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Azelastine is a second-generation antihistamine with anti-inflammatory properties, commonly used to treat allergic conditions. It works by blocking histamine H₁ receptors and inhibiting the release of inflammatory mediators like leukotrienes. Available as a nasal spray and eye drops, it provides rapid relief—often within 15–30 minutes—for symptoms of allergic rhinitis (sneezing, runny nose, itching) and allergic conjunctivitis (red, itchy eyes). It’s also effective for non-allergic (vasomotor) rhinitis, making it versatile for nasal inflammation. Due to its local application, systemic side effects are minimal; the most common issues are a mild bitter taste (from nasal spray) or temporary eye stinging. Azelastine is well-tolerated, non-sedating at standard doses, and widely prescribed for both seasonal and year-round allergies. Its dual action—antihistaminic and mast cell-stabilizing—makes it a valuable tool in managing upper airway and ocular allergic disorders.
Items | Specifications | Results |
Appearance | White or almost white powder | White powder |
Loss on Drying | ≤1.0% | 0.46% |
Purity (HPLC) | ≥98.0% | 99.12% |
Conclusion | The product conforms to the above specifications. | |
Azelastine is a potent, second-generation antihistamine with additional anti-inflammatory properties. It is primarily used to treat allergic conditions affecting the eyes and nasal passages.
Chemical & Pharmacological Profile:
Class: Phthalazinone derivative
Mechanism: Blocks histamine H₁ receptors and inhibits the release of inflammatory mediators (e.g., leukotrienes, serotonin, platelet-activating factor).
Formulations: Available as nasal spray, ophthalmic (eye) drops, and occasionally oral tablets (less common).
Onset of Action: Rapid—within 15–30 minutes for nasal and ocular forms.
Main Medical Uses:
Allergic Rhinitis (Seasonal & Perennial)
Azelastine nasal spray reduces symptoms like sneezing, runny nose, itching, and congestion.
Allergic Conjunctivitis
Eye drops relieve redness, itching, and watering caused by allergens (e.g., pollen, dust).
Vasomotor Rhinitis (Non-allergic rhinitis)
Effective in reducing nasal symptoms not caused by allergies, thanks to its anti-inflammatory effects.
Adjunct in Asthma or Chronic Cough (Off-label, limited use)
Occasionally used when upper airway inflammation contributes to symptoms.
Advantages:
Dual action: antihistaminic + mast cell stabilizing
Local administration minimizes systemic side effects
Generally well-tolerated; common side effect is mild bitter taste (nasal spray) or transient stinging (eye drops)
Azelastine is valued for its fast relief and effectiveness in managing both allergic and non-allergic upper airway conditions.



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