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Dorzamed 5 ml of 2% eye drops




The instruction for medical use of Dorzamed Torgovye medicine names Dorzamed Mezhdunarodnoye the unlicensed name Dorzolamid Lekarstvennaya the Drop form eye 20 mg/ml, 5 ml Structure of 1 ml of drug contains active agent – dorzolamid 20.0 mg (in the form of a dorzolamid of a hydrochloride of 22.25 mg), excipients: hydroxyethylcellulose, Mannitolum, citric acid monohydrate, a benzalkoniya chloride, sodium hydroxide, water purified. Description Transparent, colourless or almost colourless, slightly viscous solution Pharmacotherapeutic group Sense bodys. Ophthalmologic drugs. Protivoglaukomny drugs and miotik. Karboangidraza inhibitors. Dorzolamid. The ATX S01EC03 code the Pharmacological Pharmacokinetics At properties topical administration dorzolamid gets into a system blood stream. At prolonged use dorzolamid collects in erythrocytes as a result of selection binding from karboangidrazy the II type, maintaining extremely low concentration of free drug in blood plasma. Dorzolamid is metabolized with formation of the only thing of N-dezetilirovannogo of a metabolite which inhibits a karboangidraza of the II type in comparison with less actively not changed dorzolamidy, however, at the same time, is capable to inhibit a karboangidraza of the I type. The metabolite is also capable to collect in erythrocytes where contacts, mainly, karboangidrazy the I type. Communication of a dorzolamid with proteins of blood plasma makes about 33%. Dorzolamid is brought by kidneys in not changed look and also in the form of a metabolite. After drug withdrawal dorzolamid it is not linearly washed away from erythrocytes that at first leads to fast decrease in its concentration, further removal slows down. Elimination half-life (T ½) makes about 4 months. The pharmacodynamics Dorzolamid is protivoglaukomny means, selectively inhibits a karboangidraza of the II type. The inhibition of a karboangidraza of a ciliary body leads to decrease in secretion of intraocular liquid due to delay of formation of bicarbonate ions that in turn leads to delay of transport of ions of sodium (Na+) and water. After topical administration of ophthalmologic solution of a dorzolamid (20 mg/ml) the increased intraocular pressure which is a major factor of risk in pathogenesis of injury of an optic nerve and glaukomatozny deterioration in visual functions (loss of fields of vision) decreases. Does not cause an accommodation spasm, a miosis, a hemeralopia. Indications – as additional therapy to beta-blockers – as monotherapy at the patients who are not reacting to use of beta-blockers or in which beta-blockers are contraindicated For treatment of the increased intraocular pressure in diseases: – to intraocular hypertensia – an open angle glaucoma – pseudo-exfoliative glaucoma the Route of administration and doses Only for topical administration. Konjyunktivalno. At monotherapy: On 1 drop of drug in a conjunctival sac of the affected eye 3 times a day. In a combination with beta blockers for topical administration: On 1 drop of drug in a conjunctival sac of the affected eye 2 times a day. At simultaneous use of other local ophthalmologic means the interval between instillations has to be not less than 10 minutes. When prescribing drug as replacement of other protivoglaukomny ophthalmologic drug, the last should be cancelled a day before the beginning of therapy by drug. Before use of medicine it is necessary to wash up carefully hands, it is necessary to avoid contact of the pipette with eyes and surrounding objects. At misuse the bottle can be infected and to become the reason of infectious damages of an eye and the subsequent loss of sight. IInstruktsiya on use 1. Before the first use, remove a protective layer on a bottle neck. For the closed bottle the small space between a bottle and a cover is admissible. 2. It is necessary to uncover a bottle. 3. It is necessary to reject the patient’s head back and to carefully lower a lower eyelid before formation of small similarity of a pocket between a century and an eye. 4. The bottle needs to be turned and to press slightly on it before emergence of a drop and to dig it in an eye. The tip of the pipette of a bottle should not touch an eye or a century. 5. If necessary, repeat the procedure with the second eye. 6. At once after use, it is necessary to close a bottle a cover. Side effects Very often (≥ 1/10) – the shchipaniye, burning of eyes after installation Is frequent (≥ 1/100, & lt, 1/10) – a superficial dot keratitis, lachrymation, conjunctivitis, inflammation a century, an itching of eyes, irritation a century, the obscured sight – a headache – nausea and bitter smack in a mouth – asthenia/fatigue Infrequently (≥ 1/1,000, & lt, 1/100) – an iridocyclitis Seldom (≥ 1/10,000, & lt, 1/1,000) – reddening of eyes, eye pain, crusting during a century, the tranzitorny shortsightedness (passing after drug withdrawal), swelled corneas, eye hypotonia, amotio of a retina at patients after antiglaukomatozny operations – dizzinesses, paresthesias – nasal bleeding – irritation of a throat, dryness in a mouth – contact dermatitis, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis – an urolithiasis – signs and symptoms of hypersensitivity: local manifestations – palpebral reactions, system reactions – a Quincke’s disease, a small tortoiseshell, an itching, rash, an anaphylaxis and seldom a bronchospasm It is unknown – feeling of a foreign body in eyes – the Contraindication asthma – hypersensitivity to drug components – chronic kidney disease (clearance of creatinine less than 30 ml/min.) – giperkhloremichesky acidosis – pregnancy