The instruction for medical use of Klavam Torgovoye medicine a name Klavam Mezhdunarodnoye the unlicensed name Is not present the Dosage form Powder for preparation of suspension for intake, 156.25 mg / 5 ml, 228.5 mg / 5мл, 16.66 g / 100 ml Structure of 5 ml of the restored suspension contain active agents: trihydrate amoxicillin (it is equivalent to amoxicillin of 125.000 mg) clavulanate potassium (it is equivalent to clavulanic acid of 31.250 mg) (for a dosage of 156.25 mg / 5мл) 5 ml of the restored suspension contain active agents: trihydrate amoxicillin (it is equivalent to amoxicillin of 200.000 mg) clavulanate potassium (it is equivalent to clavulanic acid of 28.500 mg) (for a dosage of 228.5/5 ml) excipients: Mannitolum, sodium citrate, citric acid monohydrate, Natrium benzoicum, xanthane gum, silicon dioxide colloidal, fragrance mint DC 117, aspartame. The description the Granulated powder from white till whitish color, at cultivation with water forms homogeneous suspension of white color with taste of mint. 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 Key Pharmacokinetic Parameters properties of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid in a combination do not influence at each other. Absorption: after intake both components of drug are quickly absorbed from digestive tract. 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%. 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. After single dose in one tablet of 250 mg / 125 mg or 500 mg / 125 the mg about 60-70% of amoxicillin and 40-65% of clavulanic acid during the first 6 h is removed with urine in not changed look. 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 to 2.5-digidro-4-(2 hydroxyethyl) – 5-oxo-1H-pyrrol-3-carboxylic acid and 1 – amino – 4 – hydroxy – butane – 2 – it also is allocated with urine and a stake and also in the form of carbon dioxide through expired air. The pharmacodynamics Klavam – the combined antibiotic of a broad spectrum of activity, contains semi-synthetic penicillin amoxicillin and inhibitor beta laktamaz clavulanic acid. 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 Klavam 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 Klavam – 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. Klavam has bactericidal effect on the following microorganisms: Gram-positive aerobes: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (sensitive to Methicillinum), a coagualase – negative staphylococcus (sensitive to Methicillinum), Streptococcus agalactiae, Streptococcus pneumoniae1, Streptococcus pyogenes and other beta and hemolytic streptococci, the Streptococcus viridans group Gram-negative aerobes: Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae, Moraxella catarrhalis, Pasteurella multocida anaerobic microorganisms: Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp. Microorganisms with the possible acquired resistance Gram-positive aerobes: Enterococcus faecium * Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris Microorganisms with natural resistance: gram-negative aerobes: Acinetobacter species, Citrobacter freundii, Enterobacter species, Legionella pneumophila, Morganella morganii, Providencia species, Pseudomonas species, Serratia species, Stenotrophomonas maltophilia, other: Chlamydia trachomatis, Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae. * Natural sensitivity in the absence of the acquired resistance. 1 except for strains of Streptococcus pneumoniae resistant to penicillin Indications – acute bacterial sinusitis – acute average otitis – lower respiratory tract infections (exacerbation of chronic bronchitis, community-acquired pneumonia) – cystitis – pyelonephritis – infections of skin and soft tissues (in particular, inflammation of hypodermic cellulose – cellulitis, stings of animals, acute abscesses and phlegmons of maxillofacial area) – infections of bones and joints (in particular, osteomyelitis) the Route of administration and doses Drug is intended for use in pediatrics. The mode of dosing is set individually depending on age, body weight, function of kidneys and also from severity of an infection. Before prescribing of drug it is whenever possible necessary to allocate a microorganism and to define its sensitivity to antibiotics by a fence and the analysis of samples at the specific patient, especially in case of heavy infections. Klavam is recommended to accept at the beginning of food. It is not necessary to continue treatment more than 14 days without repeated assessment of a condition of the patient. Children since the birth 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 20 mg / 5 mg/kg/days up to 60 mg / 15 the mg/kg/days divided into 3 receptions: in infections of light severity (tonsillitis, infections of skin and soft tissues) a daily dose of drug of 20 mg / 5 mg/kg/days – 40 mg / 10 mg/kg/days, in case of development of heavy infections (average otitis, sinusitis, lower respiratory