systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk; assess bone mineral density initially and periodically thereafter May decrease growth velocity in children; monitor Risk of cataracts, glaucoma, and increased IOP; monitor Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome Risk of transient hypokalemia; may not warrant supplementation Risk of overdose if used with additional long-acting beta2-agonist in other combination products Hypercorticism and adrenal suppression; may occur with very high dosages or at regular dosage in susceptible individuals; discontinue therapy if such changes occur Pregnancy In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control There are no well-controlled human studies that have investigated the effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of therapy during labor should be restricted to those patients in whom the benefits clearly outweigh risk Lactation There are no available data on the breastfed child or on milk production; budesonide, like other inhaled corticosteroids, is present in human milk; there are no available data on the presence of formoterol fumarate in human milk; formoterol fumarate is present in rat milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal conditionPregnancy 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 Budesonide: Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity Formoterol: Long-acting selective beta2-adrenergic agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators Absorption Peak plasma time: Budesonide, 20 min; formoterol, 5-10 min Peak plasma concentration: Budesonide, 0.6-1.6 nmol/L; formoterol, 136 pmol/L Distribution Protein bound: Budesonide, 85-90%; formoterol, 46-68% Vd: Budesonide, 3 L/kg Metabolism Metabolized in liver by CYP3A4 (budesonide) or CYP2D6/CYP2C (formoterol; O-demethylation) Elimination Excretion (budesonide): Urine (60%), feces Excretion (formoterol): Urine (62%), feces (24%) Oral Inhalation Administration Prime before first use by releasing 2 test sprays into air, shaking well for 5 seconds before each spray; repeat priming if inhaler is unused for >7 days or has been dropped After inhalation, rinse mouth with water without swallowing 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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