The instruction for medical use of APDROPS medicine the Trade name of Apdrops the International unlicensed name Moxifloxacin Dosage Form of the Drop eye 0.5% Structure of 1 ml contains active agent – a moksifloksatsin a hydrochloride 5.45 mg equivalent to the main moksifloksatsin of 5.0 mg, excipients: boric acid, sodium pyroborate, sodium chloride, water for injections. The description Transparent solution of faintly yellow color Pharmacotherapeutic group Drugs for treatment of diseases of eyes. Antimicrobial drugs others. Moxifloxacin. ATX S01AX22 code Pharmacological Pharmacokinetics At properties topical administration of eye drops perhaps system absorption of a moksifloksatsin. Moxifloxacin is metabolized by a liver and kidneys. Elimination half-life of a moksifloksatsin is equal to 13 hours. The maximum concentration in blood serum makes 2.7 ng/ml. It is removed with bile and urine. A pharmacodynamics Antibacterial action of Apdrops is connected with inhibition of topoisomerase II (DNK-giraza) and topoisomerases IV. DNK-giraza – necessary enzymes which are involved in replication, a transcription and regeneration of bacterial DNA. Topoisomerase IV – the enzyme playing a role in division of chromosomal DNA during cell fission of bacteria. Apdrops the eye drops having high activity concerning Gr. + bacteria (pneumococci, streptococci, stafilokokk, enterococci) and also anaerobe bacterias and atypical intracellular microorganisms (chlamydias, mycoplasmas). Indications – topical treatment of the purulent bacterial conjunctivitis caused by microorganisms, sensitive to drug, the Route of administration and doses On 1 drop 3 times a day. In the next days on 1-2 drop 3-4 times a day. Duration of treatment is determined by the attending physician, it depends on the degree of manifestation of symptoms and features of a clinical course of the disease. The course of treatment in typical cases makes 5 days. Side effects Local it is frequent – eye pain – irritation of an eye – dryness of an eye – an itching – conjunctiva hyperaemia, eye hyperaemia Infrequently – defect of a corneal epithelium – a dot keratitis – coloring of a cornea, bleeding of a cornea – conjunctivitis – eye hypostasis, discomfort in an eye – misting of sight – decrease in visual acuity – disturbance from a century – an erythema of a century – hypersensitivity of an eye System it is frequent – disturbance of taste Infrequently – decrease in level of hemoglobin – a headache, parasthesias – discomfort in a nasal cavity – pain in pharyngolaryngeal area – feeling of a foreign body in pharyngeal area – vomiting – increase in level alanine of aminotransferase, gamma glutamiltransferazy the Frequency of manifestation of the following side reactions cannot be estimated because of insufficiency of the available data: Local – an eye allergy – a photophobia, increase in lachrymation – feeling of a foreign body in an eye – increase in intraocular pressure – entophthalmias, blefarita, discharges from eyes – an ulcer keratitis, a cornea erosion, abrasion of a cornea, – turbidity of a cornea, corneal deposits – cornea hypostasis, infiltration of a cornea System – a cardiopalmus – dizziness – short wind – nausea – an erythema, rash, an itching, hypersensitivity the Type and gravity of manifestation of side reactions at children including at newborns are similar to those which are observed at adults. The contraindication – hypersensitivity to a moksifloksatsin, other hinolona or auxiliary components of drug – the lactation period Medicinal interactions Unlike other ftorokhinolon is noted clinically significant medicinal interactions between moksifloksatsiny system use and itrakonazoly, theophylline, warfarin, digoxin, oral contraceptives, pro-benzidine, ranitidine or Glyburidum. Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9 or CYP1A2 that says that it, most likely, does not change pharmacokinetic properties of drugs, metaboliziruyemy P450 cytochrome isoenzymes. Special instructions As well as in a case with other antibacterial agents, prolonged use of drug can cause the overgrowth of insensitive organisms including mushrooms. At superinfection it is necessary to stop administration of drug and to consider alternative methods of therapy. With care to appoint along with the drugs extending QT interval as risk of developing cardiac arrhythmias increases. Not to administer the drug subkonjyunktivalno or in an anterior chamber of an eye. Contact lenses in the presence of symptoms of bacterial conjunctivitis the carrying contact lenses before full treatment is not recommended to the patient. Risk of development of anaphylactic reaction At the patients using system hinolonovy drugs deadly reactions of hypersensitivity (anaphylaxis), sometimes right after reception of the first dose were observed heavy, in some cases. Some reactions were followed by collapse of a cardiovascular system, a loss of consciousness, vascular hypostasis (including guttural, pharyngeal or front swelled), obstruction of pneumatic ways, short wind, urticaria and an itching. If at use of a moksifloksatsin the allergic reaction develops, it is necessary to stop administration of drug. The heavy acute reaction of hypersensitivity on moxifloxacin or any other component of drug can demand the emergency therapy. According to clinical indications apply oxygen and carry out artificial respiration. Pregnant women should appoint pregnancy of Apdrops only if the expected advantage of its use considerably exceeds potential risk for a fruit. Use in pediatrics As safety given for a statement and efficiency of Apdrops in treatment of conjunctivitis at newborns are limited, use of this drug at newborns for treatment of conjunctivitis is not recommended. Eye drops of Apdrops should not be used for prevention or empirical treatment of conjunctivitis, including a gonococcal blenoreyu of newborns because of a prevalence resistant to a ftorkhinolon by Neisseria gonorrhoeae microorganisms. Patients with the infection of an eye caused by microorganisms of Neisseria gonorrhoeae have to accept the corresponding system treatment. Newborns with blenorey newborns have to receive the treatment corresponding for each case, for example, to receive system treatment in case of the infection caused by Chlamydia trachomatis or Neisseria gonorrhoeae. Eye drops of Apdrops are not recommended to be used for treatment of Chlamydia trachomatis at patients 2 years are younger as the drug assessment at this group of patients was not carried out. Patients are more senior than 2 years with the infection of an eye caused by Chlamydia trachomatis have to accept the corresponding system treatment. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms As well as in a case with other eye drops, after burying the temporary ambiguity of sight or other visual concerns is possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case it is necessary to wait some time before recovery of sight. The overdose Is not present data the Form of release and packing On 3 ml or 5 ml of drug in an opaque plastic bottle with an open nose and a cap. On 1 bottle together with the instruction for medical use in the state and Russian languages place in cardboard packing. To Store storage conditions in the place protected from light, at a temperature not above 30 °C. To protect from freezing. To store out of children’s reach! A period of storage 3 years a drug Period of storage after opening of a bottle no more than four weeks. Not to use after expiry date! Prescription status According to the prescription Pharm Limited Ajanta Producer, India Ajanta the House, Charkop, Kandivli (Z), Mumbai 400,067 Name and the country of the holder of the registration certificate Ajanta Pharm Limited, India 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 Pharm Limited Ajanta Branch in Republic of Kazakhstan Republic of Kazakhstan, 050009, Almaty, Anosov St., 54/28 (ug. Roofing felt bi) Ph. / fax: 8 (727) 374-79-50, 374-79-56, E-mail: firstname.lastname@example.org the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of ConsultAsia LLP Almaty, Shevchenko St., 165 B, office 307 ph. +77778051116/+77051708825/+77051708876 (24-hour availability) fax: +727-379-42-58 e-mail:
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