NASONEX NASAL SPRAY

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
MOMETASONE FUROATE 50 MCG/DOSE
Available from:
MERCK SHARP & DOHME ISRAEL LTD
ATC code:
D07AC13
Pharmaceutical form:
SOLUTION
Administration route:
NASAL
Manufactured by:
SCHERING-PLOUGH LAB.NV BELGIUM
Therapeutic group:
MOMETASONE
Therapeutic indications:
In adults and children 3 years of age and older to treat the symptoms of seasonal or perennial rhinitis. In patients 12 years old and above who have a history of moderate to severe symptoms of seasonal allergic rhinitis prophylactic treatment with Nasonex Aqueous Nasal Spary is recommended 2- 4 weeks prior to the anticipated start of the pollen season.
Authorization number:
109852927700
Authorization date:
2013-03-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

15-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

15-01-2021

םיחקורהתונקתיפלןכרצלןולע

רישכת) םי ו"משתה( 1986

אפורםשרמבתבייחוזהפורת

הפורתבי/ישמתשתםרטבופוסדעןולעהתאןויעבי/ארק

קדבנונכותותואירבהדרשמי"עעבקנהזןולעטמרופ

לערשואו - רבמבונבודי 2012

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MometasoneFuroate50mcg

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DispersibleCelluloseBP65cps, Glycerol, Citricacidmonohydrate,Sodiumcitratedehydrate, polysorbate80,

Benzalkoniumchloridesolution,purified water

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י/ןסח רירקםוקמב הרוטרפמטב 2 °C - 25°C .

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תופורת .הזיראהתואבתונוש

:'סמםושירתדועת 1098529277

ןרצי : ואלפגנירש .נאובאל טסייה,.יו - פוא - ןד - גרב היגלב, .

:םושירהלעב לארשי)םהודופראשקרמתרבח - 1996 .ד.ת,מ"עב( 7121 חתפ, - הווקת 49170 .

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NASONEX ®

Aqueous Nasal Spray

Brand of mometasone furoate monohydrate

For Intranasal Administration

Description:

NASONEX ® AqueousNasal Spray is a metered-dose, manualpumpspray unit containing asuspension of

mometasonefuroate. Each metered-dose pumpactuation of NASONEX ® Aqueous Nasal Spray delivers

approximately 100 mg of mometasone furoatesuspension, containingmometasonefuroate monohydrate

equivalent to50 µg mometasone furoate.

Actions:

Mometasonefuroate isatopicalglucocorticosteroidwithlocalanti-inflammatory propertiesatdoses that are not

systemically active.

Preclinical Pharmacologyand Toxicology:

Preclinical studiesdemonstrate that mometasone furoateisdevoid of androgenic, anti-androgenic, estrogenic or

anti-estrogenic activity but, like otherglucocorticoids,it possesses some anti-uterotrophic activity and delays

vaginal opening in animalmodels at highoral dosesof 56 mg/kg/day and 280 mg/kg/day.

In cell culture,mometasonefuroatewas shown to beatleast ten times more potent than othersteroids, including

beclomethasone dipropionate (BDP),betamethasone, hydrocortisone anddexamethasone, at inhibiting the

synthesis/release of IL-1, IL-6, and TNFα. Mometasone furoate(IC50=0.12 Nm) was alsoat least six times more

potent than BDP and betamethasoneatinhibiting IL-5 production.Also, in mixed leukocytesfromatopic patients,

mometasonewas a more potent leukotriene production inhibitor thanBDP.

In a preclinical model, thecompound has beenshown toreducethe accumulation of eosinophilsmarkedly at the

site of an allergicreaction.For example,in allergicmice with IgE-mediated allergy, inhaled mometasone furoate at

doses aslow as 13µg/kg inhibitedeosinophilinfiltration intobronchoalveolarlavage fluidand thelungbronchi and

bronchioles.Additionally,mometasonefuroatereducedthenumberof lymphocytes,andthe levelsofmessenger

RNA for the pro-allergiccytokinesIL-4 and IL-5.

