Flixonase, 1 piece, 50 mcg/dose, metered nasal spray


Flixonase, 1 piece, 50 mcg/dose, metered nasal spray

Intranasally.

For adults and children over 12 years of age, for the prevention and treatment of allergic rhinitis, the recommended dose is 2 injections into each nasal passage once a day, preferably in the morning (total dose 200 mcg/day). Once symptom control is achieved, the dose can be reduced to 1 spray in each nostril once a day (100 mcg/day).

In some cases, 2 injections into each nasal passage 2 times a day (total dose 400 mcg/day) for a short time in order to achieve control of symptoms, after which the dose can be reduced.

The maximum daily dose (total dose 400 mcg/day) is no more than 4 injections into each nasal passage.

Elderly patients: Usual adult dose.

For children aged 4–12 years, for the prevention and treatment of seasonal allergic rhinitis - 1 injection (50 mcg) into each nasal passage 1 time per day. The maximum daily dose (total dose 200 mcg/day) is no more than 2 injections into each nasal passage.

To achieve the full therapeutic effect, regular use of the drug is important. The drug may not provide an immediate therapeutic effect; maximum relief occurs after 3-4 days of treatment.

Using an inhaler

Before use, shake the bottle carefully, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom.

When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer: point the tip away from you, make several presses until a small cloud appears from the tip. Next, you need to clear your nose (blow your nose lightly). Close one nasal passage and insert the tip into the other nasal passage. Tilt your head slightly forward while continuing to hold the bottle vertically. Then you should begin to inhale through your nose and, continuing to inhale, press once with your fingers to spray the drug. Exhale through your mouth. Repeat the procedure for a second spray into the same nasal passage, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nasal passage.

After use, blot the tip with a clean napkin or handkerchief and close it with the cap.

The sprayer should be washed at least once a week. To do this, carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the brown bottle. Put on a protective cap.

If the tip hole is clogged, the tip should be removed as described above and left in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.

Flixonase for allergic rhinitis, nasal spray, 50 mcg/dose, 120 doses

A country

Spain
Country of manufacture may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Fluticasone

Description

Flixonase is a new level in the treatment of allergic rhinitis!* It is a nasal spray to relieve the symptoms of year-round and seasonal allergic rhinitis.
The active ingredient is fluticasone propionate. Helps relieve symptoms of allergic rhinitis for 24 hours.** Helps combat the 6 symptoms of allergic rhinitis**, such as: - Runny nose - Stuffy nose - Sneezing - Itchy nose - Watery eyes - Pain and pressure in the sinuses. * The first over-the-counter intranasal corticosteroid for the treatment of allergic rhinitis. It has a fundamentally different mechanism of action compared to antihistamines. ** Instructions for medical use, RU ПN015682/01 dated 04/08/2009

Compound

Composition for 1 dose: Active ingredient, mg: Fluticasone propionate (micronized) 0.05 Excipients Dextrose 5.00 Avicel RC591 (microcrystalline cellulose, sodium carmellose) 1.50 Phenylethanol 0.25 Benzalkonium chloride1 0.02 Polysorbate 80 0.005 Hydrochloric acid 2 to pH 6.3–6.5 Purified water to 100.00

Product description

White, opaque suspension, free of foreign particles

pharmachologic effect

Mechanism of action Fluticasone propionate is a substance with a strong anti-inflammatory effect.
With intranasal administration, no pronounced systemic effect or inhibition of the hypothalamic-pituitary-adrenal system is observed. There was no significant change in the daily area under the pharmacokinetic curve of serum cortisol after administration of fluticasone propionate at a dose of 200 mcg/day compared with placebo (ratio: 1.01, 90% CI - confidence interval 0.9 to 1.14). Fluticasone propionate has an anti-inflammatory effect due to interaction with glucocorticosteroid receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils; reduces the production of inflammatory mediators and other biologically active substances (histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of the allergic reaction. Fluticasone propionate has a rapid anti-inflammatory effect on the nasal mucosa, and its antiallergic effect appears within 2-4 hours after the first application. Reduces sneezing, itchy nose, runny nose, nasal congestion, discomfort in the sinuses and pressure around the nose and eyes. In addition, it relieves eye symptoms associated with allergic rhinitis. A decrease in the severity of symptoms (especially nasal congestion) persists for 24 hours after a single administration of a spray at a dose of 200 mcg. Fluticasone propionate improves the quality of life of patients, including physical and social activity. Pharmacokinetics Absorption After intranasal administration of fluticasone propionate at a dose of 200 mcg/day, maximum steady-state plasma concentrations are not quantitatively determined in most patients (less than 0.01 ng/ml). The highest plasma concentration was recorded at 0.017 ng/mL. Direct absorption from the nasal cavity is unlikely due to low water solubility and ingestion of most of the drug. Absolute oral bioavailability is low (less than 1%) as a result of a combination of incomplete absorption from the gastrointestinal tract and extensive first-pass metabolism through the liver. The total systemic absorption is therefore extremely low. Distribution Fluticasone propionate has a large volume of distribution at steady state (approximately 318 L). The connection with blood plasma proteins is high (91%). Metabolism Fluticasone propionate is rapidly eliminated from the systemic circulation mainly due to metabolism in the liver with the formation of inactive carboxylic acid through the CYP3A4 isoenzyme of the cytochrome P450 system. The metabolism of the ingested fraction of fluticasone propionate during its first passage through the liver occurs in the same way. Elimination The elimination of fluticasone propionate is linear in the dose range from 250 to 1000 mcg and is characterized by a high plasma clearance (1.1 l/min). The maximum plasma concentration decreases by approximately 98% within 3-4 hours, and only at very low plasma concentrations a terminal half-life of 7.8 hours was observed. The renal clearance of fluticasone propionate is negligible (less than 0.2%), and the inactive metabolite is negligible. carboxylic acid – less than 5%. Fluticasone propionate and its metabolites are mainly excreted in bile through the intestines

