
Zeltas
Opsonin Pharma Ltd.
Azelastine Hydrochloride + Fluticasone Propionate is a fixed-dose combination intranasal spray that pairs an intranasal antihistamine (azelastine) with an intranasal corticosteroid (fluticasone) in…
Azelastine Hydrochloride + Fluticasone Propionate is a fixed-dose combination intranasal spray that pairs an intranasal antihistamine (azelastine) with an intranasal corticosteroid (fluticasone) in a single metered-dose device. It is used for the symptomatic relief of allergic rhinitis.
Azelastine Hydrochloride + Fluticasone Propionate is intended for patients whose symptoms are not adequately controlled with either an intranasal antihistamine or an intranasal corticosteroid used alone; it is not recommended as a routine first-line monotherapy and should be used only when combination therapy is clinically indicated.
| Indication | Age Group | Recommended Dose |
|---|---|---|
| Seasonal allergic rhinitis | Adults and children 6 years and older | 1 spray per nostril twice daily (morning and evening) |
| Perennial allergic rhinitis | Adults and children 12 years and older | 1 spray per nostril twice daily (morning and evening) |
| Perennial allergic rhinitis | Children 6–11 years | Safety and efficacy not established; not recommended (see Pediatric Use) |
Total dose is 4 sprays per day (2 sprays per nostril per day). Re-evaluate the need for continued treatment periodically; if symptoms are not improved after 14 days of consistent use, the patient should be reassessed by a physician.
No renal or hepatic dose adjustment has been well established for Azelastine Hydrochloride + Fluticasone Propionate; use with caution in hepatic impairment because systemic corticosteroid exposure may be increased.
Adverse effects of Azelastine Hydrochloride + Fluticasone Propionate are generally local to the nose and mouth. The most commonly reported effects include:
| Frequency | Effects |
|---|---|
| Common | Bitter/unpleasant taste (dysgeusia, due to post-nasal drainage of azelastine), nasal discomfort or irritation, epistaxis (nosebleed), headache, somnolence |
| Uncommon/rare | Nasal dryness, nasal septal perforation, glaucoma and cataracts (reported rarely with long-term intranasal corticosteroid use), reduced growth velocity in children on long-term therapy, hypersensitivity reactions |
Because of the sedating potential of the azelastine component, patients should use caution when driving or operating machinery until they know how Azelastine Hydrochloride + Fluticasone Propionate affects them, and should avoid combining it with alcohol.
Azelastine Hydrochloride + Fluticasone Propionate is contraindicated in patients with known hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any excipient of the formulation.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.