Amoxiclav powder for suspension 156.25 mg/5ml bottle 100ml

Mechanism of action

Broad-spectrum antibiotic; contains semi-synthetic penicillin Amoxicillin and beta-lactamase inhibitor clavulanic acid. Clavulanic acid inhibits the majority of clinically significant beta-lactamase (types 2, 3, 4, and 5 according to the classification of Richmond Sykes) produced by Staphylococcus spp., Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides spp. Inactive against beta-lactamase type I, produced by Enterobacter spp., Morganella morganii, Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
This combination provides a high bactericidal activity of Amoxiclav, including against strains of microorganisms resistant to amoxicillin. Clavulanic acid, having a higher affinity for beta-lactamase than amoxicillin, forms a stable deactivated complex with the enzyme, preventing the enzymatic degradation of amoxicillin under the action of beta-lactamase.
Thus, Amoxiclav acts bactericidal on a wide range of gram-positive and gram-negative bacteria (including strains that have become resistant to beta-lactam antibiotics due to the production of beta-lactamase).
Amoxiclav active against aerobic gram-positive bacteria: Streptococcus spp. groups A, B, C, G (including Streptococcus pneumoniae, Streptococcus viridans, Streptococcus milleri, Streptococcus pyogenes, Streptococcus bovis), Enterococcus faecium, Staphylococcus aureus (except for methicillin-resistant strains (aureus, aureus aureus ()), with a non-peregococcus pyogenes, Streptococcus pyogenes, Streptococcus milleri, Streptococcus milleri (Streptococcus pyogenes, Streptococcus bovis); strains), Corynebacterium spp., Listeria monocytogenes, Nocardia asteroides; aerobic gram-negative bacteria: Aeromonas spp., Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Citrobacter spp. (moderately sensitive), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Legionella pneumophila, Moraxella catarrhalis, Morganella spp. (moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurela multocida, Proteus mirabilis, Proteus vulgaris, Providencia spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica (Shigella spp., Vibrio cholerae, Yersinia enterocolitica) anaerobic bacteria: Actinomyces israelii, Bacteroides spp. (including Bacteroides fragilis), Prevotella melaninogenica, Clostridium spp. (except Clostridium difficile), Peptostreptococcus spp., Eikenella corrodens, Fusobacterium spp., Propionibacterium spp., Treponema pallidum.
To drug moderately sensitive Mycobacterium tuberculosis, Mycobacterium fortuitum, Mycobacterium bovis, Mycobacterium kansasii.
To drug steady Mycobacterium chelonae.

Suction
After ingestion, both components of the drug are rapidly absorbed from the gastrointestinal tract. Simultaneous food intake does not affect absorption. C_max in the blood plasma are reached in approximately 45 minutes.
Distribution
High concentrations of active substances are found in plasma, sputum, bronchial secretions, pleural fluid, lung tissue, prostate gland, perianal abscess, adipose tissue and ischemic ulcer of the leg. The active substances do not penetrate through the blood-brain barrier in non-inflamed meninges, in trace concentrations are excreted in breast milk, penetrate the placental barrier. The degree of binding to plasma proteins is low.
Removal
T_1/2 Amoxicillin is 88 minutes, clavulanic acid - 60 minutes. The main route of excretion from the body is with the urine, some of it is excreted with feces or with exhaled air. During the first 24 hours, 68% of the dose of clavulanic acid is excreted with urine, 17% with exhaled air, and 8% with feces.
Pharmacokinetics in special clinical situations
When renal dysfunction decreases the renal and extrarenal clearance of both components, which leads to their accumulation in plasma.

Indications and usage

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract (including acute and chronic sinusitis, tonsilpharyngitis);
- infections of the lower respiratory tract (including chronic bronchitis, pneumonia, pleural empyema);
- acute and chronic otitis media;
- urinary tract infections (cystitis, urethritis, pyelonephritis);
- gynecological infections (salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis);
- infections of the skin and soft tissues (including phlegmon, wound infection);
- infections of bones and joints (including chronic osteomyelitis);
- infections of the biliary tract (cholecystitis, cholangitis);
- chancroid;
- gonorrhea;
- odontogenic infections.

Inside adults and children over 14 years old appoint 1 tab. (375 mg) 3 times / day. At severe infections and respiratory tract infections - 1 tab. (625 mg) 3 times / day.
Children aged 7 to 14 years - 2 teaspoons (10 ml) of the suspension 3 times / day (every 8 hours) or 1 teaspoon (5 ml) of the suspension-forte every 8 hours Children aged 1 to 7 years - on 1 teaspoon of suspension or on 1/2 teaspoon of suspension forte 3 times / day; at the age of from 3 months to 1 year - 1/2 tsp suspension 3 times / day. Oral dose for children is 20-40 mg / kg / day (based on amoxicillin), depending on the severity of the infection (divided into 3 doses).
A suspension and a forte suspension are prepared by adding to the powder 86 and 85 ml of water, respectively, followed by agitation. Shake before use.
In case of severe infections, the drug is administered intravenously (slowly or drip); doses and intervals between injections are given in the table.

* - every 30 mg of Amoksiklava contain 25 mg of amocycillin and 5 mg of clavulanic acid.
The course of treatment is 5-14 days.
Patients with severe renal impairment dosing regimen should be adjusted.

Adverse reactions

Gastrointestinal: nausea, vomiting, diarrhea are possible (such side effects can be avoided by taking the drug simultaneously with food).
Allergic reactions: very rarely - erythema, rash.

Contraindications

- Infectious mononucleosis;
- lymphocytic leukemia;
- liver failure;
- cholestatic jaundice or hepatitis caused by a history of taking antibiotics of the penicillin group;
- hypersensitivity to the antibiotics of the penicillin group;
- hypersensitivity to the drug.

Prescription drug during pregnancy is possible when the intended benefits to the mother outweigh the potential risk to the fetus or child.
In experimental studies no teratogenic effect was detected.

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.
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.
When using Amoxiclav, a false positive reaction is possible when determining the level of glucose in the urine using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucose oxidase).

Due to the fact that the drug is low toxic, overdose is unlikely.
Symptoms: nausea, diarrhea, vomiting; may also excitement, insomnia, dizziness; in some cases - seizures.
Treatment: if necessary, conduct symptomatic therapy. Effective hemodialysis. In dialysis fluid, 23.5% amoxicillin and 40% clavulanic acid are detected.

Clavulanic acid does not affect the absorption of amoxicillin.
With simultaneous use of Amoxiclav and indirect anticoagulants, the action of the latter is enhanced.
The simultaneous use of Amoxiclav with disulfiram, Allopurinol, Methotrexate increases the risk of their side effects.
With the simultaneous use of Amoxiclav inactivates aminoglycoside antibiotics in vitro.
With the simultaneous use of Amoxiclav and antacids containing aluminum hydroxide, histamine H blockers₂-receptors, m-holinoblokatorov the absorption of active substances Amoxiclav does not change.

All dosage forms of the drug Amoxiclav should be stored in a dry, dark place at temperatures not above 25 ° C. After preparation, the suspension should be stored in the refrigerator and used within 7 days.