Qnasl (Beclomethasone Dipropionate Nasal Aerosol): Side Effects, Uses, Dosage, Interactions, Warnings (2024)

Description for Qnasl

Beclomethasone dipropionate USP, the active component of QNASL Nasal Aerosol, is an antiinflammatory 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 C₂₈H₃₇ClO₇ and a molecular weight of 521.1. It is practically insoluble in water, very soluble in chloroform, and soluble in acetone and in dehydrated alcohol.

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 canister of QNASL 40 mcg or 80 mcg Nasal Aerosol, contains 8.7 g of drug and excipients and each provides 120 actuations after priming. Additionally, QNASL 40 mcg Nasal Aerosol contains 4.9 g of drug and excipients and provides 60 actuations after priming.

Uses for Qnasl

Treatment Of Nasal Symptoms Of Allergic Rhinitis

QNASL^® Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonaland perennial allergic rhinitis in patients 4 years of age and older.

Dosage for Qnasl

Administer QNASL Nasal Aerosol by the intranasal route only. QNASL Nasal Aerosol must be primedprior to initial use by actuating four times. To do this, remove the protective dust cap from the device,hold the device upright between your thumb and forefinger (index finger) (the canister should be on top,pointing down), and spray 4 times into the air, away from your eyes and face. After the initial priming,the dose counter should read 120 for QNASL 40 mcg Nasal Aerosol and QNASL 80 mcg NasalAerosol 120-actuation products and 60 for QNASL 40 mcg Nasal Aerosol 60-actuation product. IfQNASL Nasal Aerosol is not used for 7 consecutive days it should be primed by spraying 2 times. Seeaccompanying illustrated PATIENT INFORMATION and Instructions for Use leaflet for proper use of QNASLNasal Aerosol.

Allergic 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 NasalAerosol) 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 perday administered as 1 actuation in each nostril (QNASL 40 mcg Nasal Aerosol) once daily (maximumtotal daily dose of 2 actuations per day).

HOW SUPPLIED

Dosage Forms And Strengths

QNASL Nasal Aerosol is a nonaqueous nasal spray solution.

Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate andeach actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate.

Each strength is supplied in an 8.7 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosolis also supplied in a 4.9 g canister containing 60 actuations.

Storage And Handling

QNASL Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canisterinserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, asfollows:

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 mcgfrom 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 actuatorPediatric Patients 6 to 11 Years of Age with Perennial Allergic Rhinitis (FAS)and 100 mcg from the valve.

Each canister of QNASL Nasal Aerosol has a built-in spray counter, which starts at 124 and countsdown 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 therespective products. The correct amount of medication in each intranasal dose cannot be ensured afterthe 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 Aerosolcanister should only be used with the QNASL Nasal Aerosol actuator and the actuator should not beused 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.

Manufactured By: 3M Drug Delivery Systems Northridge, CA 91324. Revised: May 2017

Side Effects for Qnasl

Systemic and local corticosteroid use may result in the following:

• Epistaxis, nasal discomfort, nasal ulcerations, Candida albicans infection, and impaired woundhealing [see WARNINGS AND PRECAUTIONS]
• Eye Disorders [see WARNINGS AND PRECAUTIONS]
• Hypercorticism, adrenal suppression, and growth reduction [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observedin the clinical trials of a drug cannot be directly compared with rates in the clinical trials of anotherdrug 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 orperennial allergic rhinitis are based on 4 placebo-controlled clinical trials of 2 to 6 weeks durationevaluating doses of beclomethasone nasal aerosol from 80 to 320 mcg once daily. These short-termtrials 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 dailyand 578 (360 female and 218 male) received placebo. Patient ages ranged from 12 to 82 years and theracial 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 treatmentbecause of adverse reactions with the rate of withdrawal among patients who received QNASL NasalAerosol similar to or lower than the rate among patients who received placebo. Table 1 displays thecommon adverse reactions (≥ 1% and greater than placebo-treated patients).

Table 1. Adverse Events With ≥ 1% Incidence and Greater than Placebo in QNASLNasal Aerosol-Treated Adult and Adolescent Patients with Seasonal orPerennial Allergic Rhinitis in Controlled Clinical Trials of 2 to 6 WeeksDuration (Safety Population)

Nasal ulcerations occurred in 2 patients treated with placebo and in 1 patient treated with QNASL NasalAerosol. 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 whetherthey respond differently than younger patients.

