oral candidiasis (1-4%)

            Muscle cramps or spasms (3%)

            Malaise or fatigue (2-3%)

            Viral GI infections (0-3%)

            Postmarketing Reports

            Cardiac: Arrhythmias, ventricular tachycardia

            Endocrine: Cushing syndrome, cushingoid features, growth velocity reduction in children and adolescents, hyperadrenocorticism

            Ophthalmologic: Glaucoma

            GI: Abdominal pain, dyspepsia, xerostomia

            Immunologic: Immediate and delayed hypersensitivity reaction, anaphylactic reaction in patients with severe milk protein allergy (very rare)

            Metabolic: Hyperglycemia, weight gain

            Musculoskeletal: Arthralgia, cramps, myositis, osteoporosis

            Neurologic: Paresthesia, restlessness

            Psychiatric: Agitation, aggression, depression, behavioral changes (eg, hyperactivity, irritability; rare and occurring primarily in children)

            Reproductive: Dysmenorrhea

            Respiratory: Congestion, tightness, dyspnea, facial and oropharyngeal edema, immediate bronchospasm, paradoxical bronchospasm, tracheitis, wheezing, upper respiratory symptoms (eg, laryngeal spasm, irritation, or swelling, such as stridor or choking)

            Dermatologic: Ecchymoses, photodermatitis

            Vascular: Pallor

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            Warnings

            Black Box Warnings

            Long-acting beta agonists (LABAs), such as salmeterol, may increase risk of asthma-related death; therefore, they should be used only as additional therapy for patients whose asthma is not adequately controlled on other asthma-control medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including LABAs

            Because of risk, use of LABAs without concomitant long-term asthma-control medication (eg, inhaled corticosteroid) is contraindicated

            Once asthma control is achieved or maintained, assess at regular intervals; step down therapy (eg, discontinue LABA) if doing so is possible without loss of asthma control, and maintain patient on long-term asthma-control medication (eg, inhaled corticosteroid)

            Do not use LABAs if asthma is adequately controlled on low- or medium-dose inhaled corticosteroids

            Controlled clinical trials suggest that LABAs increase risk of asthma-related hospitalization in pediatric and adolescent patients; if such patients require addition of LABA to inhaled corticosteroid, use fixed-dose combination product containing both inhaled corticosteroid and LABA to ensure adherence

            Contraindications

            Hypersensitivity to drug, components of frmulation, or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria

            Not to be used as rescue therapy for status asthmaticus, acute bronchospasm

            Patients with acute asthma, pulmonary tuberculosis, arrhythmias, or acute COPD

            Aerosol not indicated in pediatric patients

            Cautions

            Dosing frequency should not exceed q12hr

            Risk of potentially fatal acute asthma

            Aerosol not recommended when patient is being switched from PO to inhaled corticosteroids

            Risk of localized Candida albicans infections in mouth and pharynx in some patients; mouth must be rinsed after inhalation to reduce risk

            Monitor COPD patients for signs and symptoms of pneumonia and lung infection

            Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

            Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress

            Particular care is needed in switching patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually by reducing daily prednisone dose by 2.5 mg on weekly basis

            During stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should resume PO corticosteroids immediately

            Risk of paradoxical bronchospasm, which may be life-threatening; discontinue, and treat immediately with inhaled SABA

            Cardiovascular and central nervous system (CNS) effects may occur as consequences of excess beta-adrenergic stimulation; may result in asthma-related death; caution is advised in patients with cardiovascular or convulsive disorders or thyrotoxicosis

            Bone mineral density may decrease after long-term administration of corticosteroids; monitor patients at risk

            May decrease growth velocity in children

            Risk of cataracts, glaucoma, and increased intraocular pressure

            Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome

            Risk of transient hypokalemia; supplementation may not be required

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether agent is excreted in breast milk; salmeterol plasma levels are very low after inhalation

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Salmeterol: Selective LABA; stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells

            Fluticasone: Trifluorinated corticosteroid with potent anti-inflammatory activity; inhibits multiple cell types (eg, mast cells, eosinophils, basophils, lymphocytes, macrophages, neutrophils) and mediator production or secretion (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in the asthmatic response

            Absorption

            Bioavailability: Fluticasone, 5%

            Onset (salmeterol): Asthma, 30-48 min; COPD, 2 hr

            Onset (fluticasone): >1-2 weeks

            Peak plasma time: Fluticasone, 1-2 hr; salmeterol, 20 min

            Peak plasma concentration: Fluticasone, 110 pg/mL; salmeterol, 196-223 pg/mL

            Time to peak effect (salmeterol): Asthma, 3 hr; COPD, 2-5 hr

            Distribution

            Protein bound: Fluticasone, 99%; salmeterol, 96%

            Vd: Fluticasone, 4.2 L/kg

            Metabolism

            Minimally metabolized, because of minimal absorption

            Fluticasone metabolized in liver by CYP3A4 to metabolite with negligible activity; salmeterol extensively metabolized by hydroxylation

            Elimination

            Half-life: Fluticasone, 11-12 hr; salmeterol, 5.5 hr

            Excretion (fluticasone): Feces (95%), urine (5%)

            Excretion (salmeterol): Feces (60%), urine (25%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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