Product description

Amoksiklav is a combined preparation that belongs to the group of beta-lactam antibiotics. Therapeutic effects are provided by active substances - amoxicillin - one of the best penicillin antibiotics and clavulanic acid - the most powerful of the known beta-lactamase inhibitors.

The combination of these substances leads to the appearance of special properties of amoksiklav:

• irreversible blockade of β-lactamases of microorganisms, which allows amoxicillin to exert an antibacterial effect even on resistant pathogens;
• high bioavailability;
• penetrates well into most tissues and body fluids, creating a high concentration that is necessary to destroy sensitive pathogenic bacteria.

The mechanism of action of amoxicillin in the composition of amoksiklav consists in bactericidal activity - a violation of the synthesis of the component of the cell wall of bacteria, which causes their dissolution. Clavulanic acid is a β-lactam inhibitor and exhibits the same activity against both gram-positive and gram-negative bacteria. Protects amoxicillin from destruction by enzymes - β-lactamases, thereby expanding the spectrum of action of amoxicillin.

Amoksiklav is manufactured by the pharmaceutical company Lek Pharmaceuticals dd in Slovenia. There are various dosage forms of the preparation on the pharmaceutical market of Ukraine. This is an important point in the choice of amoksiklav when prescribing to patients of different age categories and severity of the disease.

Advantages of using amoksiklav:

• expected effectiveness and non-toxicity of penicillins;
• a wider spectrum of action compared to amoxicillin and oral cephalosporins due to the presence of clavulanic acid;
• used in all age groups;
• food does not affect the absorption of the preparation.

Among the dosage forms, it should be noted the convenience of using the Amoksiklav suspension. The preparation is equipped with a measuring syringe for dosing accuracy. The possibility of using the suspension three times in children minimizes the development of resistance and meets the international requirements of rational antibiotic therapy.

Indication

Treatment of bacterial infections caused by microorganisms sensitive to the preparation in adults and children:

• acute bacterial sinusitis (confirmed);
• 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 widespread cellulitis;
• infections of bones and joints, including osteomyelitis.

When prescribing antibacterial preparations, one should be guided by the rules of their proper use.

Storage

Active substances in 5 ml of suspension

amoxicillin in the form of trihydrate - 125 mg

clavulanic acid in the form of potassium salt - 31.25 mg

Excipients: anhydrous citric acid, anhydrous sodium citrate, sodium carboxymethylcellulose-microcrystalline cellulose, xanthan gum, colloidal anhydrous silicon dioxide, silicon dioxide, strawberry flavoring, sodium benzoate (E 211), sodium saccharin, mannitol (E 421).

Contraindication

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

History of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other β-lactam agents (including cephalosporins, carbapenems or monobactams).

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

Method of application and dosage

Doses are indicated in units of amoxicillin / clavulanic acid.

When selecting the dose of Amoksiklav ®, the following should be taken into account:

• expected pathogenic microorganisms and their possible sensitivity to active substances;
• severity and localization of infection;
• age, body weight and state of kidney function of the patient.

If necessary, the feasibility of using alternative forms of amoksiklav ® (for example, containing higher doses of amoxicillin and / or a different ratio of amoxicillin and clavulanic acid) should be considered.

The duration of therapy depends on the course of the disease. Treatment should not be continued for more than 14 days without assessment of the patient's condition.

Adults and children with body weight ≥ 40 kg: 500 mg / 125 mg 3 times a day.

Children with body weight <40 kg: from 20 mg / 5 mg per 1 kg of body weight per day (for mild and moderate infections) to 60 mg / 15 mg per 1 kg of body weight per day (for severe infections) in the form of three individual doses. The maximum daily dose is 2400 mg / 600 mg.

Children under 2 years should use a dose of no more than 40 mg / 10 mg/kg of body weight per day.

There are no clinical data on the use of amoksiklav ® in the form of a suspension for the treatment of children under 2 months of age, therefore there are no dosage recommendations.

