Azelastine Hydrochloride + Fluticasone Propionate
Azelastine Hydrochloride + Fluticasone Propionate Uses, Dosage, Side Effects, Food Interaction and all others data.
Fluticasone propionate is a synthetic glucocorticoid. These drugs are available as inhalers, nasal, sprays, and topical treatments for various inflammatory indications. Fluticasone propionate was first approved in 1990.
Systemically, fluticasone propionate activates glucocorticoid receptors, and inhibits lung eosinophilia in rats. Fluticasone propionate as a topical formulation is also associated with vasoconstriction in the skin.
| Trade Name | Azelastine Hydrochloride + Fluticasone Propionate |
| Generic | Azelastine Hydrochloride + Fluticasone Propionate |
| Type | |
| Therapeutic Class | Nasal Steroid Preparations |
| Manufacturer | |
| Available Country | Bangladesh |
| Last Updated: | September 24, 2024 at 5:38 am |
Uses
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.Azelastine Hydrochloride + Fluticasone Propionate is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Allergy to Mold, Allergy; Dander, Asthma, Bacterial Sinusitis, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease (COPD), Chronic Sinusitis, Dermatitis, Emphysema, House Dust Mite Allergy, House dust allergy, Itching of the nose, Nasal Congestion, Nonallergic Rhinitis, Oesophagitis, Eosinophilic, Perennial Rhinitis, Pollen Allergy, Rhinitis, Rhinorrhoea, Seasonal Allergic Rhinitis, Sneezing, Moderate, severe Perennial Allergic Rhinitis (PAR), Moderate, severe Seasonal Allergic Rhinitis
How Azelastine Hydrochloride + Fluticasone Propionate works
Fluticasone propionate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. Fluticasone propionate activates glucocorticoid receptors and inhibits lung eosinophilia in rats.
Dosage
Azelastine Hydrochloride + Fluticasone Propionate 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. 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. Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows- 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.Side Effects
The most common adverse reactions (>2% incidence) are: dysgeusia, epistaxis, and headache.Toxicity
Fluticasone propionate's use in specific populations has not been well studied. Fluticasone propionate is not carcinogenic, mutagenic, or clastogenic, nor did it affect fertility in animal studies. Subcutaneous fluticasone propionate has been shown to produce teratogenic effects in rats though oral administration does not. Generally, there are no reported adverse effects with fluticasone in pregnancy. Fluticasone propionate in human milk may cause growth suppression, effects on endogenous corticosteroid production, or other effects. Pediatric patients treated with fluticasone propionate ointment experienced adrenal suppression. Geriatric patients treated with fluticasone propionate did not show any difference in safety or efficacy compared to other patient groups, though older patients may be more sensitive to adverse effects. There is no difference in the clearance of fluticasone propionate across genders or race. Patients with hepatic impairment should be closely monitored due to the elimination mechanism.
Precaution
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.Volume of Distribution
The volume of distribution of intravenous fluticasone propionate is 4.2L/kg. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 577L following intravenous administration.
Elimination Route
Intranasal bioavailability of fluticasone propionate is 10. Intranasal exposure results in the majority of the dose being swallowed. Topical absorption of fluticasone propionate is very low but can change depending on a number of factors including integrity of the skin and the presence of inflammation or disease. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 9.0%.
Half Life
7.8 hours for intravenous fluticasone propionate. A study of 24 healthy Caucasian males shows a half life of 14.0 hours following intravenous administration and 10.8 hours following inhalation.
Clearance
1093mL/min for fluticasone propionate. A study of 24 healthy Caucasian males showed a clearance of 63.9L/h following intravenous administration.
Elimination Route
Fluticasone propionate is mainly eliminated in the feces with 10,5.
Pregnancy & Breastfeeding use
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.Contraindication
There is no known contraindication.Acute Overdose
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 Condition
Store below 25° C. Protected from light. Do not store in the refrigerator. Keep out of the reach of children.Innovators Monograph
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