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DENR 15 ml nasal spray




The instruction for medical use of DOSPREY® medicine Trade name ДОСПРЕЙ® the International unlicensed name Is not present the Dosage form Spray of nasal 15 ml Structure 1 ml of solution contains active agents – dexamethasone (in the form of phosphate sodium dexamethasone) 1.0 mg, oxymetazoline a hydrochloride of 0.5 mg excipients: boric acid of 18.0 mg, a benzalkoniya chloride of 50% solution (in terms of 100% substance), propylene glycol, povidone (PVP), sodium pyroborate to rn 4.8 – 6.8, water for injections the Description Transparent colourless or yellowish solution. Pharmacotherapeutic group Drugs for treatment of diseases of a respiratory system. Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Glucocorticosteroids. Dexamethasone in a combination with other drugs. The ATX R01AD53 code the Pharmacological Pharmacokinetics Drug properties with vasoconstrictive, anti-inflammatory and antiallergic action for topical administration in diseases of ENT organs. Dexamethasone At inflammation or injury of a mucous membrane of a nasal cavity the speed of absorption of dexamethasone increases. A small amount of the dexamethasone which came to a system blood stream contacts proteins of plasma. It is metabolized in a liver under the influence of cytochromium enzymes, removed generally by kidneys. Elimination half-life (T1/2) averages 3 hours. Absorption of dexamethasone in system blood circulation at topical treatment of nasal diseases is insignificant, due to vasoconstrictive effect of oxymetazoline of a hydrochloride. Oxymetazoline. At topical intranasal administration, oxymetazoline in small degree is exposed to system absorption therefore its concentration in blood plasma is insignificant. Has no systemic action. After absorption, oxymetazoline contacts proteins of plasma and gets into fabrics from which it is slowly removed. Elimination half-life (T1/2) makes 5-8 hours. Drug is metabolized only in moderate degree and removed generally in an invariable view with urine and a stake. The pharmacodynamics Dexamethasone – a synthetic glucocorticosteroid, has no mineralokortikoidny activity. Has the anti-inflammatory, antiallergic and desensibilizing effect. At topical administration has antipruritic and vasoconstrictive effect. Oppresses emission by eosinophils of mediators of inflammation, migration of mast cells and reduces permeability of capillaries. Brakes activity of hyaluronidase, a collagenase and proteases. Oxymetazoline – alpha adrenomimetik, derivative imidazoline. Provides instant and long vasoconstrictive action on veniplexes of a mucous nasal cavity and adnexal bosoms. Reduces pathological exudation, improves functions of a ciliary epithelium. After removal of hypostasis of a mucous membrane the removing channels for aeration of adnexal bosoms of a nose, an acoustical pipe open and extend. It stimulates drainage function of nasal cavities and prevents development of bacterial complications. Duration of action is 10-12 hours. Does not irritate mucous and does not cause hyperaemia. The combination to dexamethasone provides antiallergic effect. The propylene glycol and povidone (PVP) which are a part of drug protect a mucous membrane of a nose from excessive drying. In addition povidone (PVP) possesses disintoxication action. Indications – rhinitises (including an infectious and inflammatory, allergic etiology) – an acute nasopharyngitis – acute and chronic sinusitis (including an allergic etiology, for secret outflow simplification) the Route of administration and doses Duration of use depends on type of defeat and the therapeutic answer. The adult appoint on 1-2 injection in each nasal course 2 times a day. Duration of a course of treatment is determined by the attending physician. Side effects Often (from ≥ 1% to & lt, 10%): – the burning sensation or xeromycteria – sneezing Is rare (from ≥ 0.01% to & lt, 0.1%): – a headache – insomnia – feeling of congestion of a nose Infrequently (from ≥ 0.1% to & lt, 1%): – tachycardia, increase in blood pressure at prolonged use in high doses. System side effects are possible only at persons with hypersensitivity to adrenomimetika. Contraindications – hypersensitivity to drug components – closed-angle glaucoma – atrophic rhinitis (Sukhoi rhinitis – inflammation mucous the nasal courses without secret discharge) – perhaps mutual strengthening of side effects is contraindicated to patients who accept the inhibitors of a monoaminooxidase and other drugs promoting increase in arterial blood pressure – pregnancy and the period of a lactation – children’s age up to 18 years Medicinal interactions At simultaneous use of drug with other vasoconstrictors (irrespective of a method of administration). Oxymetazoline slows down absorption of mestnoanesteziruyushchy means and prolongs their effect. At considerable overdose of drug against the background of use of tricyclic antidepressants the increase in arterial blood pressure can be observed, with MAO inhibitors strengthening of effect of drugs on central nervous system is possible. Dexamethasone can strengthen effect of Phenytoinum, barbiturates and warfarin. Because of the inducing action on an isoenzyme of CYP3A4 reduces efficiency of blockers of calcium channels, quinidine and erythromycin. Co-administration with m-holinoblokatorami (including antihistaminic drugs, tricyclic antidepressants), nitrates contributes to the development of increase in intraocular pressure. Special instructions With care it is necessary to appoint drug in arterial hypertension, cardiovascular diseases, the profound atherosclerosis, tachycardia, a hyperthyroidism, diabetes, a pheochromocytoma. It is not necessary to use drug it is long also in high doses since it can lead to increase in intraocular pressure, to weakening of effect of drug and also to a mucosal atrophy of a nose, a reactive hyperemia with medicamentous rhinitis, to damage and dysfunction of an epithelium of a nose. Use during pregnancy and a lactation drug is not intended for pregnant women and nursing mothers. Use in pediatrics the Data on efficiency and safety of medicine at children up to 18 years are absent. Not to accept more than in 30 days after the first opening. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At prolonged use of drug in the doses exceeding recommended cannot exclude the general influence on a cardiovascular system. In such cases the ability to run the vehicle or potentially dangerous mechanisms, can decrease. The overdose At the usual mode of topical administration overdose is improbable. Symptoms: at considerable overdose or intake the narrowing of pupils, nausea, vomiting, cyanosis, fervescence, tachycardia, arrhythmia, vascular insufficiency, arterial hypertension, breath disorders, a fluid lungs, drowsiness, fall of temperature of a body, bradycardia, arterial hypotension, an apnoea can be observed and development of a coma, cardiac arrest is possible. At accidental overdose it is necessary to stop use of drug and to see immediately a doctor. Treatment: gastric lavage, intake of activated carbon, symptomatic therapy. In hard cases the administration of phentolamine, an intubation and artificial respiration can be necessary. The form of release and packing On 15 ml spill polyethylene in spray bottles. The bottle together with the instruction for medical use in the state and Russian languages is placed in a pack cardboard with control of the first opening. To Store storage conditions at a temperature from 15 wasps up to 25 wasps, in the place protected from light. To store out of children’s reach! A period of storage 3 years a drug Period of storage after opening of a bottle – 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription LeKos LLP Producer 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67. The owner of the registration certificate of LeKos LLP, Republic of Kazakhstan 050000, Almaty, Kabangbai St. of the batyr, 114-13. Packer of LeKos LLP, Republic of Kazakhstan 050000, Almaty, Kabangbai St. of the batyr, 114-13. The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of medicines 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67. e-mail:, the Address of the organization responsible for post-registration observation of safety of medicine of LeKos LLP, Republic of Kazakhstan 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.
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