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Opsonin Pharma LtdProduct Description
Here is a structured, easy-to-read summary of the provided information for **Zeltas Nasal Spray**:
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### **1. Overview & Indications**
* **Active Ingredients:** Azelastine Hydrochloride (Antihistamine) + Fluticasone Propionate (Corticosteroid).
* **Drug Class:** Nasal Steroid / Antihistamine Preparation.
* **Indication:** Relief of symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and older.
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### **2. Dosage & Administration**
* **Dosage:**
* **Adults & Children ($\ge$ 6 years):** 1 spray in each nostril twice daily.
* **Children (< 6 years):** Safety and efficacy have not been established.
* **How to Use:**
1. Gently blow the nose to clear nostrils.
2. Shake the bottle gently and remove the dust cover.
3. **Prime:** If using for the first time or if unused for 1+ weeks, press down several times until a fine mist appears.
4. Close one nostril, insert the nozzle into the open nostril, tilt your head slightly forward, and keep the spray upright.
5. Breathe in gently through your nose while pressing firmly down once on the applicator. Exhale through your mouth.
6. Repeat for the other nostril or consecutive doses.
* **Cleaning Instructions (Weekly):** Remove the dust cover and applicator, wash them in warm water, shake off excess water, and let them air dry without external heat before reassembling.
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### **3. Side Effects & Contraindications**
* **Contraindications:** No specific contraindications known.
* **Common Side Effects ($>2\%$ incidence):**
* Dysgeusia (altered or bitter taste)
* Epistaxis (nosebleeds)
* Headache
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### **4. Precautions & Warnings**
* **Drowsiness & Alertness:** Avoid driving, operating machinery, or engaging in hazardous tasks as it may impair mental alertness.
* **CNS Depressants & Alcohol:** Avoid concurrent alcohol consumption or CNS depressants due to enhanced sedation and central nervous system depression.
* **Steroid Effects:** Excessive dosage or long-term use in susceptible individuals can cause hypercorticism or adrenal suppression; discontinue slowly if these occur.
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### **5. Special Populations & Overdose**
* **Pregnancy:** Pregnancy Category C. Use only if the expected benefit to the mother outweighs potential risks to the fetus.
* **Lactation:** It is unknown if active ingredients pass into human breast milk. Use with caution in nursing mothers.
* **Overdose:** Acute overdose is unlikely to cause severe events beyond increased drowsiness. Chronic fluticasone overdose may lead to hypercorticism symptoms.
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### **6. Storage Conditions**
* Store below 25°C and protect from light.
* **Do not refrigerate.** Keep out of reach of children.
*(Note: Always use medication under the direction of a registered physician.)*
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