This combination nasal spray is indicated for the management of symptoms associated with seasonal allergic rhinitis in patients aged 6 years and above who require dual therapy with Azelastine Hydrochloride and Fluticasone Propionate for effective symptom relief.

Azelastine Hydrochloride acts as a selective histamine H1-receptor antagonist in various tissues. Its primary active metabolite, desmethylazelastine, also contributes to antihistamine activity. Fluticasone Propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory properties. Although its exact mechanism in relieving allergic rhinitis symptoms is not fully defined, corticosteroids are known to affect multiple inflammatory cells (including mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (such as histamine, leukotrienes, cytokines, and eicosanoids), thereby reducing inflammation and allergic responses.

Adult: The recommended dosage is one spray each nostril twice daily.
Paediatric: The safety and effectiveness of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray has not been established for patients less than 6 years of age.

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 specific contraindications have been identified for this combination nasal spray.

The most frequently reported adverse effects (incidence >2%) include dysgeusia (altered taste), epistaxis (nosebleed), and headache.

This combination is classified as Pregnancy Category C. Adequate and well-controlled studies in pregnant women are not available. It should be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus.

Nursing Mothers: It is not known whether azelastine hydrochloride and fluticasone propionate are excreted in human breast milk. As many drugs are excreted in breast milk, caution should be exercised when administering to lactating women.

Activities requiring full mental alertness, such as driving or operating machinery, should be avoided while using this nasal spray. Concomitant use with alcohol or other CNS depressants should also be avoided due to the risk of increased drowsiness and impaired CNS function.

High doses or prolonged use may lead to hypercorticism and adrenal suppression in susceptible individuals. If such effects occur, the medication should be tapered gradually rather than stopped abruptly.

No cases of overdose with azelastine hydrochloride have been reported. Acute overdose is unlikely to cause significant clinical effects other than increased drowsiness. Chronic overuse of fluticasone propionate may result in signs of hypercorticism.

Nasal steroid preparations.

Store below 25°C, protected from light. Do not refrigerate. Keep out of reach of children.