Long-Term 52-Week Safety Trial

In a 52-week placebo-controlled long-term safety trial in patientswith PAR, 415 patients (128 males and 287 females, aged 12 to 74 years) were treated with QNASLNasal Aerosol at a dose of 320 mcg once daily and 111 patients (44 males and 67 females, aged 12 to 67years) were treated with placebo. Of the 415 patients treated with QNASL Nasal Aerosol, 219 patientswere treated for 52 weeks and 196 patients were treated for 30 weeks. While most adverse events weresimilar in type and rate between the treatment groups, epistaxis occurred more frequently in patients whor*ceived QNASL Nasal Aerosol (45 out of 415, 11%) than in patients who received placebo (2 out of111, 2%). Epistaxis also tended to be more severe in patients treated with QNASL Nasal Aerosol. In 45reports 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 receivedplacebo were of mild (1) and moderate (1) intensity. Seventeen patients treated with QNASL NasalAerosol experienced adverse reactions that led to withdrawal from the trial compared to 3 patientstreated with placebo. There were 4 nasal erosions and 1 nasal septum ulceration which occurred inpatients who received QNASL Nasal Aerosol, and no erosions or ulcerations noted in patients whor*ceived 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 perennialallergic rhinitis are based on 3 placebo-controlled clinical trials. These trials were 2 to 12 weeks induration, evaluated doses of beclomethasone nasal aerosol 80 mcg to 160 mcg once daily and includeda total of 1360 patients with either seasonal or perennial allergic rhinitis. Of these, 668 (312 female and356 male) received at least one dose of QNASL Nasal Aerosol, 80 mcg once daily, 241 (116 femaleand 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. Basedon the results from the dose ranging trial, 80 mcg once daily was chosen as the dose in pediatricpatients.

Less than 1.5% of patients in the clinical trials discontinued treatment because of adverse reactions withthe rate of withdrawal among patients who received QNASL Nasal Aerosol 80 mcg once daily similarto or lower than the rate among patients who received placebo. Table 2 displays the common adversereactions (≥ 2% and greater than placebo-treated patients). Additionally, epistaxis was reported at a rateof 4% for both QNASL Nasal Aerosol 80 mcg once daily and placebo treated patients.

Table 2. Adverse Events With ≥ 2% Incidence and Greater than Placebo in QNASL NasalAerosol-Treated Pediatric Patients with Seasonal or Perennial Allergic Rhinitis inControlled Clinical Trials of 2 to 12 weeks Duration (Safety Population)

Postmarketing Experience

In addition to adverse reactions reported from clinical trials for QNASL Nasal Aerosol, the followingadverse events have been reported during postmarketing use of QNASL Nasal Aerosol or otherintranasal and inhaled formulations of beclomethasone dipropionate. Because these reactions arereported voluntarily from a population of uncertain size, it is not always possible to reliably estimatetheir frequency or establish a causal relationship to drug exposure. These events have been chosen forinclusion due to either their seriousness, frequency of reporting, or causal connection tobeclomethasone 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 includinganaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration ofbeclomethasone dipropionate.

Inhaled beclomethasone dipropionate: Hypersensitivity reactions, including anaphylaxis, angioedema,rash, urticaria, and bronchospasm have been reported following the oral inhalation of beclomethasonedipropionate.

Drug Interactions for Qnasl

No drug interaction studies have been performed with QNASL Nasal Aerosol.

Warnings for Qnasl

Included as part of the "PRECAUTIONS" Section

Precautions for Qnasl

Local Nasal Effects

Nasal Discomfort, Epistaxis, And Nasal Ulceration

In clinical trials of 2 to 52 weeks duration, epistaxisand nasal ulcerations were observed more frequently and some epistaxis events were more severe inpatients treated with QNASL Nasal Aerosol than those who received placebo. In the 52-week safetytrial in patients with perennial allergic rhinitis, nasal erosions were identified in 4 of 415 patients and anasal ulceration was identified in 1 of 415 patients treated with QNASL Nasal Aerosol. No nasalerosions or ulcerations were reported for patients who received placebo. In clinical trials conducted inpediatric patients ages 4 to 11 years, the local nasal effect was similar to those reported in patients 12years of age and older. Patients using QNASL Nasal Aerosol over several months or longer should beexamined periodically for possible changes in the nasal mucosa. If an adverse reaction (e.g., erosion,ulceration) is noted, discontinue QNASL Nasal Aerosol [see ADVERSE REACTIONS].

Candida Infection

In previous clinical trials with an aqueous formulation of beclomethasonedipropionate administered intranasally, localized infections of the nose and pharynx with Candidaalbicans had been reported. There were no instances of similar infections observed in clinical trialswith QNASL Nasal Aerosol. If such an infection develops, it may require treatment with appropriatelocal therapy and discontinuation of QNASL Nasal Aerosol treatment. Thus, patients using QNASLNasal Aerosol over several months or longer should be examined periodically for evidence of Candidainfection.

Nasal Septal Perforation

Instances of nasal septal perforation have been reported in patients followingthe intranasal application of beclomethasone dipropionate. There were no nasal septal perforationsreported during clinical trials in the indicated dose of QNASL 80 mcg Nasal Aerosol administered as320 mcg once daily in adults and adolescents. There was one report of nasal septal perforationobserved in the dose-ranging pediatric clinical trial.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing,patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not useQNASL Nasal Aerosol until healing has occurred.

Eye Disorders

Use of intranasal and inhaled corticosteroids may result in the development of increased intraocularpressure, blurred vision, glaucoma and/or cataracts. Therefore, close monitoring is warranted inpatients with a change in vision or with a history of increased intraocular pressure, blurred vision,glaucoma, and/or cataracts.

