Amoxiclav 2S powder for oral suspension 400 mg/57 mg in 5 ml in a bottle of 11 g for the preparation of 70 ml of suspension

Treatment of bacterial infections caused by microorganisms sensitive to the drug 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 drugs, one should follow the rules for their proper use.

Active ingredients 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 flavor, sodium benzoate (E 211), sodium saccharin, mannitol (E 421).

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 β-lactam agents (including cephalosporins, carbapenems or monobactams).

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

Doses are given in units of amoxicillin/clavulanic acid.

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

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

If necessary, the use of alternative forms of Amoxiclav® (e.g. containing higher doses of amoxicillin and/or a different ratio of amoxicillin to 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 assessing the patient’s condition.

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

Children weighing <40 kg: 20 mg/5 mg per kg body weight per day (for mild to moderate infections) to 60 mg/15 mg per kg body weight per day (for severe infections) in three divided doses. The maximum daily dose is 2400 mg/600 mg.

Children under 2 years of age should receive 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 Amoxiclav ^® in the form of a suspension for the treatment of children under 2 months of age, therefore there are no dosage recommendations.

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

Treatment can be started with parenteral administration of the drug, and then continued with the oral form of the drug.

Preparation of 100 ml of suspension: before use, check the integrity of the cap, which closes. Shake the bottle so that the powder separates from the walls and bottom. Add drinking water in two portions (first 2/3, and then up to the circular mark on the bottle in the form of a recess in the glass), shaking the bottle each time. BEFORE EACH ADMINISTRATION, shake WELL!

Use during pregnancy or breastfeeding

Pregnancy. Animal reproduction studies with oral and parenteral forms of Amoxiclav have not revealed teratogenic effects. In one study involving women with premature rupture of membranes, it was reported that prophylactic use of amoxiclav may be associated with an increased risk of necrotizing enterocolitis in newborns. As with other drugs, the use of the drug should be avoided during pregnancy, especially in the first trimester, unless, in the opinion of the physician, such use is necessary.

Breastfeeding. 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 a breastfed infant, so breastfeeding should be discontinued. The possibility of allergic reactions should be taken into account. Amoxiclav can be used during breastfeeding only if, in the opinion of the doctor, the benefit of use outweighs the risk.

Children

The drug in suspension form should be prescribed to children aged 2 months and older.

Ability to influence reaction speed when driving vehicles or other mechanisms

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 that may affect the ability to drive or use other mechanisms.

symptoms

Gastrointestinal symptoms and fluid and electrolyte imbalance may occur. Amoxicillin-associated crystalluria has been reported, leading in isolated cases to renal failure (see section 4.4).

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

Amoxicillin has been reported to precipitate in bladder catheters, mainly after administration of high doses. Catheters should be checked regularly for patency.

treatment

Gastrointestinal disturbances can be treated symptomatically, paying attention to fluid/electrolyte balance.

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

Concomitant use of probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Concomitant use with Amoxiclav ^® may lead to increased plasma levels of amoxicillin for a prolonged period, but does not affect the levels of clavulanic acid.

Concomitant 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 Amoxiclav ^® .

Like other antibiotics, Amoxiclav® ^may affect the intestinal flora, leading to reduced reabsorption of estrogens and reduced effectiveness of combined oral contraceptives.

There have been reports of increased international normalized ratio (INR) in patients treated with acenocoumarol or warfarin and taking amoxicillin. If such use is necessary, prothrombin time or INR should be closely monitored with the addition or withdrawal of a combination product containing amoxicillin.

Amoxiclav should not be used together with bacteriostatic chemotherapeutic agents/antibiotics (chloramphenicol, macrolides, tetracycline or sulfonamides), since antagonistic effects have been observed in vitro with such combinations ^.

Concomitant use of amoxiclav ^and methotrexate may increase the toxicity of the latter (leukopenia, thrombocytopenia, skin ulceration).

When amoxicillin/clavulanic acid was co-administered with mycophenolate mofetil, a decrease in plasma concentrations of the active metabolite mycophenolic acid by approximately 50% has been reported. This change in overdosage may not fully reflect the change in total exposure to mycophenolic acid. Therefore, a change in the dosage of mycophenolate mofetil is usually not necessary unless there is clinical evidence of graft dysfunction. However, close monitoring is necessary during co-administration and for some time after antibiotic therapy.

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

Keep out of reach of children.

Store the vial with the prepared suspension tightly closed at 2-8°C; use within 7 days.

Shelf life – 2 years.