Fluticasone furoate
GlaxoSmithKline
850 Items
2019-09-19
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Clinical Pharmacology
FLIXONASE - HX for intranasal use. It has a pronounced anti-inflammatory, anti-edematous and anti-allergic effect.
Anti-inflammatory effect is realized as a result of the interaction of the drug with glucocorticosteroid receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils. Fluticasone propionate reduces the production of inflammatory mediators and a number of biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of an allergic reaction. It has a quick anti-inflammatory effect on the nasal mucosa. Antiallergic effect appears already after 2-4 h after the first use. Reduces sneezing, itching in the nose, rhinorrhea, nasal congestion, discomfort in the region of the paranasal sinuses and the sensation of pressure around the nose and eyes. In addition, it relieves the eye symptoms associated with allergic rhinitis. Reduction of symptoms (especially nasal congestion) persists for 24 hours after a single spray application at a dose of 200 μg.
Indications
- prevention and treatment of seasonal allergic rhinitis;
- prevention and treatment of year-round allergic rhinitis.
Composition
1 dose:
- fluticasone propionate (micronized) 50 mcg
Excipients: anhydrous dextrose, microcrystalline cellulose, microcrystalline carboxymethylcellulose, phenylethyl alcohol, solution of benzalkonium chloride, polysorbate 80, hydrochloric acid diluted, purified water.
Fluticasone furoate is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Flixonase® | GlaxoSmithKline | Spain | spray |
| Avamys | GlaxoSmithKline | UK | spray |
| Nazarel | Teva | Israel | spray |
| Flixotide | GlaxoSmithKline | UK | inhalation spray |
| Cutivate® | GlaxoSmithKline | UK | cream |
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Dosage and Administration
Flixonase is intended for intranasal use only. To achieve the full therapeutic effect of the drug should be used regularly.
Adults and children over 12 years old for the prevention and treatment of seasonal allergic rhinitis and year-round allergic rhinitis, 100 mcg (2 doses) are prescribed in each nostril 1 time / day (total dose 200 mcg / day), preferably in the morning. After attaining symptom control, 50 mcg (1 dose) can be administered to each nostril 1 time / day (total dose 100 mcg / day).
In some cases, it is required to use 100 μg (2 doses) in each nostril 2 times / day (total dose 400 μg / day) for a short time in order to achieve control over the symptoms, after which the dose can be reduced. The maximum daily dose of the drug is 400 micrograms (4 doses in each nostril).
Elderly patients do not require correction dosing regimen.
Children aged 4-12 years for the prevention and treatment of seasonal allergic rhinitis, it is recommended to prescribe 50 μg (1 dose) in each nostril 1 time / day. The maximum daily dose of the drug is 200 micrograms (2 doses in each nostril).
The maximum therapeutic effect is manifested after 3-4 days of therapy. To achieve the full therapeutic effect, you must regularly use the drug.
Mode of application
Before use, gently shake the bottle, take it, placing the index and middle fingers on both sides of the tip, and the thumb - under the bottom. At the first use of the drug or a break in its use for more than 1 week, you should check the serviceability of the sprayer (having directed the tip away from you, make several presses until a small cloud emerges from the tip).
Next you need:
- clear your nose (blow your nose slightly);
- close one nostril and insert the tip into the other nostril;
- tilt your head slightly forward, while continuing to hold the aerosol bottle vertically;
- start breathing in through the nose and, continuing to inhale, press once with your fingers to dispense the preparation;
- exhale through the mouth.
Repeat the procedure for the second spray in the same nostril, if necessary. Then completely repeat the procedure described by inserting the tip into the other nostril.
After use, blot the tip with a clean cloth or handkerchief and cover it with a cap.
Rinse the sprayer at least 1 time per week. To this end, you must carefully remove the tip, rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully set the tip to its original place at the top of the brown bottle. Wear protective cap. If the tip hole is clogged, the tip should be removed as described above and left for some time in warm water. Then rinse under running cold water, dry and put on the bottle again. Do not clean the tip opening with a pin or other sharp objects.
Adverse reactions
Local reactions: dryness and irritation of the nasopharynx, unpleasant taste and smell, nosebleeds, burning sensation, nasal congestion; very rarely (less than 1/10 000 cases) - perforation of the nasal septum (especially during surgical interventions in the nasal cavity in history).
Allergic reactions: possible skin rash, swelling of the face and tongue; very rarely (less than 1/10 000 cases) - anaphylactic reactions and bronchospasm.
Other: headache.
Very rare cases of development of glaucoma, elevation of intraocular pressure and cataracts have been reported during long-term use of fluticasone propionate, however, a causal relationship during clinical studies of up to 1 year has not been identified.
