Beclomethasone dipropionate.
Each 100 mg spray delivered by the nasal applicator contains beclomethasone 50 mcg.
Each bottle provides approximately 200 metered sprays in recommended use.
BECONASE Aqueous Nasal Spray is a presentation of an aqueous suspension of microfine beclomethasone dipropionate delivered by a metering atomising pump.
Beconase Aqueous Nasal Spray is supplied in a polypropylene bottle fitted with a metering, atomizing pump and nasal applicator.
Excipients/Inactive Ingredients: Microcrystalline cellulose, Carboxymethylcellulose sodium, Anhydrous glucose, Polysorbate 80, Purified water, Benzalkonium chloride, phenylethylalcohol, Hydrochloric acid.
Pharmacology: Pharmacodynamics: Following topical administration beclomethasone-17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.
BDP is a pro-drug with a weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active metabolite, beclomethasone-17-monoproprionate (B-17-MP), which has high topical anti-inflammatory activity.
BECONASE 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.
Pharmacokinetics: 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 (<50 pg/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, beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (BOH), are also formed but these contribute little to systemic exposure.
Distribution: The tissue distribution at steady-state for BDP is moderate (20 L) but more extensive for B-17-MP (424 L). Plasma protein-binding is moderately high (87%).
Elimination: The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 and 120 L/hr) with corresponding terminal elimination half-lives of 0.5 h and 2.7 h. Following oral administration of titrated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine. The renal clearance of BDP and its metabolites is negligible.
Prophylaxis and treatment of perennial and seasonal allergic rhinitis and vasomotor rhinitis. Beclomethasone dipropionate BP has a potent anti-inflammatory effect within the respiratory tract at doses which are not systemically active.
BECONASE is for administration by the intranasal route only.
Adults and Children over 6 years of age: The recommended dose is two applications into each nostril twice daily.
A dosage regimen of one application into each nostril three or four times daily may be preferred.
Total daily administration should not normally exceed 8 puffs (400 micrograms).
For full therapeutic benefit, regular usage is essential.
The cooperation 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.
Children under 6 years old: There are insufficient clinical data to recommend use.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
There is no specific treatment for an overdose of beclometasone dipropionate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
The only harmful effect that follows inhalation of larger amounts of the drug over a short time period is suppression of hypothalamic-pituitary-adrenal (HPA) function. No special emergency action need be taken. Treatment with BECONASE Aqueous Nasal Spray should be continued at the recommended dose. HPA function recovers in a day or two.
BECONASE Aqueous Nasal Spray is contraindicated in patients with a history of hypersensitivity to any of its components.
Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with BECONASE Aqueous Nasal Spray.
Care must be taken while transferring patients from systemic steroid treatment to BECONASE Aqueous Nasal Spray if there is any reason to suppose that their adrenal function is impaired.
Systemic effects with nasal corticosteroids have been reported, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapies, systemic effects may occur including reduction in growth velocity. Visual disturbances has been reported, including cataract, glaucoma or central serous chorioretinopathy.
Although BECONASE Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens, in certain instances, necessitate appropriate additional therapy particularly to control eye symptoms.
Effects on Ability to Drive and Use Machines: None reported.
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
There is inadequate evidence of safety of BECONASE in human pregnancy. In animal reproduction studies adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure.
The excretion of beclometasone dipropionate in milk has not been studied in animals. It is reasonable to assume that beclometasone dipropionate is secreted in milk but at the dosage used for the intranasal application, there is low potential for significant levels in breast milk. BECONASE should only be used in a nursing mother if the expected benefit justifies the risk to the infant.
Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account, since these rates were generally comparable to those in the active treatment group.
Immune system disorders: Very rare: Hypersensitivity reactions including rashes, urticaria, pruritus, erythema and angioedema, face, anaphylactoid/anaphylactic reactions, bronchospasm.
Nervous system disorders: Common: Unpleasant taste, unpleasant smell.
Eye disorders: Very rare: Glaucoma, raised intraocular pressure, cataract.
Respiratory, thoracic and mediastinal disorders: Common: Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation.
Very rare: Nasal septal perforation.
Incompatibilities: None reported.
Store below 30°C.
Do not refrigerate.
Discard 3 months after using the spray.
R01AD01 - beclometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Beconase Aqueous nasal spray 50 mcg/metered spray
200 dose x 1's (RM50.95/container)
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