Flixonase nasal spray 50mkg dose 120dose
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Active ingredients
Fluticasone
Release form
Spray
Composition
Active ingredient: Fluticasone propionate (micronized) Excipients: Dextrose-5, 00mg Avitsel RC591 (microcrystalline cellulose, carmellose sodium) - 1, 50mg Phenylethanol- 0, 25mg Benzalkonium chloride solution- 0, 02mg, 40, 40, 40, 40 oz. pH 6, 3 - 6, 5 Purified water to 100, 00 Add to achieve a pH of 6, 3-6, 5, if the pH of the final suspension is above 6, 8. Concentration of the active substance (mcg): 0, 05 mg.
Pharmacological effect
GCS for intranasal use. It has a pronounced anti-inflammatory effect. With intranasal administration, no systemic action is observed, and the hypothalamic-pituitary-adrenal system is practically inhibited. A significant change in the daily AUC index of serum cortisol was not detected after fluticasone propionate was administered at a dose of 200 mcg / day compared to placebo (ratio: 1.01, 90% DI - 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. It has a quick anti-inflammatory effect on the nasal mucosa. Antiallergic effect appears already 2-4 hours 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 in 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 (200 mcg / day) Cmax in the blood plasma in the equilibrium state in most patients is not quantified (less than 0.01 ng / ml). Cmax in plasma is 0.017 ng / ml. Direct absorption from the mucous membrane of the nasal cavity is unlikely due to the low solubility of the drug in water and swallowing most of the drug.When administered 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 passage through the liver. The overall systemic absorption is thus extremely low. DistributionIn the equilibrium state, fluticasone propionate has a large Vd - about 318 l. Binding to plasma proteins is high - about 91%. MetabolismFluticasone propionate is rapidly eliminated from the systemic circulation, mainly due to metabolism in the liver with the formation of an inactive carbohydrate acid by isoenzyme CYP3A4. The metabolism of the swallowed fraction of fluticasone propionate during the first passage through the liver occurs in the same way. Excretion The release of fluticasone propionate is linear in the dose range from 250 to 1000 μg 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 concentrations in plasma, a final T1 / 2 of 7.8 h was observed. The renal clearance of fluticasone propionate is insignificant (less than 0.2%), and the inactive metabolite, carboxylic acid, is less than 5%. Fl tikazona propionate and its metabolites are mostly excreted in bile via the intestine.
Indications
Prevention and treatment of seasonal and year-round allergic rhinitis.
Contraindications
Hypersensitivity to fluticasone propionate or any other component of the drug; children up to 4 years old. With caution Simultaneous intake with strong inhibitors of CYP3A4 isoenzyme, such as ritonavir and ketoconazole, may cause an increase in plasma concentrations of fluticasone propionate. When used simultaneously with other dosage forms of glucocorticosteroids. In the presence of nasal infections or paranasal sinuses. At the same time, infectious diseases of the nose require appropriate treatment, but are not Contraindications to the use of Flixonaz nasal spray. After a recent nose injury or surgery in the nasal cavity or in the presence of ulceration of the nasal mucosa.
Precautionary measures
Take with caution if you have an infection of the nasal cavity or sinuses. Note that infectious diseases of the nose require appropriate treatment, but are not a contraindication to the use of nasal spray Flixonase.
Use during pregnancy and lactation
Before using Flixonase during pregnancy and lactation, you should consult with your doctor. Flixonase can be prescribed to pregnant and lactating women only when the expected benefit for the patient exceeds any possible risk to the fetus or child.
Dosage and administration
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 For the prevention and treatment of seasonal and year-round allergic rhinitis, 2 injections into each nostril 1 time per day, preferably in the morning (200 mcg per day). In some cases, you can apply 2 injections to each nostril 2 times a day (400 μg per day) for a short time in order to achieve control over the symptoms, after which the dose can be reduced. The maximum daily dose is 400 mcg (no more than 4 injections in each nostril). Special patient groups Elderly patients Normal dose for adults. Children from 4 to 12 years For the prevention and treatment of seasonal and perennial allergic rhinitis 1 s injection (50 mcg) in each nostril 1 time per day, preferably in the morning. In some cases, it may be necessary to administer 1 injection into each nostril 2 times a day. The maximum daily dose is 200 mcg (no more than 2 injections in each nostril). Using an inhaler 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, the condition of the sprayer should be checked: send the tip away from you, make several presses until a small cloud emerges 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 the nose and, while 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 cap it. Rinse the sprayer at least 1 time per 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 set the tip to its original place at the top of the vial. 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.
