Rizonel 50 ug / dose of 18g nasal spray metered

The instruction for medical use of Rizonel Torgovoye medicine a name Rizonel Mezhdunarodnoye the unlicensed name Mometazon Lekarstvennaya a form Spray the nasal Structure dosed 50 mkg / a dose, 9 g (70 doses) and 18 g (140 doses) Contains in 1 bottle active agent: a mometazona furoate the monohydrate (micronized) (in terms of a mometazon furoate) 0.518 (0.500) excipients: glycerin, microcrystalline cellulose – sodium carboxymethylcellulose (Avicel RC – 591), citrate sodium a dihydrate, citric acid monohydrate, a chloride benzalkoniya solution (50%), polysorbate 80, water the Viscous uniform suspension of almost white color purified the Description, flavourless. Pharmacotherapeutic group Decongestants and other nasal drugs for topical administration. Glucocorticosteroids. Mometazon the ATX R01AD09 Code the Pharmacological Mometazona Pharmacokinetics Absorption properties the furoate intended for use as nasal aqueous solution has system bioavailability of ˂1% in plasma with a definition threshold in 0:25 pg/ml. Distribution Data are absent as mometazon it is badly absorbed from a nasal cavity. Biotransformation the Swallowed small amount of drug is exposed to intensive primary metabolism in a liver. Elimination the Absorbed part of a mometazon of furoate extensively is metabolized, and metabolites are removed with urine and bile. The pharmacodynamics the Mechanism of action Mometazona furoate is the nasal glucocorticosteroid with local anti-inflammatory activity applied in the doses which are not showing system influence. Possibly the mechanism of antiallergic and anti-inflammatory action of a mometazon of furoate is based on ability to oppress release of mediators of allergic reaction. Mometazona furoate considerably oppresses release of leukotrienes from leukocytes at the patients having allergic rhinitis. In cellular substrate of a mometazon furoate showed high potential activity in inhibition of synthesis and release of IL-1, IL-5, IL-6 and FNO-α, also it is potential inhibitor of products of leukotrienes. In addition, it is extremely potential inhibitor of products of the cytokines produced T2-helperami, IL-4 and IL-5 produced by CD4+ T-helperami. Indications ˗ treatment of symptoms of seasonal or year-round allergic rhinitis at adults and children are more senior than 12 years ˗ treatment of symptoms of seasonal allergic or year-round allergic rhinitis at children from 6 to 11 years ˗ prevention of allergic rhinitis of an average and heavy course (it is recommended in 4 weeks prior to the expected beginning of a season of blossoming) ˗ treatment of nasal polyps at adult patients 18 years the Route of administration and doses Each pressing of spray are more senior releases 100 mg of suspension with the maintenance of a mometazon of furoate of monohydrate 50 mkg of a mometazon of furoate are equivalent. Seasonal and year-round allergic rhinitis At teenagers is aged more senior than 12 years and adults, including elderly patients, the recommended dose of drug makes 2 injections (on 50 mkg everyone) in each nostril of 1 times/days (the general daily dose makes 200 mkg of drug). After achievement of positive clinical effect as maintenance therapy the decrease in a dosage to 1 injection in each nostril is recommended (the general daily dose - 100 mkg). If weakening of symptoms of a disease does not manage to be reached, the dose can be increased to the maximum daily dose and make 4 injections in each nostril of 1 times/days (the general daily dose - 400 mkg). After weakening of symptoms of a disease the dose decline is recommended. At children aged from 6 to 11 years the recommended dose makes 1 injection (on 50 mkg everyone) in each nostril of 1 times/days (the general daily dose - 100 mkg). At some patients with seasonal allergic rhinitis the beginning of clinical effect can be observed in the first 12 hours after the beginning of therapy though full action can be reached only in 48 hours. Therefore for achievement of full clinical effect it is important to use medicine regularly. nasal polyposes the Usual recommended dose for treatment the polypose is 2 injections (50mkg/injection) in each nasal course once in day (general dose of 200 mkg). If after 5-6 weeks of treatment the symptoms remain, it is possible to increase a daily dose to 2 injections in each nasal course twice a day (general daily dose of 400 mkg). The dose should be selected to the minimum effective. If improvement of symptoms is not observed within 5-6 weeks of double reception a day, it is necessary to carry out the assessment of a condition of the patient and to reconsider treatment tactics. Researches of efficiency and safety of spray of a mometazon of furoate in treatment nasal a polypose were conducted within 4 months. Before use the bottle needs to be stirred up and made well 10 single pressing (to an exit of a uniform stream). If the bottle was not used within 14 days and more, before use it is necessary to make 2 single pressing before formation of a uniform stream. It is also necessary to stir up well a bottle before each use. The bottle should not be used after end of the number of injections noted on it or 2 months later after the first use. Side effects In allergic rhinitis it is frequent - nasal bleeding, pharyngitis, burning, irritation and ulcer changes of a mucous membrane of a nose - a headache At a nasal polyp Is very frequent - nasal bleeding Is frequent - irritation in a throat, an upper respiratory tract infection - a headache Seldom - reactions of hypersensitivity, including a bronchospasm and dispnoe Is very rare - an anaphylaxis and a Quincke's disease - disturbance of taste and sense of smell - perforation of a nasal partition there Are rare messages about development of glaucoma, increase in intraocular pressure, a cataract when assigning intranasal corticosteroids. Contraindications - hypersensitivity to active agent or to any of inactive components of nasal spray - presence of the undertreated localized infection with damage of a mucous membrane of a nose - recently undergone surgeries or injuries of a nasal cavity (corticosteroids slow down healing of wounds therefore it is not necessary to appoint corticosteroids for topical intranasal administration before full healing of wounds) Medicinal interactions the Research of interaction was conducted with loratadiny during which interaction was not revealed. Special instructions Immunnosupressiya Mometazona furoate