Indications for use

Treatment of year-round and seasonal allergic rhinitis, including hay fever (hay fever) in adults and children over 4 years of age (elimination of symptoms such as pain and pressure in the paranasal sinuses, nasal congestion, runny nose, sneezing, itchy nose, lacrimation) .

Contraindications

Hypersensitivity to fluticasone propionate or any other component of the drug. — Children under 4 years of age. — Recent nasal trauma or surgery in the nasal cavity

Carefully

Before using the drug, you should consult your doctor if you are taking: - medications to treat HIV infection, such as ritonavir; - glucocorticosteroids for the treatment of bronchial asthma, allergies, skin rashes; - medicines to treat fungal infections, such as ketoconazole; - other potent inhibitors of the CYP3A isoenzyme, for example, itraconazole. Also, consult your doctor if you have glaucoma or cataracts. Use with caution if you have a fever or infection of the nasal cavity or paranasal sinuses. It should be borne in mind that infectious diseases of the nose require appropriate treatment, but are not a contraindication to the use of Flixonase nasal spray.

Use during pregnancy and lactation

Before using Flixonase during pregnancy and lactation, you should consult your doctor. Pregnant and lactating women should only be prescribed Flixonase if the expected benefit to the patient outweighs any possible risk to the fetus or child.

Directions for use and doses

Only intranasally. To achieve the full therapeutic effect, it is necessary to use the drug regularly. The maximum therapeutic effect can be achieved after 3-4 days of therapy. Adults and children over 12 years of age 1st week: 2 sprays in each nostril once a day (200 mcg per day). From the 2nd week to 3 months: 1 or 2 injections into each nostril once a day (100-200 mcg per day). The maximum daily dose is 200 mcg per day (no more than 2 injections into each nostril). Special groups of patients Elderly patients Usual dose for adults. Children from 4 to 12 years old: 1 injection into each nostril 1 time per day (100 mcg per day). Do not exceed the recommended dose (100 mcg per day). Children aged 4 to 12 years should use the drug for the shortest period of time necessary to achieve control of symptoms. A doctor should be consulted if the child needs to use the drug for a period of time exceeding 2 months per year. The maximum daily dose is 100 mcg (no more than 1 injection into each nostril). If there is no effect from the use of the drug in all age groups of patients, it is necessary to consult a doctor. Instructions for use Before use, carefully shake the bottle, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer: point the tip away from you, make several presses until a small cloud appears from the tip. Next, you need to clear your nose (blow your nose). Close one nostril and insert the tip into the other nostril. Tilt your head slightly forward while continuing to hold the bottle vertically. Then you should begin to inhale through your nose and, continuing to inhale, press once with your fingers to spray the drug. Exhale through your mouth. Repeat the procedure for a second spray in the same nostril, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nostril. After use, blot the tip with a clean napkin or handkerchief and close it with the cap. The sprayer should be washed at least once a week. To do this, carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the bottle. Put on the protective cap. If the tip hole is clogged, the tip should be removed as described above and left in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.

Side effect

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and Overdose There is no data on acute or chronic overdose of fluticasone propionate. In healthy volunteers, intranasal administration of 2 mg fluticasone propionate twice a day for 7 days does not had an effect on the function of the hypothalamic-pituitary-adrenal system (doses 20 times higher than therapeutic). Use of the drug in doses higher than recommended for a long period of time can lead to temporary suppression of adrenal function. In case of overdose, consult a doctor.

