Flixonase nasal spray 50mcg / dose, 60 dose

Treatment of perennial and seasonal allergic rhinitis, including hay fever (hay fever) in adults and children from 4 years of age:

• pain, feeling of pressure in the area of ??the paranasal sinuses;

• nasal congestion, sneezing, itchy nose;

• lacrimation.

FlixonaseЃ is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly. The maximum therapeutic effect is manifested after 3-4 days of therapy.

Adults and children over 12 years old

1st week: 2 injections into each nostril 1 time / day (200 mcg / day);

from the 2nd week to 3 months: 1 or 2 injections into each nostril 1 time / day (100-200 mcg / day).

The maximum daily dose is 200 mcg / day (no more than 2 injections into each nostril).

Elderly patients are prescribed in the usual dose for adults.

Children aged 4 to 12

1 injection into each nostril 1 time / day (100 mcg / day). Do not exceed the recommended dose (100 mcg / day). In children aged 4 to 12 years, the drug should be used for the shortest possible period of time necessary to achieve control over the symptoms of the disease. It is necessary to contact the attending physician if the child needs to use the drug for a period of time exceeding 2 months a year.

The maximum daily dose is 100 mcg (no more than 1 injection and 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.

Terms of use of the drug

Before use, you should gently shake the bottle, take it by placing your index and middle fingers on both sides 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 operability of the nebulizer: direct the tip away from you, press several times 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 forward slightly while continuing to hold the bottle upright. Then you should begin to inhale through the nose and, while 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 nostril, if necessary. Then completely repeat the described procedure, introducing the tip into the other nostril. After use, blot the handpiece with a clean cloth or handkerchief and close it with a cap.

The spray should be flushed at least once a week. To do this, carefully remove the handpiece 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 back on 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 on the bottle again. Do not use a pin or other sharp object to clean the tip hole.

• hypersensitivity to fluticasone propionate and other components of the drug;

• children under 4 years of age;

• recent injury to the nose or surgery and nasal cavity.

Carefully

Before using the drug, the patient should consult a doctor in the following cases:

• Taking medications to treat HIV infection, such as ritonavir

• taking GCS for the treatment of bronchial asthma, allergies, skin rashes;

• Taking medications to treat fungal infections such as ketoconazole

• taking other potent inhibitors of the CYP3A isoenzyme, such as itraconazole;

• if you have glaucoma or cataracts.

Use with caution if you have a nasal or sinus infection. It should be borne in mind that infectious diseases of the nose require appropriate treatment, but are not a contraindication to the use of FlixonaseЃ nasal spray.

Clinical and pharmacological group: GCS for intranasal use

Pharmaco-therapeutic group: Topical glucocorticosteroid

pharmachologic effect

GCS for intranasal use. It has a pronounced anti-inflammatory effect. With intranasal administration, there is no systemic effect, practically does not inhibit the hypothalamic-pituitary-adrenal system.

There was no significant change in the daily AUC of serum cortisol after administration of fluticasone propionate at a dose of 200 ?g / day compared with placebo (ratio: 1.01, 90% CI - confidence interval from 0.9 to 1.14).

The anti-inflammatory effect of fluticasone propionate is realized as a result of its interaction with glucocorticoid 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. Has a fast anti-inflammatory effect on the nasal mucosa. Antiallergic effect appears within 2-4 hours after the first application. Reduces sneezing, itchy nose, rhinorrhea, nasal congestion, sinus discomfort and pressure around the nose and eyes. It also relieves eye symptoms associated with allergic rhinitis.A decrease in the severity of symptoms (especially nasal congestion) persists for 24 hours after a single application of the spray at a dose of 200 ?g.

Fluticasone propionate improves the quality of life of patients, including physical and social activity.

Pharmacokinetics

Suction

After intranasal administration of fluticasone propionate (200 ?g / day), Cmax in blood plasma in an equilibrium state in most patients is not quantitatively determined (less than 0.01 ng / ml). Cmax in plasma is 0.017 ng / ml. Direct absorption from the nasal mucosa is unlikely due to the low solubility of the drug in water and the swallowing of most of the drug. When taken orally, the absolute bioavailability is low (less than 1%) as a result of a combination of incomplete absorption from the gastrointestinal tract and active metabolism during the 'first pass' through the liver. The total systemic absorption is thus extremely low.

Distribution

In the equilibrium state, fluticasone propionate has a high Vd of about 318 liters. Plasma protein binding is high - about 91%.

Metabolism

Fluticasone propionate is rapidly excreted from the systemic circulation, mainly due to metabolism in the liver with the formation of inactive carboxylic acid through the isoenzyme CYP3A4. The metabolism of the swallowed fraction of fluticasone propionate during the 'first pass' through the liver occurs in the same way.

Withdrawal

Excretion of fluticasone propionate is linear in the dose range from 250 to 1000 ?g and is characterized by a high plasma clearance (1.1 L / min).