Glaucoma and cataract formation was evaluated with ocular assessments that included intraocularpressure measurements and slit lamp examinations in 245 adolescent and adult patients (12 years of ageand older) with perennial allergic rhinitis who were treated with QNASL Nasal Aerosol 320 mcg daily(N=197) or placebo (N=48) for up to 52 weeks. In 94% of patients, intraocular pressure (IOP) remainedwithin the normal range (<21 mmHg) during the treatment portion of the trial. There were 10 patients(5%) treated with QNASL Nasal Aerosol and 1 patient (2%) treated with placebo that had intraocularpressure that increased above normal levels (≥21 mmHg) and greater than baseline during the treatmentportion of the trial. Two of these occurrences in patients treated with QNASL Nasal Aerosol werereported as adverse reactions, one serious. No instances of cataract formation or other clinicallysignificant ocular incidents were reported in this 52-week safety trial [see ADVERSE REACTIONS].

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reportedfollowing administration of beclomethasone dipropionate nasally administered and inhalationallyadministered products. Angioedema, urticaria, and rash have been reported following administration ofQNASL Nasal Aerosol. Discontinue QNASL Nasal Aerosol if any such reactions occur [see CONTRAINDICATIONS].

Immunosuppression

Persons who are using drugs that suppress the immune system (e.g., corticosteroids) are moresusceptible to infections than healthy individuals. Chickenpox and measles, for example, can have amore serious or even fatal course in susceptible children or adults using corticosteroids. In children oradults who have not had these diseases or been properly immunized, particular care should be taken toavoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk ofdeveloping a disseminated infection is not known. The contribution of the underlying disease and/orprior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox,prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed tomeasles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see therespective package inserts for complete VZIG and IG prescribing information). If chickenpox ormeasles develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculousinfections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemicviral or parasitic infections, or ocular herpes simplex because of the potential for worsening of theseinfections.

Hypothalamic-Pituitary-Adrenal Axis Effect

When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals atrecommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppressionmay appear. If such changes occur, the dosage of QNASL Nasal Aerosol should be discontinuedslowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied bysigns of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroidwithdrawal (e.g., joint and/or muscular pain, lassitude, and depression). Patients previously treated forprolonged periods with systemic corticosteroids and transferred to topical corticosteroids should becarefully monitored for acute adrenal insufficiency in response to stress. In patients who have asthma orother clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases insystemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

Effect On Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol [see Use In Specific Populations].

Patient Counseling Information

See FDA-Approved Patient Labeling accompanying the product.

Local Nasal Effects

Inform patients that treatment with QNASL Nasal Aerosol may lead to adverse reactions, includingepistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment withQNASL Nasal Aerosol. In addition, nasal beclomethasone dipropionate products are known to beassociated with nasal septal perforation and impaired wound healing. Patients who have experiencedrecent nasal ulcers, nasal surgery, or nasal trauma should not use QNASL Nasal Aerosol until healinghas occurred [see WARNINGS AND PRECAUTIONS].

Eye Disorders

Inform patients that blurred vision, glaucoma and cataracts are associated with nasal and inhaledcorticosteroid use. Patients should inform their health care providers if a change in vision is notedwhile using QNASL Nasal Aerosol [see WARNINGS AND PRECAUTIONS].

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reportedfollowing administration of beclomethasone dipropionate nasally administered and inhalationallyadministered products. Angioedema, urticaria, and rash have been reported following administration ofQNASL Nasal Aerosol. If any such reactions occur, patients should discontinue use of QNASL NasalAerosol [see WARNINGS AND PRECAUTIONS].

Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposureto chickenpox or measles and, if exposed, to consult their physician without delay. Patients should beinformed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections;or ocular herpes simplex [see WARNINGS AND PRECAUTIONS].

Use Daily For Best Effect

Patients should use QNASL Nasal Aerosol on a regular, once-daily basis since its effectivenessdepends on its regular use. QNASL Nasal Aerosol may not have an immediate effect on rhinitissymptoms. The patient should not increase the prescribed dosage but should contact their physician ifsymptoms do not improve or if the condition worsens.

Keep Spray Out Of Eyes Or Mouth

Patients should be informed to avoid spraying QNASL Nasal Aerosol in their eyes or mouth.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

The carcinogenicity of beclomethasone dipropionate was evaluated in rats that were exposed for a totalof 95 weeks: 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oraland inhalation doses up to 2.4 mg/kg. In this trial, there was no evidence of carcinogenicity at thehighest dose: approximately 70 and 120 times the maximum recommended human daily intranasal dose(MRHDID) in adults and children, respectively, on a mg/m² basis.

Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinesehamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg(approximately 490 times the MRHDID in adults on a mg/m² basis). There was no significant effect ofbeclomethasone dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 50 times theMRHDID in adults on a mg/m² basis). Inhibition of the estrous cycle in dogs was observed followingoral doses of 0.5 mg/kg (approximately 50 times the MRHDID in adults on a mg/m² basis). No inhibitionof the estrous cycle in dogs was seen following 12 months of exposure at an estimated inhalation doseof 0.33 mg/kg (approximately 35 times the MRHDID in adults on a mg/m² basis).

