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Generic Name
Beclomethasone Dipropionate
Brand Names
QNASL, Qvar Redihaler
FDA approval date: November 01, 2017
Classification: Corticosteroid
Form: Aerosol
What is QNASL (Beclomethasone Dipropionate)?
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.
Approved To Treat
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A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil
Summary: This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollm...
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Summary: The purpose of the study is to enroll participants with uncontrolled asthma to evaluate the large and small airways and drug delivery utilizing two study drugs: * Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide (BDP/FF/G) or Trimbow * Fluticasone furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI ) or Trelegy Ellipta
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Summary: The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treati...
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Brand Information
QNASL (Beclomethasone Dipropionate)
1DOSAGE AND ADMINISTRATION
Administer QNASL Nasal Aerosol by the intranasal route only. The dose counter should read “120” for QNASL 80 mcg Nasal Aerosol 120-actuation product and “60” for QNASL 40 mcg Nasal Aerosol 60-actuation product. QNASL Nasal Aerosol does not require priming. See accompanying illustrated Patient Information and Instructions for Use leaflet for proper use of QNASL Nasal Aerosol.
1.1Allergic Rhinitis
Adults and Adolescents (12 Years of Age and Older): The recommended dose of QNASL Nasal Aerosol is 320 mcg per day administered as 2 actuations in each nostril (QNASL 80 mcg Nasal Aerosol) once daily (maximum total daily dose of 4 actuations per day).
Children (4 to 11 Years of Age): The recommended dose of QNASL Nasal Aerosol is 80 mcg per day administered as 1 actuation in each nostril (QNASL 40 mcg Nasal Aerosol) once daily (maximum total daily dose of 2 actuations per day).
2DOSAGE FORMS AND STRENGTHS
QNASL Nasal Aerosol is a nonaqueous nasal spray solution.
Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate and each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate. QNASL 80 mcg Nasal Aerosol is supplied in a 10.6 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is supplied in a 6.8 g canister containing 60 actuations.
3CONTRAINDICATIONS
QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients
4ADVERSE REACTIONS
Systemic and local corticosteroid use may result in the following:
- Epistaxis, nasal discomfort, nasal ulcerations,
- Eye Disorders
- Hypercorticism, adrenal suppression, and growth reduction
- Immunosuppression
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 Years of Age and Older:
The safety data described below for adults and adolescents 12 years of age and older with seasonal or perennial allergic rhinitis are based on 4 placebo-controlled clinical trials of 2 to 6 weeks duration evaluating doses of beclomethasone nasal aerosol from 80 to 320 mcg once daily. These short-term trials included a total of 1394 patients with either seasonal or perennial allergic rhinitis. Of these, 575 (378 female and 197 male) received at least one dose of QNASL Nasal Aerosol, 320 mcg once daily and 578 (360 female and 218 male) received placebo. Patient ages ranged from 12 to 82 years and the racial distribution of patients was 81% white, 16% black, and 4% other.
Short-Term (2–6 Weeks) Trials: Less than 2% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol similar to or lower than the rate among patients who received placebo. Table 1 displays the common adverse reactions (≥ 1% and greater than placebo-treated patients).
Nasal ulcerations occurred in 2 patients treated with placebo and in 1 patient treated with QNASL Nasal Aerosol. There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not have sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
Long-Term 52-Week Safety Trial: In a 52-week placebo-controlled long-term safety trial in patients with PAR, 415 patients (128 males and 287 females, aged 12 to 74 years) were treated with QNASL Nasal Aerosol at a dose of 320 mcg once daily and 111 patients (44 males and 67 females, aged 12 to 67 years) were treated with placebo. Of the 415 patients treated with QNASL Nasal Aerosol, 219 patients were treated for 52 weeks and 196 patients were treated for 30 weeks. While most adverse events were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received QNASL Nasal Aerosol (45 out of 415, 11%) than in patients who received placebo (2 out of 111, 2%). Epistaxis also tended to be more severe in patients treated with QNASL Nasal Aerosol. In 45 reports of epistaxis in patients who received QNASL Nasal Aerosol, 27, 13, and 5 cases were of mild, moderate, and severe intensity, respectively, while the reports of epistaxis in patients who received placebo were of mild (1) and moderate (1) intensity. Seventeen patients treated with QNASL Nasal Aerosol experienced adverse reactions that led to withdrawal from the trial compared to 3 patients treated with placebo. There were 4 nasal erosions and 1 nasal septum ulceration which occurred in patients who received QNASL Nasal Aerosol, and no erosions or ulcerations noted in patients who received placebo. No patient experienced a nasal septum perforation during the trial.
