Eltair Forte Aqueous

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Budesonide 100 µg
Available from:
Douglas Pharmaceuticals Limited
INN (International Name):
Budesonide 100 µg
Dosage:
100 mcg/dose
Pharmaceutical form:
Nasal spray solution
Composition:
Active: Budesonide 100 µg Excipient: Butylated hydroxyanisole Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Hypromellose Macrogol 400 Microcrystalline cellulose Potassium sorbate Purified water Sodium citrate dihydrate Sodium laurilsulfate
Units in package:
Spray bottle, glass, metered, 200 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sicor (Societa Italiana Corticosteroidi) Srl
Product summary:
Package - Contents - Shelf Life: Spray bottle, glass, metered, - 200 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light
Authorization number:
TT50-4712/1
Authorization date:
1989-02-27

DATASHEET

ELTAIR FORTEAQUEOUS

budesonide

100 µg/dose

Presentation

ELTAIR FORTE AQUEOUS nasal spray is a uniform, white, liquid suspension packed in a

12mL amber glass bottle fitted with a metered dose pump.

Uses

Actions

Budesonide is a non-halogenated corticosteroid. In investigations in animalsandman,

budesonide has shown a favourable relationship between local anti-inflammatory activityand

systemic glucocorticoid side effects overa wide dose range. This favourablerelationbetween

therapeuticeffectandsystemic side effects is due to budesonide's high glucocorticoid receptor

affinity and high first-pass metabolism with a short half-life.

The mechanism of action of intranasally administered budesonide has not yetbeencompletely

defined,however, budesonide has been shown to counteract the mainly IgE mediated lung

anaphylaxis in guinea pigs.

Pre-treatmentfor one week with intranasal budesonide 400mcg daily in asymptomatic patients

with seasonal rhinitis significantly inhibited the immediate reaction to allergen challenge.

Pharmacokinetics

Duetoextensivefirst pass metabolism in the liver, the oral bioavailability of budesonide is low

(approximately 10%). After nasal administration of a largedose(1mg)ofbudesonidefroma

metered dose aerosol the systemicallyavailable fraction is approximately 15%.

Negligible biotransformation occurs in human nasal mucosa.

Afternasalapplication of 100mcg, budesonide peak plasma concentrations of approximately

1nmol/L were observed with 45 minutes.

The volume of distribution of budesonide inadultmanis301.341.7L and in children is 3.1 to

4.8L/kg indicating a high tissue affinity. Plasma protein binding is 88.31.5% in humans.

Budesonide is metabolised in the liver to morepolarmetaboliteswithlowglucocorticoidactivity

(ie. 100 fold lower than the parent compound).

Theplasma half-life of budesonide in humans after nasal inhalation is 2.90.4 hours and the

plasma clearance of unchanged budesonide is 55.27.8L/hour.

Indications

Budesonide is indicated for the prophylaxis and treatment ofseasonalandperennialallergic

rhinitis, vasomotor rhinitis and symptomatic relief of nasal polyposis.

Dosage andAdministration

Adults and Children (6 years and older): Initially,total daily dose 400mcg given as 100mcg

into each nostril morning and evening, or as a single daily application of 200mcgintoeachnostril

in the morning. For patients with only mild symptoms, atotaldailydoseof200mcgmaybe

sufficient.

After a good therapeutic response has been achieved, the daily dosage may bereducedtoa

total daily dose of 200mcg.

In seasonal allergic rhinitis, treatment ideally should start before exposure to the allergen.

Patientsshouldbeadvisedtoclearnasal passages of secretions prior to use and not to exceed

recommended dose.

For long-term treatment the lowest dose which keeps the patient symptom-free should be used.

Continuous long term use in children is not recommended.

Contraindications

Historyofhypersensitivity to preparations containing budesonide. Severe nasal infections,

especially candidiasis. Persons with recurrent nasal bleeding or haemorrhagic diatheses.

