beclomethasone, inhaled (Rx)

Brand and Other Names:Qvar RediHaler
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

oral inhalation aerosol

  • 40mcg/actuation
  • 80mcg/actuation
  • Available as a breath-actuated inhaler (Qvar RediHaler)
  • Note: Qvar RediHaler replaced the Qvar metered-dose inhaler February 2018
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Chronic Asthma

Indicated for maintenance treatment of asthma as prophylactic therapy

No prior history of inhaled corticosteroid use: 40-80 mcg inhaled PO q12hr initially; may increase dose if needed; not to exceed 320 mcg BID

Prior history of inhaled corticosteroid use: 40-160 mcg inhaled PO q12hr based on previous inhaled corticosteroid product and disease severity; not to exceed 320 mcg BID

See Administration

Dosing Considerations

Improvement in pulmonary function is usually apparent within 1-4 weeks after initiation of treatment

Limitations of use: Not indicated for relief of acute bronchospasm

Dosage Forms & Strengths

oral inhalation aerosol

  • 40mcg/actuation
  • 80mcg/actuation
  • Available as a breath-actuated inhaler (Qvar RediHaler)
  • Note: Qvar RediHaler replaced the Qvar metered-dose inhaler February 2018
more...

Chronic Asthma

Indicated for maintenance treatment of asthma as prophylactic therapy

<4 years: Safety and efficacy not established

4-11 years: 40 mcg inhaled PO BID for patients with/without prior history of inhaled corticosteroid use; may increase dose for adequate response after ≥2 weeks therapy; not to exceed 80 mcg inhaled BID

≥12 years

  • No prior history of inhaled corticosteroid use: 40-80 mcg inhaled PO q12hr initially; may increase dose for adequate response after ≥2 weeks therapy; not to exceed 320 mcg BID
  • Prior history of inhaled corticosteroid use: 40-160 mcg inhaled PO q12hr based on previous corticosteroid inhaled product and disease severity; may increase dose for adequate response after ≥2 weeks therapy; not to exceed 320 mcg BID

Dosing Considerations

May cause growth velocity reduction with extended use; monitor closely if on prolonged therapy; advise downward dose titration over time to the lowest level that maintains proper asthma control

Limitations of use: Not indicated for relief of acute bronchospasm

Start at lower end of dosing range due to increased risk of adverse effects

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Interactions

Interaction Checker

and beclomethasone, inhaled

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            Adverse Effects

            >10%

            ≥ 12 years (MDI)

            • Pharyngitis (5-27%)
            • Headache (8-25%)
            • Upper respiratory tract infection (URI) (5-11%)

            1-10%

            4-12 years (RediHaler)

            • Vomiting, 80-160 mcg (1.6%)
            • Headache, 80 mcg (1.6%)
            • URI, 80 mcg (2.4%)
            • Cough, 160 mcg (2.4%)
            • Pyrexia, 160 mcg (3.2%)
            • Pharyngitis, 80-160 mcg (3.2%)
            • Nasopharyngitis, 80 mcg (4%)
            • Viral URI, 80-160 mcg (4%)
            • Headache, 160 mcg (4%)
            • Nasopharyngitis, 160 mcg (8.8%)

            ≥12 years (RediHaler)

            • Increased asthma symptoms (2-4%)
            • URI, 320 mcg (4%)
            • Nasopharyngitis, 80 mcg (4%)
            • Nasopharyngitis, 80 mcg (4%)
            • Viral URI, 80 mcg (3%)
            • Sinusitis, 80 mcg (3%)
            • URI, 640 mcg (3%)
            • Oral candidiasis, 320 mcg (3%)
            • URI, 80-160 mcg (3%)
            • Rhinitis allergic, 160 mcg (3%)
            • Sinusitis (3%) Oral symptoms (2-3%)
            • Nasopharyngitis, 160 mcg (2%)
            • Oropharyngeal pain, 80-160 mcg (2%)
            • Oral candidiasis, 160 mcg (2%)
            • Nasopharyngitis, 320-640 mcg (1%)

            <1%

            4-12 years (RediHaler)

            • Cough, 80 mcg (0.8%)
            • URI, 80 mcg (0.8%)
            • Pyrexia, 80 mcg (0.8%)

            ≥12 years (RediHaler)

            • Oropharyngeal pain, 320 mcg (<1%)
            • Viral URI, 80 mcg (<1%)
            • Sinusitis, 320-640 mcg (<1%)
            • Rhinitis allergic, 640 mcg (<1%)

            Postmarketing Reports

            Psychiatric events and behavioral changes (eg, aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation [primarily in children])

            Blurred vision, central serous chorioretinopathy

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            Warnings

            Contraindications

            Hypersensitivity

            Primary treatment of status asthmaticus, acute bronchospasm

            Cautions

            Immediate hypersensitivity reactions may occur; discontinue beclomethasone inhaler if such reactions occur

            May decrease growth velocity in children; titrate dose to the lowest effective dose to relieve signs/symptoms

            Kaposi sarcoma associated with prolonged corticosteroid treatment; if observed, consider discontinuing therapy

            Psychiatric disturbances reported with corticosteroid use; psychiatric conditions, including depression, euphoria, personality changes, insomnia, and mood swings may be exacerbated by corticosteroid use

            Following initiation of inhaled corticosteroids, rare cases of vasculitis or eosinophilic conditions may occur after decrease and/or withdrawal of oral corticosteroid therapy

            Use caution in patients with heart failure (long-term use associated with fluid retention), diabetes mellitus (may lead to hyperglycemia), gastrointestinal disease (diverculitis, peptic ulcer, ulcerative colitis due to perforation risk), myasthenia gravis (exacerbation may occur), myocardial infarct (exacerbation of 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
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            Pregnancy & Lactation

            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 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

            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%)

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            Administration

            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

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            Formulary

            FormularyPatient Discounts

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.