Beclomethasone

QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm. QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm. ( 1 )

• For oral inhalation only
• Starting dosage is based on prior asthma therapy and disease severity
• Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg twice daily
• Treatment of asthma in patients 12 years of age and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first
• Do not use a spacer or volume holding chamber General Overview Administration Administer QVAR REDIHALER by oral inhalation
• After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis
• Consistent dose delivery is achieved, whether using the 40‑ or 80‑mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40‑mcg strength should provide a dose comparable to 1 actuation of the 80‑mcg strength)
• Inhaler Instructions Patients should be instructed on the proper use of their inhaler
• Do not use QVAR REDIHALER with a spacer or volume holding chamber
• Shaking the inhaler prior to use is not necessary
• Do not shake the inhaler with the cap open to avoid possible actuation of the device
• Priming QVAR REDIHALER does not require priming
• Cleaning Keep the inhaler clean and dry at all times
• Never wash or put any part of the inhaler in water

Inhalation aerosol: a pressurized, breath‑actuated, metered-dose aerosol with a dose counter in 2 strengths 40 mcg in an aluminum canister contained within a beige plastic actuator and a hinged white cap 80 mcg in an aluminum canister contained within a maroon plastic actuator and a hinged white cap Inhalation aerosol: 40 mcg or 80 mcg per breath actuation. ( 3 )

• Advise the patient to read the FDA‑Approved Patient Labeling (Patient Information and Instructions for Use)
• Patients should be given the following information: Oropharyngeal Candidiasis Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients
• If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with QVAR REDIHALER, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision
• Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush. …

• QVAR REDIHALER is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ] . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions ]
• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. …

Oropharyngeal candidiasis: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use QVAR REDIHALER for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to QVAR REDIHALER. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.4 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.9 )] Growth effects [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.4 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhi …

IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well‑controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.