salmeterol/fluticasone inhaled (Rx)

Brand and Other Names:Advair Diskus, Advair HFA, more...AirDuo RespiClick
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

salmeterol/fluticasone inhaled

powder for inhalation (Advair Diskus)

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

Powder for inhalation (AirDuo RespiClick)

  • (14mcg/55mcg)/actuation
  • (14mcg/113mcg)/actuation
  • (14mcg/232mcg)/actuation

aerosol for inhalation (Advair HFA)

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

Asthma

For maintenance therapy; not for acute bronchospasm

Starting dosage is based on prior asthma therapy and disease severity

Inhaled powder (Advair Diskus): 1 actuation PO q12hr; not to exceed 1 actuation of 50 mcg/500 mcg q12hr; do not use with a spacer

Inhaled powder (AirDuo RespiClick): 1 actuation PO q12hr; not to exceed 1 actuation of 14 mcg/232 mcg q12hr; do not use with a spacer

Inhaled aerosol (Advair HFA): 2 actuations PO q12hr; not to exceed 2 actuations of 21 mcg/230 mcg q12hr

Chronic Obstructive Pulmonary Disease

Inhaled powder (Advair Diskus): 1 actuation of 50 mcg/250 mcg PO q12hr

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

Exophthalmos (Orphan)

Treatment of symptomatic exophthalmos associated with thyroid-related eye disease

Orphan sponsor

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

Dosage Forms & Strengths

salmeterol/fluticasone inhaled

powder for inhalation (Advair Diskus)

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

Powder for inhalation (AirDuo RespiClick)

  • (14mcg/55mcg)/actuation
  • (14mcg/113mcg)/actuation
  • (14mcg/232mcg)/actuation

aerosol for inhalation (Advair HFA)

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

Asthma

For maintenance therapy; not for acute bronchospasm

Starting dosage is based on prior asthma therapy and disease severity

Inhaled powder (Advair Diskus)

  • <4 years: Safety and efficacy not established
  • 4-11 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
  • Do not use with spacer

Inhaled powder (AirDuo RespiClick)

  • <12 years: Safety and efficacy not established
  • ≥12 years: 1 actuation PO q12hr; not to exceed 1 actuation of 14 mcg/232 mcg q12hr
  • Do not use with a spacer

Inhaled aerosol (Advair HFA)

  • <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

and salmeterol/fluticasone inhaled

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    Contraindicated

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        Significant - Monitor Closely

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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

            Eye: Glaucoma, cataracts, blurred vision, and central serous chorioretinopathy

            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

            Contraindications

            Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures

            Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients

            Cautions

            Risk of LABAs used as monotherapy

            • Use of LABAs as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death
            • Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient
            • These findings are considered a class effect of LABA monotherapy
            • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

            Dosing frequency should not exceed q12hr

            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

            Hypercorticism and adrenal suppression may occur even at regular dosage in susceptible individuals; if such changes occur, discontinue therapy slowly

            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

            Should not be used for relief of acute symptoms, like, rescue therapy for treatment of acute episodes of bronchospasm; acute symptoms should be treated with inhaled, short-acting beta2-agonist

            May decrease growth velocity in children; monitor

            Risk of cataracts, glaucoma, and increased intraocular pressure

            Rare cases of vasculitis (Churg-Strauss syndrome) or other systemic eosinophilic conditions may occur

            Use caution in patients with diabetes mellitus; beta2 agonists may increase glucose levels

            Use caution in patients with hepatic impairment; may lead to accumulation of fluticasone in plasma; monitor closely; glaucoma: consider eye exams in chronic users

            Use caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation

            Changes in thyroid status may require dosage adjustments; hyperthyroidism may increase corticosteroids clearance while it may decrease in hypothyroidism

            Prolonged corticosteroid use may increase incidence of secondary infection, mask acute infection, prolong or exacerbate viral infections, or limit response to vaccines

            Corticosteroids may cause psychiatric manifestations, including depression, euphoria, insomnia, mood swings, and personality changes; may also exacerbate preexisting psychiatric conditions

            Laryngeal spasm, irritation and swelling (choking) may occur

            Risk of transient hypokalemia; supplementation may not be required

            Long-acting beta agonist (LABA) monotherapy increases risk of serious asthma-related events

            Not for use in acutely deteriorating asthma or COPD; not for treatment of acute symptoms

            Not for use in combination with an additional medicine containing a LABA because of risk of overdose

            Potential worsening of infections (eg, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex); use caution in patients with these infections

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            Pregnancy & Lactation

            Pregnancy

            There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control

            Lactation

            There are no available data on presence of fluticasone propionate or salmeterol in human milk, effects on breastfed child, or effects on milk production; other corticosteroids have been detected in human milk; however, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            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.

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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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            Administration

            Diskus Oral Inhalation Preparation

            Remove from foil pouch before first time use; indicate date opened on diskus

            Open top cover; slide lever until it clicks

            Avoid closing or tilting the diskus

            Diskus Oral Inhalation Administration

            For oral inhalation only

            Breathe out fully through your mouth, expelling as much air from lungs as possible; hold diskus upright, placing the mouthpiece fully into the mouth, closing your lips around it

            Continue breathing in slowly until lungs are full; avoid breathing out

            Hold breath as comfortably possible, up to 10 sec

            Remove diskus from mouth; breathe through nose while keeping lips closed;

            Close cover after use; rinse mouth out with water (do not swallow water)

            Inhaler Oral Inhalation Preparation

            Priming

            • Prime inhaler before first use or unused for > 4 wks
            • Release 3 test puffs into air, away from face
            • Remove cap; shake well for 5 sec before each test puff

            Instructions

            • Check mouthpiece for objects before use
            • Make sure canister is fully inserted
            • Shake well before each use

            Inhaler Oral Inhalation Administration

            For oral inhalation only

            Remove cap; place middle or index finger on canister top while placing thumb underneath mouthpiece

            Breathe out fully through your mouth, expelling as much air from lungs as possible; hold inhaler upright, placing the mouthpiece fully into the mouth, closing your lips around it

            While pushing firmly on canister top, continue breathing in slowly until lungs are full; avoid breathing out

            Hold breath as comfortably possible, up to 10 sec

            Remove inhaler from mouth; breathe through nose while keeping lips closed

            Repeating dose

            • Wait at least 30 seconds prior preceding second puff
            • Shake well prior to use; repeat steps (See Inhaler Oral Inhalation Administration)
            • Replace the cap after use
            • When finished administering 2 puffs, rinse mouth out with water (do not swallow water)

            Cleaning

            Wash and dry mouthpiece at least weekly

            When mouthpiece becomes blocked, wash mouthpiece thoroughly

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • Compare formulary status to other drugs in the same class.
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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.