Amoxiclav 875mg+125mg tablets p pl o 14
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875 mg+125 mg
Amoxicillin (in the form of a trihydrate) - 875 mg, clavulanic acid (in the form of clavulanate potassium) - 125 mg.
Excipients: silicon dioxide colloidal, crospovidone, sodium croscarmellose, magnesium stearate, talc, microcrystalline cellulose.
Composition of the film shell: hypromellose, ethyl cellulose, povidone, triethyl citrate, titanium dioxide, talc.
Broad-spectrum antibiotic; contains semi-synthetic penicillin amoxicillin and β-lactamase inhibitor clavulanic acid.
Clavulanic acid provides a persistent inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of β-lactamases produced by microorganisms.
Clavulanic acid, similar in structure beta-lactam antibiotics, has a weak own antibacterial activity.
Amoxiclav ® has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive strains, including strains producing lactamase β, including aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp.; aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteur multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
After taking the drug inside, both components are well absorbed from the gastrointestinal tract, food intake does not affect the degree of absorption.
C max in the blood plasma are achieved 1 hour after taking the drug and are (depending on the dose) for amoxicillin 3-12 μg / ml, for clavulanic acid - about 2 μg / ml.
Both components are characterized by a good volume of distribution in the fluids and tissues of the body (lungs, middle ear, pleural and peritoneal fluid, uterus, ovaries).
Amoxicillin also penetrates into the synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, secretion of the paranasal sinuses, saliva, bronchial secretion.
Amoxicillin and clavulanic acid do not penetrate the BBB in non-inflamed meninges.
Active substances penetrate the placental barrier and are excreted in trace concentrations with breast milk. The degree of binding to plasma proteins is low.
Amoxicillin is partially metabolized, clavulanic acid is apparently subjected to intensive metabolism.
Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs. T 1/2 amoxicillin and clavulanic acid is 1-1.5 hours.
Pharmacokinetics in special clinical cases
In severe renal failure T 1/2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and small amounts by peritoneal dialysis.
Indications for use
Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis);
- infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
- urinary tract infections;
- gynecological infections;
- Infection skin and soft tissues, including human and animal bites;
- infections of bone and connective tissue;
- infections of the biliary tract (cholecystitis, cholangitis);
- odontogenic infections.
- indication in the anamnesis of cholestatic jaundice or for impaired liver function caused by the intake of amoxicillin / clavulanic acid;
- infectious mononucleosis;
- lymphocytic leukemia;
- hypersensitivity to antibiotics of the penicillin group, cephalosporins and other beta-lactam antibiotics (in the anamnesis);
- hypersensitivity to amoxicillin or clavulanic acid.
With caution, the drug is prescribed to patients with pseudomembranous colitis in the anamnesis, with liver failure, severe renal dysfunction, as well as during lactation.
Dosage and Administration
Adults and children over 12 years of age (or with a body weight of >40 kg) with a mild or moderate course of infection are prescribed 1 tab. (250 mg + 125 mg) every 8 hours or 1 tab. (500 mg + 125 mg) every 12 hours, in case of severe infection and respiratory tract infections - 1 tab. (500 mg + 125 mg) every 8 hours or 1 tab. (875 mg + 125 mg) every 12 hours.
The drug in the form of tablets is not prescribed to children under 12 years of age (with a body weight of <40 kg).
The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults, 10 mg / kg of body weight for children. The maximum daily dose of amoxicillin for adults - 6 g, for children - 45 mg / kg body weight.
The course of treatment is 5-14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not last more than 14 days without a second medical examination.
With odontogenic infections, 1 tab is prescribed. (250 mg + 125 mg) every 8 hours or 1 tab. (500 mg+125 mg) every 12 hours for 5 days.
In renal failure of moderate severity (KK 10-30 ml / min), 1 tab is prescribed. (500 mg + 125 mg) every 12 hours, with severe renal failure (CK <10 ml / min) - 1 tab. (500 mg + 125 mg) every 24 h. With anuria, the interval between doses should be increased to 48 hours or more.
From the digestive system: possible loss of appetite, nausea, vomiting, diarrhea; rarely - abdominal pain, transient increase in the activity of liver enzymes (ALT, AST), impaired liver function; in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis.
Allergic reactions: erythematous rash, itching, urticaria; rarely - erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis; in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis.
From the hematopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - hemolytic anemia, reversible increase in prothrombin time (when used together with anticoagulants), eosinophilia, pancytopenia.
From the nervous system: dizziness, headache; very rarely - convulsions (can occur in patients with impaired renal function when taking the drug in high doses), hyperactivity, anxiety, insomnia.
From the urinary system: very rarely - interstitial nephritis, crystalluria.
Other: rarely - the development of superinfection (including candidiasis).
Side effects in most cases are mild and transient.
The drug should be stored out of the reach of children, a dry place at a temperature not exceeding 25 ° C.
- Lek Pharmaceuticals (Sandoz)
- Dosage form
- Amoxicillin+[Clavulanic Acid]
- Number of tablets
- INN Russian
- Амоксициллин+(Клавулановая кислота)
- Russian title