FLIXONASE Nasal spray Ref.[27690] Active ingredients: Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Glaxo Wellcome UK Limited trading as: GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

4.1. Therapeutic indications

The prophylaxis and treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis. Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity.

4.2. Posology and method of administration

Flixonase Aqueous Nasal Spray is for administration by the intranasal route only.

Contact with the eyes should be avoided.

Adults and children over 12 years of age

For the prophylaxis and treatment of seasonal allergic rhinitis and perennial 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. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose should be used at which effective control of symptoms is maintained. The maximum daily dose should not exceed four sprays into each nostril.

Elderly patients

The normal adult dosage is applicable.

Children under 12 years of age

For the prophylaxis and treatment of seasonal allergic rhinitis and perennal rhinitis in children aged 4-11 years a dose of one spray into each nostril once daily preferably in the morning is recommended. In some cases one spray into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays into each nostril. The minimum dose should be used at which effective control of symptoms is maintained.

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.

4.9. Overdose

There are no data from patients available on the effects of acute or chronic overdosage with Flixonase Aqueous Nasal Spray. Intranasal administration of 2 mg fluticasone propionate twice daily for seven days to healthy human volunteers has no effect on hypothalamo-pituitary-adrenal (HPA) axis function.

Inhalation or oral administration of high doses of corticosteroids over a long period may lead to suppression of HPA axis function.

Treatment

Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.

In these patients, treatment with fluticasone propionate should be continued at a dose sufficient to control.

6.3. Shelf life

36 months

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

Flixonase Aqueous Nasal Spray is supplied in an amber glass bottle fitted with a metering, atomising pump. Pack size of 120 and 150 metered sprays.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Shake gently before use.

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