The instruction for medical use of Avimentin Torgovoye medicine a name Avimentin Mezhdunarodnoye the unlicensed name Is not present the Dosage form Powder for preparation of suspension of 200 mg / 28.5 mg and 400 mg / 57 mg the Structure of 5 ml of suspension contains active agents: amoxicillin trihydrate it is equivalent to amoxicillin of 200 mg, potassium clavulanate of diluted it is equivalent to clavulanic acid of 28.50 mg, excipients: sorbitol, xanthane gum, Natrium benzoicum, monosodium citrate, sodium citrate, aspartame, hydroxytoluene bottled, Trusil fragrance fruit, Trusil fragrance banana. 5 ml of suspension contain active agents: amoxicillin trihydrate it is equivalent to amoxicillin of 400 mg, potassium clavulanate of diluted it is equivalent to clavulanic acid of 57.00 mg, excipients: silicon dioxide colloidal, silicon dioxide, xanthane gum, monosodium citrate, sodium citrate, aspartame, Trusil fragrance fruit, Trusil fragrance banana. Description Powder of white or almost white color. The restored suspension (with water) – white or pale yellow color with a characteristic smell. Pharmacotherapeutic group Antibacterial drugs for system use. Penicillin in a combination with inhibitors beta laktamaz. Clavulanic acid + amoxicillin. The ATX J01CR02 code the Pharmacological Pharmacokinetics Absorption Amoxicillin properties and clavulanate are well dissolved in aqueous solutions with physiological value rn, quickly and completely soaked up from digestive tract after oral administration. Absorption of amoxicillin and clavulanic acid is optimum in case of administration of drug at the beginning of food. After administration of drug in its bioavailability makes 70%. Profiles of both components of drug are similar and reach peak concentration in plasma (Tmax) approximately in 1 hour. Concentration of amoxicillin and clavulanic acid in blood serum is identical as in case of combined use of amoxicillin and clavulanic acid, and each component separately. Distribution Therapeutic concentration of amoxicillin and clavulanic acid are reached in different bodies and fabrics, interstitial liquid (lungs, abdominal organs, the gall bladder, fat, bone and muscular fabrics, pleural, synovial and peritoneal liquids, skin, bile purulent separated to a phlegm). Amoxicillin and clavulanic acid practically do not get into cerebrospinal fluid. Linking of amoxicillin and clavulanic acid with proteins of plasma moderate: 25% for clavulanic acid and 18% for amoxicillin. Amoxicillin, as well as the majority of penicillin, is emitted with breast milk. In breast milk trace amounts of clavulanic acid are also found. except for risk of a sensitization, amoxicillin and clavulanic acid has no negative impact on health of the babies raised by breast milk. Amoxicillin and clavulanic acid get through a placental barrier. Elimination Amoxicillin is removed, mainly by kidneys whereas clavulanic acid – by means of both renal, and extrarenal mechanisms. From about 60 to 70% of amoxicillin and from about 40 to 65% of clavulanic acid are allocated from an organism without changes in urine during the first 6 h after reception of one avimentin 228.5 mg (200 mg / 28.5 to mg) and 457 mg (400 mg / 57 with mg). About 27-60% of clavulanic acid are removed during the 24-hour period, the greatest number of clavulanic acid is brought out of an organism within the first 2 hours after introduction. Metabolism Amoxicillin is partially allocated with urine in the form of inactive penicillic acid in the quantity equivalent to 10-25% of the accepted dose. Clavulanic acid in an organism is exposed to intensive metabolism and is emitted with urine and a stake in the form of carbon dioxide through expired air. Poluvyvedeniya’s children of amoxicillin it is identical to children aged from 3 months to 2 years. For newborn children (including premature) within the first week of life the interval of introduction should not exceed two times a day because of immaturity of an urinogenital system. Patients with a renal failure the General serumal clearance of amoxicillin / clavulanic acid in proportion decreases with reduction of renal function. Decrease in clearance of drug is more expressed for amoxicillin, than for clavulanic acid as the most part of amoxicillin is brought out of an organism through kidneys. Doses in a renal failure have to be moderate to prevent excessive accumulation amoxicillin at preservation of adequate levels of clavulanic acid. Adjustment of a dose is not required from patients with clearance of creatinine more, than 30 ml/min. Patients with clearance of creatinine have less than 30 ml/min. use of amoxicillin with clavulanic acid in the ratio 7:1 is not recommended as there are no data for dose adjustment. Patients with a liver failure At patients with a liver failure it is necessary to dose with care with control hepatic functions. A