Beconase Allergy & Hayfever

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Beclometasone dipropionate 50 µg (as monohydrate);  
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Beclometasone dipropionate 50 µg (as monohydrate)
Dosage:
50 mcg/dose
Pharmaceutical form:
Nasal spray suspension
Composition:
Active: Beclometasone dipropionate 50 µg (as monohydrate)  
Units in package:
Spray bottle, metered, propylene, 100 dose units
Class:
Pharmacy only
Prescription type:
Pharmacy only
Manufactured by:
Farmabios SpA
Therapeutic indications:
BECONASE Allergy & Hayfever is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis including hayfever.
Product summary:
Package - Contents - Shelf Life: Spray bottle, metered, propylene - 100 dose units - 24 months from date of manufacture stored at or below 30°C - Spray bottle, metered, propylene - 200 dose units - 24 months from date of manufacture stored at or below 30°C - Spray bottle, metered, glass - 200 dose units - 24 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-2420/5
Authorization date:
1997-04-01

NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

BECONASE Allergy & Hayfever nasal spray suspension 50 mcg/dose.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

BECONASE Allergy & Hayfever contains microfine beclometasone dipropionate.

Each 100 mg spray delivered by the nasal applicator contains 50 micrograms

beclometasone dipropionate.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

BECONASE Allergy & Hayfever is a white aqueous suspension delivered by a

metering, atomising pump.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

BECONASE Allergy & Hayfever is indicated for the prophylaxis and treatment of

seasonal and perennial allergic rhinitis including hayfever.

4.2 Dose and method of administration

BECONASE Allergy & Hayfever is for administration by the intranasal route only.

Adults and children over 12 years of age:

The recommended dose is 100 micrograms into each nostril twice daily. Total daily

administration should not normally exceed 400 micrograms.

Once symptoms are controlled, protection can be maintained at half the dose; one

spray into each nostril twice daily. This dose may need to be increased if symptoms

worsen.

For full therapeutic benefit regular usage is essential. The co-operation of the patient

should be sought to comply with the regular dosage schedule and it should be

explained that maximum relief may not be obtained within the first few applications.

For children under twelve years old, there are insufficient clinical data to recommend

use.

Do not use for more than six months without obtaining medical advice.

4.3 Contraindications

Hypersensitivity to any component of BECONASE Allergy & Hayfever.

4.4 Special warnings and precautions for use

Infections of the nasal passages and paranasal sinuses should be appropriately

treated

constitute

specific

contra-indication

treatment

with

BECONASE Allergy & Hayfever.

Care must be taken while transferring patients from systemic steroid treatment to

BECONASE Allergy & Hayfever if there is any reason to suppose that their adrenal

function is impaired.

If recommended doses of intranasal beclometasone are exceeded or if individuals

particularly

sensitive

predisposed

virtue

recent

systemic

steroid

therapies, systemic effects may occur, including reduction in growth velocity.

Although BECONASE Allergy & Hayfever will control seasonal allergic rhinitis in

most cases, an abnormally heavy challenge of summer allergens may in certain

instances

necessitate

appropriate

additional

therapy

particularly

control

symptoms.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a

patient presents with symptoms such as blurred vision or other visual disturbances,

the patient should be considered for referral to an ophthalmologist for evaluation of

possible causes which may include cataract, glaucoma or rare diseases such as

central serous chorioretinopathy (CSCR) which have been reported after use of

systemic and topical corticosteroids.

4.5 Interactions with other medicines and other forms of

interaction

No known interactions have been observed.

4.6 Fertility, pregnancy and lactation

Use in pregnancy

Administration of medicines during pregnancy should only be considered if the

expected benefit to the mother is greater than any possible risk to the foetus. There

inadequate

evidence

safety

beclometasone

dipropionate

human

pregnancy.

animal

reproduction

studies

adverse

effects

typical

potent

corticosteroids are only seen at high systemic exposure levels; direct intranasal

application ensures minimal systemic exposure.

Use in lactation

No specific studies examining the transference of beclometasone dipropionate into

the milk of lactating animals have been performed. It is reasonable to assume that

beclometasone dipropionate is secreted in milk but at the dosages used for direct

intranasal application, there is low potential for significant levels in breast milk. The

use of beclometasone dipropionate in mothers breast feeding their babies requires

that the therapeutic benefits of the medicine be weighed against the potential

hazards to the mother and baby.

4.7 Effects on ability to drive and use machines

Beclometasone dipropionate is unlikely to produce an effect on the ability to drive or

use machines.

