Ecoclav powder for suspension 125mg + 3.125mg/5ml 25g

Dosage form

Powder for suspension for oral administration

Composition

5 ml of the prepared suspension (one dosing spoon) contains: active substances: Amoxicillin trihydrate (in terms of amoxicillin) 125 mg, clavulanate potassium (in terms of clavulanic acid) 31.25 mg

Packing

Bottle 25 g.

Mechanism of action

Ecoclav - a combination drug of amoxicillin and clavulanic acid - an inhibitor of beta-lactamase. Bactericidal effect, inhibits the synthesis of the bacterial wall. Active against aerobic gram-positive bacteria (including strains producing beta-lactamase): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus of the viridans group, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; Aerobic Gram-Negatives (including Beta-Lactamase-Producing Beans): Proteus mirabilis, IRA, Nee Sech, Shigella spp. ) Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid inhibits type II, III, IV, and V beta-lactamase, is inactive against type I beta-lactamase, produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, thereby forming a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamase.

Bacterial infections caused by susceptible pathogens: lower respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess), otolaryngitis infections (sinusitis, tonsillitis, otitis media), infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, soft chancre, gonorrhea, infections of the skin and soft tissues (erysipelas, impetigo, orichno infected dermatoses, abscesses, cellulitis, wound infection), osteomyelitis, postoperative infections, prevention of infections in surgery.

Contraindications

Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis (includingwith the appearance of a core-like rash), phenylketonuria, jaundice episodes, or abnormal liver function as a result of amoxicillin / clavulanic acid in history.

Dosage and administration

Inside Doses are given in terms of amoxicillin. Dosing regimen set individually, depending on the severity and localization of infection, the sensitivity of the pathogen. Children under 12 years old - in the form of a suspension. A single dose is set depending on age: children up to 3 months - 30 mg / kg / day in 2 divided doses; 3 months and older - for mild infections - 25 mg / kg / day in 2 doses or 20 mg / kg / day in 3 doses, for severe infections - 45 mg / kg / day in 2 doses or 40 mg / kg / day in 3 doses. Adults and children over 12 years old or with a body weight of 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day. For severe infections and respiratory tract infections - 875 mg 2 times / day or 500 mg 3 times / day. The maximum daily dose of amoxicillin for adults and children over 12 years old is 6 g, for children under 12 years old it is 45 mg / kg body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years old is 600 mg, for children under 12 years old it is 10 mg / kg body weight. In case of difficulty swallowing in adults, the use of a suspension is recommended. When preparing the suspension, syrup and drops, water should be used as a solvent.

Adverse reactions

On the part of the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of "liver" transaminases, in rare cases - cholestatic jaundice, hepatitis, liver failure (often in the elderly, men, with prolonged therapy), pseudomembranous and hemorrhagic colitis (may also develop after therapy), enterocolitis, black "hairy" tongue, darkening of the tooth enamel. From the side of blood-forming organs: reversible increase in prothrombin time and time of bleeding, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia. On the part of the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, seizures. Local reactions: in some cases - phlebitis at the site of / in the introduction. Allergic reactions: urticaria, erythematous rash, rarely - erythema multiforme exudative, anaphylactic shock,angioedema, extremely rare - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exantmatous pustullosis. Others: Candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

Special notes

In the course of treatment, it is necessary to monitor the state of the function of the blood-forming organs, liver and kidneys. In order to reduce the risk of side effects from the gastrointestinal tract should take the drug during meals. The development of superinfection is possible due to the growth of microflora insensitive to it, which requires a corresponding change in antibacterial therapy. May give false positive results in the determination of glucose in the urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. In patients with hypersensitivity to penicillins, allergic cross-reactions with cephalosporin antibiotics are possible. Cases of necrotizing colitis have been identified in newborns and in pregnant women with premature rupture of the membranes.

Drug Interactions

Antacids, Glucosamine, laxatives, drugs, aminoglycosides slow down and reduce absorption; Ascorbic acid increases absorption. Bacteriostatic drugs (macrolides, chloramphenicol, linkosamides, tetracyclines, sulfonamides) have an antagonistic effect. Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). At the same time taking anticoagulants, it is necessary to monitor blood clotting rates. Decreases the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces PABK, ethinyl estradiol - the risk of bleeding "breakthrough". Diuretics, Allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is derived mainly by glomerular filtration). Allopurinol increases the risk of skin rash.

Overdosage

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance.
Treatment: symptomatic. Hemodialysis is effective.

In a dry, dark place at a temperature not higher than 25 ° C.