pharmacodynamics Avimentin is the combined antibiotic containing amoxicillin and clavulanic acid with a wide range of bactericidal action, resistant to a beta laktamaze. Amoxicillin is the semi-synthetic antibiotic of a broad spectrum of activity active concerning many gram-positive and gram-negative microorganisms. Amoxicillin collapses under the influence of a beta laktamaz and does not affect microorganisms which produce this enzyme. The mechanism of effect of amoxicillin consists in inhibition of biosynthesis of peptidoglikan of a cell wall of a bacterium that usually leads to lysis and death of a cell. Clavulanic acid is beta laktamat, on chemical structure close to penicillin which has ability to inactivate enzymes beta laktamaz the microorganisms showing to rezistentnosit to penicillin and cephalosporins, thereby preventing an amoxicillin inactivation. Beta laktamazy are produced by many gram-positive and gram-negative bacteria. Action beta laktamaz can lead to destruction of some antibacterial drugs even prior to their impact on pathogens. Clavulanic acid blocks effect of enzymes, restoring sensitivity of bacteria to amoxicillin. In particular, it has high activity concerning plasmid beta laktamaz with which the medicinal resistance is often connected, but is less effective concerning chromosomal beta laktamaz 1 type. Presence of clavulanic acid as a part of Avimentin protects amoxicillin from the destroying action beta laktamaz and expands its range of antibacterial activity with inclusion in it of the microorganisms usually resistant to other penicillin and cephalosporins. Clavulanic acid in the form of monodrug does not render clinically significant antibacterial effect. The mechanism of development of resistance Exists 2 mechanisms of development of resistance to Avimentin – an inactivation bacterial beta lactamelements which are insensitive to clavulanic acid influence, including the classes B, C, D – deformation penicillin – the connecting protein that the Impermeability of a bacterial wall leads to reduction of affinity of an antibiotic in relation to a microorganism and also mechanisms of a pomp can cause or contribute to the development of resistance, especially at gram-negative microorganisms. Avimentin has bactericidal effect on the following microorganisms: the activity of a combination of amoxicillin with in vitro clavulanic acid is given below. The bacteria usually sensitive to an amoxicillin combination with clavulanic acid Gram-positive aerobes of Bacillus anthracis Enterococcus faecalis Gardnerella vaginalis Listeria monocytogenes Nocardia asteroides Streptococcus pneumoniae1.2 Streptococcus pyogenes1.2 Streptococcus agalactiae1.2 Streptococci of the Viridans2 Streptococcus spp group. (other beta and hemolytic streptococci) 1.2 Staphylococcus aureus (sensitive to Methicillinum) 1 * Staphylococcus saprophytics (sensitive to Methicillinum) Koagulazonegativnye staphylococcus (sensitive to Methicillinum) Gram-positive anaerobe bacterias of Clostridium spp. Peptococcus niger Peptostreptococcus magrtus Peptostreptococcus micros Peptostreptococcus spp. Gram-negative aerobes of Bordetella pertussis Haemophilus influenzae1 Helicobacter pylori Moraxella catarrhal Neisseria gonorrhoeae Pasteurella multocida Vibrio cholerae Gram-negative anaerobe bacterias of Bacteroides fragilis Bacteroides spp. Capnocytophaga spp. Eikenella corrodens Fusobacterium nucleatum Fusobacterium spp. Porphyromonas spp. Prevotella spp. Other Borrelia burgdorferi Leptospira icterohaemorrhagiae Treponema pallidum of the Bacterium for which the acquired resistance to an amoxicillin combination with clavulanic acid Gram-negative aerobes of Escherichia coli1 Klebsiella oxytoca Klebsiella pneumoniae1 Klebsiella spp is probable. Proteus mirabilis Proteus vulgaris Proteus spp. Salmonella spp. Shigella spp. Gram-positive aerobes of Corynebacterium spp. Enterococcus faecium of the Bacterium having natural resistance to an amoxicillin combination with clavulanic acid Gram-negative aerobes of Acinetobacter spp. Citrobacter freundii Enterobacter spp. Hafnia alvei Legionella pneumophila Morganella morganii Providencia spp. Pseudomonas spp. Serratia spp. Stenotrophomonas maltophilia Yersinia enterocolitica Other Chlamydia pneumoniae Chlamydia psittaci Chlamydia spp. Coxiella burnetii Mycoplasma spp. 1 – for these bacteria the clinical performance of a combination of amoxicillin with clavulanic acid was shown in clinical trials. 