Zeltas Nasal Spray (137 mcg+50 mcg)/ 120 spray

৳ 320.00

Opsonin Pharma Ltd.

Azelastine Hydrochloride + Fluticasone Propionate

Indications

Azelastine and Fluticasone Nasal Spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both Azelastine Hydrochloride and Fluticasone Propionate for symptomatic relief.

Therapeutic Class

Nasal Steroid Preparations

Pharmacology

Azelastine Hydrochloride exhibits histamine H1-receptor antagonist activity in isolated tissues. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity. Fluticasone Propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which Fluticasone Propionate affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes etc.) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

Dosage & Administration

Adult: The recommended dosage is one spray each nostril twice daily.

Paediatric: The safety and effectiveness of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray has not been established for patients less than 6 years of age.

Contraindications

There is no known contraindication.

Side Effects

The most common adverse reactions (>2% incidence) are: dysgeusia, epistaxis, and headache.

Pregnancy & Lactation

Pregnancy category C. There are no adequate and well-controlled clinical trials of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Azelastine Hydrochloride only or Fluticasone Propionate only in pregnant women. It should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

Precautions

Engagement in hazardous occupations requiring complete mental alertness such as driving or operating machinery should be avoided when taking Azelastine and Fluticasone Nasal Spray. Concurrent use of alcohol or other central nervous system (CNS) depressants with this Nasal Spray should also be avoided because of further decreased alertness and impairment of CNS. Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals may appear. If such changes occur, the spray should be discontinued slowly.

Overdose Effects

There have been no reported over dosages with Azelastine Hydrochloride. Acute Azelastine Hydrochloride overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence. Chronic Fluticasone Propionate overdosage may result in symptoms of hypercorticism.

Storage Conditions

Store below 25° C. Protected from light. Do not store in the refrigerator. Keep out of the reach of children.

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