Contraindications
- children's age up to 4 years;
- hypersensitivity to fluticasone propionate and other components of the drug.
Drug interactions
Due to the very low plasma concentrations of fluticasone propionate, after the application of Flixonase, a clinically significant interaction is unlikely.
With the simultaneous use of flicsonase with ritonavir, which is a strong inhibitor of the CYP3A4 isoenzyme, a significant increase in the concentration of fluticasone propionate in the blood plasma is possible. As a result, there is a sharp decrease in serum cortisol concentration and side effects due to the systemic action of corticosteroids, including Cushing syndrome and suppression of the function of the adrenal cortex, develop.
With simultaneous use of flicsonase with other CYP3A4 isoenzyme inhibitors, there is a negligible (with erythromycin) or a slight (with ketoconazole) increase in plasma concentrations of fluticasone propionate, which does not cause a marked decrease in serum cortisol concentrations.
Pregnancy and Lactation
It is not recommended to prescribe Flixonase during pregnancy. If necessary, the use of the drug in this category of patients should consider the expected benefit of therapy for the mother and the potential risk to the fetus.
Special instructions
Care must be taken when transferring patients with systemic corticosteroid therapy for treatment with Flixonase, if there is reason to assume dysfunction of the adrenal glands.
With prolonged use of the drug requires regular monitoring of the function of the adrenal cortex.
The patient should be warned that if after 7 days of constant use of the drug does not improve, then you should consult a doctor.
With continued use of the drug for more than 6 months, medical monitoring of the patient’s condition is necessary.
In most cases, the use of Flixonase allows you to successfully control the symptoms of seasonal allergic rhinitis, but in some cases, with a very high concentration of allergens in the air in the summer, additional therapy may be required.
For relief of ophthalmic manifestations on the background of successful therapy of seasonal allergic rhinitis, additional treatment may be required.
Overdosage
Symptoms of acute and chronic overdose of the drug is not registered. When administered intranasally to healthy volunteers, 2 mg of fluticasone propionate 2 times / day. no effect on the function of the hypothalamic-pituitary-adrenal system was detected for 7 days.
- Brand name: Flixonase®
- Active ingredient: Fluticasone furoate
- Dosage form: Spray nasal dosed.
- Manufacturer: GlaxoSmithKline
- Country of Origin: Spain
Studies and clinical trials of Fluticasone furoate (Click to expand)
- Fluticasone propionate and mometasone furoate have equivalent transcriptional potencies
- Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial
- Non-inferiority efficacy comparison of mometasone furoate/formoterol versus fluticasone propionate/salmeterol combination therapies in subjects with persistent asthma
- Efficacy and safety of fluticasone furoate nasal spray in adult and adolescent subjects with uncomplicated acute rhinosinusitis
- Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal sprays
- Pharmacokinetic/pharmacodynamic evaluation of urinary cortisol suppression after inhalation of fluticasone propionate and mometasone furoate
- Dissolution in nasal fluid, retention and anti-inflammatory activity of fluticasone furoate in human nasal tissue ex vivo
- Efficacy of fluticasone furoate nasal spray vs. placebo for the treatment of ocular and nasal symptoms of allergic rhinitis: a systematic review
- Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis
- Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen
- Prolonged protection of the new inhaled corticosteroid fluticasone furoate against AMP hyperresponsiveness in patients with asthma
- Comparable in vivo anti-inflammatory potency at trough using inhaled fluticasone furoate and propionate
- Efficacy and safety of once-daily fluticasone furoate nasal spray in children with seasonal allergic rhinitis treated for 2 wk
- HPA axis safety of fluticasone furoate nasal spray once daily in children with perennial allergic rhinitis
- Fluticasone furoate/fluticasone propionate – different drugs with different properties
- Fluticasone furoate (Avamys): new intranasal steroid spray
- Long-acting fluticasone furoate has a superior pharmacological profile to fluticasone propionate in human respiratory cells
- Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma
- Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma
- Absolute Bioavailability of Intranasal Fluticasone Furoate in Healthy Subjects
- A 2-Week, Crossover Study to Investigate the Effect of Fluticasone Furoate Nasal Spray on Short-Term Growth in Children with Allergic Rhinitis
- Preferences of adult patients with allergic rhinitis for the sensory attributes of fluticasone furoate versus fluticasone propionate nasal sprays: A randomized, multicenter, double-blind, single-dose, crossover study
- A new drug for managing both nasal and ocular symptoms of allergic rhinitis: Fluticasone furoate nasal spray
- Evaluation of patients' preferences for triamcinolone acetonide aqueous, fluticasone propionate, and mometasone furoate nasal sprays in patients with allergic rhinitis
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