Pediatric Patients Aged 4 to 11 Years:
The safety data described below for pediatric patients 4 to 11 years of age with seasonal or perennial allergic rhinitis are based on 3 placebo-controlled clinical trials. These trials were 2 to 12 weeks in duration, evaluated doses of beclomethasone nasal aerosol 80 mcg to 160 mcg once daily and included a total of 1360 patients with either seasonal or perennial allergic rhinitis. Of these, 668 (312 female and 356 male) received at least one dose of QNASL Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received QNASL Nasal Aerosol 160 mcg once daily, and 451 (203 female and 248 male) received placebo. The racial distribution of patients was 73% white, 20% black, and 6% other. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose in pediatric patients.
Less than 1.5% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol 80 mcg once daily similar to or lower than the rate among patients who received placebo.
4.2Postmarketing Experience
In addition to adverse reactions reported from clinical trials for QNASL Nasal Aerosol, the following adverse events have been reported during postmarketing use of QNASL Nasal Aerosol or other intranasal and inhaled formulations of beclomethasone dipropionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to beclomethasone dipropionate or a combination of these factors.
QNASL Nasal Aerosol: sneezing, burning sensation
Intranasal beclomethasone dipropionate: Nasal septal perforation, blurred vision, glaucoma, cataracts, central serous chorioretinopathy (CSC), loss of taste and smell, and hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration of beclomethasone dipropionate.
Inhaled beclomethasone dipropionate: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and bronchospasm have been reported following the oral inhalation of beclomethasone dipropionate.
5DRUG INTERACTIONS
No drug interaction studies have been performed with QNASL Nasal Aerosol.
6OVERDOSAGE
Chronic overdosage may result in signs/symptoms of hypercorticism
7DESCRIPTION
Beclomethasone dipropionate USP, the active component of QNASL Nasal Aerosol, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17, 21-dipropionate and the following chemical structure:
Beclomethasone dipropionate, a di-ester of beclomethasone (a synthetic corticosteroid chemically related to dexamethasone), is a white to almost white, odorless powder with a molecular formula of C
QNASL Nasal Aerosol is a pressurized, nonaqueous solution in a metered-dose aerosol device intended ONLY for intranasal use. It contains a solution of beclomethasone dipropionate in propellant HFA‑134a (1,1,1,2‑tetrafluoroethane) and dehydrated ethanol. QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve. QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve. Each strength delivers 59 mg of solution from the valve with each actuation. Each QNASL 80 mcg Nasal Aerosol canister contains 10.6 g of drug and excipients and provides 120 actuations. Each QNASL 40 mcg Nasal Aerosol canister contains 6.8 g of drug and excipients and provides 60 actuations.
8HOW SUPPLIED/STORAGE AND HANDLING
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 80 mcg Nasal Aerosol contains 10.6 g of drug and excipients and provides 120 actuations (NDC 59310-410-12). Each actuation delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve.
QNASL 40 mcg Nasal Aerosol contains 6.8 g of drug and excipients and provides 60 actuations (NDC 59310-406-06). Each actuation delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve.
Each canister of QNASL Nasal Aerosol has a dose counter, which initially reads 60 sprays or 120 sprays for the respective products, and counts down each time a spray is released. 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 temperature between 20° and 25°C (68° and 77°F); excursions are permitted between 15° and 30°C (59° and 86°F).
Keep out of reach of children.
9PATIENT COUNSELING INFORMATION
See
9.1Local Nasal Effects
Inform patients that treatment with QNASL Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort.
