Nasobek nasal spray 50mcg/dose 200 doses №1

Name:
Nasobek
Description:
Opaque suspension of white color, does not contain visible foreign particles. The main active ingredient Beclomethasone Release form Dosed nasal spray 50 mcg / dose in a bottle of 200 doses. Suspension in a polyethylene bottle with a capacity of 30 ml, nominally contains 200 doses. The bottle is equipped with a dosing valve. 1 bottle with instructions for use in a cardboard box. Dosage 50 mcg / 1 dose 200 doses Pharmacodynamics Beclomethasone dipropionate (BDP) is a diester of beclomethasone, a synthetic glucocorticoid that has anti-inflammatory and immunosuppressive effects. At recommended doses, the drug has a local effect on the lungs without significant systemic effects, although the mechanism of this action is not yet known. When applied topically, beclomethasone 17,21-dipropionate (BDP) produces a powerful anti-inflammatory and vasoconstrictor effect. BDP is a prodrug with weak binding affinity for corticosteroid receptors. It is hydrolyzed by esterases to a highly active metabolite of beclomethasone-17-monopropionate (B-17-MP), which has a high local anti-inflammatory activity. Beclomethasone dipropionate is used for the preventive treatment of hay fever before exposure to an allergen. Further, regular use of BDP is continued to prevent recurrence of allergy symptoms. PharmacokineticsAbsorption Following intranasal administration of BDP to healthy male volunteers, systemic absorption was assessed by measuring plasma concentrations of its active metabolite, B-17-MP. Its absolute bioavailability after intranasal administration is 44% (95% CI 28%, 70%). After intranasal application, 1% of the dose is absorbed by the nasal mucosa. The rest of the drug is excreted from the nose by drainage or mucociliary clearance, absorption from the gastrointestinal tract is possible. The plasma-bound metabolite B-17-MP is formed by the conversion of BDP absorbed from the ingested portion of the dose. Following oral administration of BDP, systemic absorption was also assessed by measuring the plasma concentration of its active metabolite B-17-MP. Its absolute bioavailability after oral administration was 41% (95% CI 27%, 62%). After an oral dose, B-17-MP is absorbed slowly, peak plasma concentration is reached after 3-5 hours. Metabolism After oral and intranasal administration, BDP is rapidly eliminated from the circulation and plasma concentrations are undetectable (50 pg/ml). The main part of the accepted dose of BDP is metabolized during the first pass through the liver. The main metabolic product is the active metabolite B-17-MP. The minimally active metabolites beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (BOH) are also formed, but they have little systemic effect. Distribution BDP is moderately distributed in tissues (201); B-17-MP is distributed more intensively (4241). Plasma protein binding of BDP is moderately high (87%). Excretion Excretion of BDP and B-17-MP is characterized by high plasma clearance (150 and 120 l / h, terminal elimination half-lives are 0.5 hours and 2.7 hours, respectively. After oral administration of BDP, approximately 60% of the dose is excreted in the feces within 96 hours, mainly as free and conjugated polar metabolites.Approximately 12% of the dose is excreted as free and conjugated polar metabolites in the urine.Indications for useNasobek is indicated for the prevention and treatment of: seasonal and perennial allergic rhinitis, including hay fever rhinitis ( hay fever); vasomotor rhinitis. Dosage and administrationAdults and children over 6 years of age: 2 doses in each nasal passage twice a day (400 mcg of beclomethasone per day) are recommended. For individual patients, it is preferable to use the drug one dose in each nasal passage three or four times a day.When symptoms are controlled, the dose is reduced to one dose twice a day in each nasal passage (200 micrograms of beclomethasone in a day). The lowest dose should be used to maintain effective symptom control. If symptoms recur, patients should return to the recommended dosage of two doses in each nasal passage in the morning and evening. The full therapeutic effect is achieved after a few days of treatment. Do not exceed the maximum recommended daily dose of 400 micrograms of beclomethasone. Elderly patients: adult dose. Children under 6 years of age: Nasobek is not indicated for the treatment of children under 6 years of age due to lack of clinical data. Use during pregnancy and lactation Use during pregnancy The safety of the drug in humans during pregnancy has not been established. Early animal studies have demonstrated an increase in cleft palate and decreased fetal growth with maternal oral corticosteroids. There is a very small risk of developing such effects in a human fetus. It should be noted that similar changes in the fetus of animals were noted after exposure to relatively high systemic