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.
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
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.
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.
Administration
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
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.
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 & Warnings
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.
Therapeutic Class
Nasal Steroid Preparations
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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