Flixonase 100mg AQUEOUS NASAL SPRAY

FLIXONASE AQUEOUS NASAL SPRAY is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis including hay fever in adults and the short term treatment of seasonal allergic rhinitis in children 4 - 11 years old.

Shake gently before use. FLIXONASE AQUEOUS NASAL SPRAY is for administration by the intranasal route only. For full therapeutic benefit regular usage is essential. The absence of an immediate effect should be explained to the patient as maximum relief may not be obtained until after 3 to 4 days of treatment.

Adults and children over 12 years of age: For the prophylaxis and treatment of seasonal and perennial allergic rhinitis: Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays twice daily into each nostril.

Elderly: The normal adult dose is applicable.

Children under 12 years of age: For the prophylaxis and treatment of seasonal allergic rhinitis in children aged 4 - 11 years a dose of one spray into each nostril once daily is recommended. The maximum daily dose should not exceed two sprays into each nostril. Safety and efficacy has not been studied for periods longer than 4 weeks. For the prophylaxis and treatment of perennial allergic rhinitis in children of this age (4 - 11 years), there are insufficient clinical data at present to recommend the use of FLIXONASE AQUEOUS NASAL SPRAY.

FLIXONASE AQUEOUS NASAL SPRAY is contra-indicated in patients with a sensitivity to any of its ingredients.

Infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with FLIXONASE AQUEOUS NASAL SPRAY. The full benefit of FLIXONASE AQUEOUS NASAL SPRAY may not be achieved until treatment has been administered for several days. Care must be taken while transferring patients from systemic steroid treatment to FLIXONASE AQUEOUS NASAL SPRAY if there is any reason to suppose that their adrenal function is impaired. FLIXONASE AQUEOUS NASAL SPRAY may cause hypothalamic-pituitary-adrenal (HPA) axis suppression following intranasal application at dosages higher than recommended. A heavy challenge of summer allergens may necessitate appropriate additional therapy, particularly to control eye symptoms.

Care should be taken when co-administering known strong CYP3A4 inhibitors, e.g., ritonavir and ketoconazole, as there is potential for increased systemic exposure to fluticasone propionate.

Safety during pregnancy and lactation has not been established. Corticosteroids have been shown to be teratogenic in animals. As these agents may be absorbed systemically when administered intranasally, teratogenicity cannot be excluded.

Dryness and irritation of the nose and throat, unpleasant taste and smell, headache and epistaxis have been reported. Hypersensitivity reactions including skin rash and oedema of the face or tongue have been reported. There have also been less frequent reports of anaphylaxis/anaphylactic reactions and bronchospasm. Extremely rare cases of nasal perforation have been reported following the use of intranasal corticosteroids.

See SIDE EFFECTS. Chronic - Administration of fluticasone propionate in daily doses in excess of that recommended, or in conjunction with other corticosteroid formulations, may lead to some degree of suppression of hypothalamic-pituitary-adrenal function. Monitoring of adrenal reserve may be indicated. Further treatment is symptomatic and supportive.