should be used with care if patients have an active or passive form of tuberculosis of a respiratory path or not treated fungal, bacterial or system viral infections. The patients accepting corticosteroids with potential immune suppression, are subject to risk of developing infections (for example, chicken pox, measles) and need medical observation. Local nasal effects In a research of use of nasal spray of a mometazon of furoate within 12 months at patients with year-round allergic rhinitis of an atrophy mucous it was not observed, on the contrary, a mometazona furoate promoted restoration of a normal histologic picture mucous. Nevertheless, the patients applying nasal spray of a mometazon of furoate within several months or more have to undergo periodically inspection on existence of changes of mucous. In case of development of a fungal infection of a nasal cavity or a throat, therapy it is necessary to stop or appoint the corresponding treatment. Constant presence of irritation of nasopharyngeal area can be a reason for therapy cancellation. Use of the drug Rizonel is not recommended in case of perforation of a nasal partition. In clinical trials epistaxis developed much more often at use of a mometazon of furoate, in comparison with placebo. Symptoms of an epistaxis most often passed independently and were light severity. Rizonel contains a benzalkoniya chloride which can cause irritation. Systemic action of corticosteroids Systemic action of nasal corticosteroids can develop at reception in high doses for a long time. This manifestation is more probable at reception of oral corticosteroids and can vary at individual patients and depending on a type of corticosteroids. Potential system effects can include Cushing's syndrome, cushingoid signs, adrenal insufficiency, a growth inhibition at children and teenagers, development of a cataract, glaucoma and, more seldom, various mental and behavioural disturbances, including psychomotor hyperactivity, sleep disorders, concern, a depression or aggression (in particular at children). It was reported about cases of increase in intraocular pressure at use of intranasal corticosteroids. The patients switched from long-term use of system corticosteroids to nasal spray of a mometazon of furoate require special attention. Cancellation of system corticosteroids at such patients can result in adrenal insufficiency within several months before normal restoration of gipotalamo-hypophysial function. In case of development in patients of signs and symptoms of adrenal insufficiency or a withdrawal (for example, joint and muscles pain, slackness and the beginning depression), despite simplification of nasal symptoms, therapy by system corticosteroids has to be resumed, and other types of therapy with the appropriate measures are connected. The existing earlier allergic background, such as allergic conjunctivitis and eczema suppressed by reception of system corticosteroids can unmask similar transition. Use of drug in the doses exceeding recommended can result in clinically significant adrenal insufficiency. In case of need reception of the doses exceeding recommended it is necessary to use in addition system corticosteroids about time of the period of elective surgery or the stressful period. nasal polyposes the Efficiency and safety of nasal spray of a mometazon of furoate was not studied in treatment of unilateral polyps, the polyps associated with cystous fibrosis or at full obstruction by polyps of nasal cavities. At unilateral to a polypose, shown irregularly or shown unusually, in particular in the presence of ulcers or bleedings, it is necessary to carry out the further assessment. Influence on growth at children At the prolonged treatment at children it is necessary to carry out growth change control. In case of a growth inhibition it is necessary to lower a drug dose to minimum effective for the supporting treatment. In addition, it is necessary to consult with the pediatrician. Ekstranazalny symptoms In spite of the fact that use of the drug Rizonel will allow to control nasal symptoms at bigger number of patients, for simplification of other symptoms, for example, of eye, it is necessary to perform additional therapy. Pregnancy Data on use of a mometazon of furoate for pregnant women are limited. Researches at animals revealed reproductive toxicity. As well as in a case with other nasal corticosteroids, Rizonel it is possible to apply during pregnancy if the potential advantage exceeds potential risk for mother, a fruit or the newborn. The children who were born from mothers receiving therapy by corticosteroids during pregnancy have to be examined on presence of adrenal insufficiency. A lactation It is unknown whether the mometazona furoate with breast milk is excreted. As well as in a case with other nasal corticosteroids, it is necessary or to stop a lactation, or stop/are temporary to cancel therapy by the drug Rizonel, in view of a ratio advantage/risk for the child and mother. Fertility Clinical data on influences of a mometazon of furoate on fertility are absent. Researches at animals revealed reproductive toxicity, but influences on fertility did not show. Influence is not established to feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Overdose Symptoms Excess reception of corticosteroids, is inhalation or orally, can lead to suppression gipotalamo - a hypophysial and adrenal system. Treatment Because the system bioavailability of Rizonel spray is less than 1%, overdose is improbable will demand other therapy, except observation. The form of release and packing On 9 g or 18 g of drug place in the bottle from polyethylene of high density supplied with a spray and a cover of white color. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions in the dry, protected from light place at a temperature not higher than 25 wasps. To store out of children's reach! A period of storage 3 years not to use drug after an expiration date. Prescription status According to the prescription ABDI IBRAHIM Istanbul Producer, Turkey the Owner of the registration certificate of "ABDI IBRAHIM" Istanbul, Turkey the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products and responsible for post-registration observation of safety of medicine of Abdi Ibrahim Global Pharm LLP, the Republic of Kazakhstan, the Almaty Region, the Iliysky area, Industrial zone 282, ph.: +7 (727) 356-11-00, 8-800-070-1100, the e-mail address:
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