9.2Eye Disorders
Inform patients that blurred vision, glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform their healthcare providers if a change in vision is noted while using QNASL Nasal Aerosol
9.3Hypersensitivity Reactions Including Anaphylaxis
Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of beclomethasone dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QNASL Nasal Aerosol. If any such reactions occur, patients should discontinue use of QNASL Nasal Aerosol
9.4Immunosuppression
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
9.5Use Daily for Best Effect
Patients should use QNASL Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. QNASL Nasal Aerosol may not have an immediate effect on rhinitis symptoms. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens.
9.6Keep Spray Out of Eyes or Mouth
Patients should be informed to avoid spraying QNASL Nasal Aerosol in their eyes or mouth.
Distributed by:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
©2020, Teva Respiratory, LLC. All rights reserved.
United States Patent No. 7,780,038
QNSPI-002
10PATIENT INFORMATION
Distributed by:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
© 2020, Teva Respiratory, LLC. All rights reserved.
QNSPL-002
Rev. 02/2020
PLEASE SEE REVERSE SIDE FOR INSTRUCTIONS FOR USE.
INSTRUCTIONS FOR USE
QNASL®
(beclomethasone dipropionate)
(beclomethasone dipropionate)
Read these Instructions for Use for QNASL Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Note: For Use in the Nose Only.
- Do not spray QNASL Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).
The Parts of Your QNASL Nasal Aerosol
The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap.
- Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler.
- Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler.
- Do not remove the QNASL Nasal Aerosol canister from the actuator.
- When you first remove the QNASL Nasal Aerosol device from the carton, the spray counter should read “120”
- You
Using Your QNASL Nasal Aerosol Device
Step 1: Blow your nose to clear your nostrils.
Step 2: Remove the protective dust cap from your QNASL Nasal Aerosol device by pulling it straight off.
Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.
Step 4: Hold your QNASL Nasal Aerosol device upright and insert the nasal actuator tip into one nostril (See Figure C).
Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between your nostrils (nasal septum) while holding your other nostril closed (See Figure D).
Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray (See Figure E). Continue to hold your breath for 5 seconds after releasing the spray and then breathe out slowly through your mouth. Take the QNASL Nasal Aerosol device out of your nostril.
Step 7: Repeat steps 3-6 for the second spray in the same nostril.
Step 8: Repeat steps 3-7 for your other nostril.
Step 9: You should not blow your nose for the next 15 minutes.
Note: The spray counter will count down each time there is a spray released from your QNASL Nasal Aerosol device.
Step 10: Clean and store your device. See "Cleaning Your QNASL Nasal Aerosol Device."
Cleaning Your QNASL Nasal Aerosol Device
- Wipe the nasal actuator tip with a clean, dry tissue or cloth
- Do NOT wash or put any part of the QNASL Nasal Aerosol canister or actuator in water (See Figure G).
- Replace the protective dust cap.
- Keep your device clean and dry at all times.
How to Know When to Stop Using your QNASL Aerosol Device
- The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine you have left.
- Do not use your QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure H).
- Throw away your QNASL Nasal Aerosol device when the spray counter reaches 0.
- Do not throw your QNASL Nasal Aerosol canister into a fire or an incinerator.
- Talk with your healthcare provider before your QNASL Nasal Aerosol medicine runs out to see if you should get a refill.
Distributed by:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
©2020 Teva Respiratory, LLC. All rights reserved.
QNSIFU80-002
Rev. 02/2020
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
QNASL®
(beclomethasone dipropionate)
Nasal Aerosol
(beclomethasone dipropionate)
Nasal Aerosol
Read these Instructions for Use for QNASL Nasal Aerosol before your child starts using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to the healthcare provider about your child’s medical condition or treatment.
Note: For Use in the Nose Only.
- Do not spray QNASL Nasal Aerosol in the eyes, mouth or directly onto the nasal septum (the wall between the 2 nostrils).
The Parts of Your QNASL Nasal Aerosol
The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap.
- Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler.
- Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler.
- Do not remove the QNASL Nasal Aerosol canister from the actuator.
- When you first remove the QNASL Nasal Aerosol device from the carton, the spray counter should read “60”
- You
Using the QNASL Nasal Aerosol 40 mcg Device in Children 4 Years to 11 Years of Age
Children may need help from parents, guardians or caregivers.
Step 1: Have your child blow their nose to clear their nostrils.