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled clinical trials in pregnant women treated with QNASL NasalAerosol. Beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbitalthough these effects were not observed in rats. QNASL Nasal Aerosol should be used duringpregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oralcorticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggeststhat rodents are more prone to teratogenic effects from corticosteroids than humans.

Beclomethasone dipropionate administered subcutaneously was teratogenic and embryocidal in themouse and rabbit at doses approximately twice the maximum recommended human daily intranasal dose(MRHDID) in adults (on a mg/m² basis at maternal doses of 0.1 and 0.025 mg/kg/day in mice and rabbits,respectively). No teratogenicity or embryocidal effects were seen in rats at approximately 460 timesMRHDID (in adults on a mg/m² basis at a maternal inhalation dose of 15 mg/kg/day).

Non-Teratogenic Effects

Hypoadrenalism may occur in infants born of mothers receivingcorticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

It is not known whether beclomethasone dipropionate is excreted in human breast milk. However, othercorticosteroids have been detected in human breast milk and thus caution should be exercised whenQNASL Nasal Aerosol is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of QNASL Nasal Aerosol in children 4 years and older have beenestablished [see ADVERSE REACTIONS , CLINICAL PHARMACOLOGY , Clinical Studies]. The safetyand effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not beenestablished. Controlled pediatric clinical trials with QNASL Nasal Aerosol included 909 children 4 to11 years of age and 188 adolescent patients 12 to 17 years of age [see Clinical Studies].

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growthvelocity in pediatric patients. This effect has been observed in the absence of laboratory evidence ofhypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a moresensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly usedtests of HPA-axis function. The long-term effects of reduction in growth velocity associated withintranasal corticosteroids, including the impact on final adult height, are unknown. The potential for"catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not beenadequately studied. The growth of pediatric patients receiving intranasal corticosteroids, includingQNASL Nasal Aerosol, should be monitored routinely (e.g., via stadiometry).

A 12-month, randomized, controlled clinical trial evaluated the effects of QVAR^®, an orally inhaledHFA beclomethasone dipropionate product, without spacer versus chlorofluorocarbon-propelled(CFC) beclomethasone dipropionate with large volume spacer on growth in children with asthma ages 5to 11 years. A total of 520 patients were enrolled, of whom 394 received HFA-beclomethasonedipropionate (100 to 400 mcg/day ex-valve) and 126 received CFC-beclomethasone dipropionate (200to 800 mcg/day ex-valve). When comparing results at month 12 to baseline, the mean growth velocity inchildren treated with HFA-beclomethasone dipropionate was approximately 0.5 cm/year less than thatnoted with children treated with CFC-beclomethasone dipropionate via large volume spacer. Thepotential growth effects of prolonged treatment should be weighed against the clinical benefits obtainedand the risks/benefits of treatment alternatives.

The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patientsor when given at higher than recommended dosages cannot be ruled out.

Geriatric Use

Clinical trials of QNASL Nasal Aerosol did not include sufficient numbers of subjects aged 65 yearsand older to determine whether they responded differently than younger subjects. Other reportedclinical experience has not identified differences in responses between the elderly and youngerpatients. In general, administration to elderly patients should be cautious, reflecting the greaterfrequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drugtherapy.

Overdose Information for Qnasl

Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. There are no data available on the effects of acute or chronic overdosage with QNASL NasalAerosol.

Contraindications for Qnasl

QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity tobeclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients [see WARNINGS AND PRECAUTIONS].

Clinical Pharmacology for Qnasl

Mechanism Of Action

Beclomethasone dipropionate is a prodrug that is extensively converted to the active metabolite,beclomethasone-17-monopropionate. The precise mechanism through which beclomethasonedipropionate affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multipleanti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils,lymphocytes, macrophages, and neutrophils) and the release of inflammatory mediators (e.g., histamine,eicosanoids, leukotrienes, and cytokines).

Beclomethasone-17-monopropionate has been shown in vitro to exhibit a binding affinity for the humanglucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that oftriamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate.

The clinical significance of these findings is unknown.

Pharmacodynamics

Adrenal Function: The effects of QNASL Nasal Aerosol on the HPA axis were evaluated in two 6-week, randomized, double-blind, parallel-group perennial allergic rhinitis trials – one in adult andadolescent patients 12 to 45 years of age and another in children 6 to 11 years of age. In the first studywith adolescent and adult patients aged 12 to 45, QNASL Nasal Aerosol 320 mcg, once daily, wascompared with both placebo nasal aerosol and a positive control (a placebo/prednisone group thatreceived prednisone 10 mg orally once daily for the final 7 days of the treatment period). In the secondstudy with pediatric patients aged 6 to 11, QNASL Nasal Aerosol 80 mcg once daily was compared toplacebo nasal aerosol. HPA-axis function was assessed by 24-hour serial serum cortisol levels prior tothe first dose and after 6 weeks of treatment. Patients were domiciled for the 24-hour serum cortisolassessments. The change from baseline in the 24-hour serum cortisol weighted mean for QNASL NasalAerosol and placebo after 6 weeks of treatment were compared.