It is likely thatmuchof themechanism for the anti-allergic and anti-inflammatoryeffects of mometasone furoate lies

in its ability to inhibit the release ofmediators of allergicreactions. Mometasone furoate significantly inhibits the

releaseof leukotrienes from leukocytesof allergicpatients. Inaddition, it isan extremely potent inhibitor of the

productionof the Th2 cytokines, IL-4 andIL-5 from human CD4+T-cells.

Mometasonefuroate was nonmutagenic in the mouse-lymphoma assay and thesalmonella/mammalian-microsome

bioassay. Mometasone furoate wasnegative in themouse bone-marrow erythrocyte-micronucleusassay,the rat

bone-marrow clastogenicityassay, the mouse mitotic male germ-cell clastogenicity assay, and the Chinese

hamsterlung-cellchromosomal-aberrations assay.At cytotoxicdoses inChinese hamster ovary cellcultures,

mometasonefuroate induced a dose-related increase insimplechromosome aberrationswhencontinuously

exposed (7.5hours) in thenonactivation phase, but not in the presence of rat liver S9 fraction. This finding is not

consideredto be ofsignificance in the riskassessmentof mometasone furoate, since the S9 phaseof the

chromosomal-aberration assay and all in vivoassays were negative. Clastogenic responses without human health

risk implications have beenobserved at cytotoxic doseswith othercorticosteroids,suchasdexamethasone.

In subcutaneous SegmentI and III studies, mometasone furoate was well tolerated at dosesup to 7.5 µg/kg (2.6

times thehuman dose byinhalation).At 15 µg/kgprolonged gestation andprolongedanddifficult labor occurred

with a reduction in offspring survival and body weightor body weight gain. There was no effect on fertility.

Like other glucocorticoids,mometasonefuroate isa teratogen in rodents and rabbits. Teratology studies were

conducted inrats, miceand rabbits by the topical(dermal)and/or subcutaneousroutes. Umbilicalherniaoccurred

in ratsadministered≥600µg/kg dermally, cleft palate in mice administered180 µg/kgsubcutaneously, and gall-

bladderagenesis, umbilical hernia,and flexed frontpaws inrabbits administered≥150µg/kgdermally. In these

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teratogenicitystudies, there werealso reductionsinmaternal bodyweightgains, effects onfetal growth(lowerfetal

body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in mice.

No toxicologic effects unique to mometasone furoate exposure were demonstrated. Allobserved effects are typical

of this class ofcompounds and are related to exaggerated pharmacologic effectsof glucocorticoids.

Clinical Pharmacology:

Mometasonefuroate, administeredasanasalspray, has negligible(≤0.1%)systemicbioavailability and is

generally undetectable in plasma, despite the useof a sensitive assay with a lower quantitation limit of 50 pg/ml;

thus, there are norelevantpharmacokinetic data for thisdosageform. Mometasone furoate suspensionis very

poorly absorbed from thegastrointestinal tract, andthe smallamount that may be swallowed and absorbed

undergoes extensive first-pass metabolism prior to excretion in urineand bile.

Instudiesutilizing nasal antigen challenge, NASONEX®Aqueous NasalSprayhas shown anti-inflammatory

activity in both theearly- andlate- phase allergicresponses. Thishas beendemonstrated bydecreases (vs

placebo) in histamineandeosinophil activity and reductions(vs baseline) in eosinophils, neutrophils, andepithelial

cell adhesionproteins.

Indications and Usage:

NASONEX®Aqueous Nasal Spray is indicated for use inadultsand children3yearsof age and older to treat the

symptomsof allergicseasonal or allergicperennial rhinitis.

In patients 12years andolder who havea historyof moderate toseveresymptomsof seasonalallergicrhinitis,

prophylactictreatment withNASONEX® AqueousNasalSprayis recommended two to fourweeks prior to the

anticipated start of the pollen season.