Step 2: Remove the protective dust cap from the QNASL Nasal Aerosol device by pulling it straight off.
Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.
Step 4: Hold the QNASL Nasal Aerosol device upright and insert the nasal actuator tip into 1 nostril (See Figure C).
Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between the nostrils (nasal septum) while holding the other nostril closed (See Figure D).
Step 6: Have your child hold their breath and press down firmly and completely on the canister to release 1 spray (See Figure E). Continue to have your child hold their breath for 5 seconds after releasing the spray and then have them breathe out slowly through their mouth. Take the QNASL Nasal Aerosol device out of the nostril.
Step 8: Your child should not blow their nose for the next 15 minutes.
Note: The spray counter will count down each time there is a spray released from the QNASL Nasal Aerosol device.
Step 9: Clean and store the device. See "Cleaning the QNASL Nasal Aerosol Device."
Cleaning the QNASL Nasal Aerosol Device
- Wipe the nasal actuator tip with a clean, dry tissue or cloth
- Do NOT wash or put any part of the QNASL Nasal Aerosol canister or actuator in water (See Figure G).
- Replace the protective dust cap.
- Keep QNASL Nasal Aerosol device clean and dry at all times.
How to Know When to Stop Using the QNASL Nasal Aerosol Device
- The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine are left.
- Do not use the QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure H).
- Throw away the QNASL Nasal Aerosol device when the spray counter reaches
- Do not throw the QNASL Nasal Aerosol canister into a fire or an incinerator.
- Talk with the healthcare provider before the QNASL Nasal Aerosol medicine runs out to see if you should get a refill.
Distributed by:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
©2020 Teva Respiratory, LLC. All rights reserved.
QNSIFU40-002
Rev. 02/2020
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
11INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
QNASL®
(beclomethasone dipropionate)
(beclomethasone dipropionate)
Read these Instructions for Use for QNASL Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Note: For Use in the Nose Only.
- Do not spray QNASL Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).
The parts of your QNASL Nasal Aerosol
The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap.
- Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler.
- Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler.
- Do not remove the QNASL Nasal Aerosol canister from the actuator.
- When you first remove the QNASL Nasal Aerosol device from the carton, the spray counter should read “120”
- You
Using Your QNASL Nasal Aerosol Device
Step 1: Blow your nose to clear your nostrils.
Step 2: Remove the protective dust cap from your QNASL Nasal Aerosol device by pulling it straight off.
Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.
Step 4: Hold your QNASL Nasal Aerosol device upright and insert the nasal actuator tip into one nostril (See Figure C).
Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between your nostrils (nasal septum) while holding your other nostril closed (See Figure D).
Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray (See Figure E). Continue to hold your breath for 5 seconds after releasing the spray and then breathe out slowly through your mouth. Take the QNASL Nasal Aerosol device out of your nostril.
Step 7: Repeat steps 3-6 for the second spray in the same nostril.
Step 8: Repeat steps 3-7 for your other nostril.
Step 9: You should not blow your nose for the next 15 minutes.
Note: The spray counter will count down each time there is a spray released from your QNASL Nasal Aerosol device.
Step 10: Clean and store your device. See "Cleaning Your QNASL Nasal Aerosol device."
Cleaning Your QNASL Nasal Aerosol device
- Wipe the nasal actuator tip with a clean, dry tissue or cloth
- Do NOT wash or put any part of the QNASL Nasal Aerosol canister or actuator in water (See Figure G).
- Replace the protective dust cap.
- Keep your device clean and dry at all times.
How to know when to stop using your QNASL Aerosol device
- The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine you have left.
- Do not use your QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure H).
- Throw away your QNASL Nasal Aerosol device when the spray counter reaches 0.
- Do not throw your QNASL Nasal Aerosol canister into a fire or an incinerator.
- Talk with your healthcare provider before your QNASL Nasal Aerosol medicine runs out to see if you should get a refill.
Manufactured for:
Teva Respiratory, LLC
Frazer, PA 19355
By:
Norton (Waterford) Limited
Unit 301, IDA Industrial Park, Cork Road
Waterford, Ireland
©2018 Teva Respiratory, LLC
All rights reserved.
