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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for medical use of Medoklav® medicine the Trade name of Medoklav ® the International unlicensed name Is not present the Dosage form of the Tablet, film coated, 1 g Structure One tablet contains active agents: amoxicillin trihydrate of 1004.00 mg (it is equivalent to amoxicillin of 875.00 mg), potassium clavulanate of 297.80 mg + cellulose microcrystalline 1:1 (it is equivalent to clavulanic acid of 125.00 mg), excipients: microcrystalline cellulose, sodium of starch glikolit, silicon dioxide colloidal anhydrous, magnesium stearate structure of a cover: a hydroksipropilmetiltsellyuloza, propylene glycol, polyethyleneglycol 6000, talc, the titan dioxide (E171) the Description of the Tablet of a capsulovidny form, with a convex surface, coated white color. Pharmacotherapeutic group Antibacterial drugs for system use. Beta laktamnye antibacterial drugs. Penicillin. Penicillin in a combination with inhibitors beta laktamaz. Clavulanic acid + amoxicillin. The ATX J01CR02 code the Pharmacological Pharmacokinetics Both Components properties differ in high bioavailability. After administration of drug inside both active agents are quickly adsorbed from digestive tract. Reception together with food does not influence adsorption. The maximum concentration in blood plasma is reached approximately in 1 hour after reception. Both components are characterized by good penetration into liquids and body tissues (lungs, a middle ear, pleural and peritoneal liquids, a uterus, ovaries, etc.). Amoxicillin also gets into synovial fluid, a liver, a prostate, palatine tonsils, muscle tissue, a gall bladder, secretion of adnexal bosoms of a nose, saliva and bronchial secretion. Amoxicillin and clavulanic acid do not get through a blood-brain barrier at the intact meninx. Both components get through a placental barrier and in trace concentration get into breast milk. Amoxicillin and clavulanic acid are characterized by the low level of linking with proteins of blood plasma. Amoxicillin biotransformirutsya partially, clavulanic acid is exposed to intensive metabolism. Amoxicillin is removed by kidneys, practically in an invariable look, by canalicular secretion and glomerular filtration. Clavulanic acid is removed by glomerular filtration, partially in the form of metabolites. Small amounts can be removed through intestines and lungs. Elimination half-life of amoxicillin and clavulanic acid makes 1-1.5 hours. Both components are removed at a hemodialysis and in insignificant quantities – at peritoneal dialysis. At patients with a heavy renal failure the elimination half-life of amoxicillin increases till 7.5 o’clock, and till 4.5 o’clock clavulanic acid. Mедоклав® pharmacodynamics, is the combined drug containing amoxicillin and clavulanic acid. Amoxicillin – a semi-synthetic antibiotic from group of aminopenicillin with a wide range of bactericidal action concerning many gram-positive and gram-negative microorganisms. Lactamelements destroy amoxicillin and therefore the range of its activity does not extend to the microorganisms producing these enzymes, in particular, on penitsillinazoobrazuyushchy staphylococcus, a klebsiyella, indolpositive proteas, a tsitrobakter and bacteroids. Clavulanic acid is a natural β-lactam and has ability to inactivate a number β-лактамаз, usually present at the microorganisms resistant to action of the majority of penicillin and many cephalosporins. The combination of amoxicillin and clavulanic acid provides resistance of amoxicillin to the destroying action β-лактамаз, and effectively expands a range of antimicrobial activity of amoxicillin, including bacteria which usually are resistant to it and many other β-laktamny antibiotics. Медоклав® possesses a wide range of bactericidal action concerning the gram-positive and gram-negative microorganisms including producing beta lactamelements of 2,3,4 and 5 types. Range of antibacterial activity of Medoklava® following: Gram-positive microorganisms: Aerobes: Staphyloccocus aureus (except Methicillinum – resistant strains), Staphyloccocus epidermides (except Methicillinum – resistant strains), Staphyloccocus saprophyticus (except Methicillinum – resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus faecalis, Enterococcus faecium, Corinebacterium spp., Listeria monocytogenes, Nocardia asteroids, Anaerobe bacterias: Clostridium spp., (except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp., Treponema pallidum, Gram-negative bacteria: Aerobes: Aeromonas spp., Bordetella pertussis, Brucella spp., Campilobacter jejuni, Campilobacter coli, Citrobacter spp. it (is moderately sensitive), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp, Legionella pneumophila, Moraxella catarrhalis, Morganella spp. it (is moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica (is moderately sensitive), Anaerobe bacterias: Bacteroides spp., Fusobacterium spp. Indications of Medoklav® are appointed for treatment of the diseases caused by microorganisms, sensitive to drug: – an infection of ENT organs (sinusitis, pharyngitis, tonsillitis, average otitis), – lower respiratory tract infections (acute and chronic bronchitis, share and bronchial pneumonia, a pleura empyema, abscess of lungs) – infections of skin and soft tissues (furunculosis, abscess, phlegmon, a wound fever) – infections of an urinogenital system (pyelonephritis, cystitis, an urethritis, a salpingitis, an oophoritis, tubo-ovarian abscess, an endometritis, a vaginitis, septic abortion, postnatal sepsis, a venereal ulcer, gonorrhea) – osteomyelitis – sepsis – peritonitis – postoperative infections the Route of administration and doses Meal does not influence drug absorption, however, for reduction of risk of developing of gastrointestinal disorders, drug should be used to or at meal time. Duration of therapy depends on weight and type of an infection, but should not exceed 14 days without repeated assessment of a condition of the patient. On average a course of treatment – 7 days. To adults and children 12 years or with body weight more than 40 kg are more senior – on 1 tablet (Медоклава® 1 g) 2 times a day. The maximum daily dose Medoklava ® – no more than 2 tablets. In a renal failure: Adults (at clearance of creatinine ≥ 30ml mines) – changes of the mode of dosing