QNASL- beclomethasone dipropionate aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z)

Available from:

Teva Respiratory, LLC

INN (International Name):

BECLOMETHASONE DIPROPIONATE

Composition:

BECLOMETHASONE DIPROPIONATE 80 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

QNASL® Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients [see Warnings and Precautions (5.3)] . Teratogenic Effects : Pregnancy Category C There are no adequate and well-controlled clinical trials in pregnant women treated with QNASL Nasal Aerosol. Beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit although these effects were not observed in rats. QNASL Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Beclomethasone dipropionate ad

Product summary:

QNASL Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canister inserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, as follows: QNASL 40 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-206-12) and for the 60-actuation product, 4.9 g of drug and excipients (NDC 59310-206-06). Each actuation delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve. QNASL 80 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-210-12). Each actuation delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve. Each canister of QNASL Nasal Aerosol has a built-in spray counter, which starts at 124 and counts down each time a spray is released for the 120 actuation product and 64 for the 60 actuation product. After the 4 initial priming sprays, the spray counter should read 120 sprays or 60 sprays for the respective products. The correct amount of medication in each intranasal dose cannot be ensured after the counter reads 0; therefore, the device should be discarded when the counter reads 0. Do not remove the QNASL Nasal Aerosol canister from the actuator. The QNASL Nasal Aerosol canister should only be used with the QNASL Nasal Aerosol actuator and the actuator should not be used with any other drug product. CONTENTS UNDER PRESSURE Do not puncture. Do not store near heat or open flame. Do not expose to temperatures higher than 49°C (120°F) as this may cause bursting of the canister. Never throw the device into a fire or an incinerator. Store at 25°C (77°F); excursions are permitted between 15° and 30°C (59° and 86°F). Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

QNASL- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
TEVA RESPIRATORY, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QNASL NASAL AEROSOL SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR QNASL NASAL AEROSOL.
QNASL (BECLOMETHASONE DIPROPIONATE) NASAL AEROSOL
FOR INTRANASAL USE ONLY
INITIAL U.S. APPROVAL: 1976
RECENT MAJOR CHANGES
Warnings and Precautions, Eye Disorders (5.2) 05/17
INDICATIONS AND USAGE
QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of
nasal symptoms associated with seasonal and
perennial allergic rhinitis in patients 4 years of age and older.
(1.1)
DOSAGE AND ADMINISTRATION
QNASL Nasal Aerosol is for intranasal use only.
The recommended dose of QNASL 80 mcg Nasal Aerosol in patients 12
years and older is 320 mcg per day
administered as 2 actuations in each nostril once daily (maximum total
daily dose of 4 actuations per day). (2.1)
The recommended dose of QNASL 40 mcg Nasal Aerosol in children aged 4
to 11 years of age is 80 mcg per day
administered as 1 actuation in each nostril once daily (maximum total
daily dose of 2 actuations per day). (2.1)
DOSAGE FORMS AND STRENGTHS
QNASL Nasal Aerosol is available in two strengths:
Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of
beclomethasone dipropionate. (3)
Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of
beclomethasone dipropionate. (3)
Each strength is supplied in an 8.7 g canister containing 120
actuations; QNASL 40 mcg Nasal Aerosol is also supplied in
a 4.9 g canister containing 60 actuations. (3)
CONTRAINDICATIONS
Patients with a history of hypersensitivity to beclomethasone
dipropionate and/or any other QNASL Nasal Aerosol
ingredients. (4)
WARNINGS AND PRECAUTIONS
Nasal discomfort, epistaxis, nasal ulceration, _Candida albicans_
infection, nasal septal perforation, impaired wound
healing. Monitor patients periodically for signs of adverse effects on
the nasal mucosa. Avoid use in patients with recent
nasal ulcer