Amoksiklav prig.susp.dlya powder for oral 400mg + 57mg / 5ml 70ml 17.5g vial 1 piece with doz.pipetkoy

Description

Composition
Active substance:
5 ml of a suspension of 125 mg + 31.25 mg contains: amoxicillin (in trihydrate form), based on active substance – 125,000 mg; Clavulanic acid (in potassium salt form), based on active substance – 31,250 mg;
5 ml of a suspension of 250 mg + 62.5 mg contains: amoxicillin (in trihydrate form), based on active substance – 250,000 mg; Clavulanic acid (in potassium salt form), based on active substance – 62,500 mg;
5 ml of a suspension of 400 mg + 57.5 mg contains: amoxicillin (in trihydrate form), based on active substance – 400.000 mg; Clavulanic acid (in potassium salt form), based on active substance – 57,000 mg ;.
Excipients:
Citric acid (anhydrous); Sodium citrate (anhydrous); sodium benzoate; and microcrystalline cellulose carmellose sodium; xanthan gum; colloidal silicon dioxide; silicon dioxide; flavor of wild cherry; sodium saccharinate; mannitol.
Description:
Powder: Crystalline powder from white to yellowish-white in color.
A suspension: homogeneous suspension from almost white to yellow.
Product form:
Powder for suspension for oral administration.
For doses of 125 mg + 31.25 mg / 5 ml and 250 mg + 62.5 mg / 5 ml
Primary packaging 25 grams (100 ml ready suspension) in dark glass bottles with an annular label (100 mL) with a screw cap of high density polyethylene with a control ring and with sealing cone inside the cap or a screw metallic cap with a control ring, inside cover – laying low density polyethylene.
secondary packaging
One vial with a dosing spoon with annular marks in a cavity of 2.5 ml and 5 ml ( “2.5 CS” and “5 MOP”), maximum fill mark 6 ml ( “MOP 6”) on the spoon handle and instructions for medical application in a cardboard box.
Or one vial with a graduated pipette dosage for medical use in a cardboard box.
For dosage of 400 mg + 57 mg / 5 ml
Primary packaging
According to 8.75 g (35 ml final suspension), or 12.50 g (50 ml final suspension), or 17.50 g (70 ml final suspension) or 35.0 g (140 ml ready slurry) of the powder into the bottle dark glass with a high density polyethylene screw cap with a control ring and with sealing cone inside the cap.
Or 17.50 g (70 ml final suspension) in a dark glass vial with an annular label (70 mL) with high density polyethylene screw cap with a control ring and with sealing cone inside the cap.
secondary packaging
One vial with a graduated pipette and dosage instructions for medical use in a cardboard box.
Contraindications
Hypersensitivity to any component of the drug; Hypersensitivity history to penicillins, cephalosporins and other beta-lactam antibiotics; a history indication cholestatic jaundice and / or liver dysfunction caused by intake of amoxicillin / clavulanic acid; Infectious mononucleosis; lymphocytic leukemia.
Precautions: pseudomembranous colitis with a history of gastrointestinal disorders, hepatic insufficiency, serious disturbances of kidney function, pregnancy, lactation, while the use of anticoagulants.
Dosage
400 mg + 57.5 mg / 5 ml
Indications
Infectious and inflammatory diseases caused by susceptible to amoxicillin + clavulanic acid by microorganisms: infections of the upper respiratory and ENT (acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis); lower respiratory tract infections (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); Urinary tract infections (e.g., cystitis, urethritis, pyelonephritis); infections in gynecology; Skin and soft tissue infections, including animal bites, and humans; Infection of bone and connective tissue; biliary tract infection (cholecystitis, cholangitis); odontogenic infection.
Interaction with other drugs
Antacids, glucosamine, laxatives, drugs, aminoglycosides delay absorption, ascorbic acid increases the absorption.
Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs and other drugs that block tubular secretion (probenecid), increase the concentration of amoxicillin (Clavulanic acid is derived largely by glomerular filtration).
Simultaneous use of the drug methotrexate Amoksiklav® and increases the toxicity of methotrexate.
Appointment, together with allopurinol increases the incidence of exanthema. Avoid concurrent use with disulfiram.
Reduces the effectiveness of drugs, which are formed during the metabolism of p-aminobenzoic acid, ethinylestradiol – the risk of bleeding “breakthrough”.
