Dosing & Uses
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
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (10)
- aldesleukin
beclomethasone, inhaled decreases effects of aldesleukin by Other (see comment). Avoid or Use Alternate Drug. Comment: Cordicosteroids may interfere with antitumor effects of biological response modulators.
- BCG intravesical live
beclomethasone, inhaled increases effects of BCG intravesical live by Other (see comment). Avoid or Use Alternate Drug. Comment: May interfere with response to intravesicle TICE BCG response.
- BCG vaccine live
beclomethasone, inhaled increases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. May interfere with generation of an adequate immune response to BCG vaccine.
- echinacea
echinacea decreases effects of beclomethasone, inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Monitor for reduced efficacy of immunosuppressant when used concomitantly.
- hyaluronidase
beclomethasone, inhaled will decrease the level or effect of hyaluronidase by unspecified interaction mechanism. Avoid or Use Alternate Drug. Larger hyaluronidase doses may be required to achieve desired effect
- leflunomide
beclomethasone, inhaled increases toxicity of leflunomide by unspecified interaction mechanism. Avoid or Use Alternate Drug. May increase risk of hematologic toxicities; should monitor for bone marrow suppression at least monthly throughout duration of concurrent therapy when leflunomide is given with another immunosuppressants.
- macimorelin
beclomethasone, inhaled, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH growth hormone release before administering prior to administration of macimorelin. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.
- natalizumab
beclomethasone, inhaled increases toxicity of natalizumab by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating natalizumab, taper of steroids patients receiving chronic corticosteroids .
- pimecrolimus
beclomethasone, inhaled increases toxicity of pimecrolimus by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Effects are dependent on immunosuppression, intensity, and duration.
- tacrolimus ointment
beclomethasone, inhaled increases toxicity of tacrolimus ointment by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Effects are dependent on immunosuppression, intensity, and duration.
Monitor Closely (14)
- amphotericin B deoxycholate
beclomethasone, inhaled increases toxicity of amphotericin B deoxycholate by Mechanism: unspecified interaction mechanism. Use Caution/Monitor. Corticosteroids may increase the hypokalemic effect of amphotericin B.
- bumetanide
beclomethasone, inhaled increases toxicity of bumetanide by increasing elimination. Use Caution/Monitor. Corticosteroids may increase the hypkalemic effects of loop diuretics.
- chlorothiazide
beclomethasone, inhaled increases toxicity of chlorothiazide by increasing elimination. Use Caution/Monitor. May increase the hypokalemic effects of thiazide diuretics.
- chlorthalidone
beclomethasone, inhaled increases toxicity of chlorthalidone by increasing elimination. Use Caution/Monitor. May increase the hypokalemic effects of thiazide diuretics.
- corticorelin
beclomethasone, inhaled decreases effects of corticorelin by unspecified interaction mechanism. Use Caution/Monitor. May blunt plasma ACTH response to corticorelin.
- deferasirox
beclomethasone, inhaled increases toxicity of deferasirox by unspecified interaction mechanism. Use Caution/Monitor. Increases risk for GI ulceration/irritation or GI bleeding.
- denosumab
denosumab increases toxicity of beclomethasone, inhaled by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ethacrynic acid
beclomethasone, inhaled increases toxicity of ethacrynic acid by increasing elimination. Use Caution/Monitor. Corticosteroids may increase the hypkalemic effects of loop diuretics.
- furosemide
beclomethasone, inhaled increases toxicity of furosemide by increasing elimination. Use Caution/Monitor. Corticosteroids may increase the hypkalemic effects of loop diuretics.
- hydrochlorothiazide
beclomethasone, inhaled increases toxicity of hydrochlorothiazide by increasing elimination. Use Caution/Monitor. May increase the hypokalemic effects of thiazide diuretics.
- sipuleucel-T
beclomethasone, inhaled decreases effects of sipuleucel-T by unspecified interaction mechanism. Use Caution/Monitor. Drugs that suppress the immune system may inhibit clinical activity of sipuleucel-T.
- torsemide
beclomethasone, inhaled increases toxicity of torsemide by increasing elimination. Use Caution/Monitor. Corticosteroids may increase the hypkalemic effects of loop diuretics.
- trastuzumab
trastuzumab, beclomethasone, inhaled. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, beclomethasone, inhaled. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
trastuzumab deruxtecan increases toxicity of beclomethasone, inhaled by unspecified interaction mechanism. Use Caution/Monitor. May enhance the neutropenic effect of immunosuppressants.
Minor (0)
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
Immunosuppression and risk of infections
Hypercorticism and adrenal suppression
Reduction in bone mineral density
Glaucoma and cataracts
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
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.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%)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| QNASL nasal - | 80 mcg/actuation aerosol |  | |
| QNASL nasal - | 40 mcg/actuation aerosol |  | |
| Qvar RediHaler inhalation - | 40 mcg/actuation aerosol |  | |
| Qvar RediHaler inhalation - | 80 mcg/actuation aerosol |  |
Copyright © 2010 First DataBank, Inc.
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