4.8 Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is

important. It allows continued monitoring of the benefit/risk balance of the medicine.

Healthcare professionals are asked to report any suspected adverse reactions to

https://nzphvc.otago.ac.nz/reporting/.

tremely rare cases of nasal septal perforation have been reported following the

use of intranasal corticosteroids.

As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant

taste and smell and epistaxis have been commonly reported.

Occasionally headache has been reported.

Rare cases of raised intraocular pressure or glaucoma in association with intranasal

formulations of beclometasone have been reported. Central serous chorioretinopathy

(CSCR) has been reported for all corticosteroid containing products.

Hypersensitivity reactions including rashes, urticaria, pruritis, erythema and oedema

of the eyes, face, lips and throat have been reported.

4.9 Overdose

For advice on the management of overdose please contact the National Poisons

Centre on 0800 POISON (0800 764766).

The only harmful effect that follows inhalation of larger amounts of the medicine over

a short time period is suppression of hypothalamic-pituitary-adrenal (HPA) function.

No special emergency action need be taken.

Treatment

with

BECONASE

Allergy

&

Hayfever

should

continued

recommended dose. HPA function recovers in a day or two.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Following topical administration beclometasone 17,21-dipropionate (BDP) produces

potent anti-inflammatory and vaso-constrictor effects.

BDP is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed

via esterase enzymes to the active metabolite beclometasone-17-monopropionate

(B-17-MP), which has high topical anti-inflammatory activity.

Beclometasone dipropionate offers a preventative background treatment for hayfever

when taken prior to allergen challenge. After which with regular use, BDP can

continue to prevent allergy symptoms from re-appearing by reducing the sensitivity

of nasal membranes.

5.2 Pharmacokinetic properties

Absorption

Following intranasal administration of BDP the systemic absorption was assessed by

measuring the plasma concentrations of its active metabolite B-17-MP, for which the

absolute bioavailability following intranasal administration is 44%.

Following oral administration of BDP the systemic absorption was also assessed by

measuring the plasma concentrations of its active metabolite B-17-MP, for which the

absolute bioavailability following oral administration is 41%.

Metabolism

BDP is cleared very rapidly from the circulation and plasma concentrations are

undetectable (< 50pg/mL) following oral or intranasal dosing. Metabolism is mediated

via esterase enzymes found in most tissues. The main product of metabolism is the

active

metabolite

(B-17-MP).

Minor

inactive

metabolites,

beclometasone-21-

monopropionate (B-21-MP) and beclometasone (BOH) are also formed but these

contribute little to systemic exposure.

Distribution

The tissue distribution at steady-state for BDP is moderate (20L) but more extensive

for B-17-MP (424L). Plasma protein binding is moderately high (87%).

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance

(150 and 120L/hour) with corresponding terminal elimination half-lives of 0.5 hours

and 2.7 hours. Following oral administration of tritiated BDP, approximately 60% of

the dose was excreted in the faeces within 96 hours mainly as free and conjugated

polar

metabolites.

Approximately

dose

excreted

free

conjugated polar metabolites in the urine. The renal clearance of BDP and its

metabolites is negligible.

5.3 Preclinical safety data

No data included.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline

cellulose,

carboxymethylcellulose

sodium,

glucose

anhydrous,

polysorbate 80, purified water, benzalkonium chloride and phenylethylalcohol.

6.2 Incompatibilities

None reported.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store below 30°C, but do not refrigerate. Protect from light. Discard 3 months after

first using.

6.5 Nature and contents of container

BECONASE Allergy & Hayfever is supplied in an amber glass bottle fitted with a

metering, atomising pump and nasal applicator. Each bottle contains 200 sprays.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7.

MEDICINE SCHEDULE

Pharmacy medicine.

8.

SPONSOR

Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks

Auckland, New Zealand

Telephone: (09) 918 5100

Email: aspen@aspenpharma.co.nz

9.

DATE OF FIRST APPROVAL

1 April 1997

10. DATE OF REVISION OF THE TEXT

14 June 2018

SUMMARY TABLE OF CHANGES

Section

changed

Summary of new information

Addition of storage information to align with labelling.

Addition of telephone and email.

Update to the SPC-style.

4.4 & 4.8

4.4: Addition of ‘visual disturbance’ safety text at the request of

Medsafe.

4.8: Addition of central serous chorioretinopathy (CSCR) as an

adverse event.

Similar products

Search alerts related to this product

Share this information