doses. Intranasal use at recommended doses has minimal systemic effects. The use of beclomethasone dipropionate during pregnancy should be avoided. Nasobek is contraindicated in the first trimester of pregnancy. In the next two trimesters, the benefit / risk ratio for the mother and fetus should be weighed. Application during lactation No special studies have been conducted on the penetration of beclomethasone dipropionate into the breast milk of lactating animals. It is likely that beclomethasone dipropionate is excreted in breast milk. But at relatively low doses intranasally, breast milk levels seem to be low. Before using the drug in nursing mothers, it is necessary to weigh the ratio of benefit to the mother and risk to the child. Nasobek should not be used during lactation without consulting a doctor. Precautions Systemic effects of nasal corticosteroids may be observed, in particular when high doses are used for a long time. These effects are less common than with oral glucocorticosteroids and may vary between patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and more rarely, a range of psychological and behavioral effects, including psychomotor hyperactivity, sleep disturbance, fear, depression, and aggression (in particular , in children). It is recommended to constantly monitor the growth of children who receive treatment with nasal corticosteroids for a long time. If growth is retarded in children, therapy should be reviewed to reduce the dose of nasal corticosteroids, if possible, the lowest dose that provides effective control of symptoms should be prescribed. Additionally, the decision of the pediatrician in relation to the patient is made. Treatment with doses higher than those recommended may result in clinically significant adrenal suppression. Caution is required when transferring patients from systemic corticosteroid therapy to Nasobek, as hypothalamic disorders are possible. In most cases, Nasobek controls seasonal allergic rhinitis, but concomitant therapy for ocular symptoms may be needed for severe allergies. Appropriate treatment of infections of the nasal passages and paranasal sinuses should be carried out, but this should not create a specific contraindication to treatment with Nasobek. Patients with glaucoma, recent wound, surgery or ulceration in the nasal area should seek medical advice before using Nasobek. Influence on the ability to drive a car and other mechanisms Nasobek does not affect the ability to drive a car and other mechanisms. Interactions with other drugs are not known. Contraindications Hypersensitivity to beclomethasone dipropionate or excipients of the drug, hemorrhagic diathesis, frequent nosebleeds, viral or fungal infections, pulmonary tuberculosis, children under 6 years of age, first trimester of pregnancy. Composition 25 g of the drug contains: beclomethasone dipropionate 0.01250 g; excipients: benzalkonium chloride, phenylethyl alcohol, polysorbate 80, glucose, dispersed cellulose (a mixture of microcrystalline cellulose and sodium carboxymethylcellulose), hydrochloric acid 3594, purified water. One dose contains 50 micrograms of beclomethasone dipropionate. OverdoseSymptoms: when taking large amounts of beclomethasone dipropionate in a short period of time, the only harmful effect is the suppression of the function of the hypothalamic-pituitary-adrenal system. Treatment: no emergency measures are carried out, and treatment with Nasobek should continue at the recommended dose. The function of the hypothalamic-pituitary-adrenal system returns to normal within one to two days. Side effects Systemic effects of nasal corticosteroids are possible only when high doses are used for a long time. In rare cases, perforation of the nasal septum may develop after the use of intranasal corticosteroids. Dryness and irritation of the nasal mucosa, the formation of blood-stained crusts in the nose with the use of intranasal sprays are possible, but these conditions do not progress and rarely cause concern. Changes in olfactory and gustatory perception, epistachys, have been rarely reported. Rare cases of increased intraocular pressure, glaucoma, cataracts have been reported with intranasal use of beclomethasone dipropionate. Widespread use of beclomethasone dipropionate over decades has not shown serious local lesions of the nasal mucosa. Very rarely, cases of hypersensitivity reactions have been noted, including urticaria, pruritus and erythema, swelling of the eyes, face, lips and throat, anaphylactoid / anaphylactic reactions, dyspnea and / or bronchospasm. Growth retardation has been reported in children receiving intranasal corticosteroids. Storage conditions Store at a temperature not exceeding 25 0 C. Do not freeze. Keep out of the reach of children Shelf life 4 years in unopened original packaging; 6 months after first opening the package. Do not use after the expiration date. Buy Nasobek nasal spray 50mcg/dose 200 doses No. 1