Dosage andAdministration:

After initial primingof theNASONEX®AqueousNasalpump(usually 10actuations, until a uniformspray is

observed), eachactuation delivers approximately 100 mgof mometasonefuroatesuspension, containing

mometasonefuroate monohydrate equivalent to 50 µgmometasonefuroate. If the spray pump has not been used

for 14 days orlonger, it should be reprimed with 2 actuations, until a uniformspray is observed, before nextuse.

Shakecontainer well before each use.

The bottle should be discarded after 120 actuationsor within 2 months of first use.

Adults (including geriatricpatients) and children 12 years of age and older:

The usual recommended dose for treatment is two sprays (50 µg/spray) in each nostril oncedaily (total dose 200

µg).Once symptoms are controlled,dose reductiontoonespray in each nostril(total dose 100 mg) may be

effective for maintenance.

If symptomsareinadequately controlled, thedosemay beincreased to foursprays ineach nostril(total400µg).

Dose reduction is recommended following control of symptoms.

Children 3 to11 years of age:

The usualrecommendeddose for treatmentof thenasal symptoms ofseasonal allergicand perennialallergic

rhinitis is1 spray (50 µg of mometasone furoate ineachspray) ineach nostrilonce daily (total daily dose of 100

µg).

Administrationto young childrenshouldbe aided by an adult.

Clinically significant onset of action occurs asearly as12 hours after the first dose.

Drug Interactions:

NASONEX® Aqueous NasalSprayhas beenadministered concomitantly with loratadinewithno apparent effect on

plasmaconcentrations of loratadine orits major metabolite. Mometasone furoate plasmaconcentrations were not

detectable. The combination therapy was well tolerated.

Adverse Effects:

Treatment-related local adverseevents reportedinclinicalstudiesinclude headache(8%),epistaxis(i.e., frank

bleeding, blood-tinged mucous, and blood flecks)(8%), pharyngitis (4%), nasal burning(2%), nasal irritation (2%),

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and nasal ulcerationwhichare typically observedwithuse ofa corticosteroid nasalspray. Epistaxiswasgenerally

self-limiting and mild inseverity, andoccurredat ahigher incidence comparedto placebo (5%), but at a

comparable orlowerincidencecomparedtothe activecontrol nasal corticoidsstudied(up to15%).Theincidence

of all other effectswas comparable with that of placebo.

In the pediatric population,the incidence of adverseeffects, e.g., headache (3%), epistaxis(6%), nasalirritation

(2%) and sneezing(2%)was comparableto placebo.

Rarely, immediatehypersensitivity reactions(e.g.bronchospasm, dyspnea) may occurafter intranasal

administration of mometasone furoate monohydrate.Very rarely, anaphylaxis and angioedema have been

reported.

Disturbancesof test and smell have been reportedvery rarely.

Contraindications:

Hypersensitivity to any ingredients of NASONEX ® Aqueous Nasal Spray.

NASONEX ® AqueousNasal Sprayshould notbe used in the presence of untreated localizedinfectioninvolving the

nasal mucosa.

Becauseof the inhibitory effect of corticosteroidsonwound healing, patientswho have experienced recent nasal

surgery or trauma should not use a nasal corticosteroiduntil healing has occurred.

Special Warnings and Precautions for Use:

Following 12months of treatment withNASONEX®AqueousNasal Spray, there was noevidence of atrophy of the

nasal mucosa; also, mometasonefuroate tendedto reverse the nasalmucosacloser to anormalhistologic

phenotype. As withanylong-termtreatment, patientsusingNASONEX® Aqueous Nasal Spray overseveral

months orlongershouldbe examinedperiodically for possible changes in the nasal mucosa. If localized fungal

infection ofthenose or pharynx develops,discontinuanceof NASONEX ® Aqueous NasalSpraytherapy or

appropriate treatment may be required.Persistenceof nasopharyngeal irritation maybe anindication for

discontinuing NASONEX ® Aqueous Nasal Spray.