QNSIFU80-001
Rev. 03/2018
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
QNASL
(beclomethasone dipropionate)
Nasal Aerosol
(beclomethasone dipropionate)
Nasal Aerosol
Read these Instructions for Use for QNASL Nasal Aerosol before your child starts using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to the healthcare provider about your child’s medical condition or treatment.
Note: For Use in the Nose Only.
- Do not spray QNASL Nasal Aerosol in the eyes, mouth or directly onto the nasal septum (the wall between the 2 nostrils).
The parts of your QNASL Nasal Aerosol
The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap.
- Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler.
- Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler.
- Do not remove the QNASL Nasal Aerosol canister from the actuator.
- When you first remove the QNASL Nasal Aerosol device from the carton, the spray counter should read “60”
- You
Using the QNASL Nasal Aerosol 40 mcg device in Children 4 years to 11 Years of Age
Children may need help from parents, guardians or caregivers.
Step 1: Have your child blow their nose to clear their nostrils.
Step 2: Remove the protective dust cap from the QNASL Nasal Aerosol device by pulling it straight off.
Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.
Step 4: Hold the QNASL Nasal Aerosol device upright and insert the nasal actuator tip into 1 nostril (See Figure C).
Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between the nostrils (nasal septum) while holding the other nostril closed (See Figure D).
Step 6: Have your child hold their breath and press down firmly and completely on the canister to release 1 spray (See Figure E). Continue to have your child hold their breath for 5 seconds after releasing the spray and then have them breathe out slowly through their mouth. Take the QNASL Nasal Aerosol device out of the nostril.
Step 7: Repeat steps 3-6 for the other nostril.
Step 8: Your child should not blow their nose for the next 15 minutes.
Note: The spray counter will count down each time there is a spray released from the QNASL Nasal Aerosol device.
Step 9: Clean and store the device. See "Cleaning the QNASL Nasal Aerosol device."
Cleaning the QNASL Nasal Aerosol device
- Wipe the nasal actuator tip with a clean, dry tissue or cloth
- Do NOT wash or put any part of the QNASL Nasal Aerosol canister or actuator in water (See Figure G).
- Replace the protective dust cap.
- Keep QNASL Nasal Aerosol device clean and dry at all times.
How to know when to stop using the QNASL Nasal Aerosol device
- The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine are left.
- Do not use the QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure H).
- Throw away the QNASL Nasal Aerosol device when the spray counter reaches
- Do not throw the QNASL Nasal Aerosol canister into a fire or an incinerator.
- Talk with the healthcare provider before the QNASL Nasal Aerosol medicine runs out to see if you should get a refill.
Manufactured for:
Teva Respiratory, LLC
Frazer, PA 19355
By:
Norton (Waterford) Limited
Unit 301, IDA Industrial Park, Cork Road
Waterford, Ireland
©2018 Teva Respiratory, LLC
All rights reserved.
QNSIFU40-001
Rev. 03/2018
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
12mcg Trade Carton Display Panel
NDC 59310-410-12
Qnasl
(beclomethasone diproprionate) Nasal Aerosol
80 mcg per spray
No Priming Required
For Intranasal Use with Qnasl Actuator Only
Rx only
120 Metered Sprays
TEVA
13mcg Trade Carton Display Panel
NDC 59310-406-06
Children’s Qnasl
(beclomethasone diproprionate)
Nasal Aerosol 40 mcg per spray
No Priming Required
For Intranasal Use with Qnasl Actuator Only
Rx only
60 Metered Sprays
TEVA
14mcg Sample Carton Display Panel
NDC 59310-406-08
Children’s Qnasl
(beclomethasone diproprionate)
Nasal Aerosol 40 mcg per spray
No Priming Required
Professional Sample Not for Sale or Reimbursement
For Intranasal Use with Qnasl Actuator Only
Rx only
60 Metered Sprays
TEVA
15mcg Sample Carton Display Panel
NDC 59310-410-13
Qnasl
(beclomethasone diproprionate)
Nasal Aerosol 80 mcg per spray
No Priming Required
Professional Sample Not for Sale or Reimbursement
For Intranasal Use with Qnasl Actuator Only
Rx only
50 Metered Sprays
TEVA