Abiklav (amoxicillin) coated tablets 500 mg/125 mg. №20

Description

Amoxicillin (Abiklav) Pharmacodynamics.
Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and breaks down under its influence, so the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme.

Clavulanic acid has a β-lactam structure similar to penicillins and inactivates β-lactamase enzymes that produce microorganisms resistant to penicillins and cephalosporins. In particular, clavulanic acid has pronounced activity against clinically important plasmid β-lactamases, which are often responsible for the emergence of cross-resistance to antibiotics. The presence of clavulanic acid in the composition of the drug protects amoxicillin from degradation due to the action of β-lactamases and expands the spectrum of antibacterial action of amoxicillin.

Pharmacokinetics.
The pharmacokinetic parameters of the two components of the drug are closely related. The peak concentration in blood serum of both components is reached approximately 1 hour after oral administration of the drug. The optimal level of absorption is achieved if the drug is taken at the beginning of a meal.

Doubling the dose of Amoxicillin (Abiklav) increases the level of the drug in the blood serum by approximately two times.

Both components of the drug, clavulanate and amoxicillin, have a low level of binding to blood serum proteins, approximately 70% of them remain in the blood serum in an unbound state.

Indications
Film-coated Amoxicillin (Abiklav) tablets 500 mg/125 mg
Treatment of bacterial infections caused by microorganisms sensitive to the drug, such as:

• acute bacterial sinusitis;
• acute otitis media;
• confirmed exacerbation of chronic bronchitis;
• nosocomial pneumonia;
• cystitis;
• pyelonephritis;
• skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
• bone and joint infections, including osteomyelitis.

Film-coated tablets 875 mg/125 mg

Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the drug, such as:

• acute bacterial sinusitis;
• acute otitis media;
• confirmed exacerbation of chronic bronchitis;
• nosocomial pneumonia;
• cystitis;
• pyelonephritis;
• skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
• bone and joint infections, including osteomyelitis.

Contraindications
Hypersensitivity to active substances, to any drug from the group of penicillins or to any excipient.
A history of a severe immediate-type hypersensitivity reaction (eg, anaphylaxis) to another β-lactam drug (eg, a cephalosporin, carbapenem, or monobactam).

Probenecid. Simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Its simultaneous use with Abiclav can lead to increased levels of amoxicillin in the blood for a long time, but does not affect the levels of clavulanic acid.

Allopurinol. Simultaneous use of allopurinol during treatment with amoxicillin may increase the likelihood of skin allergic reactions. There are no data on the simultaneous use of the drug and allopurinol.

Like other antibiotics, the drug can affect the intestinal flora, which will lead to a decrease in the reabsorption of estrogens and a decrease in the effectiveness of combined oral contraceptives.
There is some evidence of an increase in the level of international normalized ratio (INR) in patients treated with acenocoumarol or warfarin and taking amoxicillin. If such use is necessary, the prothrombin time or international normalized ratio should be carefully monitored with the addition or discontinuation of Abiclava treatment.

In patients treated with mycophenolate mofetil, after starting the use of oral amoxicillin with clavulanic acid, the overdose concentration of the active metabolite of mycophenolic acid may decrease by approximately 50%. This change in overdose level may not exactly correspond to the change in total mycophenolic acid exposure.

Penicillins can reduce the elimination of methotrexate, which can cause an increase in the toxicity of the latter.

Overdose
Overdose may be accompanied by symptoms from the digestive tract and a disorder of water and electrolyte balance. These phenomena are treated symptomatically, paying attention to correcting the water-electrolyte balance. Cases of crystalluria, which in some cases may cause renal failure, have been reported. The drug can be removed from the bloodstream by hemodialysis

Storage conditions
Keep out of the reach of children at a temperature not higher than 25 °C.