Country: United States
Language: English
Source: NLM (National Library of Medicine)
BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z)
Teva Respiratory, LLC
BECLOMETHASONE DIPROPIONATE
BECLOMETHASONE DIPROPIONATE 40 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: - QVAR is NOT indicated for the relief of acute bronchospasm. 4.1 Status Asthmaticus QVAR is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity QVAR is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR [see Warnings and Precautions (5.6)]. Risk Summary There are no adequate and well-controlled studies with QVAR 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] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other
QVAR is supplied in 2 strengths: QVAR 40 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a beige plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-202-12. QVAR 80 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a dark mauve plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-204-12. The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 8.7 g canister even though the canister is not completely empty. Patients should be informed to discard the QVAR inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. Store at 25ºC (77ºF). Excursions between 15º and 30ºC (59º and 86ºF) are permitted (see USP Controlled Room Temperature). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product. Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with plastic actuator on top. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.
New Drug Application
QVAR- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED TEVA RESPIRATORY, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QVAR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QVAR INHALATION AEROSOL. QVAR® (BECLOMETHASONE DIPROPIONATE HFA), INHALATION AEROSOL, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 1976 RECENT MAJOR CHANGES Indications and Usage (1) 09/2017 Dosage and Administration (2.1,2.2) 09/2017 Warnings and Precautions (5.10) 09/2017 INDICATIONS AND USAGE QVAR is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1) 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 12 years and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily.(2.2) Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg twice daily. (2.2) Discard QVAR inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. (2.1) DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 40 or 80 mcg per actuation (3) CONTRAINDICATIONS Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Hypersensitivity to any of the ingredients of QVAR. (4) WARNINGS AND PRECAUTIONS Localized infections: _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. (5.1) Deterioration of asthma and acute episodes: Do not use QVAR 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 transfer Read the complete document