Description
Release form
Tablets
Packing
14 pcs.
Pharmacological action
Amoxiclav – a broad-spectrum antibiotic contains semisynthetic penicillin amoxicillin and a b-lactamase clavulanic acid inhibitor. Clavulanic acid inhibits most clinically significant b-lactamases (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 type 1 b-lactamases produced by Enterobacter spp., Morganella morganii, Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
This combination provides a high bactericidal activity of Amoxiclav (including in relation to strains of microorganisms resistant to amoxicillin). Clavulanic acid, having a higher affinity for b-lactamase than amoxicillin, forms a stable deactivated complex with the enzyme, preventing the enzymatic degradation of amoxicillin under the action of b-lactamases.
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 b-lactamases).
Indications
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)
infection lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia)
urinary tract infection
gynecological infection
skin and soft tissue infection
bone infection her and
joint biliary tract infections (cholecystitis, cholangitis)
odontogenic infections.
Contraindications
Cholestatic jaundice or impaired liver function caused by a history of amoxicillin / clavulanic acid hypersensitivity to amoxicillin, clavulanic acid or penicillins.
With caution, the drug should be prescribed for allergic reactions to cephalosporins and pseudomembranous colitis in the anamnesis, liver failure, severe renal impairment.
Due to the fact that in 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 such patients is not recommended.
Use during pregnancy and lactation
Amoxicillin and clavulanic acid pass into breast milk in small amounts.
Amoxiclav can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus.
Special instructions
During the course of treatment, the function of hematopoiesis, liver and kidneys should be monitored.
Patients with severe renal impairment require adequate dosage adjustment or increased dosing intervals.
In order to reduce the risk of adverse reactions from the gastrointestinal tract, the drug should be taken with meals.
When using Amoxiclav, a false-positive reaction is possible when determining the level of glucose in the urine when using Benedict’s reagent or Felling’s solution (enzymatic reactions with glucose oxidase are recommended).
Concurrent administration with disulfiram should be avoided.
Composition
1 tablet contains:
Active ingredients: amoxicillin (as trihydrate) 875 mg clavulanic acid (as potassium salt) 125 mg
Excipients: silicon colloidal dioxide – 12 mg crospovidone – 61 mg croscarmellium sodium 47 mg croscarmell stearate – 17.22 mg MCC up to 1435 mg.
Dosage and administration
Adults and children over 12 years of age (or weighing more than 40 kg) for mild or moderate infections are prescribed 1 tab. 375 mg every 8 hours, in case of severe infection and respiratory tract infections – 1 tab. 625 mg every 8 hours or 1 tab. 1000 mg every 12 hours.
The drug in the form of coated tablets is not prescribed for children under 12 years of age (weighing less than 40 kg).
The maximum daily dose of clavulanic acid for adults is 600 mg, for children – 10 mg / kg body weight.
The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg of body weight for children.
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.
For odontogenic infections, 1 tab. 375 mg every 8 hours for 5 days.
Side effects of the
From the digestive system: possible loss of appetite, nausea, vomiting, diarrhea rarely – 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, pruritus, urticaria rarely – multiforme exudative erythema, angioedema, anaphylactic shock in isolated cases – exfoliative dermatitis, Stevens-Johnson syndrome.
Other: rarely – development of superinfection, candidiasis.
Drug interaction
With the simultaneous use of Amoxiclav and indirect anticoagulants, an increase in prothrombin time is noted. Therefore, this combination is prescribed with caution.
With the simultaneous use of Amoxiclav with allopurinol, the risk of developing side effects such as exanthema increases.
With the simultaneous use of Amoxiclav enhances the toxicity of methotrexate.
The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial effect).
Amoxiclav should not be used simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of Amoxiclav.
With the simultaneous use of Amoxiclav reduces the effectiveness of oral contraceptives.
Overdose
There are no reports of fatal or life-threatening side effects due to drug overdose.
Symptoms: in most cases, disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), may also cause anxiety, insomnia, dizziness, in isolated cases – convulsive seizures.
Treatment: in case of overdose the patient should be under the supervision of a doctor, treatment is symptomatic.
In the case of a recent intake (less than 4 h), the stomach should be flushed and activated charcoal should be used to reduce suction. Amoxicillin / clavulanate potassium is removed by hemodialysis.
Storage conditions
The product should be stored in a dry place out of the reach of children at a temperature not exceeding 25 ° C.
Expiration date
2 years
Deystvuyushtee
substance Amoxicillin, clavulanic acid
Terms and conditions
prescription
Dosage form
tablets
Prescription
Prescription
Pregnant as prescribed by a doctor, Nursing mothers as prescribed by a doctor, For adults as prescribed by the doctor, Children over 12 years old, Children as prescribed by the doctor