Although NASONEX ® Aqueous Nasal Spraywill control the nasalsymptomsinmost patients, the concomitant use

of antihistamines may provide additionalrelief ofother symptoms, particularly ocular symptoms.

NASONEX ® AqueousNasal Spray should beusedwith caution, ifat all, in patientswith active orquiescent

tuberculous infectionsof the respiratory tract, or inuntreatedfungal, bacterial,systemicviral infectionsor ocular

herpes simplex.

Thereis no evidenceof hypothalmic-pituitary-adrenal (HPA) axissuppression following prolonged treatment with

NASONEX ® AqueousNasal Spray. However, patients who aretransferredfrom long-term administration of

systemicallyactivecorticosteroidstoNASONEX ® Aqueous NasalSpray requirecareful attention.Systemic

corticosteroidwithdrawal insuchpatients may result inadrenalinsufficiency fora numberofmonths until recovery

of HPA axis function. If these patients exhibit signs andsymptomsof adrenal insufficiency, systemic corticosteroid

administration should be resumed and other modesof therapy and appropriatemeasuresinstituted.

During transfer fromsystemiccorticosteroids toNASONEX ® AqueousNasal Spray, somepatients may experience

symptomsof withdrawal from systemically active corticosteroids (e.g., joint and/or muscularpain, lassitude, and

depressioninitially) despite relieffromnasal symptomsand will requireencouragementto continue NASONEX ®

AqueousNasal Spray therapy. Suchtransfer mayalso unmaskpre-existingallergicconditionssuchas allergic

conjunctivitis and eczema, previously suppressed bysystemiccorticosteroidtherapy.

Patients receiving corticosteroids who are potentially immunosuppressedshouldbe warned ofthe risk of exposure

to certain infections(e.g., chickenpox, measles) and ofthe importance of obtainingmedical advice if such exposure

occurs.

Following theuse of intranasal aerosolizedcorticosteroids, instances ofnasalseptum perforationorincreased

intraocular pressure havebeen reportedvery rarely.

Full benefit of treatment may not beachieved in the first 48 hours.

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In a placebo-controlledclinical trial inwhich pediatric patientswere administeredNASONEX ® Aqueous Nasal

Spray 100 µgdaily for one year, no reduction in growthvelocity was observed.

The potentialof NASONEX ® AqueousNasal Sprayto causegrowth suppression insusceptible patientsorwhen

given at highdosescannotbe ruled out.

Usage DuringPregnancyand Lactation:

There are noadequate orwell controlled studiesinpregnantwomen. Following intranasaladministration of the

maximal recommendedclinicaldose topatients, mometasone plasmaconcentrations arenot measurable; thus

fetal exposure is expectedto be negligible and thepotential for reproductive toxicity, very low.

As withother nasalcorticosteroidpreparations,NASONEX ® AqueousNasalSprayshould beused inpregnant

women, nursing mothers orwomen ofchildbearing age only ifthepotential benefit justifies the potential risk to the

mother,fetusorinfant.Infants born of mothers who receivedcorticosteroids duringpregnancyshouldbeobserved

carefully for hypoadrenalism.

Overdosage:

Becauseof the negligible(≤0.1%)systemic bioavailability of NASONEX ® AqueousNasalSpray, overdose is

unlikely to requireany therapy other than observation, followed byinitiation of the appropriate prescribeddosage.

Inhalationor oral administrationofexcessive doses ofcorticosteroidsmayleadto suppression of HPAaxis

function.

Storage:

Do not freeze. Keep away from heat.

Store in a cool place between 2º and 25ºC.

Manufacturer:

Schering-Plough LaboratoriesN.V., Belgium

a wholly owned subsidiaryof Schering-Plough Corporation, U.S.A.

License Holder:

Merck Sharp& Dohme (Isarel-1996) Company Ltd.,

P.O.Box 7121 Petah-Tikva 49170.

Proposed: September 2008

Theformatofthisleafletwas decidedbytheministryofhealthanditscontentwas checkedandapprovedon03/2009 .

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