2 – strains of these species of bacteria do not produce beta lactamelements. The sensitivity at monotherapy by amoxicillin allows to assume similar sensitivity to an amoxicillin combination with clavulanic acid. * – certain representatives of the specified genus of microorganisms, produce β-lactamazu that does them insensitive to amoxicillin. Indications the Bacterial infections caused by microorganisms, sensitive to drug: – upper respiratory tract infection and ENT organs: recurrent tonsillitis, sinusitis, average otitis – infections of lower parts of airways: exacerbations of chronic bronchitis, community-acquired pneumonia, bronchial pneumonia – infections of an urinogenital path: cystitis, pyelonephritis – infections of skin and soft tissues – infections of bones and joints, in particular osteomyelitis the Route of administration and doses the Mode of dosing is set individually depending on age, body weight, function of kidneys, infectious agents and also from severity of an infection. Avimentin is recommended to accept at the beginning of food. Time of the carried-out therapy depends on the response of the patient to the carried-out treatment. Some pathologies (in particular, osteomyelitis) can demand longer course. It is not necessary to continue treatment more than 14 days without repeated assessment of a condition of the patient. If necessary performing step therapy is possible (intravenous administration of drug with the subsequent transition to oral administration in the beginning). Children up to 12 years or with body weight less than 40 kg, depending on age and weight, specify the Dose in body weight mg/kg a day or in milliliters of ready suspension. The recommended dosing mode: – from 25 mg / 3.6 mg/kg/days up to 45 mg / 6.4 the mg/kg/days divided into 2 receptions, in slight and moderate infections (recurrent tonsillitis, infections of skin and soft tissues) – from 45 mg / 6.4 mg/kg/days up to 70 mg / 10 the mg/kg/days divided into 2 receptions for treatment of more serious infections (average otitis, sinusitis, lower respiratory tract infections). The table of the choice of a single dose of drug of Avimentin depending on body weight. The body weight (kg) of 25 mg / 3.6 mg/kg/days of 45 mg / 6.4 mg/kg/days * 5 0,8 ml 2 times in day of 1.4 ml 2 times in day of 6 0,9 ml 2 times in day of 1.7 ml 2 times in day of 7 1,1 ml 2 times in day of 2.0 ml 2 times in day of 8 1,3 ml 2 times in day of 2.3 ml 2 times in day of 9 1,4 ml 2 times a day – 10 1,6 ml 2 times a day – 11 1,7 ml 2 times a day – 12 1,9 ml 2 times a day – 13 2,0 ml 2 times a day – 14 2,2 ml 2 times a day – 15 2,3 ml 2 times a day – * For children with the body weight & gt, 8 kg use Avimentin 400 mg / 57 mg in order to avoid single administration of drug more than 5 ml. There are no clinical these uses of this dosage of Avimentin over 45 mg / 6.4 mg/kg/days at children 2 years are younger. For children with body weight less than 40 kg the maximum daily dose makes 1000-2400 mg of amoxicillin / 143-600 mg of clavulanic acid. In need of purpose of higher daily dose of amoxicillin, it is necessary to appoint other dosage of Avimentin in order to avoid reception of high doses of clavulanic acid needlessly. Patients with a renal failure of Correction of doses are based on the maximum recommended dose of amoxicillin and value of clearance of creatinine. Children Clearance of creatinine the Mode of dosing of Avimentin & gt, 30 ml/min. Correction of a dose is not required also to lt, the drug having a ratio amoxicillin/clavulanic acid in the ratio 7:1 as there are no recommendations about dosing Patients with abnormal liver functions Treatment is not recommended to use 30 ml/min. carry out with care, regularly carry out monitoring of function of a liver. The suspension route of administration Suspension gets divorced just before the first use. Check integrity of a cover before use. Stir up a bottle with powder. Powder should be dissolved in the boiled water cooled to room temperature gradually stirring up and adding water to a tag on a bottle. The ready volume of suspension is equal to 100 ml. The bottle should be turned and to stir up carefully before full dissolution. The bottle should be shaken up before each use. For drug dosing it is necessary to use a measured glass which needs to be rinsed well with water after each use. For more exact dosing of small volumes of suspension, especially at children is younger than 3 months, use of the standard disposable medical syringe is necessary. At treatment of children under 2 years, ready suspension of Avimentin can be dissolved with water half. Side effects Very often ≥ 1 of 10, is frequent ≥ 1 of 100 and & lt, 1 of 10, sometimes ≥ 1 of 1000 and & lt, 1 of 100, is rare ≥ 1 of 10000 and & lt, 1 of 1.000, also lt is very rare, 1 of 10000 is frequent – candidiasis of skin and mucous covers – nausea, vomiting, diarrhea Nausea meets at use of high doses of drug more often. For decrease in extent of manifestation it is recommended to accept suspension at the beginning of meal. Infrequently – dizziness, a headache – dyspepsia – moderate increase in level of liver enzymes of ALT/nuclear heating plant – skin rash, an itching, a small tortoiseshell Seldom – a reversible leukopenia (including a