Warnings and Precautions

Clinical response: The full effect ofELTAIR FORTE AQUEOUSis not achieved until at least 2

to 3 days of treatment.

Unwanted effects: Systemiceffectsof nasal corticosteroids may occur particularly at high

doses prescribed for prolonged periods. These effects varybetweenpatientsanddifferent

corticosteroids.Theseeffectsare much less likely to occur than with oral corticosteroids and

may vary in individual patients and betweendifferentcorticosteroidpreparations.Potential

systemiceffects may include Cushing’s syndrome, Cushingoid features, adrenal suppression,

growthretardation in children and adolescents, cataract, glaucoma and more rarely a range of

psychological or behavioural effects includingpsychomotor hyperactivity, sleep disorders,

anxiety, depression or aggression (particularly in children).

Concomitant treatment: Concomitant treatment may sometimes be necessary to counteract

potential eye symptoms caused by the allergy.

Transfer from oral corticosteroids: Cautionshouldbe observed when transferring patients

previously treated with systemic corticosteroids toELTAIR FORTE AQUEOUS, particularly if

adrenal function deficiency may be present. During transfer patients mayneedsupplementary

systemic steroids during periods of stress.

Concomitant corticosteroid therapy: ShouldELTAIR FORTEAQUEOUSbe prescribed for

patients already using corticosteroids for oral inhalation, care should betakentoensurethatthe

combined daily intake via all routes of administration is consideredwhendeterminingtotaldaily

corticosteroid dose.

Intranasal corticosteroids may cause a reduction in growth velocity whenadministeredto

paediatric patients (See Paediatric Use)

Continuous, long termuse: In continuous, long term treatment, the nasal mucosa should be

inspected at least twice a year.

Severe nasal obstruction/congestion: In some patients with severe nasal obstruction and

congestion, concomitant treatment with local decongestants for 2-3 daysshouldbeconsidered,

eitherbefore commencing or together with, budesonide. Nasal polypectomy may be indicated

initially for patients with nasal obstruction due to nasal polyposis.

Tuberculosis: Whenevercorticosteroidadministrationis required in patients with quiescent or

activetuberculosis,therapeutic advantages should be weighed against possible undesirable

effects.

Infection: Ifinfectionoftherespiratorytract,nasal passages, or paranasal sinuses is present or

occurs during administration ofELTAIR FORTE AQUEOUS,adequate antibacterial therapy

should be promptly instituted.

Wound healing: Becauseof the inhibitory effect of corticosteroids on wound healing, patients

whohaveexperiencedrecentnasal septal ulcers, nasal surgery or trauma should not use a

nasal corticosteroid until healing has occurred.

Use in pregnancy: Administration during pregnancy should be avoided unless thereare

compelling reasons. In pregnant animals, administration of budesonide causesabnormalitiesof

foetal development. The relevance of these finding tomanhasnotbeenestablished.Iftreatment

with corticosteroids during pregnancy is unavoidable, inhaled corticosteroidsshouldbepreferred

becauseoftheirlowersystemiceffect compared with equipotent antiasthmatic doses of oral

corticosteroids.

Use during lactation: There is no information available on the passage of budesonide into

breastmilk.It is recommended, therefore, that breast-feeding be discontinued in women

receiving budesonide.

Paediatric Use: ELTAIR FORTE AQUEOUS is not recommended for useinchildrenundersix

years of age.Controlled clinical studies have shown that intranasal corticosteroids may cause a

reductionin growth velocity in paediatric patients. This effect has been observed in the absence

oflaboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that

growthvelocity is a more sensitive indicatorof systemic corticosteroid exposure in paediatric

patients than some commonly used tests of HPA axis function.Thelong-termeffectsofthis

reductioningrowthvelocityassociatedwith intranasal corticosteroids, including the impact on

finaladultheight,areunknown.The potential for "catch up" growth following discontinuation of

treatmentwithintranasalcorticosteroidshasnot been adequately studied. The growth of

paediatricpatientsreceivingintranasal corticosteroids, should be monitored routinely (e.g. via

stadiometry). The potential growth effects of prolonged treatment shouldbeweighedagainst

clinical benefits obtained and the availability of safe and effective non corticosteroidtreatment

alternatives.Tominimizethesystemiceffects of intranasal corticosteroids, each patient should

be titrated to his/her lowest effective dose.

