Amoxicillin, Clavulanic Acid

Amoxiclav 2X is indicated for the treatment of bacterial infections caused by drug-sensitive microorganisms:

• acute bacterial sinusitis (confirmed)
• acute otitis media,
• exacerbation of chronic bronchitis confirmed;
• community-acquired pneumonia
• cystitis;
• pyelonephritis;
• infections of the skin and soft tissues, including cellulitis, animal bites, severe dentoalveolar abscesses with common cellulitis;
• infections of bones and joints, including osteomyelitis.

Structure

active substances: amoxicillin, clavulanic acid;

1 tablet contains 500 mg of amoxicillin in the form of a trihydrate and 125 mg of clavulanic acid in the form of a potassium salt;

Excipients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

shell: hydroxypropyl methyl cellulose, ethyl cellulose, polysorbate, triethyl citrate, talc, titanium dioxide (E 171).

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotics) that inhibits one or more enzymes (often called penicillin-binding proteins) during the biosynthetic metabolism of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, resulting in lysis and cell death.

Amoxicillin is sensitive to the breakdown of beta-lactamases produced by resistant bacteria, therefore, the spectrum of activity of amoxicillin as monotherapy does not include organisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It disables certain beta-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid in the form of monotherapy does not have a clinically useful antibacterial effect.

Contraindications

Hypersensitivity to the components of the drug, to any antibacterial agents of the penicillin group.

The presence in the history of severe hypersensitivity reactions (including Anaphylaxis) associated with the use of other beta-lactam agents (including Cephalosporins, carbapenems or monobactams).

A history of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanate.

Dosage and administration

The drug should be used according to official recommendations for antibiotic therapy and local antibiotic susceptibility data. Sensitivity to amoxicillin / clavulanate varies from region to region and may change over time. If necessary, refer to the local sensitivity data and, if necessary, conduct a microbiological determination and sensitivity test. The range of proposed doses depends on the expected pathogens and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, age, body weight and kidney function of the patient.

For adults and children with body weight ≥ 40 kg, the daily dose is 1500 mg of amoxicillin / 375 mg of clavulanic acid (3 tablets) when prescribed as follows.

For children from 6 years old with a body weight of 25 to 40 kg, the maximum daily dose is 2400 mg of amoxicillin / 600 mg of clavulanic acid (4 tablets) when prescribed as follows.

If large doses of amoxicillin should be prescribed for treatment, other forms of the drug should be used to avoid the appointment of unnecessary high doses of clavulanic acid.

The duration of treatment is determined by the doctor according to the clinical response of the patient to treatment. Some infections (e.g. osteomyelitis) require long-term treatment.

Adults and children weighing ≥ 40 kg 1 tablet 500 mg / 125 mg 3 times a day.

Children aged 6 years and over with a body weight of 25 to 40 kg, a dose of 20 mg / 5 mg / kg / day to 60 mg / 15 mg / kg / day, divided into 3 doses.

Since the tablet cannot be divided, children with body weight less than 25 kg should not be prescribed this form of the drug.

Children from the age of 6 years with a body weight of 25 to 40 kg. Since the tablet cannot be divided, children over 6 years old with a body weight of 25 to 40 kg with a creatinine clearance of less than 30 ml / min or children undergoing hemodialysis should not be prescribed this form of the drug.

The tablet should be swallowed whole without chewing. For optimal absorption and reduce possible side effects from the digestive tract, the drug should be taken at the beginning of a meal.

The duration of treatment is determined by the doctor individually. Treatment should not be continued for more than 14 days without an assessment of the patients condition.

Treatment can be started with parenteral administration and then continued with oral administration.

Application features

Use during pregnancy or lactation

Pregnancy. Reproductive studies in animals of oral and parenteral forms of the drug did not reveal any teratogenic effects. In one study involving women with premature rupture of the fetal membranes, it was reported that the prophylactic use of the drug may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other drugs, the use of the drug during pregnancy should be avoided, especially in the first trimester, except when, in the opinion of the doctor, such use is necessary.

Lactation period . 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, a breast-fed infant may experience diarrhea and fungal infection of the mucous membranes, so breast-feeding should be discontinued. The possibility of allergic reactions should be considered. The drug during breastfeeding can be used only when, according to the doctor, the benefit of the application will prevail risk.

Children

The drug in this dosage can be used for children aged 6 years and over with a body weight of at least 25 kg.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Studies on the ability of the drug to influence the reaction rate when driving vehicles or other mechanisms have not been conducted. However, adverse reactions (eg, allergic reactions, dizziness, convulsions) can occur that can affect the ability to drive a car or other mechanisms.

Overdose

Symptoms Symptoms of gastrointestinal upset and imbalance in fluid and electrolytes may be observed. Crystalluria was observed associated with the administration of amoxicillin, which in some cases led to renal failure.

In patients with impaired renal function and in patients taking high doses of the drug, seizures may occur.

Amoxicillin precipitation has been reported in bladder catheters, mainly after administration in high doses. The patency of the catheters should be checked regularly (see Section "Application Features").

Treatment. The gastrointestinal tract can be treated symptomatically, paying attention to the fluid / electrolyte balance.

Amoxicillin / clavulanic acid can be removed from the bloodstream by hemodialysis.

Adverse reactions

Adverse reactions to the drug, such as diarrhea, nausea, and vomiting, were most often reported.

Interaction with other drugs and other types of interactions

Anticoagulants for oral use.

Anticoagulants for oral administration and antibiotics of the penicillin series are widely used in practice in the absence of reports of interaction. However, cases of an increase in the international normalization coefficient have been described in patients taking acenocoumarol or warfarin and with what course of treatment with amoxicillin was prescribed. If simultaneous administration of drugs is necessary, the prothrombin index or the international normalization coefficient should be carefully monitored when amoxicillin is added or stopped. In addition, dose adjustment of anticoagulants for oral administration may be required (see Sections "Peculiarities of use" and "Adverse reactions").

The simultaneous use of probenecide is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. The simultaneous use of probenecid can lead to an increase in the level and duration of amoxicillin (but not clavulanic acid) in the blood.

The simultaneous use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions. Data on the concomitant use of allopurinol and amoxiclav ^® 2X no.

Like other antibiotics, Amoxiclav ^® 2X can affect the intestinal flora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives.

Amoxiclav ^® 2X should not be used together with bacteriostatic chemotherapeutic agents / antibiotics (chloramphenicol, macrolides, tetracyclines or sulfanilamides), since in vitro with such combinations an antagonistic effect was observed.

Methotrexate. Penicillins can reduce the excretion of methotrexate, which causes a potential increase in toxicity.

Mofetila mycophenolate. In patients who are treated with mycophenolate mofetil, after the start of oral administration of amoxicillin with clavulanic acid, the pre-dose concentration of the active metabolite of IFC may decrease by about 50%. This change in the pre-dose level may not fully correspond to the change in the total exposure of the IFC. Thus, a change in the dosage of mycophenolate mofetil is usually not required unless there is clinical evidence of transplant dysfunction. However, close monitoring is necessary during joint use and for some time after antibiotic therapy.

Storage conditions

Store at a temperature not exceeding 25 ° C in the original packaging.

Keep out of the reach of children.

Shelf life is 2 years.