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General characteristics. Structure:

Active ingredient: 500 mg or 1000 mg of amoxicillin (in the form of amoxicillin of sodium salt), 100 mg or 200 mg of clavulanic acid (in the form of clavulanate of potassium salt) - in the form of mix of amoxicillin of sodium salt and potassium of clavulanate (5:1).

The combined bactericidal drug.

Pharmacological properties:

Pharmacodynamics. The combined drug of amoxicillin and clavulanic acid - inhibitor beta лактамаз. Works bakteritsidno, synthesis of a bacterial wall oppresses.

It is active concerning aerobic gram-positive bacteria (including the strains producing beta lactamelements): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis.

The following activators are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus of the group viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria (including the strains producing beta lactamelements): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (before Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including the strains producing beta lactamelements): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid suppresses II, III, IV and V types beta лактамаз, is inactive concerning a beta laktamaz of the I type, Pseudomonas aeruginosa, Serratia spp are produced., Acinetobacter spp.

Clavulanic acid possesses a high tropnost to penicillinases thanks to what forms a stable complex with enzyme that prevents enzymatic degradation of amoxicillin under the influence of a beta laktamaz.

Indications to use:

The bacterial infections caused by sensitive activators: lower respiratory tract infections (bronchitis, pneumonia, a pleura empyema, lung abscess), infections of ENT organs (sinusitis, tonsillitis, average otitis), infections of urinogenital system and bodies of a small pelvis (pyelonephritis, a pyelitis, cystitis, an urethritis, prostatitis, a cervicitis, a salpingitis, a salpingo-oophoritis, tubo-ovarian abscess, an endometritis, a bacterial vaginitis, septic abortion, postnatal sepsis, a pelviperitonitis, a venereal ulcer, gonorrhea), infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis, abscess, phlegmon, a wound fever), osteomyelitis, postoperative infections, prevention of infections in surgery.

Route of administration and doses:

Intravenously. Doses are given in terms of amoxicillin. The mode of dosing is set individually depending on weight of a current and localization of an infection, sensitivity of the activator.

At intravenous administration by the adult and to teenagers 12 years are more senior enter 1 g (on amoxicillin) 3 times a day, if necessary - 4 times a day. The maximum daily dose - 6 g. For children of 3 months-12 of years - 25 mg/kg 3 times a day; in hard cases - 4 times a day; for children up to 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the post-perinatal period - 25 mg/kg 3 times a day. Treatment duration - up to 14 days, acute average otitis - up to 10 days.

For prevention of postoperative infections at operations, lasting less than 1 h, during introduction anesthesia enter in a dose 1 g intravenously. At longer operations - on 1 g each 6 h within a day. At high risk of infection introduction can be continued within several days.

At a chronic renal failure carry out dose adjustment and frequency rates of introduction depending on clearance of creatinine: at clearance of creatinine more than 30 ml/min. of dose adjustment are not required; at clearance of creatinine of 10-30 ml/min. - 1 g, then on 500 mg in/in; at a creatine kinase it is less than 10 ml/min. - 1 g, then on 500 mg/days intravenously. For children of a dose it is necessary to reduce in the same way. The patients who are on a hemodialysis - 500 mg intravenously, in addition 1 dose during dialysis and 1 more dose at the end of dialysis session.

Features of use:

At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys. Development of superinfection due to growth of microflora, insensitive to it, is possible that demands corresponding change of antibacterial therapy.

Can yield false positive results when determining glucose in urine. In this case it is recommended to apply a glyukozoksidantny method of definition of concentration of glucose in urine. At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.

Cases of development of necrotizing colitis in newborns, at pregnant women with a premature rupture of fetal membranes were revealed.

Side effects:

From the alimentary system: nausea, vomiting, diarrhea, gastritis, stomatitis, a glossitis, increase in activity of "hepatic" transaminases, in isolated cases - cholestatic jaundice, hepatitis, a liver failure (is more often at elderly, men, at long therapy), pseudomembranous and hemorrhagic colitis (can also develop after therapy), a coloenteritis, black "hairy" language, darkening of an adamantine substance of tooth.

From bodies of a hemopoiesis: reversible increase in a prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolitic anemia.

From a nervous system: dizziness, headache, hyperactivity, alarm, change of behavior, spasm.

Local reactions: in some cases - phlebitis in the place of intravenous administration. Allergic reactions: urticaria, erythematic rashes, it is rare - a multiformny exudative erythema, an acute anaphylaxis, a Quincke's disease, is extremely rare - exfoliative dermatitis, a malignant exudative erythema (Stephens-Johnson's syndrome), the allergic vasculitis, a syndrome similar to a serum disease, acute generalized exanthematous пустуллез.

Others: candidiasis, development of superinfection, intersticial nephrite, crystalluria, hamaturia.

Interaction with other medicines:

Bacteriostatic medicines (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) have antagonistic effect.

Increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and a prothrombin ratio).

At a concomitant use of anticoagulants it is necessary to watch indicators of coagulability of blood. Reduces efficiency of oral contraceptives, medicines in the course of which metabolism para-aminobenzoic acid, ethinylestradiol - risk of development of bleedings of "break" is formed.

Diuretics, Allopyrinolum, phenylbutazone, non-steroidal anti-inflammatory drugs, etc. the medicines blocking canalicular secretion increase concentration of amoxicillin (clavulanic acid is removed generally by glomerular filtering).

Allopyrinolum increases risk of development of skin rash.

Contraindications:

Hypersensitivity (including to cephalosporins, etc. beta лактамным to antibiotics), an infectious mononucleosis (including at emergence of korepodobny rash), a fenilketonuriya, episodes of jaundice or an abnormal liver function as a result of use of amoxicillin/clavulanic acid in the anamnesis.

With care: pregnancy, the lactation period, a heavy liver failure, digestive tract diseases (including the colitis in the anamnesis connected using penicillin), a chronic renal failure.

Overdose:

Symptoms: dysfunction of digestive tract and water and electrolytic balance.

Treatment: symptomatic. The hemodialysis is effective.

Storage conditions:

To store drug in protected from moisture, light and the place, unavailable to children, at a temperature not above 25 °C. Period of validity 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Powder for preparation of solution for intravenous administration 0,5g/0,1g and 1,0g/0,2g in bottles with a capacity of 20 ml in packaging No. 1, No. 5 and No. 40.