Interaction with other drugs

Ritonavir (a highly active inhibitor of the CYP3A4 isoenzyme of the cytochrome P450 enzyme system) is capable of significantly increasing the concentrations of fluticasone propionate in the blood plasma, resulting in a sharp decrease in the concentration of cortisol in the serum. The use of inhaled or intranasal fluticasone propionate and ritonavir leads to the development of systemic glucocorticoid effects, including Cushing's syndrome and suppression of adrenal function. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential benefits outweigh the risks of systemic effects. Concomitant use of fluticasone propionate for inhalation and less potent inhibitors of the CYP3A isoenzyme, such as ketoconazole and itraconazole, leads to increased exposure of fluticasone propionate and an increased risk of systemic side effects. Caution is recommended and, if possible, avoiding long-term co-administration of these drugs. Inhibitors of the CYP3A4 isoenzyme of the cytochrome P450 enzyme system cause a negligible (erythromycin) or insignificant (ketoconazole) increase in plasma fluticasone propionate concentrations, which do not entail any noticeable decrease in serum cortisol concentrations. However, caution should be exercised when combining inhibitors of the CYP3A4 isoenzyme of the cytochrome P450 enzyme system (for example, ketoconazole) and fluticasone propionate due to a possible increase in the plasma concentration of the latter.

special instructions

The drug is indicated for intranasal use only. For adults and children over 12 years of age: Do not use Flixonase nasal spray for more than 3 months. If it is necessary to use the drug for more than 3 months, consult a doctor. For children from 4 to 12 years old: do not use Flixonase nasal spray for more than 2 months. If it is necessary to use the drug for more than 2 months, consult a doctor. With long-term use, regular monitoring of the function of the adrenal cortex is necessary. There are reports of systemic effects when using nasal glucocorticosteroids, especially in high doses for a long time. These effects are much less likely than with oral administration. Systemic effects may occur with nasal corticosteroids, particularly when high doses are used over a long period of time. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid medications. Possible systemic effects may include Cushing's syndrome, Cushing's signature features, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a number of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (in characteristics in children). In children receiving therapy with certain intranasal corticosteroids in approved doses, a decrease in growth rate was observed. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal glucocorticosteroids. If growth slows, treatment should be reconsidered to reduce the dose of intranasal glucocorticosteroid, if possible, to the minimum dose that ensures effective control of symptoms and contact a pediatrician. The simultaneous use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient outweighs the possible risk of systemic side effects of corticosteroids (see section "Interaction with other drugs"). The full effect of fluticasone propionate in the form of a nasal spray may appear only after 3-4 days of treatment. It is recommended to stop taking the drug and consult a doctor if there is no improvement within 4 days. Consultation with a doctor is also necessary if you develop new symptoms, such as severe facial pain, thick nasal discharge, which may indicate an infection and are not related to allergies. Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to the use of Flixonase nasal spray. For most patients, fluticasone propionate nasal spray relieves the symptoms of seasonal allergic rhinitis, but in some cases, when the concentration of allergens in the air is very high, additional therapy may be necessary. Additional therapy may be required to relieve eye symptoms during successful treatment of seasonal allergic rhinitis. To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use. Caution should be exercised when transferring patients from systemic corticosteroid therapy to treatment with fluticasone propionate nasal spray, especially if adrenal dysfunction is observed during regular monitoring. Flixonase aqueous nasal spray contains benzalkonium chloride, which may cause bronchospasm. Visual impairment has been observed in patients receiving systemic and/or local glucocorticosteroids. For blurred vision and other visual disturbances, possible causes should be assessed, which may include cataracts, glaucoma and central serous chorioretinopathy. In case of contact with patients with chickenpox, measles, or in case of changes in vision, it is recommended to stop treatment and consult a doctor.

Release form

Nasal spray metered, 50 mcg/dose. Primary packaging 120 doses in a yellow glass bottle, type I or type III. Each bottle is equipped with a dispensing device. An adapter for intranasal administration is attached to the bottle and dosing device. The bottle is additionally equipped with a cap to protect the adapter from dust. 120 doses in a polypropylene bottle. Each bottle is equipped with a dispensing device. An adapter for intranasal administration is attached to the bottle and dosing device. The bottle is additionally equipped with a cap to protect the adapter from dust. Secondary packaging One bottle each along with a dispensing device, an adapter, a protective cap (assembled) and instructions for use in a cardboard box. Secondary packaging is allowed to have a first-opening control.

Storage conditions

Store at a temperature not exceeding 30C. Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date stated on the packaging.