In the HPA–axis study in patients 12 to 45 years of age, baseline geometric mean serum cortisolweighted mean values were similar in the QNASL Nasal Aerosol 320 mcg/day and placebo treatmentgroups (9.04 and 8.45 mcg/dL, respectively). After 6 weeks of treatment, the geometric mean valueswere 8.18 and 8.01 mcg/dL, respectively, with a change from baseline in 24-hour serum cortisolweighted mean for the QNASL Nasal Aerosol and placebo groups of 0.86 and 0.44, resulting in adifference of 0.42. The geometric mean ratio for QNASL Nasal Aerosol 320 mcg/day to placebo was0.96 (95% CI: 0.87, 1.06). For comparison, in the positive-control (prednisone) treatment group, thegeometric mean ratio for placebo to placebo/prednisone 10 mg/day was 3.17 (95% CI: 2.68, 3.74).

In the HPA-axis study in patients 6 to 11 years of age, baseline geometric mean serum cortisol weightedmean values were similar in the QNASL Nasal Aerosol 80 mcg/day and placebo treatment groups (5.97and 6.47 mcg/dL, respectively). After 6 weeks of treatment the geometric mean values were 6.19 and7.13 mcg/dL, respectively with no decrease from baseline values in both treatment groups. Thegeometric mean ratio for QNASL Nasal Aerosol 80 mcg/day to placebo was 0.91 (95% CI; 0.81, 1.03).

Pharmaco*kinetics

Absorption

Following intranasal administration, most of the beclomethasone dipropionate undergoes extensiveconversion to its active metabolite, beclomethasone-17-monopropionate, during absorption. Plasmaconcentrations of beclomethasone dipropionate and beclomethasone-17-monopropionate have beenmeasured with QNASL Nasal Aerosol in 2 adult and/or adolescent clinical trials and 1 pediatric clinicaltrial.

The single-dose pharmaco*kinetics of QNASL Nasal Aerosol were evaluated in a randomized, openlabel,3-period, crossover trial in healthy adult volunteers. Systemic levels of beclomethasone-17-monopropionate and beclomethasone dipropionate after single-dose intranasal administration ofbeclomethasone dipropionate at doses of 80 and 320 mcg were compared with the systemic levels ofbeclomethasone-17-monopropionate and beclomethasone dipropionate after administration of orallyinhaled beclomethasone dipropionate HFA at a dose of 320 mcg (QVAR^® Inhalation Aerosol). Theresults of this trial demonstrated that the systemic bioavailability of QNASL Nasal Aerosol 320 mcgwas approximately 27.5% (approximately 4-fold lower) of that of orally inhaled beclomethasonedipropionate HFA 320 mcg/day based on the plasma concentrations of beclomethasone-17-monopropionate (AUClast: 1139.7 vs 4140.3 hr*pg/mL; GMR: 0.275; 90% CI for the GMR: 0.214,0.354). The peak exposure to QNASL Nasal Aerosol 320 mcg/day was approximately 19.5%(approximately 5-fold lower) of that of orally inhaled beclomethasone dipropionate HFA 320 mcg/dayas measured by beclomethasone-17-monopropionate (Cmax: 262.7 vs 1343.7 pg/mL; GMR: 0.195; 90%CI for the GMR: 0.158, 0.241).

Following repeated once-daily administration of QNASL Nasal Aerosol, there was no accumulation orincrease in plasma exposure to beclomethasone-17-monopropionate or beclomethasone dipropionate,most likely due to the short plasma half-life relative to the dosing frequency.

Distribution

The in vitro protein binding for beclomethasone-17-monopropionate was reported to be 94% to 96%over the concentration range of 1000 to 5000 pg/mL. The volume of distribution at steady state forbeclomethasone dipropionate is moderate (20 L) but more extensive for beclomethasone-17-monopropionate (424 L).

Metabolism

Beclomethasone dipropionate undergoes extensive first-pass metabolism, forming three metabolites viaCYP3A4, beclomethasone-17-monopropionate, beclomethasone-21-monopropionate, andbeclomethasone. Beclomethasone-17-monopropionate is the major and most active metabolite.

Elimination

The major route of elimination of inhaled beclomethasone dipropionate appears to be via metabolism.More than 90% of inhaled beclomethasone dipropionate is found as beclomethasone-17-monopropionate in the systemic circulation. The mean elimination half-life of beclomethasone-17-monopropionate is 2.8 hours. The terminal elimination half-lives of beclomethasone dipropionate andbeclomethasone-17-monopropionate following intranasal dosing with QNASL Nasal Aerosol (320mcg) were approximately 0.3 hours and 4.5 hours, respectively. Irrespective of the route ofadministration (injection, oral, or inhalation), beclomethasone dipropionate and its metabolites are mainlyexcreted in the feces. Less than 10% of the drug and its metabolites are excreted in the urine. It is likelythat intranasal beclomethasone dipropionate follows a similar elimination pathway.