Application method

For optimal absorption and reduction of possible side effects from the digestive tract, the preparation should be taken at the beginning of a meal.

You can start treatment with parenteral administration of the preparation, and then continue with the form of the preparation for oral administration.

Preparation of 100 ml of suspension: before use, check the integrity of the lid, which closes. Shake the bottle so that the powder separates from the walls and bottom.

Add drinking water in two portions (first in 2/3, and then up to the circular mark on the bottle in the form of a depression in the glass), shaking the bottle each time. GOOD TO SHAKE BEFORE EACH SERVE!

Features of application

Application during pregnancy and lactation

Pregnancy. Reproductive studies on animals of oral and parenteral forms of Amoksiklav did not reveal a teratogenic effect. One study in women with premature rupture of membranes reported that prophylactic use of amoksiklav may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other medicines, the use of the preparation during pregnancy, especially in the first trimester, should be avoided, except when, in the opinion of the doctor, such use is necessary.

Breastfeeding period. Both active components of the preparation are excreted in breast milk (there is no information on the effect of clavulanic acid on a breast-fed infant). Accordingly, a breastfed infant may develop diarrhea and a fungal infection of the mucous membranes, so breastfeeding should be discontinued. The possibility of allergic reactions should be taken into account. Amoksiklav during breastfeeding can be used only when, in the doctor's opinion, the benefit of use will outweigh the risk.

Children

The preparation in the form of a suspension should be prescribed to children aged 2 months and older.

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

Studies on the ability of the preparation to influence the speed of reaction when driving a motor vehicle or other mechanisms were not conducted. However, side effects (such as allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive or operate machinery.

Overdose

symptoms

Symptoms of gastrointestinal tract disorders and fluid and electrolyte imbalance may be observed. Crystalluria associated with taking amoxicillin was observed, which in some cases led to renal failure (see the "Particulars of use" section).

Convulsions may occur in patients with impaired renal function and in patients taking high doses of the preparation.

Deposition of amoxicillin in the bladder catheter has been reported, mainly after administration in high doses. The patency of catheters should be checked regularly.

treatment

Disturbances from 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.

Interaction with other medicinal products and other forms of interaction

Simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Simultaneous use with Amoksiklav ® can lead to an increase in the level of amoxicillin in the blood plasma for a long time, but does not affect the level of clavulanic acid.

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

Like other antibiotics, Amoksiklav ® can affect the intestinal flora, which leads to a decrease in the reabsorption of estrogens and a decrease in the effectiveness of combined oral contraceptives.

Some reports suggest an increase in international normalized ratio (INR) in patients treated with acenocoumarol or warfarin and amoxicillin. If such use is necessary, prothrombin time or INR level should be carefully monitored with the addition or discontinuation of treatment with a combination preparation containing amoxicillin.

Amoksiklav ® should not be used together with bacteriostatic chemotherapeutic agents/antibiotics (chloramphenicol, macrolides, tetracycline or sulfonamides), since in vitro an antagonistic effect was observed with such combinations.

Simultaneous use of amoksiklav ® and methotrexate can increase the toxicity of the latter (leukopenia, thrombocytopenia, formation of ulcers on the skin).

With the simultaneous use of the combination of amoxicillin with clavulanic acid and mycophenolate mofetil, a decrease in the concentration of the active metabolite of microphenolic acid in the blood plasma by approximately 50% was reported. This change in overdose level may not fully correspond to the change in total mycophenolic acid exposure. Thus, a change in mycophenolate mofetil dosage is usually not required unless there is clinical evidence of graft dysfunction. However, careful observation is necessary during joint use and for some time after antibiotic therapy.

Storage conditions

Store at a temperature not higher than 25 °C in the original packaging to protect from moisture.

Keep out of the reach of children.

Store the vial with the finished suspension tightly closed at a temperature of 2-8 °C; use within 7 days.