Cmax in plasma decreases by approximately 98% within 3-4 hours, and only at very low plasma concentrations there was a final T1 / 2 of 7.8 hours.The renal clearance of fluticasone propionate is insignificant (less than 0.2%), and the inactive metabolite, carboxylic acid, is less five%.

Fluticasone propionate and its metabolites are mainly excreted in the bile through the intestines.

Indications

Treatment of perennial and seasonal allergic rhinitis, including hay fever (hay fever) in adults and children from 4 years of age:

• pain, feeling of pressure in the area of ??the paranasal sinuses;

• nasal congestion, sneezing, itchy nose;

• lacrimation.

Dosage regimen

FlixonaseЃ is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly. The maximum therapeutic effect is manifested after 3-4 days of therapy.

Adults and children over 12 years old

1st week: 2 injections into each nostril 1 time / day (200 mcg / day);

from the 2nd week to 3 months: 1 or 2 injections into each nostril 1 time / day (100-200 mcg / day).

The maximum daily dose is 200 mcg / day (no more than 2 injections into each nostril).

Elderly patients are prescribed in the usual dose for adults.

Children aged 4 to 12

1 injection into each nostril 1 time / day (100 mcg / day). Do not exceed the recommended dose (100 mcg / day). In children aged 4 to 12 years, the drug should be used for the shortest possible period of time necessary to achieve control over the symptoms of the disease. It is necessary to contact the attending physician if the child needs to use the drug for a period of time exceeding 2 months a year.

The maximum daily dose is 100 mcg (no more than 1 injection and 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.

Terms of use of the drug

Before use, you should gently shake the bottle, take it by placing your index and middle fingers on both sides 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 operability of the nebulizer: direct the tip away from you, press several times 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 forward slightly while continuing to hold the bottle upright. Then you should begin to inhale through the nose and, while 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 nostril, if necessary. Then completely repeat the described procedure, introducing the tip into the other nostril. After use, blot the handpiece with a clean cloth or handkerchief and close it with a cap.

The spray should be flushed at least once a week. To do this, carefully remove the handpiece 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 back on 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 on the bottle again. Do not use a pin or other sharp object to clean the tip hole.

Side effect

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1 / 1000), very rarely (<1/10 000, including isolated cases).

Very often, often and infrequently occurring adverse reactions are mainly established on the basis of data from clinical studies. Reactions, which are rare and very rare, are mostly determined from spontaneous messages.

When forming the frequency of occurrence of adverse reactions, the baseline values ??in the placebo group were not taken into account, since they were generally comparable to the active treatment group.

From the immune system: very rarely - hypersensitivity reactions, incl. bronchospasm, rash, swelling of the face and tongue, anaphylactic reactions, anaphylactoid reactions.

From the nervous system: often - headache, a feeling of unpleasant taste and smell. Headache, unpleasant taste and odor have also been reported with other nasal sprays.

From the side of the organ of vision: very rarely - glaucoma, increased intraocular pressure, cataract. A small number of spontaneous reports were associated with long-term drug therapy.

From the respiratory system: very often - epistaxis; often - dryness of the mucous membrane in the nasal cavity and pharynx, irritation of the mucous membrane in the nasal cavity and pharynx (these adverse reactions, as well as nosebleeds were observed with the use of other intranasal drugs); very rarely - perforation of the nasal septum (reported when taking intranasal corticosteroids).

With the use of some intranasal corticosteroids, systemic effects may develop, especially when administered in high doses for a long time.

Contraindications for use

• hypersensitivity to fluticasone propionate and other components of the drug;

• children under 4 years of age;

• recent injury to the nose or surgery and nasal cavity.

Carefully

Before using the drug, the patient should consult a doctor in the following cases:

• Taking medications to treat HIV infection, such as ritonavir

• taking GCS for the treatment of bronchial asthma, allergies, skin rashes;

• Taking medications to treat fungal infections such as ketoconazole

• taking other potent inhibitors of the CYP3A isoenzyme, such as itraconazole;

• if you have glaucoma or cataracts.

Use with caution if you have a nasal or sinus infection. It should be borne in mind that infectious diseases of the nose require appropriate treatment, but are not a contraindication to the use of FlixonaseЃ nasal spray.

Application during pregnancy and lactation

Before using FliksonaseЃ during pregnancy and lactation, you should consult your doctor.

Pregnant and lactating women should be prescribed FlixonaseЃ only if the expected benefit to the patient outweighs any possible risk to the fetus or child.

Application in children

For children aged 4-12 years, it is recommended to prescribe 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). Contraindication: children under 4 years of age.

Use in elderly patients

Elderly patients do not need to adjust the dosage regimen.

special instructions

The drug is indicated for intranasal use only.

For adults and children over 12 years of age: Do not use FlixonaseЃ nasal spray for more than 3 months. If it is necessary to use the drug for more than 3 months, a doctor's consultation is required.