FLIXONASE nasal spray. 50 mcg/dose vial-doses 60 doses

Directions for use and doses

Flixonase is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly. For the prevention and treatment of seasonal allergic rhinitis and year-round allergic rhinitis, adults and children over 12 years of age are prescribed 100 mcg (2 doses) in each nostril 1 time per day (total dose 200 mcg/day), preferably in the morning. After achieving control of symptoms, you can prescribe 50 mcg (1 dose) in each nostril 1 time / day (total dose 100 mcg / day). In some cases, it is necessary to use 100 mcg (2 doses) in each nostril 2 times / day (total dose 400 mcg / day) for a short time in order to achieve control of symptoms, after which the dose can be reduced. The maximum daily dose of the drug is 400 mcg (4 doses in each nostril). Elderly patients do not require dosage adjustment. For the prevention and treatment of seasonal allergic rhinitis, it is recommended that children aged 4-12 years be prescribed 50 mcg (1 dose) in each nostril 1 time/day. The maximum daily dose of the drug is 200 mcg (2 doses in each nostril). The maximum therapeutic effect appears after 3-4 days of therapy. To achieve the full therapeutic effect, it is necessary to use the drug regularly. Directions for use: Before use, carefully shake the bottle, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer (pointing the tip away from you, make several presses until a small cloud appears from the tip). Next you need:

  • clear your nose (blow your nose lightly),
  • 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 inhaling through your nose and, continuing to inhale, press once with your fingers to spray the drug,
  • exhale through your mouth.

Repeat the procedure for a second spray in the same nostril, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nostril. After use, blot the tip with a clean napkin or handkerchief and close it with the cap. The sprayer should be washed at least once a week. For this purpose, you must carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the brown bottle. Put on the protective cap. If the hole in the tip is clogged, the tip should be removed as described above and left in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.

Flixonase

Flixonase is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly.

Adults and children over 12 years old

Prescribe 100 mcg (2 doses) in each nostril 1 time/day (total dose 200 mcg/day), preferably in the morning. After achieving control of symptoms, you can prescribe 50 mcg (1 dose) in each nostril 1 time / day (total dose 100 mcg / day).

In some cases, it is necessary to use 100 mcg (2 doses) in each nostril 2 times / day (total dose 400 mcg / day) for a short time in order to achieve control of symptoms, after which the dose can be reduced. The maximum daily dose of the drug is 400 mcg (4 doses in each nostril).

Elderly patients

no dosage regimen adjustment is required.

Children aged 4-12 years

It is recommended to administer 50 mcg (1 dose) in each nostril 1 time/day. The maximum daily dose of the drug is 200 mcg (2 doses in each nostril).

The maximum therapeutic effect appears after 3-4 days of therapy. To achieve the full therapeutic effect, it is necessary to use the drug regularly.

Mode of application

Before use, shake the bottle carefully, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer (pointing the tip away from you, make several presses until a small cloud appears from the tip).

Next you need:

- clear your nose (blow your nose lightly);

- close one nostril and insert the tip into the other nostril;

— tilt your head slightly forward, continuing to hold the aerosol bottle vertically;

- begin to inhale through your nose and, continuing to inhale, press once with your fingers to spray the drug;

- exhale through your mouth.

Repeat the procedure for a second spray in the same nostril, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nostril.

After use, blot the tip with a clean napkin or handkerchief and close it with the cap.

The sprayer should be washed at least once a week. For this purpose, you must carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the brown bottle. Put on the protective cap. If the tip hole is clogged, the tip should be removed as described above and left in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.

Flixonase nasal spray 50 mcg 120 doses (Glaxo)

Flixonase is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly. For the prevention and treatment of seasonal allergic rhinitis and year-round allergic rhinitis, adults and children over 12 years of age are prescribed 100 mcg (2 doses) in each nostril 1 time per day (total dose 200 mcg/day), preferably in the morning. After achieving control of symptoms, you can prescribe 50 mcg (1 dose) in each nostril 1 time / day (total dose 100 mcg / day). In some cases, it is necessary to use 100 mcg (2 doses) in each nostril 2 times / day (total dose 400 mcg / day) for a short time in order to achieve control of symptoms, after which the dose can be reduced. The maximum daily dose of the drug is 400 mcg (4 doses in each nostril). Elderly patients do not require dosage adjustment. For the prevention and treatment of seasonal allergic rhinitis, it is recommended that children aged 4-12 years be prescribed 50 mcg (1 dose) in each nostril 1 time/day. The maximum daily dose of the drug is 200 mcg (2 doses in each nostril). The maximum therapeutic effect appears after 3-4 days of therapy. To achieve the full therapeutic effect, it is necessary to use the drug regularly. Directions for use: Before use, carefully shake the bottle and take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer (pointing the tip away from you, make several presses until a small cloud appears from the tip). Next you need to: Repeat the procedure for a second spray in the same nostril, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nostril. After use, blot the tip with a clean napkin or handkerchief and close it with the cap. The sprayer should be washed at least once a week. For this purpose, you must carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the brown bottle. Put on the protective cap. If the tip hole is clogged, the tip should be removed as described above and left in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.

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