neutropenia), thrombocytopenia – a multiformny erythema 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 – aseptic meningitis – the antibiotiko-associated colitis (including pseudomembranous and hemorrhagic) – the overgrowth of insensitive microflora – black hairy language (chronic hyperplasia of threadlike nipples of language) – change of coloring of a blanket of adamantine substance of tooth – hepatitis, cholestatic jaundice – Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, bullous exfoliative dermatitis, sharp generalized exanthematous pustulyoz At development of these symptoms drug has to be cancelled. – interstitial nephrite, the Contraindication crystalluria – hypersensitivity or to any component of drug – the known hypersensitivity to others beta laktamnym to antibiotics (cephalosporins, karbapenema, monobaktama) – the jaundice or an abnormal liver function which developed against the background of reception of a combination of amoxicillin/clavulanic acid – phenylketonuria (in connection with presence of aspartame as a part of drug) – glyukozo-galaktozny malabsorption (in connection with presence of maltodextrin (glucose) as a part of drug) – children’s age up to 2 months is not recommended to apply Medicinal interactions Avimentin along with probenitsidy to penicillin. Probenitsid reduces canalicular secretion of amoxicillin and therefore simultaneous use of Avimentin and probenitsid
can lead to increase in amoxicillin level blood. Simultaneous use of Allopyrinolum and Avimentin can increase risk of emergence of allergic reactions. Data on simultaneous use of Allopyrinolum and Avimentin are absent now. Avimentin influences indestinal flora and leads to reduction of the return absorption, decrease in efficiency of the combined oral contraceptives. Cases of increase in a prothrombin time were revealed (atsenokumarol and warfarin) at simultaneous use of Avimentin and anticoagulants it is necessary to carry out the corresponding monitoring with correcting of a dose Avimentin if necessary. Penicillin can reduce removal of a methotrexate that is potential risk of increase in its toxicity. At the patients accepting mikofenolat mofetit, at combined use with Avimentin the concentration of an active metabolite of mikofenolovy acid when assigning an initial dose decreases approximately by 50%. Change of level of concentration of an initial dose can not correspond to changes of concentration of total exposure of mikofenolovy acid. Special instructions to Adults and children are more senior than 12 years or with body weight more than 40 kg are recommended Avimentin’s use in tablets. Before an initiation of treatment Avimentin it is necessary to collect 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 which came to light at patients with the previous hypersensitivity on penicillin more often are described serious, and sometimes. In case of allergic reaction it is necessary to stop treatment by Avimentin 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. In case of confirmation of the disease caused amoxicillin – sensitive strains, it is necessary to refuse a combination amoxicillin/clavulanic acid and to appoint amoxicillin separately. Avimentin at high risk of possible resistance to a beta lactamnoma is not recommended to apply to a drug component. Avimentin should not be applied to treatment of the pathologies caused by Streptococcus pneumoniae, having resistance to penicillin. Avimentin 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. When prescribing drug to patients with reduced function of kidneys or when using high doses the development of spasms is possible. Combined use of Allopyrinolum and amoxicillin increases a likelihood of development of skin allergic reactions. Long-term treatment Avimentin can be followed by the overgrowth of microorganisms, insensitive to it. For prevention of discoloration of adamantine substance of tooth it is necessary to brush teeth after each intake of suspension. Cases of development of pseudomembranous colitis against the background of use of antibiotics which weight varied from easy to heavy degree were revealed. Thus, it must be kept in mind possibility of this pathology at patients with diarrhea at reception of antibiotics or after the termination of a course of therapy. In case of development of long or considerable diarrhea, in the presence of spasms in a stomach, treatment by Avimentin has to be immediately stopped and patients have to be directed to further inspection. In general, Avimentin is had well and has hypotoxicity inherent to all penicillin. At long treatment by Avimentin it is recommended to estimate periodically functions of kidneys, a liver, bodies of a hemopoiesis. At the patients receiving Avimentin the increase in a prothrombin time therefore at simultaneous use of Avimentin and anticoagulants it is necessary to carry out the corresponding