tract infections and infections of an urinogenital path) are applied high doses of drug – 60 mg / 15 by mg/kg/days. There are no clinical these uses of Klavam of 125 mg / 31.25 mg / 5 ml over 40 mg / 10 mg/kg/days at children 2 years are younger. The table of the choice of a single dose of the drug Klavam depending on body weight. The body weight (kg) of 20 mg/kg/days 40 mg/kg/days 60 mg/kg/days * 2 0,5 ml 3 times in day of 1.0 ml 3 times in day of 1.6 ml 3 times in day of 3 0,8 ml 3 times in day of 1.6 ml 3 times in day of 2.4 ml 3 times in day of 4 1,1 ml 3 times in day of 2.1 ml 3 times in day of 3.2 ml 3 times in day of 5 1,3 ml 3 times in day of 2.7 ml 3 times in day of 4 ml 3 times in day of 6 1,6 ml 3 times in day of 3.2 ml 3 times in day of 4.8 ml 3 times in day of 7 1,9 ml 3 times in day of 3.7 ml 3 times a day – 8 2,1 ml 3 times in day of 4.3 ml 3 times a day – 9 2,4 ml 3 times in day of 4.8 ml 3 times a day – 10 2,7 ml 3 times in day of 5.3 ml 3 times a day – * For children with the body weight & gt, 6 kg at a daily dose of 60 mg/kg/days use Klavam 200 mg / 28.5 mg in order to avoid single administration of drug more than 5 ml. 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 Klavama & gt, 30 ml/min. Correction of a dose is not required to 10-30 ml/min. 15 mg / 3.75 by mg/kg (1.2 ml) 2 times a day (at most 500 mg / 125 in mg (20 ml) twice a day) & lt, 10 ml/min. 15 mg / 3.75 the Patients who are on a hemodialysis of Correction of doses are based by mg/kg (1.2 ml) of 1 times a day (at most 500 mg / 125 mg (20 ml) once a day) on the maximum recommended amoxicillin dose. Children: 15 mg / 3.75 mg/kg (1.2 ml) of 1 times a day. Before a session of a hemodialysis it is necessary to accept one additional dose of 15 mg / 3.75 mg/kg (1.2 ml). For restoration of concentration of Klavama active agents in blood the second additional dose of 15 mg / 3.75 mg/kg (1.2 ml) should be accepted after the hemodialysis session. Patients with abnormal liver functions carry out Treatment with care, regularly carry out monitoring of function of a liver. The suspension route of administration Suspension prepares just before the first use. Powder should be dissolved in 92 ml of 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 prepared suspension – white or almost white color. The bottle should be stirred up well before each use. For an exact dosage of drug it is necessary to use a measured cap cover 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 Klavama suspension can be dissolved with water half. Side effects Often (≥1/100, & lt, 1/10) – 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 (≥1/1000, & lt, 1/100) – dizziness, a headache – dyspepsia – moderate increase in level of liver ALT, nuclear Heating Plant enzymes – skin rash, an itching, a small tortoiseshell Seldom (≥1/10000, & lt, 1/1000) – a reversible leukopenia (including a neutropenia), thrombocytopenia – a multiformny erythema Very seldom – the antibiotiko-associated colitis (including pseudomembranous and hemorrhagic) – black hairy language (chronic hyperplasia of threadlike nipples of language) – reversible superficial coloring of adamantine substance of tooth (easily is removed when cleaning by a brush). Respect for hygiene of an oral cavity helps to prevent coloring of adamantine substance of tooth. It is unknown – rapid growth of insensitive organisms – 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 – 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 to antibiotics of group of penicillin, to others beta laktamnym to antibiotics (cephalosporins, karbapenema, monobaktama) – hypersensitivity to amoxicillin or clavulanic acid or other components of drug – an infectious mononucleosis – a lymphoid leukosis – a liver failure – the jaundice or an abnormal liver function caused by reception of antibiotics of group of penicillin (including combinations of amoxicillin/clavulanic acid) – bronchial asthma, a senny pollinosis – phenylketonuria (in connection with presence of aspartame as a part of drug) Medicinal interactions At simultaneous use of Klavam and indirect anticoagulants (atsenokumarol and warfarin) is noted increase in a prothrombin time (PTV). Therefore this combination is appointed with care and need of carrying out the corresponding monitoring of PTV from a korrekttsiy dose of Klavam if necessary. At simultaneous use of Klavam with Allopyrinolum the risk of development of such side effects as a dieback increases. At simultaneous use Klavam enhances toxicity of a methotrexate due to decrease in removal of a methotrexate. At the patients accepting mikofenolat mofetit, at combined use with Klavam 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. The amoxicillin combination with rifampicin is antagonistic (mutual weakening of antibacterial action is noted). Klavam it is not necessary to apply along with bacteriostatic antibiotics (macroleads, tetracyclines), streptocides because of