Amoxiclav powder for suspension 312.5 mg/5ml vial 100ml *

Mechanism of action

Broad-spectrum antibiotic; It contains semi-synthetic penicillin - Amoxicillin and an irreversible beta-lactamase inhibitor - clavulanic acid.
Clavulanic acid inhibits the majority of clinically significant beta-lactamases (types 2,3,4 and 5 - according to the Richmond Sykes classification) and protects amoxicillin from the loss of antibacterial activity caused by the production of beta-lactamases by the main pathogens and co-pathogens.
Clavulanic acid has a weak intrinsic antibacterial activity.
Amoxiclav 2x has a wide spectrum of antibacterial action.
Active against gram-positive aerobes: Streptococcus pneumoniae, S. viridans, S. pyogenes, S. bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Listeria spp., Enterococcus spp.
Gram-negative aerobes: Bordetella pertussis, Brucella sp Vibrio cholerae, Yersinia enterocolitica.
Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelli, Bacteroides spp.

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Suction
After taking the drug inside both active substances are rapidly absorbed from the gastrointestinal tract. Consumption with food does not affect absorption. C_max in the blood plasma are reached approximately 1 hour after administration.
Distribution
Both components are characterized by good V_d in body fluids and tissues (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc.). Amoxicillin also penetrates the synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, the secret of the sinuses, saliva and bronchial secretions.
Amoxicillin and clavulanic acid do not penetrate through the BBB with intact meninges.
Amoxicillin and clavulanic acid penetrate the placental barrier and in trace concentrations are excreted into breast milk.
Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins.
Metabolism
Amoxicillin is partially biotransformed, clavulanic acid undergoes, apparently, an intensive metabolism.
Removal
Amoxicillin is excreted by the kidneys practically 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.
Both components are derived during hemodialysis and in small quantities during peritoneal dialysis.
Pharmacokinetics in special clinical situations
In patients with severe renal insufficiency T_1/2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

Indications and usage

Treatment of infectious and inflammatory diseases caused by strains sensitive to the drug:
- mixed infections caused by gram-positive, gram-negative aerobes and anaerobes (including breast abscess, aspiration pneumonia, peritonitis, complications after abdominal operations, abdominal infections);
- infections of the upper respiratory tract (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillopharyngitis);
- infections of the lower respiratory tract (including chronic bronchitis, pneumonia);
- urinary tract infections;
- gynecological infections;
- infections of the skin and soft tissues (including animal bites);
- infections of bones and joints;
- infections of the biliary tract (including cholecystitis, cholangitis);
- sexually transmitted diseases (including gonorrhea, chancroid);
- odontogenic infections.

Inside children under 12 years old The dose is calculated per kg of body weight, depending on the severity of the infection, and is (in terms of amoxicillin) 25-45 mg / kg of body weight per day. The drug is taken 2 times / day (every 12 hours).
At otitis, sinusitis, lower respiratory infections and other serious infections usually the daily dose is 45 mg / kg body weight.
At infections of mild and moderate course The dosage is 25 mg / kg body weight per day, divided into 2 doses.
Inside adults and children over 12 years old (or weighing more than 40 kg) for mild and moderate infections, 1 tab. (625 mg) every 12 hours. When severe infections and respiratory tract infections - 1 tab. (1000 mg) every 12 hours
Children under 12 years old (body weight less than 40 kg) pills are not prescribed.
The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg / kg of body weight for children.
The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg body weight for children.
The course of treatment is 5-14 days. The duration of the course of treatment is determined individually and should not exceed more than 14 days without re-medical examination.
At odontogenic infections - 1 tab. 625 mg every 12 hours for 5 days.
Patients with severe renal impairment (CC 10-30 ml / min), the dose is 1 tab. 625 mg every 12 h; (CC <10 ml / min), the dose is 1 tab. 625 mg every 24 hours
With anuria, the interval between doses should be increased to 48 hours or more.
Guidelines for the preparation of suspensions
Vigorously shake the bottle of powder, add water in the amount indicated on the label and in the table in 2 doses (up to the mark) and shake thoroughly until the powder is completely dissolved.

The finished suspension should be shaken vigorously before each use.
To facilitate proper dosing of the suspension for oral administration, a graduated pipette is attached to the packaging.

Adverse reactions

Gastrointestinal: loss of appetite, nausea, vomiting, diarrhea (such side effects can be avoided by taking the drug during meals); rarely pseudomembranous colitis; extremely rare - transient increase in liver transaminases, cholestatic jaundice, hepatitis.
Allergic reactions: itching, skin rashes, angioedema, bronchospasm; rarely - anaphylactic shock.
Other: development of superinfection (stomatitis, candidal vaginitis).
Side effects quickly disappear after discontinuation of the drug.

Contraindications

- cholestatic jaundice or hepatitis caused by a history of taking antibiotics of the penicillin group;
- liver failure;
- hypersensitivity to the antibiotics of the penicillin group in history;
- hypersensitivity to amoxicillin and clavulanic acid or any other components of the drug.

Pregnancy and breastfeeding

No marked teratogenic effects of the drug. For well-defined indications, Amoxiclav 2x can be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.
Amoxicillin and clavulanic acid penetrate in small quantities into breast milk, so care must be taken when prescribing the drug during lactation.

With caution, the drug is prescribed to patients who are prone to allergic reactions, as well as to patients with known hypersensitivity to cephalosporin antibiotics, as there is a risk of developing cross-sensitivity.
With caution, the drug is prescribed to patients with severely impaired liver function.
Patients with severely impaired renal function require adequate dose adjustment or an increase in the intervals between doses.
Due to the fact that a large number of patients with infectious mononucleosis and lymphocytic leukemia who received ampicillin, the appearance of an erythematous rash was observed, the use of ampicillin antibiotics in these patients is not recommended.
Oral administration of Amoxiclav 2x leads to the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false positive reaction to urine glucose using Benedict's reagent or Felling's solution. It is recommended to use enzymatic reactions with glucose oxidase.
Influence on ability to drive motor transport and control mechanisms
The drug does not affect the speed of psychomotor reactions and ability to concentrate.

Symptoms: abdominal pain, diarrhea, vomiting, agitation, insomnia, dizziness; in some cases, convulsive seizures.
Treatment: symptomatic therapy, Activated carbon , gastric lavage (in the case of a recent intake - less than 4 hours). Effective hemodialysis.

The simultaneous use of Amoxiclav 2x and Methotrexate increases the toxicity of methotrexate. Appointment with Allopurinol increases the incidence of exanthema.
With the simultaneous appointment of anticoagulants and Amoksiklava 2x possible prolongation of prothrombin time.
Concurrent use with disulfiram should be avoided.
Amoxiclav 2x should not be used in combination with bacteriostatic antibiotics (macrolides, tetracyclines) because of the possible reduction in the effectiveness of Amoxiclav 2x.
The combination with rifampicin is antagonistic.
It is shown that antibiotics reduce the effectiveness of oral contraceptives.
Probenecid reduces the excretion of amoxicillin, increasing its serum concentration.

Store in a dry place inaccessible to children at a temperature not exceeding 25 ° C. Shelf life - 2 years.
Pharmacy sales terms
The drug is available on prescription.