Avamist 27.5 mcg/spray

INDICATIONS

Fluticasone Furoate nasal spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.Fluticasone Furoate inhalation powder is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. This is not indicated for the relief of acute bronchospasm.

PHARMACOLOGY

Fluticasone Furoate is a synthetic trifluorinated corticosteroid with potent anti inflammatory activity. Like other corticosteroids Fluticasone Furoate is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

DOSAGE

Fluticasone Furoate Nasal Spray:

Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Fluticasone Furoate nasal spray at regular intervals as directed since its effectiveness depends on its regular use.
Children (under 2 years of age): There are no data to recommend use of Fluticasone Furoate Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.

Fluticasone Furoate Inhalation Capsule: should be administered as 1 inhalation once daily by the orally inhaled route. Fluticasone Furoate should be used at the same time every day. Do not use fluticasone furoate more than 1 time every 24 hours.

Adults and Adolescents Aged 12 Years and Older: The starting dosage for Fluticasone Furoate should be based upon patients' asthma severity.
The usual recommended starting dose for adults and adolescents aged 12 years and older not on an inhaled corticosteroid (ICS) is 100 mcg.
For other adults and adolescents aged 12 years and older, the starting dose should be based on previous asthma drug therapy and disease severity.
For adults and adolescents aged 12 years and older who do not respond to Fluticasone Furoate 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate 200 mcg may provide additional asthma control.

If a dosage regimen of Fluticasone Furoate fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of Fluticasone Furoate with a higher strength, initiating an ICS and long- acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.The highest recommended daily dose in adults and adolescents aged 12 years and older is 200 mcg. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.Pediatric Patients Aged 5 to 11 Years: The recommended dosage for children aged 5 to 11 years is 50 mcg administered once daily

INTERACTION

Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Fluticasone Furoate. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole.Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.

SIDE EFFECTS

Fluticasone Furoate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and an increase in the incidence of nosebleeds may occur.Most common adverse reactions of Fluticasone Furoate inhalation capsule reported in ≥5% of adult and adolescent subjects are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.

PREGNANCY & LACTATION

Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fluticasone Furoate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.Use in lactation: It is not known whether Fluticasone Furoate is excreted in human breast milk. However, since other corticosteroids have been detected in human milk, caution should be exercised when Fluticasone Furoate is administered to a nursing woman.

PRECAUTIONS & WARNINGS

Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Fluticasone Furoate nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Furoate. Although systemic effects have been minimal with recommended doses of Fluticasone Furoate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Furoate nasal spray should be avoided.

USE IN SPECIAL POPULATIONS

Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.Use in hepatic impairment: Use Fluticasone Furoate with caution in patients with severe hepatic impairment.Use in renal impairment: No dosage adjustment is required in patients with renal impairment.

THERAPEUTIC CLASS

Nasal Steroid Preparations

STORAGE CONDITIONS

Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep out of the reach of children.