Ripened nasal spray 50mcg dose 120 doses
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Active ingredients
Fluticasone
Release form
Spray
Composition
In 1 dose: fluticasone propionate 50 mcg; Excipients: Polysorbate 80 - 0.005 mg, microcrystalline cellulose + carmellose sodium (dispersive cellulose) - 1.55 mg, dextrose - 5 mg, benzalkonium chloride (50% solution) - 0.04 mg, phenylethanol - 0.25 mg, water - qs
Pharmacological effect
GCS for local use. In recommended doses it has a pronounced anti-inflammatory, anti-edema and anti-allergic effect. Anti-inflammatory effect is due to the interaction of the drug with GCS receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of an allergic reaction.; Antiallergic action manifests itself 2-4 hours after the first use. Reduces itching in the nose, sneezing, rhinitis, nasal congestion, discomfort in the region of the paranasal sinuses and the sensation of pressure around the nose and eyes. It relieves eye symptoms associated with allergic rhinitis. When used in therapeutic doses, fluticasone propionate does not show a systemic effect and has virtually no effect on the hypothalamic-pituitary-adrenal system. The effect of the drug lasts for 24 hours after a single application.
Pharmacokinetics
Absorption; After intranasal administration of fluticasone propionate at a dose of 200 mcg / day Cmax in the blood plasma in the majority of patients below the level of determination (<0.01 ng / ml). Absorption from the mucous membrane of the nasal cavity is extremely small due to the low solubility of the drug in water (as a result, most of the dose is swallowed). When oral fluticasone propionate is taken orally, less than 1% of the dose enters the blood due to low absorption and first-pass metabolism. These reasons are due to the extremely low total absorption of the drug from the mucous membrane of the nasal cavity and gastrointestinal tract.; Distribution; Fluticasone propionate in a stable state has a significant Vd - about 318 l. Plasma protein binding is 91%; Metabolism; Exposed to “first pass” effect through the liver.Metabolized in the liver with the participation of CYP3A4 isoenzyme with the formation of an inactive carboxyl metabolite.; Elimination; T1 / 2 is 3 hours. Excreted mainly through the intestines. The renal clearance of fluticasone propionate is less than 0.2%, the renal clearance of a metabolite containing a carboxyl group is less than 5%.
Indications
Prevention and treatment of seasonal and year-round allergic rhinitis.
Contraindications
- children's age up to 4 years; - hypersensitivity to the drug.
Use during pregnancy and lactation
It is not recommended to prescribe the drug during pregnancy. If necessary, consideration should be given to the intended benefit of therapy for the mother and the potential risk to the fetus.; Fluticasone propionate is unlikely to be excreted in breast milk. However, at the time of use of the drug, breastfeeding is recommended to stop.
Dosage and administration
The drug is used intranasally.; Adults and children 12 years and older are prescribed 2 doses (100 mcg) in each nasal passage 1 time / day, preferably in the morning. In some cases, it is necessary to introduce 2 doses in each nasal passage 2 times / day (the maximum daily dose is 400 μg). After reaching the therapeutic effect, you can enter a maintenance dose of 50 mcg / day in each nasal passage (100 mcg). The maximum daily dose should not exceed 400 mcg (4 doses in each nasal passage) .; Elderly patients do not need dose adjustment.; Children between the ages of 4 to 12 years should be prescribed 1 dose (50 mcg) 1 time / day each nasal passage, preferably in the morning. The maximum daily dose should not exceed 200 mcg in each nasal passage. A minimum dosage should be applied to ensure effective elimination of symptoms. To achieve the full therapeutic effect, the drug should be applied regularly. Use of the drug; A bottle with a nasal spray is equipped with a protective cap that protects the tip from dust and contamination. by pressing the dispenser 6 times. Spray mechanism unlocks. If the drug has not been used for more than one week, the vial should be re-prepared and the spraying mechanism unlocked. Next, you need: - clean the nasal cavity; - 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; - start breathing in through the nose and continuing to inhalepress once with your fingers; - exhale through the mouth.; Next, in the same way inject the drug into another nasal passage.; After use, wet the tip with a clean napkin or handkerchief and cover it with a cap. Spray should be washed at least 1 time per week. To do this, remove the tip, rinse it in warm water, dry it and then carefully set it in the upper part of the bottle. Wear protective cap. If the tip hole is clogged, the tip should be removed and left for some time in warm water. Then rinse under running water, dry and put on the bottle again. Do not clean the hole with a pin or other sharp objects. After the package has been opened, the preparation can be used before the expiration date.
Side effects
Determination of the frequency of adverse reactions (as recommended by WHO): very often (≥10%), often (≥1%, but <10%), infrequently (≥0.1%, but <1%), rarely (≥0.01%, but < 0.1%), very rarely, including isolated cases (<0.01%); On the part of the immune system: rarely - bronchospasm, anaphylactic reaction; very rarely - skin hypersensitivity reaction, angioedema. From the nervous system: often - headache, taste disturbance, impaired sense of smell.; From the organ of vision: very rarely - increased intraocular pressure, glaucoma, cataract.; From the respiratory system : very often - nosebleeds; often - dryness and irritation of the mucous membrane of the nasopharynx; very rarely - perforation of the nasal septum. From the skin and subcutaneous tissues: very rarely - ulceration of the subcutaneous mucous layer.; Other: very rarely - growth retardation in children, reduced function of the adrenal cortex, osteoporosis.
Overdose
Symptoms of acute and chronic overdose are not registered. With intranasal administration to volunteers, 2 mg of fluticasone propionate 2 times / day for 7 days did not reveal any effect on the hypothalamic-pituitary-adrenal system.
Interaction with other drugs
Interaction with other drugs is unlikely, since intranasal plasma concentrations of fluticasone are very low. When used simultaneously with strong inhibitors of the CYP3A4 isoenzyme (ritonavir), it is possible to enhance the systemic action of fluticasone and the development of side effects (Cushing's syndrome, inhibition of adrenal cortex function) .; With simultaneous use with other inhibitors of the cytochrome P450 system (erythromycin,ketoconazole) there is a slight increase in the concentration of fluticasone propionate in the blood, which has virtually no effect on the content of cortisol.
special instructions
Simultaneous use with CYP3A4 isoenzyme inhibitors (ritonavir, ketonazole) requires careful monitoring of patients, because these drugs can cause an increase in plasma concentrations of fluticasone propionate; . With prolonged use of the drug Nazarel, regular monitoring of the function of the adrenal cortex is necessary. GCS for intranasal use, even when used in therapeutic doses, can cause growth retardation in children with long-term therapy, it is necessary to monitor the growth of the child regularly and promptly adjust the dose of the drug Nasarel; Rarely effective in treating seasonal allergic rhinitis, however summer time allergens may require additional treatment.; When prescribing the drug, narel patients with tuberculosis, infectious process, herpes Keratitis, as well as those who have recently undergone surgery on the mouth and nose, should carefully evaluate the ratio of the possible risk and the expected benefit.