Enhances effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). At the same time taking anticoagulants need to monitor the performance of blood clotting.
The literature describes the rare cases of increased international normalized ratio (INR) in patients with concomitant use of warfarin and acenocoumarol or amoxicillin. If necessary, the simultaneous application of anticoagulants prothrombin time and INR should be monitored closely in the appointment or revocation of the drug.
Combination with rifampicin antagonistic (the mutual weakening of the antibacterial effect). Amoksiklav® The drug should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in efficiency Amoksiklav® preparation.
In patients treated with mycophenolate mofetil, after initiation of the combination of amoxicillin with clavulanic acid was observed decrease in concentration of the active metabolite – mycophenolic acid before receiving the next dose of the drug is approximately 50%. This concentration change may not accurately reflect the overall exposure changes mycophenolic acid.
Amoksiklav® drug reduces the effectiveness of oral contraceptives.
Overdose
Reports of deaths or the occurrence of life-threatening side effects due to an overdose of the drug Amoksiklav® not.
Symptoms of overdose include from the gastrointestinal tract disorders (abdominal pain, diarrhea, vomiting) and disorders of water and electrolyte balance. Recorded messages crystalluria caused by intake of amoxicillin, which, in some cases, led to the development of renal failure.
Perhaps the development of seizures in patients with renal insufficiency or in patients receiving high doses of the drug.
In case of overdose the patient should be under medical supervision, treatment – symptomatic.
If overdose recommended gastric lavage and intake adsorbent (activated carbon).
Amoxicillin / clavulanic acid output by hemodialysis.
pharmachologic effect
Pharmacological group:
Antibiotic – penicillin semisynthetic + beta-lactamase inhibitor.
Pharmacodynamics:
Mechanism of action
Amoxicillin – a semi-synthetic broad-spectrum antibiotic with activity against many Gram-positive and Gram-negative microorganisms. At the same time, amoxicillin susceptible to destruction of beta-lactamases and therefore the spectrum of activity of amoxicillin does not apply to micro-organisms that produce this enzyme.
Clavulanic acid – a beta-lactamase inhibitor, structurally related penicillins, has the ability to inactivate a wide range of beta-lactamase detected in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficiency in plasmid against beta-lactamases, which often cause bacterial resistance, and is not effective against chromosomal beta-lactamase I type which is not inhibited by clavulanic acid.
The presence of clavulanic acid in a preparation of amoxicillin protects from degradation enzymes – beta-lactamases, allowing to extend the antibacterial spectrum of amoxicillin.
Below is a combination of amoxicillin with clavulanic acid activity in vitro.
Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, other beta-hemolytic steptokokki1,2, Staphylococcus aureus (methicillin sensitive) 1, Staphylococcus saprophyticus (methicillin sensitive), coagulase-negative staphylococci (methicillin sensitive).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
Others: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: species of the genus Clostridium, Peptococcus niger, Peptostrepiococcus magnus, Peptostreptococcus micros, species of the genus Peptostreptococcus.
Gram-negative anaerobes: Vacteroides fragilis, Bacteroides species of the genus, species of the genus Capnocytophaga, Eikenella corrodens, Fusobacterium nucleatum, species of the genus Fusobacterium, species of the genus Porphyromonas, species of the genus Prevotella.
Bacteria, which are likely to acquired resistance to the combination of amoxicillin with clavulanic acid
Gram-negative aerobes: Escherichia soli1, Klebsiella oxytoca, Klebsiella pneumoniae, species of the genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of the genus Proteus, species of the genus Salmonella, species of the genus Shigella. Streptococcus pneumoniae1,2, streptococci Viridans group.
Gram-positive aerobes: species of the genus Corynebacterium, Enterosoccus faecium.
Bacteria have natural resistance to the combination of amoxicillin with clavulanic acid
Gram-negative aerobes: species of the genus Acinetobacter, Citrobacter freundii, species of Enterobacter, Hafnia alvei, Legionella pneumophila, Morganella morganii, species of the genus Providencia, species of the genus Pseudomonas, species of the genus Serratia, Stenotrophomonas maltophilia, Yersinia enterocolitica.
Others: Chlamydia pneumoniae, Chlamydia psittaci, species of the genus Chlamydia, Coxiella burnetii, species of the genus Mycoplasma.