Special Populations

Formal pharmaco*kinetic studies using QNASL Nasal Aerosol were not conducted in any specialpopulations.

Clinical Studies

Seasonal And Perennial Allergic Rhinitis

Adult And Adolescent Patients Aged 12 Years And Older

The efficacy and safety of QNASL Nasal Aerosol have been evaluated in 3 randomized, double-blind, parallel-group, multicenter, placebocontrolledclinical trials of 2 to 6 weeks duration in adult and adolescent patients 12 years and olderwith symptoms of seasonal or perennial allergic rhinitis. The 3 clinical trials included one 2-weekdose-ranging trial in patients with seasonal allergic rhinitis, one 2-week efficacy trial in patients withseasonal allergic rhinitis, and one 6-week efficacy trial in patients with perennial allergic rhinitis. Thetrials included a total of 1049 patients (366 males and 683 females). About 81% of patients wereCaucasian and 17% African American, the mean age was approximately 38 years. Of these patients 521received QNASL Nasal Aerosol 320 mcg once daily administered as 2 actuations in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS). TNSS is calculated as thesum of the patients' scoring of the 4 individual nasal symptoms (rhinorrhea, sneezing, nasal congestion,and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe)as reflective (rTNSS) or instantaneous (iTNSS). rTNSS required the patients to record symptomseverity over the previous 12 hours; iTNSS required the patients to record symptom severity over theprevious 10 minutes. Morning and evening TNSS scores were averaged over the treatment period andthe difference from placebo in the change from baseline rTNSS was the primary efficacy endpoint. Themorning iTNSS reflects the TNSS at the end of the 24-hour dosing interval and is an indication ofwhether the effect was maintained over the 24-hour dosing interval.

Dose-Ranging Trial

The dose-ranging trial was a 2-week trial that evaluated the efficacy of 3 doses ofbeclomethasone dipropionate nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonalallergic rhinitis. In this trial, only treatment with beclomethasone dipropionate nasal aerosol at the doseof 320 mcg/day resulted in statistically significant improvements compared with placebo in the primaryefficacy endpoint, rTNSS (Table 3).

Table 3. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 2Weeks in Adult and Adolescent Patients with Seasonal Allergic Rhinitis (ITTPopulation)

The 320 mcg dose also demonstrated a statistically significant decrease in morning iTNSS than placebo,indicating that the effect was maintained over the 24-hour dosing interval.

Seasonal And Perennial Allergic Rhinitis Trials

In 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trials, once-daily treatment with QNASL Nasal Aerosol for 2weeks in patients with seasonal allergic rhinitis and for 6 weeks in patients with perennial allergicrhinitis resulted in statistically significant greater decreases from baseline in the rTNSS and morningiTNSS than placebo (Table 4).

Table 4. Mean Changes From Baseline in Reflective and Instantaneous Total NasalSymptom Scores in Adult and Adolescent Patients with Seasonal or PerennialAllergic Rhinitis (ITT Population)

Pediatric Patients 4 To 11 Years Of Age

The efficacy and safety of QNASL Nasal Aerosol have beenevaluated in 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trialsof 2 to 12 weeks duration in pediatric patients 4 to 11 years of age with symptoms of seasonal orperennial allergic rhinitis. The 2 clinical trials included one 2-week dose-ranging trial in patients withseasonal allergic rhinitis (6 - 11 years of age), and one 12-week efficacy trial in patients with perennialallergic rhinitis (4 - 11 years of age). The trials included a total of 1255 patients (680 males and 575females). About 73% of patients were Caucasian and 20% African American, the mean age wasapproximately 8 years for one study and 9 years for the second study. Of these patients 596 receivedQNASL Nasal Aerosol 80 mcg once daily administered as 1 actuation of QNASL 40 mcg NasalAerosol in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS) as described in adult andadolescents efficacy studies.

Dose-Ranging Seasonal Allergic Rhinitis Trial: The dose-ranging trial was a 2-week trial thatevaluated the efficacy of 2 doses of beclomethasone dipropionate nasal aerosol (80 and 160mcg, oncedaily) in patients with seasonal allergic rhinitis. In this trial, treatment with beclomethasone dipropionatenasal aerosol at the dose of 80 mcg/day resulted in statistically significant improvements compared withplacebo in the primary efficacy endpoint, rTNSS (Table 5).

Table 5. Mean Changes from Baseline in Reflective and Instantaneous Total NasalSymptom Scores Over 2 Weeks in Pediatric Patients with Seasonal AllergicRhinitis (ITT Population)

The 80 mcg daily dose also demonstrated a statistically significant decrease in morning iTNSS thanplacebo, indicating that the effect was maintained over the 24-hour dosing interval. Based on the resultsfrom the dose ranging trial, 80 mcg once daily was chosen as the dose for pediatric patients 4-11 yearsof age.

Perennial Allergic Rhinitis Trial

In a randomized, double-blind, parallel-group, multicenter, placebocontrolledefficacy trial, treatment with QNASL Nasal Aerosol 80 mcg once daily in patients withperennial allergic rhinitis resulted in statistically significant greater decreases from baseline in therTNSS (the primary endpoint) and iTNSS than placebo over the first six weeks of treatment (Table 6).