For children from 4 to 12 years old: Do not use FlixonaseЃ nasal spray for more than 2 months. If it is necessary to use the drug for more than 2 months, a doctor's consultation is required. With prolonged use, regular monitoring of the function of the adrenal cortex is necessary.

There are reports of the manifestation of systemic effects when using nasal corticosteroids, especially in high doses for a long time. These effects are much less likely than when taken orally. Systemic effects with the use of nasal corticosteroids can occur, in particular, when used in high doses for a long time. These effects are much less likely to occur than with oral corticosteroids, and they can vary between patients and between different corticosteroid drugs.

Possible systemic effects may include Itsenko-Cushing syndrome, characteristic features of Cushingoid, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggressiveness (in especially in children).

Growth retardation was observed in children receiving therapy with certain intranasal corticosteroids in approved doses. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal corticosteroids. If growth is slowed down, treatment should be reviewed in order to reduce the dose of intranasal GCS, if possible, to the minimum dose that maintains effective control over symptoms and consult a pediatrician.

The concomitant use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient outweighs the possible risk of developing systemic side effects of corticosteroids.

It is recommended that you stop taking the drug and consult your doctor if there is no improvement within 4 days. A consultation with a doctor is also necessary if the patient develops new symptoms, such as severe facial pain, thick nasal discharge, which may indicate an infection and are not associated with an allergy.

Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to the use of FlixonaseЃ nasal spray.

In most patients, fluticasone propionate nasal spray relieves symptoms of seasonal allergic rhinitis, but in some cases, if the concentration of allergens in the air is very high, additional therapy may be necessary.

Additional therapy may be required to relieve eye symptoms with successful treatment of seasonal allergic rhinitis.

To achieve the maximum therapeutic effect, it is necessary to adhere to a regular application regimen.

Care must be taken when transferring patients from systemic GCS therapy to treatment with fluticasone propionate in the form of a nasal spray, especially if adrenal dysfunction is observed against the background of regular monitoring.

FlixonaseЃ, aqueous nasal spray contains benzalkonium chloride, which can cause bronchospasm.

¬ случае контакта с больными ветр¤ной оспой, корью и в случае изменений со стороны зрени¤ рекомендуетс¤ прекратить лечение и обратитьс¤ к врачу.

¬ли¤ние на способность управл¤ть транспортными средствами и механизмами

¬ клинических исследовани¤х не получено данных о вли¤нии препарата на способность управл¤ть транспортными средствами и другими механизмами, однако следует учитывать побочные эффекты, которые может вызвать препарат.

ѕередозировка

?анных об острой и хронической передозировке препарата не имеетс¤.

ѕри интраназальном введении здоровым добровольцам по 2 мг флутиказона пропионата 2 раза/сут в течение 7 дней не оказывало вли¤ни¤ на функцию гипоталамо-гипофизарно-надпочечниковой системы (дозы в 20 раз выше терапевтической). ѕрименение препарата в дозах, выше рекомендованных, в течение длительного времени может привести к временному угнетению функции надпочечников.

¬ случае передозировки пациент должен обратитьс¤ к врачу.

Ћекарственное взаимодействие

ѕри одновременном применении флутиказона пропионата с ритонавиром, который ¤вл¤етс¤ сильным ингибитором изофермента CYP3A4, возможно значительное повышение концентрации флутиказона пропионата в плазме крови. ¬ результате этого происходит резкое уменьшение концентрации кортизола в сыворотке. ѕрименение флутиказона пропионата ингал¤ционное или интраназально и ритонавира приводит к развитию побочных эффектов, обусловленных системным действием v —, включа¤ синдром  ушинга и угнетение функции коры надпочечников. ѕоэтому следует избегать одновременного применени¤ флутиказона пропионата и ритонавира, за исключением случаев, когда возможна¤ польза превышает риск возникновени¤ системных эффектов.

ѕри одновременном применении флутиказона пропионата с другими, менее мощными ингибиторами изофермента CYP3A4, такими как кетоконазол и итраконазол, приводит к повышению экспозиции флутиказона пропионата и повышению риска системных побочных эффектов. –екомендуетс¤ соблюдать осторожность и, по возможности, избегать долгосрочного совместного применени¤ этих препаратов.

»нгибиторы изофермента CYP3A4 вызывают ничтожно малое (эритромицин) или незначительное (кетоконазол) повышение концентраций флутиказона пропионата в плазме, которые не влекут за собой сколько-нибудь заметного снижени¤ концентрации сывороточного кортизола. “ем не менее, следует соблюдать осторожность при сочетанном применении ингибиторов изофермента CYP3A4 (например, кетоконазол) и флутиказона пропионата ввиду возможного повышени¤ плазменной концентрации последнего.

”слови¤ хранени¤

The drug should be stored out of the reach of children at a temperature not exceeding 30 ? C.

Shelf life

Shelf life is 3 years.

Terms of sale

The drug is dispensed without a prescription.

Contacts for inquiries

GLAXOSMITKLINE HELSKER AO (Russia)