are not required, at clearance of creatinine 10-30ml/min. – 375mg-750 to mg 2 times a day, at clearance of creatinine ≤ 10ml/min. – no more than 375 mg 2 times a day. Children – similar decrease in frequency rate of introduction. To apply on doctor’s orders. Side effects Very often – diarrhea Often – candidiasis mucous – nausea, vomiting Infrequently – dizziness, a headache – dyspepsia – moderate increase in level of liver enzymes – skin rash, an itching, a small tortoiseshell Seldom – a reversible leukopenia (including a neutropenia), thrombocytopenia – a multiformny erythema Frequency is unknown – a reversible agranulocytosis and hemolytic anemia, increase in a bleeding time and the index of a prothrombin time – a Quincke’s disease, an anaphylaxis, the syndrome similar to a serum disease, an allergic vasculitis – reversible superactivity and spasms – pseudomembranous or hemorrhagic colitis – change of coloring of a blanket of adamantine substance of tooth – increase in the ALT, nuclear Heating Plant level, bilirubin in blood serum, hepatitis, cholestatic jaundice – Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, bullous exfoliative dermatitis, sharp generalized exanthematous pustulyoz – interstitial nephrite, a hamaturia, a crystalluria the Majority of undesirable effects are weak and short-term. Contraindications – the known hypersensitivity to antibacterial drugs of a penicillinic row or any component of drug – an infectious mononucleosis – a heavy renal or liver failure – pseudomembranous colitis – children’s age up to 12 years – children are more senior than 12 years with body weight less than 40 kg Medicinal interactions Simultaneous use of Medoklava® and inhibitors of canalicular secretion can lead to long increase in level of amoxicillin in blood, in connection with reduction of its discharge kidneys. Antibiotics of bactericidal action, in particular, aminoglycosides, have sinergidny effect. Antibiotics of bacteriostatic action (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) have antagonistic effect. Antacids, a glycosamine, depletive, aminoglycosides slow down and reduce absorption of Medoklava®, ascorbic acid raises it. Медоклав® strengthens effect of indirect anticoagulants, suppressing intestinal microflora, reduces synthesis of vitamin K and the prothrombin ratio. Reduces efficiency of oral contraceptives. Diuretics, Allopyrinolum, phenylbutazone, NPVS and other drugs reducing kanaltsiyevy secretion increase concentration of amoxicillin. Allopyrinolum increases risk of developing skin rash. Special instructions Before an initiation of treatment of Medoklavom® need to be collected the detailed anamnesis concerning the previous reactions of hypersensitivity to penicillin, cephalosporins or others beta laktamnye antibiotics. Also fatal reactions of hypersensitivity (acute anaphylaxis) on penicillin are described serious, and sometimes. In case of allergic reaction it is necessary to stop treatment of Medoklavom® and to begin alternative therapy. At development of serious reactions of hypersensitivity the patient should enter adrenaline immediately. Oxygenotherapy, the intravenous administration of steroids and ensuring passability of airways including an intubation can be required. Медоклав® it is not necessary to appoint at suspicion of an infectious mononucleosis as with this disease amoxicillin can cause skin rash in patients that complicates diagnosis of a disease. In general, Medoklav® is transferred well and has hypotoxicity inherent to all penicillin. At treatment of Medoklavom® more than 7 days it is recommended to estimate functions of kidneys, a liver, bodies of a hemopoiesis. With care it is necessary to apply Medoklav® at patients with an abnormal liver function. At the patients receiving Medoklav® the increase in a prothrombin time therefore at simultaneous use of Medoklava® and anticoagulants it is necessary to carry out the corresponding monitoring is occasionally observed. Patients with a reduced diuresis, in rare instances can have a crystalluria. At introduction of high doses of amoxicillin it is recommended to accept enough liquid and to support an adequate diuresis for reduction of probability of formation of crystals of amoxicillin. Presence of clavulanic acid at Medoklave® can be the cause of nonspecific binding of IgG and albumine with a membrane of erythrocytes that leads to the false gram-positive test. Pregnancy and the period of a lactation of Medoklav® is not recommended to be applied during pregnancy. Медоклав® gets into breast milk that can cause diarrhea and fungal infections of mucous membranes in the children who are on breastfeeding. The decision on use of drug during pregnancy and breastfeeding is accepted after careful assessment of a ratio of advantage and risk. When assigning in the period of a lactation it is recommended to stop breastfeeding. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect speed of psychomotor reactions and ability to concentration of attention, however, considering a possibility of development of side reactions (dizziness, spasms) it is necessary to be careful. Overdose Symptoms: dysfunctions of a GIT and water and electrolytic balance. Treatment: gastric lavage, intake of activated carbon and performing symptomatic therapy. Amoxicillin can be removed from an organism by means of a hemodialysis. The form of release and packing On 7 tablets place in blister strip packaging from a film polyvinylchloride with a covering from the aluminum foil and printing aluminum foil varnished. On the 2nd blister strip packagings together with the instruction for use in the state and Russian languages place in a pack from cardboard bandbox. To Store storage conditions in the dry, protected from light place, at a temperature not over 25º C. To store in places inaccessible for children! A period of storage 2 years not to use drug after an expiration date. Prescription status According to the prescription Medokemi Ltd Producer, CYPRUS 51409 From Ү-3505 Limassol Tel 357-25-867600 Fax357-25-560863 the Owner of the registration certificate of Medokemi Ltd, CYPRUS the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of Medokemi Ltd in Republic of Kazakhstan Almaty, Mukanov St., 241 office 1B ph. / fax: 313-73-76 E-mail:
To Develop medochemie@mail.ru
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