Carcinogenicity, Mutagenicity: Themutagenicpotential of budesonide was evaluated in 6

different test systems. No mutagenic or clastogenic properties were found.

Operation of motorised vehicle or machinery: Presumedto be safe or unlikely to produce an

effect on the ability to drive or use machinery.

Adverse Effects

Adverse local reactions following budesonide use are mild andusuallytransient.Systemic

corticosteroid side effects have not been reported during clinicalstudiesofbudesonidenasal

presentations.

Adverse effects reported during studies with budesonide nasal presentations:

More Common (more than 1%):

Nose and throat: nasal irritation, haemorrhagic secretion or nose bleeding, dry mucous

membranes, sneezing after spraying, nasal crust.

Central Nervous System: Headache.

Uncommon (less than 1%):

Nose andthroat: itching, strong smell of spray, bad taste, itching of throat and larynx, sore

throat, dry mouth, earache.

Respiratory: Cough.

Gastrointestinal: Loss of appetite, stomach disorder, nausea.

Skin and Appendages: Skin itching.

Central Nervous System: Tremor, tiredness, sedation.

Immune SystemDisorders :immediate or delayed hypersensitivity reaction (urticaria, rash,

itching, dermatitis, angioedema)

Rare (less than or equal to 0.2%):

Ear And Labyrinth Disorders : Ear itching

Musculoskeletal And Connective Tissue Disorders : joint aches, osteoporosis (with long term

treatment).

Eye Disorders : glaucoma ( with long term treatment), cataract ( with long term treatment)

Veryrare (<0.01%): adrenal suppression

Laboratoryvariables: All changes in haematology, biochemistryandurinalysiswerewithinthe

normal range and were not considered clinically significant.

Interactions

Budesonide is primarily metabolisedbytheenzymeCYP3A4, a subfamily of cytochrome P450.

The interaction between budesonide and inhibitors of CYP3A4 suchasketoconazoleand

itraconazole may result in increased systemic exposure to budesonide.

Inhibition of CYP3A4 increases the risk of Cushing’s syndrome, a condition due to

hyperadrenocortism.

Overdosage

Budesonide 400mcg/day does not suppress the HPA axis as assessed by morning plasma

cortisol and synacthen tests. The dose of intra-nasal budesonide, which maycausesuppression

of the HPA axis, is not known. In the unlikely event of adrenal suppression duetopro-longed

excessive use of

ELTAIR FORTE AQUEOUS ,treatmentshouldbe discontinued, although normalisation of the

HPA-axis may be a slow process.

Pharmaceutical Precautions

Store below 25 o C. Keep out of reach of children.

Medicine Classification

Prescription Medicine.

Package Quantities

ELTAIR FORTE AQUEOUS: 100mcg/spray, 200 sprays.

Further Information

Budesonide is 16,17-Butylidene bis (oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione.Ithasa

molecular formula and weight of C

and 430.55 respectively.

Other ingredients are: Purified water, Dispersible cellulose, Hydroxypropylmethylcellulose,

Sodium lauril sulphate, Polyethylene glycol 400, Butylated hydroxy Anisole, Sodium citrate, Citric

acid monohydate, Potassium sorbate and Disodium edetate.

Name andAddress

Douglas Pharmaceuticals Ltd, P.O. Box 45-027, Auckland 0651

Ph: (09) 835-0660, Fax: (09) 835-0665

Date of Preparation

27 November 2012

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