Allergicasone Nasal spray 140 puffs 23 g
Al Esraa Pharmaceuticals
El Esraa Pharmaceutical Optima
Composition
Each spray delivers 0.137 ml of suspension containing
Active ingredients
Azelastine hydrochloride 137 mcg
Fluticasone propionate 50 mcg
Description
Allergicasone is a metered-dose nasal spray containing a combination of azelastine hydrochloride, an antihistamine, and fluticasone propionate, a corticosteroid. It is used for the symptomatic relief of seasonal allergic rhinitis in patients aged 6 years and older who require both agents. The spray is a white to off-white suspension.
Indications for Use
Treatment of seasonal allergic rhinitis in patients 6 years of age and older who require both azelastine and fluticasone.
Directions for Use
For intranasal use only.
Recommended dose: 1 spray per nostril twice daily.
Shake gently before each use.
Prime before first use with 6 sprays or until a fine mist appears.
If unused for 14 days or more, reprime with 1 spray.
Avoid spraying into the eyes; rinse eyes with water if accidental contact occurs.
Precautions
May cause somnolence. Avoid driving or operating machinery.
Avoid alcohol or CNS depressants.
Monitor for epistaxis, nasal ulceration, and candidiasis with prolonged use.
Use with caution in patients with recent nasal surgery or trauma.
Monitor intraocular pressure in patients with a history of glaucoma or cataracts.
Increased susceptibility to infections due to immunosuppression.
Potential for adrenal suppression and growth retardation, especially in children.
Use with caution with CYP3A4 inhibitors (e.g., ritonavir, ketoconazole).
Side Effects
Common adverse effects
Headache, somnolence, dysgeusia, epistaxis, nasal irritation, cough
Less common and postmarketing reports
Growth suppression, adrenal suppression, Cushing’s syndrome, vision changes, glaucoma, cataracts, hypersensitivity reactions including anaphylaxis, bronchospasm, nasal septal perforation, nasal sores, taste and smell disturbances, nausea, vomiting, rash, urticaria, hypertension
Pregnancy and Breastfeeding
Limited human data; animal studies do not suggest major risks at clinical doses.
Can be used during pregnancy if benefits outweigh risks.
No data on presence in human milk. Use with caution during breastfeeding. Monitor infant for bitter taste rejection.
Storage Conditions
Store below 30°C. Keep out of reach of children. Do not use after expiry date printed on packaging.
Packaging
Carton box containing a 30 ml bottle (23 g suspension) and an insert leaflet.