Indication

Infections caused by microorganisms sensitive to Bactoclav:

• infections of the upper respiratory tract (including infections of the ENT organs), among them recurrent tonsillitis, sinusitis, otitis media;
• lower respiratory tract infections, including exacerbation of chronic bronchitis, segmental pneumonia and bronchopneumonia;
• infections of the genitourinary system, including cystitis, urethritis, pyelonephritis;
• skin and soft tissue infections, including burns, abscesses, inflammation of the subcutaneous tissue, wound infections.

Contraindication

The preparation is contraindicated in patients with an allergic reaction to penicillins and if there is a history of jaundice / impaired liver function after using the preparation.

Storage

active substances: amoxicillin; clavulanic acid;

1 tablet contains amoxicillin trihydrate equivalent to amoxicillin 500 mg, potassium clavulanate equivalent to clavulanic acid 125 mg;

auxiliary substances: microcrystalline cellulose, magnesium stearate, silicon dioxide colloidal anhydrous, sodium starch glycolate (type A), talc, propylene glycol, dimethicone, Tabcoat TC-1709 MB white (hydroxypropyl methylcellulose, propylene glycol, ethyl cellulose, talc, titanium dioxide (E 171)).

Application

General recommendations for the treatment of infections

Dose for the treatment of mild and moderate infections in adults and children aged 12 years: 1 tablet 2 times a day. In case of a severe infection (including chronic and recurrent urinary tract infections and bronchopulmonary infections), 1-2 tablets are prescribed 3 times a day.

Dosage in case of impaired kidney function

Creatinine clearance 30 ml/min 1 tablet 2 times a day

Creatinine clearance 10-30 ml/min 1 tablet 2 times a day

Creatinine clearance 10 ml/min 1 tablet every 24 hours

During hemodialysis, the recommended dose of the preparation is 1 tablet per day + 1 tablet during dialysis and at the end of dialysis (taking into account the decrease in the concentration of amoxicillin and clavulanic acid in the blood plasma).

Bactoclav should be used with caution in case of impaired liver function. Liver function should be regularly monitored.

Dose correction is not required in elderly patients. If necessary, the dose is adjusted depending on kidney function.

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

Treatment should not be continued for more than 14 days without assessment of the patient's condition.

Features of application

Before starting therapy with Bactoclav, it is necessary to accurately determine the presence of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam preparations in the anamnesis.

Use during pregnancy or breastfeeding

The use of the preparation during pregnancy, especially in the first trimester, should be avoided, unless the benefit outweighs the potential risk. 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.

Bactoclav during breastfeeding can be used only when, in the opinion of the doctor, the benefit of use will outweigh the risk.

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

A negative impact on the ability to drive a car and other mechanisms was not observed, but the possibility of such side effects as dizziness, allergic reactions, convulsions, which can affect the ability to drive a car and work with other mechanisms, should be taken into account.

Overdose

Symptoms

Symptoms of gastrointestinal tract disorders and fluid and electrolyte imbalance may be observed. Amoxicillin-related crystalluria has been observed, which in some cases has led to renal failure. Convulsions may occur in patients with impaired renal function and in patients taking high doses of the preparation. Deposition of amoxicillin in bladder catheters has been reported, mainly after high-dose intravenous administration. The patency of catheters should be checked regularly.

Treatment

Gastrointestinal disorders can be treated symptomatically with attention to fluid/electrolyte balance. Bactoclav can be removed from the bloodstream by hemodialysis.

Side effects

Adverse reactions are classified by organs and systems, according to the frequency of occurrence they are divided into the following categories: very often (≥1 / 10), often (≥1 / 100) and (1/10), sometimes (≥1 / 1000) and (1 / 100), rarely (≥1 / 10,000) and (1/1000), very rarely (1/10,000).

Infections and infestations: often - candidiasis of the skin and mucous membranes.

From the circulatory and lymphatic system: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia; very rarely - reversible agranulocytosis and hemolytic anemia. Increase in bleeding time and prothrombin index.

From the side of the immune system: very rarely - angioedema, anaphylaxis, serum sickness, allergic vasculitis.

From the side of the nervous system: often - dizziness, headache; very rarely - reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in patients receiving high doses of the preparation.

From the gastrointestinal tract

Adults: very often - diarrhea; often - nausea, vomiting.

Children: often - diarrhea, nausea, vomiting.

Nausea is more often associated with high doses of the preparation. The severity of the above-mentioned symptoms from the side of the gastrointestinal tract can be reduced when taking the preparation at the beginning of a meal; sometimes - indigestion; very rarely - antibiotic colitis (including pseudomembranous and hemorrhagic colitis), black hairy tongue.

From the side of the hepatobiliary system: sometimes - a moderate increase in the level of ALT and / or ALT was noted in patients who received therapy with antibiotics of the beta-lactam group, but the clinical significance of this has not been established; very rarely - hepatitis and cholestatic jaundice.

Storage conditions

Store in the original packaging at a temperature not higher than 25 ºС. In a place inaccessible to children. Shelf life - 2 years.