Prevention and treatment of allergic, seasonal rhinitis (including hay fever) and perennial rhinitis.
Composition:
1 dose of nasal spray contains 50 μg of fluticasone propionate.
Action:
Glucocorticosteroid having a strong local anti-inflammatory effect after administration to the nasal mucosa. Direct absorption through the nasal mucosa is negligible due to poor solubility in water, and most of the drug is finally swallowed. The drug is moderately related to plasma proteins (91%). Fluticasone propionate is rapidly removed from the bloodstream, mainly as a result of hepatic metabolism to an inactive carboxyl derivative. This reaction is catalyzed by CYP3A4. The swallowed portion of the fluticasone propionate dose is largely metabolised by the first pass. T0,5 is 7.8 hours.
Contraindications:
Hypersensitivity to fluticasone propionate or to any of the excipients.
Precautions:
Infection of the upper respiratory tract should be treated properly, however, it does not constitute a special contraindication to the use of the preparation. Patients should be cautious when switching from systemic glucocorticosteroids to treatment with nasal formulation, especially if there is a suspicion of adrenocortical insufficiency. Systemic effects may occur when using nasal corticosteroids, especially if high doses are used over a long period of time. The occurrence of these effects is much less likely than during oral corticosteroids. Long-term use of nasal corticosteroids in doses higher than recommended may result in clinically significant suppression of adrenocortical function. If doses higher than recommended are considered, additional systemic corticosteroids should be considered during the period of exposure to stress or before the planned surgery. After exposure to very high levels of allergen it may be necessary to use additional drugs. It is recommended that the nasal corticosteroid be monitored regularly during long-term treatment for growth in children. If growth is slowed down, treatment should be reviewed and the nasal corticosteroid dose reduced to the lowest dose that provides effective control of disease symptoms. You should also consider consulting a specialist. Avoid contact with the eyes. The preparation contains benzalkonium chloride, which may cause bronchospasm.
Pregnancy and lactation:
The drug can be used in pregnant women and breastfeeding only in cases where in the opinion of the doctor the advantage outweighs the potential risks associated with the use of the drug or alternative treatment.
Side effects:
Very often: nosebleeds. Common: headache, unpleasant taste, unpleasant odor, dryness and irritation of the nasal and throat mucosa. Very rare: hypersensitivity reactions, anaphylactic reactions, bronchospasm, skin rash, angioneurotic edema (mainly swelling of the face, mouth, tongue and throat), glaucoma, increased intraocular pressure, cataracts, perforation of the nasal septum. During intranasal use of corticosteroids, especially if used at high doses over a long period of time, systemic symptoms may occur. The occurrence of these effects is much less likely than during oral corticosteroids. Possible systemic effects include: Cushing's syndrome, curingoid facial features, suppression of the adrenal cortex, slow growth in children and adolescents, cataracts, glaucoma and less frequently, a number of psychiatric symptoms or behavioral changes, including excessive psychomotor activity, sleep disturbances, anxiety, depression or aggression (especially in children).
Dosage:
Intranasally. The basic condition for the effectiveness of the drug is its regular use. The patient should be informed about the lack of immediate therapeutic action.The full therapeutic effect occurs after 3-4 days of regular use in the treatment of allergic rhinitis or after a few weeks in the treatment of nasal polyps.Prevention and treatment of allergic, seasonal rhinitis and perennial rhinitis. Adults and children over 12 years: 2 doses of spray into each nostril once a day, preferably in the morning. In some situations, it is advisable to administer 2 doses to each nostril twice a day. Do not administer more than 4 doses to each nostril each day. The lowest dose should be used to ensure effective symptom control. Elderly patients use the same dose as for adults.Children from 4 to 11 years old: 1 dose to each nostril once a day, preferably in the morning. In some situations, it is advisable to administer 1 dose to each nostril twice daily. Do not administer more than 2 doses to each nostril each day. The lowest dose should be used to ensure effective symptom control.Symptomatic treatment of nasal polyps. Adults. Initial treatment: 2 doses of spray into each nostril twice daily (morning and evening) for 1 to 2 months. The need for treatment with the recommended dose of the drug in the second month should be determined individually for each patient after the end of the first month of treatment. Do not administer more than 4 doses to each nostril each day. Maintenance treatment: 2 doses of spray into each nostril once a day. Do not administer more than 2 doses to each nostril each day. The necessity of treatment for more than 3 months should be determined individually for each patient. Elderly patients use the same dose as for adults. The use of the drug in the treatment of nasal polyps in children and adolescents is not recommended due to the lack of sufficient data.