Beclomethasone Dipropionate BP (50mcg and 100mcg per actuation) Aqueous Nasal Spray

Beconase Aqueous Nasal Spray is a presentation of an aqueous suspension of microfine beclomethasone dipropionate delivered by a metering, atomising pump. Each 100mg spray delivered by the nasal applicator contains 50mcg Beclomethasone Dipropionate BP.

Beconase 100 Aqueous Nasal Spray is a presentation of an aqueous suspension of microfine beclomethasone dipropionate delivered by a metering, atomising pump. Each 100mg spray delivered by the nasal applicator contains 100mcg Beclomethasone Dipropionate BP.

Prophylaxis and treatment of perennial and seasonal allergic rhinitis including hayfever, and vasomotor rhinitis.

Beconase and Beconase 100 Aqueous Nasal Spray can significantly delay the recurrence of nasal polyps in those patients who have undergone nasal polypectomy. In those polyps that do recur, Beconase and Beconase 100 Aqueous Nasal Spray can suppress their increase in size.

Mode of action

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 100mcg into each nostril twice daily. A dosage regimen of 50mcg into each nostril three or four times daily may be preferred. Total daily administration should not normally exceed 400mcg.

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.

Children under six years old:-

There are insufficient clinical data to recommend use.

Beconase Aqueous Nasal Spray is contra-indicated in patients with a history of hypersensitivity to any of its components.

Precautions

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication 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.

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.

Although Beconase Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy particularly to control eye symptoms.

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 is inadequate evidence of saftey of beclomethasone dipropionate 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.

No specific studies examining the transference of beclomethasone dipropionate into the milk of lactating animals have been performed.

It is reasonable to assume that beclomethasone 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 beclomethasone 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.

Extremely 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 reported rarely.

Rare cases of raised intraocular pressure or glaucoma in association with intranasal formulations of beclomethasone have been reported.

Hypersensitivity reactions including rashes, urticaria, pruritis, erythema and oedema of the eyes, face, lips and throat have been reported.

Nil.

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 Aqueous Nasal Spray should be continued at the recommended dose. HPA function recovers in a day or two.

Beclomethasone 17,21-dipropionate (BDP) administered intravenously is cleared rapidly with a half life of approximately 30 minutes.

Beclomethasone 17-monopropionate (BMP) appears rapidly in the plasma after intravenous BDP and is itself cleared with a half life again of about 30 minutes. BDP is bound to plasma proteins to the extent of 87%.

Up to 14% of an intravenous dose of BDP is excreted in the urine in 96 hours, mainly as polar metabolites a proportion of which are conjugated. Up to 64% of the dose is excreted in faeces in this time, again primarily as free and conjugated metabolites.

After intranasal administration of BDP an undefined fraction of the dose is absorbed by the nasal mucosa. The remainder, after being cleared from the nose, either by drainage or mucociliary clearance, is swallowed and is available for absorption from the gastrointestinal tract. An intranasal dose of 200mcg BDP did not produce measurable concentrations of BDP in plasma (limit of quantitation 100pg/mL).

There is rapid metabolic inactivation of the majority of the swallowed portion of BDP during its first passage through the liver.

An oral dose (4mg) of tritium labelled BDP was absorbed slowly with peak levels of radioactivity equivalent to 20ng BDP/mL plasma being reached 5 hours after dosing. Excretion was mainly in the faeces (35-76% of the dose in 96 hours) and primarily as polar metabolites although the presence of BDP and BMP in faeces suggested incomplete absorption of the dose. Up to 14% of the dose was excreted as polar metabolites in urine.

The nasal mucosa is not known to contain any enzymes capable of metabolising BDP. The liver metabolises BDP to BMP and further converts it to polar metabolites.

Shake before use.

24 months

Store below 25°C. Do not refrigerate.

Discard three months after first using the spray.

Beconase and Beconase 100 Aqueous Nasal Spray are supplied in amber glass bottles fitted with a metering, atomising pump and nasal applicator. Each bottle contains 22 grams of suspension.