Beclomethasone Dipropionate Hfa
Generic Name: beclomethasone dipropionate hfa
Brand Names:
Qvar Redihaler
11 DESCRIPTION The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone.
Overview
11 DESCRIPTION The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone.
Uses
1 INDICATIONS AND USAGE 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 )
Dosage
2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg twice daily. ( 2.2 ) Treatment of asthma in patients 12 years of age and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily ( 2.2 ) Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. ( 2.1 ) Do not use a spacer or volume holding chamber ( 2.1 ) 2.1 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.
Side Effects
6 ADVERSE REACTIONS 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 rhinitis, oropharyngeal pain and sinusitis.
Warnings
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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 ( 5.2 )] . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions ( 5.6 )] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied QVAR REDIHALER (beclomethasone dipropionate HFA) inhalation aerosol: 40 mcg is supplied in a box of one 10.6‑g canister containing 120 actuations which is enclosed within a sealed beige plastic actuator with a dose counter and hinged white cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-302-40 80 mcg is...
Frequently Asked Questions
What is Beclomethasone Dipropionate Hfa used for?▼
1 INDICATIONS AND USAGE 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 )
What are the side effects of Beclomethasone Dipropionate Hfa?▼
6 ADVERSE REACTIONS 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 rhinitis, oropharyngeal pain and sinusitis.
What are the important warnings for Beclomethasone Dipropionate Hfa?▼
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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 ( 5.2 )] . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions ( 5.6 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.