who are sensitive to these effects If such effects occur, the dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for management of asthma symptoms 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 of asthma Labor and delivery There are no human studies evaluating effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of drug during labor should be restricted to those patients in whom benefits clearly outweigh the risks 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 Measurable levels of salmeterol and fluticasone detected in lactating rats treated with each drugPregnancy 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. 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%) 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 aerosolized inhalers 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. 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. View explanations for tiers and restrictions 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. 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