Allergicasone nasal spray 140 puffs 23 gm

Allergicasone Metered Nasal Spray 30 ml

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.