Table 6. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 6 Weeks inPediatric Patients 6 to 11 Years of Age with Perennial Allergic Rhinitis (FAS)

For pediatric patients 4-11 years of age, improvements in average patient-reported rTNSS and iTNSSwere also significantly greater in QNASL Nasal Aerosol 80 mcg per day treated patients comparedwith placebo.

Patient Information for Qnasl

QNASL
(kyoo nay’ zel)
(beclomethasone dipropionate)Nasal Aerosol

For Intranasal Use Only

Read this Patient Information before you start using QNASL Nasal Aerosol and each time you get arefill. There may be new information. This information does not take the place of talking to yourhealthcare provider about your medical condition or your treatment.

What is QNASL Nasal Aerosol?

QNASL Nasal Aerosol is a prescription medicine that treats seasonal nasal and year-round nasal allergysymptoms in adults and adolescents 12 years of age and older.

QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic)corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. Whenyou spray QNASL Nasal Aerosol into your nose, it may help reduce the nasal symptoms of allergicrhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing.

It is not known if QNASL Nasal Aerosol is safe and effective in children under 12 years of age.

Who should not use QNASL Nasal Aerosol?

Do not use QNASL Nasal Aerosol if you are allergic to beclomethasone dipropionate or any of theingredients in QNASL Nasal Aerosol. See the end of this Patient Information leaflet for a complete listof ingredients in QNASL Nasal Aerosol.

What should I tell my healthcare provider before using QNASL Nasal Aerosol?

Before you use QNASL Nasal Aerosol, tell your healthcare provider if you:

• Have had recent nose problems such as nasal sores, nasal surgery, or a nasal injury
• Have or have had eye problems, such as blurred vision, increased pressure in your eye(glaucoma) or cataracts
• Have tuberculosis or any untreated fungal, bacterial, or viral infections, or eye infections causedby herpes
• Have not had or been vaccinated for chickenpox or measles
• Are pregnant or plan to become pregnant. It is not known if QNASL Nasal Aerosol will harm yourunborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed. It is not known if QNASL Nasal Aerosol passes into yourbreast milk. Talk to your healthcare provider about the best way to feed your baby if you are usingQNASL Nasal Aerosol

Tell your healthcare provider about all of the medications you take, including prescription and nonprescriptionmedicines, vitamins, and herbal supplements.

QNASL Nasal Aerosol and other medications may affect each other and cause side effects. QNASLNasal Aerosol may affect the way other medications work, and other medications may affect the wayQNASL Nasal Aerosol works.

Especially tell your healthcare provider if you take other corticosteroid medicines.

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medications you take. Keep a list of your medications with you to show your healthcareprovider and pharmacist when a new medication is prescribed.

How should I use QNASL Nasal Aerosol?

• Read the Instructions for Use at the end of this leaflet for specific information about the right wayto use QNASL Nasal Aerosol
• QNASL Nasal Aerosol is for use in the nose only. Do not spray it in your eyes or mouth
• Use QNASL Nasal Aerosol exactly as your healthcare provider tells you to use it. Do not usemore of your medicine or take it more often than your healthcare provider tells you
• QNASL Nasal Aerosol must be primed before you use it for the first time and if you do not use itfor 7 or more days in a row. Do not prime your QNASL Nasal Aerosol every day
• Your QNASL Nasal Aerosol has a spray counter which should read 120 sprays after your 4initial priming sprays
• Do not use your QNASL Nasal Aerosol after the spray counter reads 0. You may not get the rightamount of medicine
• The usual dose of QNASL Nasal Aerosol is 2 sprays in each nostril, 1 time a day. You should notuse more than a total of 4 sprays per day
• You will get the best results if you keep using QNASL Nasal Aerosol regularly each day. If yoursymptoms do not improve or get worse, call your healthcare provider

What are the possible side effects of QNASL Nasal Aerosol?

QNASL Nasal Aerosol may cause serious side effects, including:

• Nose bleeds or nasal ulcers. Your healthcare provider should check the inside of your nose(nasal mucosa) while you take QNASL Nasal Aerosol for problems. Talk to your healthcareprovider if you have nose bleeds or nasal ulcers
• Thrush (candida), a fungal infection in your nose, mouth, or throat. Tell your healthcareprovider if you have any redness or white colored patches in your mouth or throat
• Slow wound healing. You should not use QNASL Nasal Aerosol until your nose has healed ifyou have a sore in your nose, you have had surgery on your nose, or your nose has been injured
• Eye problems such as blurred vision, glaucoma and cataracts. If you have a history ofglaucoma or cataracts or have a family history of eye problems, you should have regular eyeexams while you use QNASL Nasal Aerosol
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do notmake enough steroid hormones. Symptoms of adrenal insufficiency may include:
  • Tiredness
  • Weakness
  • Dizziness
  • Nausea
  • Vomitingo
• Allergic reactions. Serious allergic reactions can happen in people taking QNASL NasalAerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or getemergency medical help if you have:
  • Shortness of breath or trouble breathing
  • Skin rash, redness, or swelling
  • Severe itching
  • Swelling of your lips, tongue or face
• Immune system problems that may increase your risk of infections. You are more likely toget infections if you take medicines that may weaken your body's ability to fight infection. Avoidcontact with people who have contagious diseases such as chicken pox or measles while you useQNASL Nasal Aerosol. Symptoms of an infection may include:
  • Fever
  • Pain
  • Aches
  • Chills
  • Feeling tired
  • Nausea
  • Vomiting
• Slowed growth in children. A child's growth should be checked regularly while using QNASLNasal Aerosol

