Oksinazin 0.01% nasal spray 10 ml Baby

The instruction for medical use of OKSINAZIN® medicine Trade name ОКСИНАЗИН® the International unlicensed name Oxymetazoline Dosage Form Spray Spray, nasal for babies of 0.01%, Spray of nasal 0.05%, nasal for children of 0.025%, Structure of 1 ml of solution contain active agent - oxymetazoline a hydrochloride of 0.1 mg, 0.25 mg, 0.5 mg, excipients: boric acid of 18 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. Description Transparent colourless or yellowish liquid Pharmacotherapeutic group Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics. Oxymetazoline the ATX R01AA05 Code the Pharmacological Pharmacokinetics At properties topical intranasal administration, effect of drug is shown within several minutes and lasts till 12 o'clock. Oxymetazoline in small degree is exposed to system absorption therefore its concentration in blood plasma is practically not defined. After absorption, oxymetazoline contacts proteins of plasma and gets into fabrics from which it is slowly removed. The full effect lasts for 5-6 hours, and then gradually falls down within 6 hours. 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. Pharmacodynamics ОКСИНАЗИН® - vasoconstrictive drug of the prolonged action, for topical administration. Alpha adrenomimetik, derivative imidazoline. Does not irritate mucous a nose, does not cause hyperaemia. Oxymetazoline causes vasoconstriction of mucous membranes of a nose, adnexal bosoms and an Eustachian tube that leads to decrease in their hypostasis and release of nasal breath in allergic and/or infectious and inflammatory rhinitis (cold) and prevents development of bacterial complications. At intranasal use has no systemic action. 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 anti-inflammatory and dezinteksikatsionny action. Indications - rhinitis (including an infectious and inflammatory, allergic etiology) - sinusitis - the eustachitis associated by rhinitis - diagnostic vasoconstriction the Route of administration and doses to Children aged from 1 month till 1 year 0.01% appoint solution on 1 injection in each nasal course. Repeated introduction is possible in 12 hours. Also following procedure is possible: depending on age one injection of 0.01% of solution for cotton wool and wiping of the nasal courses. To children aged from 1 year up to 6 years appoint 0.025% solution on 1 injection in each nasal course. Repeated introduction is possible in 12 hours. To adults and children 6 years are more senior appoint 0.05% solution on 1-2 injection in each nasal course. Repeated introduction is possible in 12 hours. Drug use is not recommended more than 5-7 days. Side effects Often (from ≥ 1% to & lt, 10%): - burning sensation or xeromycteria - sneezing, especially at sensitive patients. Infrequently (from ≥ 0.1% to & lt, 1%): - hypostasis of a mucous membrane (feeling of congestion of a nose) can become more intensive (reactive hyperemia), nasal bleeding - hypersensitivity reactions (Quincke's disease, rash, an itching). Seldom (from ≥ 0.01% to & lt, 0.1%): - cardiopalmus, increase of pulse and increase in arterial blood pressure. Very seldom & lt, 0.01% and isolated cases: - concern, insomnia, fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children) - arrhythmias - an apnoea at babies and newborns - Contraindication spasms - hypersensitivity to oxymetazoline or to any excipient - atrophic rhinitis - states after transsphenoidal hypophysectomy or other surgical interventions on a firm meninx - the neonatality period up to 1 month (for solution of 0.01%) - children's age till 1 year (for solution of 0.025%) - children's age up to 6 years (for solution of 0.05%) Medicinal interactions At simultaneous use of the drug OKSINAZIN® with other vasoconstrictors (irrespective of a method of administration) perhaps mutual strengthening of side effects. ОКСИНАЗИН® slows down absorption of mestnoanesteziruyushchy means and prolongs their effect. At considerable overdose of the drug OKSINAZIN® against the background of use of tricyclic antidepressants and inhibitors of a monoaminooxidase (including the period within 14 days after their cancellation) it can be observed arrhythmias and increase in arterial blood pressure. Oxymetazoline, being an antagonist β – blockers and other antihypertensive drugs, for example, such as Methyldopum, betanidin, debrisokvin, guanetidin, can reduce action of the last. Strengthens cardiotoxic effect of the drugs used in Parkinson's disease (Bromocriptinum, etc.). Special instructions With care it is necessary to appoint drug in an arterial hypertension, the profound atherosclerosis, tachycardia, stenocardia, a hyperthyroidism, diabetes, a pheochromocytoma, a prostatauxe. It is not necessary to use the drug OKSINAZIN® it is long also in high doses since it can lead to weakening of its action 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. If symptoms do not decrease within 3 days, it is necessary to see a doctor. The preservative (a benzalkoniya chloride) which is contained in medicine can cause a rhinedema, especially at long use. The propylene glycol which is a part of drug can render irritant action. It is necessary to cancel administration of drug, at emergence of side reactions. In order to avoid solution pollution, you store spray bottle densely closed and avoid contact of a tip with any surface. Pregnancy and the period of a lactation is not allowed to exceed the recommended dosage. Drug has to be used only after careful assessment of a ratio of risk for a fruit or the baby and advantage for mother. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At the correct use and in the recommended doses ОКСИНАЗИН® does not affect ability to drive the car or to work with mechanisms, however at emergence of such side effects as, dizziness, it is necessary to refrain from these types of activity. Overdose Symptoms: at considerable overdose or accidental intake are possible: narrowing of pupils, nausea, vomiting, cyanosis, fervescence, tachycardia, arrhythmia, vascular insufficiency, arterial hypertension, an asthma, mental disorders, a fluid lungs, drowsiness, fall of temperature of a body, bradycardia, arterial hypotension, an apnoea and is possible development of a coma, cardiac arrest. Treatment: symptomatic therapy. At accidental intake - gastric lavage, intake of activated carbon. The form of release and packing On 10 ml (for dosages of 0.01%, 0.025%) or 15 ml (for a dosage of 0.05%) 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 °C to 25 °C, 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 Without 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 name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.