Side effects
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (more than 1/10), often (more than 1/100 and less than 1/10), infrequently (more than 1/1000 and less than 1/100), rarely (more than 1/10 000 and less than 1/1000), very rarely (less than 1 / 10,000, including isolated cases). Very often, often and infrequently occurring adverse events are mainly established on the basis of clinical research data. Phenomena that occur rarely and very rarely are mainly determined from spontaneous messages. When forming the frequency of occurrence of adverse events, the background indicators in the placebo group were not taken into account, since they were generally comparable to the active treatment group. On the part of the immune system: very rarely - hypersensitivity reactions (including bronchospasm, rash, swelling of the face and tongue, anaphylactic reactions), anaphylactoid reactions. On the part of the nervous system: often - headache, feeling of unpleasant taste and smell. The appearance of headache, unpleasant taste and odor has also been reported when using other nasal sprays. On the part of the organ of vision: very rarely - glaucoma, increased intraocular pressure, cataracts. The causal relationship between the intranasal intake of fluticasone propionate and these phenomena during clinical studies of up to 1 year has not been identified.On the part of the respiratory system, organs of the chest and mediastinum: very often - nosebleeds; often - dryness in the nasal cavity and pharynx, irritation of the mucous membrane of the nasal cavity and pharynx (reported as with the use of other intranasal preparations); very rarely - perforation of the nasal septum (reported when taking intranasal glucocorticosteroids).
Overdose
There is no data on acute and chronic overdose of the drug. When administered to healthy volunteers, 2 mg of fluticasone propionate 2 times / day for 7 days did not affect the function of the hypothalamic-pituitary-adrenal system (the dose is 20 times higher than the therapeutic one). The use of the drug in doses higher than recommended for a long time can lead to a temporary inhibition of adrenal function. In case of overdose, the patient should consult a doctor.
Interaction with other drugs
With simultaneous use of fluticasone propionate 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. The use of fluticasone propionate inhalation or intranasal and ritonavir leads to the development of side effects due to the systemic action of the GCS, including Cushing syndrome and suppression of the function of the adrenal cortex. Therefore, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless possible benefits outweigh the risk of systemic effects. When fluticasone propionate is used simultaneously with other less potent inhibitors of the CYP3A4 isoenzyme such as ketoconazole and itraconazole, the exposure of fluticasone propionate and increased risk of systemic side effects. It is recommended that caution be taken and, if possible, long-term co-administration of these drugs be avoided. CYP3A4 isoenzyme inhibitors cause a negligible (erythromycin) or a slight (ketoconazole) increase in plasma concentrations of fluticasone propionate, which do not entail any noticeable decrease in serum cortisol concentration.Nevertheless, caution should be exercised in the combined use of inhibitors of the isoenzyme CYP3A4 (for example, ketoconazole) and fluticasone propionate due to the possible increase in the plasma concentration of the latter.
special instructions
The drug is indicated only for intranasal use. For adults and children 12 years of age: Flixonase nasal spray should not be used for more than 3 months. If it is necessary to use the drug for more than 3 months, it is necessary to consult a doctor. For children from 4 to 12 years old: do not use Fliksonaz nasal spray for more than 2 months. If necessary, use of the drug for more than 2 months is necessary to consult a doctor. With prolonged use requires regular monitoring of the function of the adrenal cortex. There are reports of the manifestation of systemic effects when using nasal GCS, especially in high doses for a long time. These effects are much less likely than ingestion. Systemic effects when using nasal corticosteroids can occur, in particular, when used in high doses for a long time. The likelihood of these effects is much lower than when taking corticosteroids orally, and they can vary in individual patients and between different corticosteroid drugs. Possible systemic effects may include Itsenko-Cushing syndrome, characteristic signs of cushingoid, suppression of adrenal function, stunting in children and adolescents , cataracts, glaucoma, and more rarely a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggressiveness (especially children). Children receiving therapy with certain intranasal corticosteroids in the allowed doses experienced growth retardation. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal GCS. When growth is slowed down, treatment should be reviewed to reduce the dose of intranasal GCS, if possible, to the minimum dose that maintains effective symptom control and consult a pediatrician. Simultaneous use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient exceeds possible risk of systemic side effects of corticosteroids. It is recommended to stop taking the drug and consult a doctor if improvement from utstvuet for 4 days.Consultation with a physician is also necessary if the patient has new symptoms, such as severe facial pain, thick nasal discharge, which may indicate an infection and are not associated with allergies. Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to the use of nasal spray Fliksonaz. In most patients, fluticasone propionate nasal spray eliminates the symptoms of seasonal allergic rhinitis, but in some cases, with a very high concentration allergies in the air, additional therapy may be needed. Additional therapy may be required to relieve eye symptoms during successful therapy of seasonal allergic rhinitis. To achieve the maximum therapeutic effect, a regular regimen of application must be followed. Care should be taken when transferring patients with systemic GCS therapy to treatment with fluticasone propionate in the form of a nasal spray, especially if there is a dysfunction of the adrenal glands against the background of Flicsonase, nasal water spray contains benzalkonium chloride, which can cause bronchospasm. In case of contact with patients with chickenpox, measles and in case of changes in the view, it is recommended to stop treatment and consult a doctor. Effect on ability to drive vehicles and mechanisms In clinical studies have not obtained data on the effect of the drug on the ability to drive vehicles and other mechanisms, however, side effects that can cause a drug.