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Apo-beclomethasone

nasal spray

Beclomethasone Dipropionate Aqueous Suspension 0.05% w/w
50 g/metered spray
Corticosteroid for Nasal Use


Product Description
Apo-Beclomethasone (beclomethasone dipropionate) Nasal Spray is a suspension of beclomethasone dipropionate in an amber glass bottle fitted with a metered atomizing pump and a nasal applicator. Each spray delivered by the nasal applicator contains 50 micrograms beclomethasone dipropionate.

Pharmacology
Pharmacodynamics:
Following topical administration beclomethasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.


BDP is a pro-drug with weak corticosteroid receptor binding affinity. It is hydrolysed via esterase enzymes to the highly active metabolite beclometasone-17-monopropionate (B-17-MP), which has high topical antiinflammatory activity.


Beclometasone dipropionate offers a preventative background treatment for hay fever when taken prior to allergen challenge. After which with regular use, BDP can continue to prevent allergy symptoms from reappearing.

Pharmacokinetics
Absorption: Following intranasal administration of BDP in healthy males, 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% (95% CI 28%, 70%). After intranasal administration, <1 % of the dose is absorbed by the nasal mucosa.


Metabolism: BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (< 50g/ml) following oral or intranasal dosing.

 

Distribution: The tissue distribution at steady-state for BDP is moderate (201) but more extensive for B-17-MP (4241). Plasma protein binding of BDP is moderately high (87%).

 

Elimination: The elimination of BDP and B-17-MP are characterized by high plasma clearance (150 and 1201/h) with corresponding terminal elimination half-lives of 0.5h and 2.7h. 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 12% of the dose was excreted as free and conjugated polar metabolites in the urine.

Indication
APO-BECLOMETHASONE (beclomethasone dipropionate) Nasal Spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hayfever, and vasomotor rhinitis. Beclometasone dipropionate has a potent anti-inflammatory effect within the respiratory tract, with a lower incidence and severity of adverse events than those observed when corticosteroids are administered systemically.

Recommended Dose and Mode of Administration

Apo-Beclomethasone Nasal Spray is for administration by the intranasal route only.
Adults and children over six years of age:
The recommended dosage is two sprays into each nostril twice daily. A dosage regimen of 1 spray into each nostril 3 or 4 times daily may be preferred.


Total daily administration should not normally exceed 8 sprays (400 mcg).


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.

For children under six years old, there are insufficient clinical data to recommend use.

Contraindication
APO-BECLOMETHASONE is contra-indicated in patients with a history of hypersensitivity to any of its components.

Warnings
Use in pregnancy and Lactation:
There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. It should be noted, however, that the foetal changes in animals occur after relatively high systemic exposure. APO-BECLOMETHASONE Nasal Spray delivers beclometasone dipropionate directly to the nasal mucosa and so minimises systemic exposure.

 

The use of beclometasone dipropionate should be avoided during pregnancy unless thought essential by the doctor.


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 administration 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 drug be weighed against the potential hazards to the mother and baby.

Use in children:
Apo-Beclomethasone Nasal Spray is not suitable for children.

Precautions
When prescribing Apo-Beclomethasone Nasal Spray, the importance of continuous and regularity usage of the preparation should at all times be highlighted to the patient. When systemic corticoid or ACTH therapy is substituted by Apo-Beclomethasone Nasal Spray, the former medication should be continued concurrently with Apo-Beclomethasone Nasal Spray for about a week, hereafter the systemic drug can be progressively reduced. Any nasal infections and sinusitis must be treated effectively.

When the systemic steroid is withdrawn, other allergic conditions may emerge or weaken.

System Organ Class

Adverse Event

Frequency

Immune system disorders

Hypersensitivity reactions including :

 

Rashes, urticaria, pruritis, erythema.

Common

Oedema of the eyes, face, lips and throat

Very rare

Dyspnoea and/or bronchospasm

Very rare

Anaphylactoid/anaphylactic reactions

Very rare

Nervous system disorders

Unpleasant taste, unpleasant smell

Common

Eye disorders

Glaucoma, raised intraocular pressure, cataract.

Very rare

Respiratory, thoracic &

Mediastinal disorders

Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation.

Common

Nasal septum perforation.

Very rare

As with other nasal sprays, dryness and irritation of the nose and throat, and epistaxis have been reported. Nasal septal perforation has also been reported following the use of intranasal corticosteroids.
Systemic effects of nasal corticosteroids may occur particularly when used at high doses for prolonged periods.

Symptoms and Treatment of Overdose
When used in excessive dosages (above 600 micrograms or 12 applications of Apo-Beclomethasone (beclomethasone dipropionate) Nasal Spray per day), systemic steroid effects, such as hypercorticism and adrenal suppression, may appear. Decreasing the dosage will abolish the side-effects.

Storage Conditions
Do not refrigerate. Store at room temperature (15-30C). Protect from light.


Interactions with Other Medicaments

Not applicable.

Adverse Effects
Adverse events are listed below 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.


Shelf-life
36 months from the date of manufacture.

Availability of Dosage Forms
Apo-Beclomethasone Nasal Spray is available in 200 metered spray (22g net weight) bottles.

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