Product description

Abyclav is an antibacterial agent for systemic use.

Indications for use

Treatment of bacterial infections caused by microorganisms sensitive to the preparation, 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.

Storage

active substances: 1 film-coated tablet contains amoxicillin trihydrate in an amount equivalent to 500 mg of amoxicillin and potassium clavulanate in an amount equivalent to 125 mg of clavulanic acid or amoxicillin trihydrate in an amount equivalent to 875 mg of amoxicillin and potassium clavulanate in an amount equivalent to 125 mg of clavulanic acid;

excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate, white powder (06V58855).

Contraindication

Hypersensitivity to active substances, to any preparation from the group of penicillins or to any excipient.

A history of a severe immediate-type hypersensitivity reaction (eg, anaphylaxis) to another β-lactam preparation (eg, a cephalosporin, carbapenem, or monobactam).

History of jaundice/liver dysfunction due to amoxicillin and clavulanic acid.

Adverse reactions

Infections and infestations: candidiasis of the skin and mucous membranes, overgrowth of insensitive microorganisms.

From the blood system: reversible leukopenia (including neutropenia) and thrombocytopenia, reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin index.

From the side of the heart: Kunis syndrome.

From the side of the immune system: angioedema, anaphylaxis, serum-like syndrome, allergic vasculitis.

From the nervous system: dizziness, headache, reversible hyperactivity, aseptic meningitis and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses of the preparation.

From the digestive tract: diarrhea, nausea, vomiting, indigestion, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black "hairy" tongue, preparation-induced enterocolitis syndrome (DIES). Nausea is more often associated with high doses of the preparation. The above-mentioned symptoms from the side of the digestive tract can be reduced when taking the preparation at the beginning of a meal.

From the side of the hepatobiliary system: a moderate increase in the level of AST and/or ALT was noted in patients who were treated with antibiotics of the β-lactam group, but the clinical significance of this has not been established; hepatitis and cholestatic jaundice. These phenomena occurred with the use of other penicillins and cephalosporins.

Application method

The preparation should be used in accordance with the official recommendations on antibiotic therapy and data on local sensitivity to the antibiotic. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. If available, local susceptibility data should be consulted and microbiological determination and susceptibility testing performed if necessary.

The duration of treatment is determined by the patient's clinical response to treatment. Some infections (for example, osteomyelitis) require longer treatment.

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

The duration of treatment is determined individually. Treatment should not be continued for more than 14 days without assessment of the patient's condition.

Treatment can be started with parenteral administration, and then continue with oral administration.

The tablet should be swallowed whole, without chewing.

Tablets of 500 mg/125 mg

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

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

If higher doses of amoxicillin are required for treatment, other forms of the preparation should be used to avoid prescribing excessively high doses of clavulanic acid.

Adults and children with body weight ≥ 40 kg: 1 tablet of Abyclav 500 mg/125 mg 3 times a day.

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

Since the tablet cannot be divided, this form of the preparation should not be prescribed to children whose body weight is less than 25 kg.

Features of application

Use during pregnancy or breastfeeding

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

The preparation during breastfeeding can be used only when, in the doctor's opinion, the benefit of use will outweigh the risk.

Children

Abyklav® 500 mg/125 mg is used for children over 6 years of age with a body weight of at least 25 kg.

Abyclav® 875/125 mg is not recommended for the treatment of children under 12 years of age.

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 may occur (for example, allergic reactions, dizziness, convulsions that may affect the ability to drive or operate machinery).

Overdose

An overdose may be accompanied by symptoms from the digestive tract and a disorder of the water-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 preparation can be removed from the bloodstream by hemodialysis.

Storage conditions

Store in a place inaccessible to children at a temperature not higher than 25 °C.