Beconase Nosal Spray Adult


UGX45,500

Therapeutic indications

Beconase Hayfever Relief for Adults is indicated for the treatment of seasonal allergic rhinitis (hayfever) in adults aged 18 and over. Beconase Hayfever Relief for Adults provides symptomatic relief from nasal congestion, runny nose, sneezing, itchy nose, eye symptoms (such as itching, watering, redness) and associated sinus discomfort.

Posology and method of administration

Method of Administration

Beconase Hayfever Relief for Adults is for administration by the intranasal route only.

Posology

Adults aged 18 and over: The recommended dosage is two sprays into each nostril morning and evening (400 micrograms/day). Once control has been established, it may be possible to maintain control with fewer sprays. A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients. However, should the symptoms recur, patients should revert to the recommended dosage of two sprays into each nostril morning and evening? The minimum dose should be used at which effective control of symptoms is maintained. Total daily administration should not exceed eight sprays (400 micrograms).

Beconase Hayfever Relief for Adults quickly starts to reduce inflammation and swelling in the nose. For full therapeutic benefit, Beconase Hayfever Relief for Adults should be used regularly.

If symptoms have not improved after 7 days of treatment, medical advice must be sought.

Beconase Hayfever Relief for Adults is not recommended for children or adolescents under 18 years of age.

Special warnings and precautions for use

Systemic effects of nasal corticosteroids may occur, particularly at high doses when used 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. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Beconase Hayfever Relief contains Benzalkonium chloride which may cause bronchospasm and local reactions. Medical advice should be sought before using Beconase Hayfever Relief for Adults by patients using other forms of corticosteroid treatments such as asthma medications, tablets, injections, similar nasal sprays, eye or nose drops, creams, ointments.

This product should not be used continuously for longer than 1 month without medical advice.

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Beconase Hayfever Relief for Adults.

Although Beconase Hayfever Relief for Adults 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.

Medical advice should be sought before using Beconase Hayfever Relief for Adults in the case of recent injury or surgery to the nose, or problems with ulceration in the nose.

 Interaction with other medicinal products and other forms of interaction

Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general, interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring are advised with the use of such agents.

4.6 Fertility, pregnancy, and lactation

Fertility

No known effect.

Pregnancy

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Beconase Hayfever Relief for Adults delivers beclometasone dipropionate directly to the nasal mucosa and so minimizes systemic exposure.

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

Breast-feeding

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.

Beconase Hayfever Relief for Adults should not be used during lactation without consulting a doctor.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

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, glaucoma or cataracts in association with intranasal formulations of beclometasone dipropionate have been reported.

Very rare cases of hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and edema of the eyes, face, lips and throat, anaphylactoid/anaphylactic reactions, dyspnoea and/or bronchospasm have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

The only harmful effect that follows the inhalation of large amounts of the drug over a short time period is the suppression of the hypothalamic-pituitary-adrenal (HPA) function. No special emergency action needs to be taken. HPA function recovers in a day or two after discontinuation of treatment with Beconase Hayfever Relief for Adults.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Following topical administration, beclometasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.

BDP is a pro-drug with weak corticosteroid receptor binding affinity. It is hydrolyzed via esterase enzymes to the highly 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 reappearing.

Based on 0 reviews

0.0 overall
0
0
0
0
0

Be the first to review “Beconase Nosal Spray Adult”

There are no reviews yet.