Oksivin-DF 0,025% 10ml nasal drops

The instruction for medical use of Oksivin-DF® medicine the Trade name of Oksivin-DF® the International unlicensed name Oxymetazoline Dosage Form of the Drop nasal 0.025%, 0.05% 10 ml Structure of 1 ml of drug contains active agent - oxymetazoline a hydrochloride - 0.25 mg or 0.5 mg excipients: a benzalkoniya chloride (in the form of 10% of solution), sodium chloride, dihydrophosphate sodium a dihydrate, phosphate dinatrium dodecahydrate, water purified the Description Transparent colourless or slightly yellowish solution. Pharmacotherapeutic group Respiratory system. Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics, simple. Oxymetazoline the ATX R01AA05 Code the Pharmacological Pharmacokinetics At properties topical administration oxymetazoline in a small amount is soaked up in a system blood stream therefore its concentration in blood plasma is insignificant. Effect of drug is shown in 15 min. after use. Action duration - 10-12 h. Drug is metabolized only in moderate degree and generally removed from an organism in an invariable view with urine and a stake. The pharmacodynamics Oksimetazolin is alpha adrenomimetikom from group of derivatives of imidazoline. Stimulates α1-адренорецепторы. At intranasal use there is a narrowing of blood vessels of a mucous membrane of a nose, hypostasis and hyperaemia of a mucous membrane of a nasopharynx is eliminated. 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. Indications - acute, allergic, vasomotorial rhinitis - rinosinusit - the eustachitis associated by rhinitis - elimination of hypostasis of a mucous membrane of a nasal cavity before the diagnostic Route of administration procedures and Intranazalno's doses. The cap is unscrewed, removed and, slightly pressed the bottle body. 0.025% of a drop nasal to children from 1 year to 8 years: on 1-2 drop in each nasal course 2-3 times a day. 0.05% of a drop nasal to children are more senior than 8 years and the adult: on 1-2 drop in each nasal course 2-3 times a day. Course of treatment no more than 5-7 days. Side effects often: - burning and dryness mucous the nasal courses - dryness in a mouth and a throat - sneezing infrequently: - dizziness, a headache - insomnia - fatigue (fatigue) - nausea - swelling and hypostasis of a mucous membrane (feeling of congestion of a nose) - nasal bleeding - a reactive hyperemia - a mucosal atrophy - allergic reactions (Quincke's edema, urticaria, an itching) is very rare: - increase of pulse - arterial hypertension - tachycardia - a tachyphylaxis - arrhythmias - an apnoea at babies and newborns - Contraindication spasms - hypersensitivity to drug components - atrophic rhinitis - the profound atherosclerosis - chronic heart failure - arrhythmias - arterial hypertension - chronic kidney disease - a prostate hyperplasia - a concomitant use of inhibitors of a monoaminooxidase and the period up to 14 days after the end of their use - a state after transsphenoidal hypophysectomy or other surgical interventions on a firm meninx - diabetes - a thyrotoxicosis, a hyperthyroidism - closed-angle glaucoma - a serious illness of eyes - a pheochromocytoma - a porphyria - children's age till 1 year (for Оксивин-DF® 0.025%) - children's age up to 8 years (for Оксивин-DF® 0.05%) Medicinal interactions Drug slows down absorption of mestnoanesteziruyushchy means and prolongs their effect. At use of Oksivina-DF® with other vasoconstrictors (irrespective of a method of administration) perhaps mutual strengthening of side effects. Co-administration of inhibitors of a monoaminooxidase (including the period within 14 days after their cancellation), hypertensive means and tricyclic antidepressants can lead to increase in arterial blood pressure. Special instructions It is necessary to avoid prolonged use and overdose of Oksivina-DF®. Long or frequent use of vasoconstrictive drugs leads to reduction of efficiency of drug, also misuse them can cause an atrophy and hypostasis of mucous membranes of a nose. When assigning Oksivina-DF®, in order to avoid risk of a mucosal atrophy of a nose, it is possible to apply to treatment of chronic rhinitis only under observation of the doctor. At frequent use of high dosages the derivatives of imidazoline can result (congestion) of nasal passes in reactive stagnation. Therefore, it is not necessary to exceed independently recommended doses and to use drug more than 5 - 7 days. To apply with care in the coronary heart disease (CHD). Pregnancy and the period of a lactation Use of drug at pregnancy and in the period of a lactation perhaps only when the expected advantage for mother exceeds potential risk for the child and a fruit. The feature of influence of medicine on ability to run vehicles or potentially dangerous mechanisms In the recommended doses of Oksivin-DF® does not affect ability to run the vehicle or work with mechanisms. After prolonged use of Oksivin-DF®, in the dosages exceeding recommended it is impossible to exclude the general influence on a cardiovascular system and the central nervous system. In these cases the ability to run the vehicle or mechanisms can decrease. Overdose Symptoms: when exceeding the recommended doses or accidental intake the following symptoms can appear: narrowing of pupils, nausea, vomiting, cyanosis, temperature increase, tachycardia, arrhythmia, collapse, oppression of warm activity, arterial hypertension, fluid lungs, respiratory disorders. Besides, there can be mental disorders and also the oppression of functions of the central nervous system which is followed by drowsiness, fall of temperature of a body, bradycardia, arterial hypotension, an apnoea and possible development of a coma. Treatment: immediately appoint activated carbon (absorbent), sodium sulfate (depletive) or gastric lavage. For a lowering of arterial pressure appoint non-selective alpha adrenoblockers (phentolamine of 5 mg in saline (physiological) solution slowly in/in or 100 mg orally). Use of angiotonic means is contraindicated. If necessary carry out febrifugal, anticonvulsant therapy and artificial ventilation of the lungs. A form of release and packing On 10 ml of drug in the plastic bottles droppers corked by caps with control of the first opening or on 10 ml in the plastic bottles droppers corked by caps. On each bottle paste the label. On one bottle together with the instruction for medical use in the state and Russian languages place in a pack cardboard. To Store storage conditions in the place protected from light, at a temperature not over 25 of 0C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription DOSFARM LLP Producer, Kazakhstan, 050034, Almaty, Chaplygin St., 3, ph.: (727) 253-03-88 The holder of the registration certificate of DOSFARM LLP, Kazakhstan, 050034, Almaty, Chaplygin St., 3 the Name, the address and a contact information 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: DOSFARM LLP, Republic of Kazakhstan, Almaty, Chaplygin St., 3, ph./fax: (727) 253-03-88, el. address: dospharm@dospharm.kz