and the period of a lactation – children’s age up to 18 years Medicinal interactions Protivoglaukomny medicines (beta blockers, pilocarpine, dipivefrin, karbakhol) strengthen effect of drug. At simultaneous use with acetazoleamide the risk of development of system side effects increases. Strengthening of toxicity at reception of high doses of acetylsalicylic acid is possible. Special instructions of Dorzolamid the hydrochloride is streptocide and, despite topical administration, is exposed to system absorption. In this regard, at use of a dorzolamid in the form of eye drops there can be side reactions characteristic of streptocides, including serious reactions, such as Stephens-Johnson’s syndrome and toxic epidermal necrolysis. At emergence of serious side reactions or at manifestation of hypersensitivity the use should be stopped. Use of ophthalmologic solution of a dorzolamid (20 mg/ml) for patients with a bad attack of closed-angle glaucoma was not studied. It is necessary to use with care ophthalmologic solution of a dorzolamid (20 mg/ml) at the patients having the low density of endothelial cells of a cornea of an eye and/or transferred surgical intervention to eyes as at this category of patients the likelihood of developing hypostasis of a cornea and an irreversible decompensation of a cornea is raised. Features of use for patients with a heavy renal failure (creatinine Cl less than 30 ml/min.) are not defined. As dorzolamid (as well as its metabolite) it is removed mainly through kidneys, it is not recommended to appoint it in this pathology. Features of use for patients with an abnormal liver function are not defined (it is necessary to use with care). At long use of ophthalmologic solution of a dorzolamid (20 mg/ml) it was reported about development of local side effects, mainly, of conjunctivitis and reactions from a century. Many of these reactions had clinical manifestations and a course as allergic. At emergence of such reactions, drug should be cancelled. Dorzalamid is karboangidraza inhibitor for topical administration which can be exposed to system absorption therefore patients with an urolithiasis in the anamnesis can have an increased risk of emergence of an urolithiasis. Probability of mutual strengthening of system effects of a dorzolamid and inhibitors of a karboangidraza for internal use at their simultaneous use is not excluded. Simultaneous use of a dorzolamid and oral inhibitors of a karboangidraza is not recommended. Cases of hypostasis of a cornea and an irreversible decompensation of a cornea were observed at patients with already existing chronic defects of a cornea and/or during administration of drug when performing intraocular surgical interventions. At such patients the topical administration of a dorzolamid has to take place with care. The choroidal amotio accompanying eye hypotonia was noted after the filtering procedures using water supressant. The composition of ophthalmologic solution of a dorzolamid (20 mg/ml) includes preservative a benzalkoniya chloride which can be absorbed by soft contact lenses and have the damaging effect on eye tissues. Therefore the patients carrying soft contact lenses should remove them during drug treatment. Use of disposable bottles of drug was not studied on patients with contact lenses Use in pediatrics Medicine is not recommended to children and teenagers up to 18 years in view of lack of data on safety and efficiency (experience of medical use at children is limited). Use at pregnancy and in the period of a lactation Adequate and strictly controlled researches of safety of use for pregnant women were not conducted. Use at pregnancy is possible if the expected effect of therapy exceeds potential risk for a fruit. Category of action on a fruit on FDA — C. It is unknown whether gets dorzolamid to breast milk therefore during drug use the feeding women should stop breastfeeding. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms As drug can cause dizzinesses and visual disturbances during treatment it is necessary to avoid potentially dangerous types of activity connected with need of concentration of attention and the increased speed of psychomotor reactions. Overdose Symptoms: the following effects are possible after oral administration: emergence of drowsiness, nausea, dizziness, headache, weakness, unusual dreams, dysphagies. Treatment: symptomatic, monitoring of level of electrolytes (especially potassium) in blood and control of size rn is necessary for blood. At accidental and deliberate overdose it is necessary to see a doctor. The form of release and packing On 5 ml of drug place in a plastic bottle with a stopper dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not over 25 ºС, in the place protected from light. To store out of children’s reach! Period of storage 3 years. The use period after opening of a bottle no more than 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription the Producer “UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh.”, TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul) “WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş.”, TURKEY (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No: 50 K. 1B of Zemin 4-5-6, İstanbul). The owner of the registration certificate of “UORLD MEDITSIN OFTALMIX ILACHLARY LIMITED of SHIRKETI”, Turkey 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 of RK, Almaty, Turksibsky district, Suyunbaya Ave., 222 B Ph. / fax: 8 (7272) 529090 the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, RK, Almaty, Suyunbaya Ave., 222 B Cellular ph. +7 701 786 33 98, (24-hour access). e-mail:
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