1 for data bacteria clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies. 2shtammy these bacteria do not produce beta-lactamase. Sensitivity for amoxicillin alone suggesting a similar sensitivity to the combination of amoxicillin with clavulanic acid.
Pharmacokinetics:
Suction
The active ingredients of the drug is rapidly and completely absorbed from the gastrointestinal (GI) tract following ingestion. Absorption of active ingredients in the case of optimal use of the drug with food.
Metabolism
About 10-25% of the initial dose of amoxicillin kidneys displayed as an inactive metabolite (penitsilloevoy acid). Clavulanic acid in the human body is exposed to intensive metabolism to form 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one excreted by the kidneys and, through the digestive tract, as well as the exhaled air, in the form of carbon dioxide.
Distribution
As found in various tissues and interstitial fluid (in the gall bladder, abdominal tissue, skin, fat and muscle tissues, synovial and peritoneal fluids, bile, purulent) by intravenous administration of amoxicillin and clavulanic acid therapeutic concentrations of amoxicillin and clavulanic acid .
Amoxicillin and clavulanic acid have a low degree of binding to plasma proteins. Studies have shown that blood plasma proteins binds about 25% of the total amount of clavulanic acid and amoxicillin in 18% plasma.
The volume of distribution is about 0.3-0.4 liters / kg amoxycillin and about 0.2 l / kg for clavulanic acid.
Amoxicillin and clavulanic acid can not penetrate the blood-brain barrier in non-inflamed meninges. Amoxicillin (like most penicillins) is excreted in breast milk.
The breast milk can be detected as trace amounts of clavulanic acid. Except for the possibility of sensitization, diarrhea and candidiasis of the oral mucosa, no other known adverse effects of amoxicillin and clavulanic acid on the health of infants, breastfed.
Reproduction studies in animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no evidence of negative effects on the fetus.
breeding
Amoxicillin is derived primarily by the kidneys, while the clavulanic acid through both the renal and extrarenal mechanisms. After a single oral administration of 875 mg / 125 mg or 500 mg / 125 mg approximately 60-70% and 40-65% of amoxicillin clavulanic acid during the first 6 hours excreted by the kidneys in unchanged form.
The average half-life (T1 / 2) of amoxycillin / clavulanic acid of approximately 1 hour, the average total clearance of approximately 25 l / h in healthy patients. In various studies it was found that the excretion of amoxicillin kidneys within 24 hours approximately 50-85% of clavulanic acid – 27-60%.
The greatest amount of clavulanic acid output during the first 2 hours after ingestion. Pharmacokinetics of Amoxicillin / clavulanic acid do not depend on the sex of the patient.
Patients with impaired renal function
Total clearance of amoxicillin / clavulanic acid is reduced proportional to the reduction of renal function. Reduced clearance is more pronounced for amoxicillin than for clavulanic acid, as most of amoxicillin excreted by the kidneys. Doses in renal failure must be chosen taking into account the undesirable accumulation of amoxicillin amid maintain normal levels of clavulanic acid.
Patients with impaired liver function
In patients with impaired liver function the drug is used with caution. It is necessary to carry out continuous monitoring of liver function.
Both components are removed by hemodialysis and minor amounts – peritoneal dialysis.
Pregnancy and breast-feeding
Animal studies did not reveal data about the dangers of the drug during pregnancy and its effects on the embryonic development of the fetus.
In one study in women with premature rupture of membranes, it was found that prophylactic therapy with amoxicillin / clavulanic acid may be associated with increased risk of necrotizing enterocolitis in infants.
During pregnancy and lactation the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Amoxicillin and clavulanic acid in small amounts into breast milk, so the drug during breast-feeding to be continued only with clear indications.
Infants receiving breast-feeding may develop sensitization, diarrhea, candidiasis oral mucous membranes. In such cases, breast-feeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
According to the World Health Organization (WHO) adverse reactions are classified according to their rate of development as follows: very common (> 1/10), frequent (> 1/100,
special instructions
Before treatment, the patient should be asked to identify a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics. In patients with increased sensitivity to penicillins, possible allergic cross-reaction with cephalosporin antibiotics. In exchange treatment is necessary to monitor the condition of the function of blood, liver and kidneys. In patients with severely impaired renal function requires adequate correction doses or longer intervals between reception dose.
To reduce the risk of side effects from the gastrointestinal tract should take the drug at meal time.
Perhaps the development of superinfection due to growth insensitive to amoxicillin microflora, which requires a corresponding change of antibiotic therapy.