monitoring is occasionally observed. With care it is necessary to apply Avimentin at patients with an abnormal liver function. Signs and symptoms of damage of a liver usually arise in time or right after an initiation of treatment, but in certain cases can not be shown within several weeks after the therapy termination. As a rule, they are reversible. Hepatic violations can be very serious, and in extremely exceptional cases was reported about death. Almost always they were registered at patients with a serious basic disease or at those who at the same time took the drugs known as potentially influencing a liver. Cases of development of the antibiotiko-associated colitis against the background of reception of Avimentin which extent was from insignificant to life-threatening were reported. In this regard it is necessary to consider the possibility of development of colitis in patients with the diarrhea which developed in time or after reception of antibiotics. At confirmation of the diagnosis of colitis, Avimentin has to be immediately cancelled, the patient has to consult with the doctor for performing necessary therapy. At patients with a renal failure the dose of drug has to be adjusted according to disease severity. At patients with a renal failure or receiving high doses of drug spasms are possible. Patients with a reduced diuresis in rare instances can have a crystalluria. During 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. At patients with a catheter constant assessment of their state is necessary. During treatment by amoxicillin for determination of content of glucose in urine it is necessary to use methods of fermental oxidation of glucose, so not fermental methods can lead to obtaining false positive results. Presence of clavulanic acid in Avimentin can be the cause of nonspecific binding of IgG and albumine with a membrane of erythrocytes that leads to false positive reaction of Koombs. Avimentin, powder for preparation of suspension for intake, contains aspartame, a phenylalanine source. It is not recommended to use drug to patients with phenylketonuria. Pregnancy and the period of a lactation Use it is necessary to avoid during pregnancy if it is only not considered the necessary doctor. Both substances are emitted in breast milk (it is not known of influence of clavulanic acid on breastfeeding). Therefore, the diarrhea and a fungal infection of mucous membranes are possible in breastfeeding. Amoxicillin / clavulanic acid have to be used during breastfeeding after assessment of advantage / risk by the attending physician. Suspension for intake is intended for use in pediatrics. There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data, however, in connection with a possibility of development of side reactions (allergy, dizziness, spasms) it is necessary to be careful. Overdose Symptoms: gastrointestinal disorders and disturbances of water and electrolytic balance are possible. The amoksitsillinovy crystalluria in certain cases leading to development of a renal failure is described. When prescribing drug to patients with reduced function of kidneys or when using high doses the development of spasms is possible. Sedimentation of amoxicillin on uric catheters, especially after purpose of high doses by intravenous administration is possible. Treatment: performing symptomatic therapy, correction of water and electrolytic balance. Avimentin is brought from blood by means of a hemodialysis. The form of release and packing place Drug in polyethylene bottles of the high density with a capacity of 100 ml with the screwing-up cover from the same material. On 1 bottle together with a measured glass and the instruction for medical use in the state and Russian languages place in a pack from cardboard. Storage conditions In the dry, protected from light place, at a temperature not over 25 ºС. To store the restored suspension in the fridge at a temperature from 2 of 0C up to 8 0C and to use within 7 days. Not to freeze! To store out of children’s reach! 1.5 years not to accept a period of storage after an expiration date. Prescription status According to the prescription the Producer Veksta Laboratoriyes Pvt. Ltd., India Office Nos. 20 & 21 A, First Floor, Yashodham Shopping Complex, Gen. A.K. Vaidya Marg, Goregaon (E), Mumbai – 400063, India the Owner of the registration certificate of Avitsena-Ltd LLP, Kazakhstan 050002, Almaty, Dzhangildin St., 31, office 416 of the accepting claim (offer) from consumers on quality of medicine of Avitsena-LTD LLP 050002, Almaty, Dzhangildin St., 31, office 416 the Address of the organization responsible for post-registration observation of safety of TOO ConsultAsia Shevchenko St. medicine of 165 B, office 307
to Develop the Address of the organization in the territory of the Republic of Kazakhstan
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