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AZELASTIN-COMOD 0.5/MG EYE DROPS 10ML
- Sku : I-028990
Key features
Azelastin-Comod 0.5 mg/ml eye drops contain the active ingredient azelastine at a concentration of 0.5 mg/ml. It acts as a selective histamine H1-receptor antagonist with mast-cell stabilizing and anti-inflammatory effects, inhibiting the release of allergic mediators such as histamine and leukotrienes. It is indicated for the treatment of signs and symptoms of seasonal and perennial (non-seasonal) allergic conjunctivitis. Available as a prescription-only ophthalmic solution in a 10 ml pack.- Brand: AZELASTIN
- Active Ingredient: AZELASTINE 0.5mg/ml
- Strength: 0.5mg/ml
- Dosage Form: Eye drops, solution
- Pack Size: 10 ml
- Route: Ophthalmic use
- Prescription Status: Prescription
- Therapeutic Class: Ophthalmic
- Pharmacological Group: Decongestants & Antiallergics (Eye)
- Drug Class: Second-generation Ophthalmic Antihistamine / Mast Cell Stabilizer
- Manufacturer: URSAPHARM Arzneimittel GmbH
- Country of Origin: Germany
- SFDA Registration No.: 1610246065
- Shelf Life: 24 months
- Storage: store below 25°c
- Target Organ: Eye
- Preservative Free: No
Indications
Approved Uses
Treatment of signs and symptoms of seasonal allergic conjunctivitis and perennial (non-seasonal) allergic conjunctivitis.
Dosage & Administration
Children's Dosage
Children ≥4 years: 1 drop in each affected eye twice daily (same as adult dose). Not approved for children under 4 years.
Side Effects
Common Side Effects
Transient eye burning/stinging or irritation, bitter taste (dysgeusia), headache; may also cause temporary blurred vision.
Side Effect Frequency
Common: transient eye irritation/burning/stinging and bitter taste (dysgeusia); other common ocular effects include blurred vision and eye pain/irritation; systemic respiratory/flu-like symptoms are not typical common adverse effects for ophthalmic azelastine.
Safety & Warnings
Contraindications
Hypersensitivity to azelastine (or any excipients).
Age Restriction
Not recommended/approved in children <4 years for allergic conjunctivitis (both seasonal and perennial) for azelastine 0.5 mg/mL ophthalmic solution.
Drug Interactions
Drug Interactions
No specific interaction studies; clinically significant interactions are unlikely due to minimal systemic absorption (separate different eye drops by ~5-10 minutes).
Interaction Severity
No clinically significant drug interactions are expected with ophthalmic azelastine when used as directed.
Special Populations
Pregnancy
Consult Doctor
Breastfeeding
Consult Doctor
Children
Children ≥4 years: 1 drop in each affected eye twice daily (same as adult dose). Not approved for children under 4 years.
Storage & Patient Advice
Monitoring Requirements
No routine monitoring
Pharmacology
Mechanism of Action
Selective histamine H1-receptor antagonist with mast-cell stabilizing/anti-inflammatory effects, inhibiting release of allergic mediators (e.g., histamine, leukotrienes) and reducing ocular allergy symptoms.
Onset of Action
Within about 3 minutes.
Duration of Effect
Approximately 8-12 hours.
Product Information
Available Dosage Forms
Eye drops, solution (ophthalmic).
Target Organ
Eye
Preservative Free
No
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