At occurrence of antibiotic-associated colitis should be lifted immediately Amoksiklav®, see a doctor and begin appropriate treatment. Drugs inhibiting peristalsis are contraindicated in these situations.
Treatment continues for a required 48-72 hours after the disappearance of clinical signs of disease. With simultaneous use of estrogensoderjath oral contraceptives and amoxicillin should be possible to use other additional methods of contraception. Amoxicillin and clavulanic acid may induce non-specific binding of immunoglobulins and albumins from erythrocyte membrane, which may cause false positive reaction in the test Coombs.
In patients with reduced urine output crystalluria occur very rarely. During application of high doses of amoxycillin are advised to take a sufficient amount of fluid to maintain adequate urine output and to reduce the probability of formation of amoxicillin crystals.
Use of the drug should be avoided in cases of suspected infectious mononucleosis. Laboratory analyzes: amoxicillin high concentrations give a false positive reaction in the glucose urine using Benedict’s reagent or Fehling’s solution.
It is recommended to use the enzymatic reaction with glucosidase.
Special precautions for the destruction of unused drug
No need for special precautions in the destruction of unused Amoksiklav® drug.
Information about the negative impact of the drug at the recommended doses Amoksiklav® on the ability to drive a car or operate machinery is not. However, because of the possibility of adverse effects on the central nervous system such as dizziness, headache, convulsions, during treatment should be careful when driving and busy with other activities that require concentration and speed of psychomotor reactions.
When the described adverse events should refrain from carrying out these activities.
Storage conditions
Stored in a dry place at a temperature not higher than 25 C.
The finished suspension was stored at 2-8 C in a tightly closed vial.
Keep out of the reach of children!.
Dosing and Administration
Inside.
The batch is individually depending on age, body weight, renal function of the patient and the severity of infection.
Infants and children up to 3 months: 30 mg / kg (for amoxicillin) per day divided in 2 doses (every 12 hours).
Children older than 3 months:
20 mg / kg in infections mild and moderate severity to 40 mg / kg in severe infection, and lower respiratory tract infections, otitis media, sinusitis (as amoxycillin) per day, divided into 3 doses (every 8 hours).
The exact daily doses are calculated based on the weight of the baby’s body, not his age.
The maximum daily dose of amoxicillin is 6 g for adults, for children – 45 mg / kg.
The maximum daily dose of clavulanic acid (in potassium salt form) is for adults – 600 mg, in children of 10 mg / kg body weight.
Patients with impaired renal function dose should be adjusted according to the maximum recommended dose of amoxycillin.
Patients with CC 30 mL / min requires no dose adjustment.
Adults and children weighing more than 40 kg (specified dosing regimen used in secondary infections and severe):
Patients with CC-10-30 ml / min 500 mg / 125 mg twice a day.
When CC less than 10 ml / min, the recommended dose of 500 mg / 125 mg once a day.
Patients in hemodialysis recommended dose of 500 mg / 125 mg every 24 hours plus 500 mg / 125 mg during the dialysis session and another dose at the end of the dialysis session (since the concentration of amoxicillin and clavulanic acid in serum decreased).
Children weighing less than 40 kg:
When QA 10-30 ml / min, the recommended dose of 15 mg / 3.75 mg / kg twice a day (maximum 500 mg / 125 mg twice a day).
When CC less than 10 ml / min, the recommended dose of 15 mg / 3.75 mg / kg once a day (maximum 500 mg / 125 mg).
With hemodialysis the recommended dose of 15 mg / 3.75 mg / kg once a day. Before hemodialysis 15 mg / 3.75 mg / kg. To restore the appropriate concentration of drug in blood after hemodialysis must take another dose of 15 mg / 3.75 mg / kg.
The course of treatment is 5-14 days. The duration of treatment is determined by the attending physician. Treatment should not be extended beyond 14 days without review of the clinical situation.
Instructions for the preparation of a suspension:
Vigorously shake the vial, adding water in two steps (to the mark), every time a good shaking to completely dissolve the powder.
Shake thoroughly before use!
To prepare a powder slurry boiled recommended to dilute with water at room temperature.
The finished suspension is recommended to put in the fridge.
It is not recommended to heat the slurry prior to use (it is necessary to bring the slurry to room temperature).
After drug administration the dosage is recommended to wash the pipette boiled water.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist