symptoms reported), myocardial infarct (corticosteroids associated with myocardial rupture), ocular disease (routine eye exam recommended), history of seizure disorder (seizures reported with adrenal crisis) Dosage adjustments may be necessary with changes in thyroid status; metabolic clearance of corticosteroids may increase in hyperthyroid patients and decreases in hypothyroid ones Long term corticosteroid use Decreases in bone mineral density (BMD) have been observed; monitor Eye disorders Cataracts, glaucoma, increased IOP, and blurred vision reported after long term corticosteroid use; closely monitor for patients with changes in vision or with history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts Immunosuppression Risk for 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 Immunocompromised patients Localized effects Risk of localized infections of nose, mouth, and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic antifungal therapy; certain cases may require temporary interruption of therapy under close supervision Deterioration of asthma and acute episodes Risk of bronchospasm with immediate increase in wheezing after administration; if this occurs, discontinue therapy and administer SABA immediately Not a bronchodilator; should not be administered for rapid relief of acute bronchospasm Acute symptoms (eg, shortness of breath) should be relieved with a short-acting beta2-agonist; patients with acute episodes may require oral corticosteroids Transferring patients from systemic corticosteroid therapy Excessive use may suppress HPA function (eg, adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis); monitor closely, especially postoperatively or during periods of stress During periods of stress or severe status asthmaticus, may require supplementary systemic corticosteroids immediately; patient should carry warning card indicating possible need for supplementary systemic steroids in such emergencies Switching from systemic steroids to therapy may unmask allergic conditions (eg, conjunctivitis, eczema, rhinitis) Deaths have occurred due to adrenal insufficiency following abrupt withdrawal of oral steroids; taper withdrawal gradually Pregnancy There are no adequate and well-controlled in pregnant women; there are clinical considerations with use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women; available human data do not establish presence or absence of drug- associated risk to fetus; in animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day); in rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryo lethality at inhalation doses up to 440 times the MRHDID The risk of complications to mother and developing fetus from inadequate control of asthma must be balanced against risks from exposure to beclomethasone dipropionate Labor or delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery Fertility Impairment of fertility was observed in rats and dogs at oral doses corresponding to 250 and 25 times the MRHDID for adults on a mg/ m² basis, respectively Lactation There are no data available on presence in human milk, effects on breastfed child, or on milk production; however, other inhaled corticosteroids have been detected in human milk The 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 beclomethasone dipropionate 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 Potent anti-inflammatory glucocorticoid; inhibits inflammatory cells and release of inflammatory mediators Absorption Bioavailability: 20% systemic Onset: May occur within 24 hr of beginning of treatment; expected to be within first or second week; maximum benefit not expected until 3- 4 weeks Duration: 6 hr Peak plasma concentration: 88 pg/mL Peak plasma concentration, BDP: 6635 pg/mL Peak plasma time, BDP: 2 minutes Peak plasma concentration, active metabolite: 1464 pg/mL Peak plasma time, active metabolite: 10 minutes Distribution Protein binding: 94-96% over concentration range of 1000-5000 pg/mL Metabolism Major metabolites are formed via esterases: beclomethasone-17-monopropionate (17-BMP); beclomethasone-21-monopropionate (21-BMP); beclomethasone (BOH) Prodrug; rapidly activated by hydrolysis to active monoester (17-BMP) Liver (CYP450-3A) Elimination Half-life: 30 minutes (17-BMP: 2.8 hr) Half-time, Redihaler: 4 hr Excretion: Feces (major), urine (<10%) Oral Inhalation Administration For oral inhalation only After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis Breath-activated inhaler does not require priming; shaking the inhaler prior to use is not necessary Do not shake the breath-activated inhaler with the cap open to avoid possible actuation of the device Do not use with a spacer or volume holding chamber Cleaning Keep inhaler clean and dry at all times; never wash or put any part of the inhaler in water Routine maintenance is not required If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed Dose counter Discard inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first Storage Store at 25ºC (77ºF); excursions between 59-86ºF (15-30ºC) Do not use or store near heat or open flame; exposure to temperatures >120ºF (49ºC) may cause bursting; never throw Qvar RediHaler into fire or incinerator Keep out of reach of children BRAND FORM. UNIT PRICE PILL IMAGE QNASL nasal- 80 mcg/actuation aerosolQNASL nasal- 40 mcg/actuation aerosolQvar RediHaler inhalation- 40 mcg/actuation aerosolQvar RediHaler inhalation- 80 mcg/actuation aerosolCopyright © 2010 First DataBank, Inc.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. 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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