Medoklav tablets are used to treat bacterial infections caused by microorganisms sensitive to the drug:
Acute bacterial sinusitis; Acute otitis media; Confirmed exacerbation of chronic bronchitis; Community-acquired pneumonia; Cystitis; Pyelonephritis; Skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with extensive cellulitis; Bone and joint infections, including osteomyelitis.
Composition
One film-coated tablet contains the following active ingredients:
amoxicillin trihydrate 574 mg, equivalent to 500 mg amoxicillin; potassium clavulanate 148.9 mg, equivalent to 125 mg clavulanic acid.
Excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate; film coating contains: hydroxypropylmethylcellulose, propylene glycol, polyethylene glycol 6000, talc, titanium dioxide (E 171).
Contraindication
Hypersensitivity to the components of the drug, to any antibacterial agents of the penicillin group; history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other beta-lactam agents (including cephalosporins, carbapenems or monobactams); history of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanate.
Method of application
The drugs should be used in accordance with official antibiotic therapy guidelines and local antibiotic susceptibility data. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. Local susceptibility data should be consulted and, if necessary, microbiological determination and susceptibility testing should be performed.
The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient.
For adults and children weighing ≥ 40 kg, the daily dose is 1500 mg amoxicillin / 375 mg clavulanic acid (3 tablets) as indicated below.
For children from 6 years of age with a body weight of 25 to 40 kg, the maximum daily dose is 2400 mg amoxicillin / 600 mg clavulanic acid (4 tablets), as indicated below.
If high doses of amoxicillin are required for treatment, other forms of amoxicillin/clavulanic acid should be used to avoid the administration of unnecessarily high doses of clavulanic acid.
The duration of treatment should be determined by the patient's clinical response to treatment. Some infections (e.g. osteomyelitis) require prolonged treatment.
Adults and children weighing ≥ 40 kg: one tablet of the drug "Medoclav" 500 mg / 125 mg 3 times a day.
Children aged 6 years and over with a body weight of 25 to 40 kg: dose from 20 mg / 5 mg / kg / day to 60 mg / 15 mg / kg / day, divided into 3 doses. If it is impossible to provide an appropriate dose, other forms of the combination of amoxicillin / clavulanic acid should be used in the appropriate dosage.
Since the tablet can be divided, this dosage form should not be prescribed to children weighing less than 25 kg.
Application features
Pregnant women
As with other medicines, the use of the drug should be avoided during pregnancy, especially in the first trimester, unless the benefit of using the drug outweighs the potential risk.
Both active components of the drug are excreted in breast milk (there is no information on the effect of clavulanic acid on a breastfed infant). Accordingly, diarrhea and fungal infection of the mucous membranes may occur in the infant, so breastfeeding should be discontinued. "Medoclav" can be used during breastfeeding only if, in the opinion of the doctor, the benefit of use outweighs the risk.
Children
Use in children aged 6 years and over with a body weight of at least 25 kg.
Drivers
No studies have been conducted to study the ability of the drug to affect the reaction speed when driving or using other mechanisms. However, adverse reactions (e.g. allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive or use other mechanisms.
Overdose
Overdose may be accompanied by gastrointestinal symptoms and disturbances of water and electrolyte balance. These phenomena are treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, which can sometimes cause renal failure. "Medoclav" can be removed from the blood by hemodialysis.
Side effects
Infections and infestations: candidiasis of the skin and mucous membranes, overgrowth of non-susceptible microorganisms, aseptic meningitis.
From the side of the blood and lymphatic system: leukopenia (including neutropenia), thrombocytopenia, reversible agranulocytosis, hemolytic anemia, increased bleeding time and prothrombin index.
On the part of the immune system: angioedema, anaphylaxis, serum sickness syndrome, allergic vasculitis.
Nervous system: dizziness, headache, reversible hyperactivity and convulsions.
Hepatobiliary system: moderate increases in AST and/or ALT have been reported in patients treated with beta-lactam antibiotics, but the clinical significance of this has not been established; hepatitis, cholestatic jaundice. These phenomena have occurred with the use of other penicillins and cephalosporins.
Skin and subcutaneous tissue disorders: skin rash, pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
Renal and urinary disorders: interstitial nephritis, crystalluria.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 2 years.
