Beclomethasone Dipropionate nasal spray is indicated for the prevention and treatment of seasonal and perennial allergic rhinitis, including hay fever, as well as non-allergic (vasomotor) rhinitis. It is also used to prevent the recurrence of nasal polyps after surgical removal.

After topical application to the nasal mucosa, Beclomethasone Dipropionate exerts anti-inflammatory and vasoconstrictive effects. Although the exact mechanism is not fully understood, it is believed to reduce the number of inflammatory mediator cells such as basophils, leukocytes, and mast cells at the epithelial level, as well as decrease eosinophil count. It also lowers the sensitivity of sensory nerves to mechanical stimuli, reduces secretory response to cholinergic receptor stimulation, and inhibits fibroblast activity. Additional actions may include reduction of capillary dilation and permeability, stabilization of lysosomal membranes, and prevention of the release of proteolytic enzymes.

Dosage of intranasal Beclomethasone Dipropionate must be carefully adjusted according to individual requirements and response.

Adults: Recommended usual dosage: 02 (two) sprays (50 µgm/spray) in each nostril twice daily. For some patients, 01 (one) spray in each nostril 3 to 4 times daily may be preferred. Total daily doses of 400 µgm (08 sprays) should not generally be exceeded.

Children (6 to 12 years of age): Usual dose: 01 (one) spray in each nostril twice daily. Patients not adequately responding, or those with more severe symptoms may use 02 (two) sprays in each nostril twice daily.

Children under 6 years of age: Not recommended since safety profile studies have not been conducted. After the first few days, patients may be able to reduce their dosage to 100 µg (one spray in each nostril) once daily for maintenance therapy.

Administration

How to use the Nasal Spray

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

No clinically significant drug interactions have been identified.

Contraindicated in patients who are hypersensitive to Beclomethasone or any of its components. Nasal and paranasal infections should be properly managed; however, these conditions do not specifically contraindicate the use of Beclomethasone nasal spray.

Rare cases of nasal septum perforation have been reported with intranasal use. Other infrequent effects include dryness and irritation of the nose and throat, unpleasant taste or smell, and epistaxis. Rarely, wheezing, cataracts, glaucoma, and increased intraocular pressure may occur following intranasal administration of Beclomethasone.

Beclomethasone should be used during pregnancy only if the expected benefits outweigh potential risks to the fetus. Due to the natural increase in corticosteroid levels during pregnancy, lower doses may be sufficient and some patients may not require corticosteroid therapy. As corticosteroids can pass into breast milk, caution is advised when administering Beclomethasone nasal spray to breastfeeding mothers.

Nasal and paranasal infections should be adequately treated before use, although they are not a strict contraindication. Special caution is required when switching patients from systemic corticosteroids to Beclomethasone nasal spray, particularly if adrenal function may be compromised.

Short-term use of excessive doses may lead to temporary suppression of the hypothalamic-pituitary-adrenal (HPA) axis. No emergency treatment is usually required, and therapy can continue at the recommended dosage. Normal HPA function typically returns within one to two days.

Nasal corticosteroid preparation.

Store below 30°C. Protect from light and moisture. Keep out of reach of children.