possible decrease in efficiency of Klavam. Klavam influences indestinal flora and leads to reduction of the return absorption, at simultaneous use Klavam reduces efficiency of oral contraceptives. Probenetsid reduces renal canalicular secretion of amoxicillin. Simultaneous use with Klavam can lead it to the increased amoxicillin level in blood, however, it is not observed concerning clavulanic acid. Therefore Klavam along with probenitsidy is not recommended to apply. Special instructions to Adults and children are more senior than 12 years or with body weight more than 40 kg are recommended use of this combination in tablets. Before an initiation of treatment Klavam it is necessary to collect the detailed anamnesis about whether were at the patient in the past of 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 Klavam 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-chuvs
by vitelny strains it is necessary to refuse a combination amoxicillin + clavulanic acid and to appoint amoxicillin separately. Klavam at high risk of possible resistance to a beta lactamnoma is not recommended to apply to a drug component. Klavam should not be applied to treatment of the pathologies caused by Streptococcus pneumoniae, having resistance to penicillin. Klavam 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. For the purpose of reduction of risk of development of side reactions from digestive tract it is necessary to take the drug at meal time. Long-term treatment by a combination amoxicillin + clavulanic acid 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 Klavam has to be immediately stopped and patients have to be directed to further inspection. In general, Klavam is had well and has hypotoxicity inherent to all penicillin. At long treatment by Klavam it is recommended to estimate periodically functions of kidneys, a liver, bodies of a hemopoiesis. At the patients receiving Klavam the increase in a prothrombin time therefore at simultaneous use of Klavam and anticoagulants it is necessary to carry out the corresponding monitoring is occasionally observed. With care it is necessary to apply Klavam 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 a combination amoxicillin + clavulanic acid which degree 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, Klavam 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. 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. Because at a large number of the patients with an infectious mononucleosis and a lymphoid leukosis receiving ampicillin observed appearance of erythematic rash that complicates diagnosis of a disease. Use of antibiotics of group of ampicillin for such patients is not recommended. At the patients receiving a combination amoxicillin + clavulanic acid the increase in a prothrombin time therefore at simultaneous use of Klavam and anticoagulants it is necessary to carry out the corresponding monitoring is occasionally observed. Klavam suspension contains aspartame – a phenylalanine source therefore patients are not recommended to use drug with phenylketonuria. At use Klavama is possible false positive reaction when determining level of glucose in urine when using a reactant of Benedict or Fellinga solution (recommend to apply enzymatic reactions with glucose oxydas). It is necessary to avoid co-administration with Disulfiramum. Clavulanic acid can be the cause of nonspecific binding of IgG and albumine with a membrane of erythrocytes that leads to false positive reaction of Koombs. Pregnancy and the period of a lactation 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. The overdose is not available messages about a lethal outcome or emergence of life-threatening side effects owing to drug overdose. Symptoms: an abdominal pain, diarrhea, vomiting, it is possible also uneasiness, excitement, insomnia, dizziness, in some cases – at patients with reduced function of kidneys or when using high doses the development of spasms is possible. The crystalluria leading to development of a renal failure. Treatment: in case of recent administration of drug (less than 4 h) it is necessary to carry out gastric lavage and to appoint activated carbon for drug absorption reduction, if necessary carry out symptomatic therapy, correction of water and electrolytic balance the hemodialysis Is effective. A form of release and packing On 16.66 g in the glass bottles of amber color corked by the screwing-up aluminum cover. The dosing cap from PVC is applied to a bottle. 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 in the dry, protected from light place at a temperature not above 25 °C. To store out of children’s reach! 2 years not to use a period of storage after the expiration date specified on packing. Prescription status According to the prescription Producer ALKEM LABORATORIES LTD, Alkem House “Devashish” Senapati Bapat Marg Lower Parel, Mumbai-400013, India
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