The most common side effects with QNASL Nasal Aerosol include:

• Nasal discomfort
• Nose bleeds
• Headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of QNASL Nasal Aerosol. For more information, ask yourhealthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects toFDA at 1-800-FDA-1088.

How should I store QNASL Nasal Aerosol?

• Store QNASL Nasal Aerosol at room temperature 59°F to 86°F (15°C to 30°C)
• Do not puncture the QNASL Nasal Aerosol canister
• Do not store the QNASL Nasal Aerosol canister near heat or a flame. Temperatures above 120°F(49°C) may cause the canister to burst
• Do not throw the QNASL Nasal Aerosol canister into a fire or an incinerator
• Safely throw away medicine that is out of date or no longer needed

Keep QNASL Nasal Aerosol and all medicines out of the reach of children.

General information about the safe and effective use of QNASL Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.Do not use QNASL Nasal Aerosol for a condition for which it was not prescribed. Do not giveQNASL Nasal Aerosol to other people, even if they have the same symptoms that you have. It may harmthem.

This Patient Information summarizes the most important information about QNASL Nasal Aerosol. Ifyou would like more information, talk with your healthcare provider. You can ask your pharmacist orhealthcare provider for information about QNASL Nasal Aerosol that is written for healthprofessionals.

For more information, go to www.QNASL.com or call 1-855-55-QNASL (1-855-557-6275).

What should I know about allergic rhinitis ?

"Rhinitis" means inflammation of the lining of the nose. Allergic rhinitis is sometimes called "hayfever." Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mites, moldspores, and other things. If you have allergic rhinitis, your nose becomes stuffy, runny, and itchy. Youmay also sneeze a lot. You may also have red, itchy, watery eyes or an itchy throat; or blocked, itchyears.

What are the ingredients in QNASL Nasal Aerosol?

Active ingredient: beclomethasone dipropionate

Inactive ingredient: propellant HFA-134a and ethanol

INSTRUCTIONS FOR USE

QNASL
(kyoo nay’ zel)
(beclomethasone dipropionate)Nasal Aerosol

Read these Instructions for Use for QNASL Nasal Aerosol before you start using it and each time youget a refill. There may be new information. This leaflet does not take the place of talking to yourhealthcare provider about your medical condition or treatment.

Note: For Use in the Nose Only.

• Do not spray QNASL Nasal Aerosol in your eyes or directly onto your nasal septum (the wallbetween 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-inspray counter and protective dust cap. (See Figure A)

• 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

Priming your QNASL Nasal Aerosol for Use

• Remove your QNASL Nasal Aerosol device from its package
• Your QNASL Nasal Aerosol device must be primed before you use it for the first time or if it hasnot been used for more than 7 days in a row
• Remove the protective dust cap from the device
• Hold the nasal actuator upright between your thumb and forefinger (index finger). The canistershould be on top and the white nasal actuator tip on bottom (See Figure B)



• If you have never used your QNASL Nasal Aerosol device before, spray it 4 times into the air,away from your eyes and face, by pressing down fully on the top of the canister 4 times (SeeFigure C). Your QNASL Nasal Aerosol device is now ready to use



• After the first time you prime your QNASL Nasal Aerosol device, the spray counter should read120 (See Figure D)



• Do not prime your QNASL Nasal Aerosol device every day
• If you have used your QNASL Nasal Aerosol device before, but it has not been used in more than7 days, it must be reprimed. To reprime your QNASL Nasal Aerosol device, spray 2 times intothe air, away from your eyes and face, by pressing down fully on the top of the canister 2 times.Your QNASL Nasal Aerosol device is now ready to use

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.

Step 3: Inspect the nasal actuator tip to confirm it is clear of foreign objects.

Step 4: Hold your QNASL Nasal Aerosol device upright and insert the nasal actuator tip into onenostril (See Figure E).

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 F).

Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray (SeeFigure G). Continue to hold your breath for 5 seconds after releasing the spray and then breathe outslowly 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 NasalAerosol 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 (See Figure H)
• Do not wash or put any part of the QNASL Nasal Aerosol canister or actuator in water
• 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 manysprays of medicine you have left
• Do not use your QNASL Nasal Aerosol device when 0 is shown in the spray counter window(See Figure I).



• 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 health care provider before your supply of QNASL Nasal Aerosol runs out to seeif you should get a refill

This PPI and Instructions for Use has been approved by the U.S. Food and Drug Administration.