Amoxiclav (amoxicillin) coated tablets 875 mg/125 mg. №14

For all dosage forms

Infections caused by susceptible strains of microorganisms:

• upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis);
• lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
• urinary tract (eg cystitis, urethritis, pyelonephritis);
• in gynecology;
• skin and soft tissues, including human and animal bites;
• bone and connective tissue;
• biliary tract (cholecystitis, cholangitis);
• odontogenic.

Amoxiclav®

For powder for solution for intravenous administration additionally

• abdominal infections;
• sexually transmitted infections (gonorrhea, chancre);
• prevention of infections after surgical interventions.

During pregnancy and lactation, Amoxiclav (amoxicillin) 875 mg/125 mg. is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Amoxiclav Quiktab can be prescribed during pregnancy if there are clear indications.

Amoxicillin and clavulanic acid pass into breast milk in small amounts.

• hypersensitivity to the components of Amoxiclav (amoxicillin) 875 mg/125 mg.;
• hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics in history;
• cholestatic jaundice and / or other abnormal liver function caused by taking amoxicillin / clavulanic acid in history;
• infectious mononucleosis and lymphocytic leukemia;

With caution: history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal dysfunction, pregnancy, lactation, simultaneous use with anticoagulants.

Amoxiclav (amoxicillin) 875 mg/125 mg. film-coated tablets and powder for solution for intravenous administration

From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, darkening of tooth enamel, hemorrhagic colitis (may also develop after therapy), enterocolitis, pseudomembranous colitis, violation liver function, increased activity of ALT, AST, alkaline phosphatase and / or plasma bilirubin levels, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis.

Allergic reactions: itching, urticaria, erythematous rashes, erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness, toxic epidermal necrolysis.

From the hematopoietic and lymphatic systems: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PT (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis.

From the side of the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug).

From the urinary system: interstitial nephritis, crystalluria, hematuria.

Others: candidiasis and other types of superinfection.

Amoxiclav (amoxicillin) 875 mg/125 mg.

For film-coated tablets, powder for suspension for oral administration, powder for solution for intravenous administration

From the side of the central nervous system: hyperactivity. Feelings of anxiety, insomnia, behavioral changes, agitation.

Amoxiclav®

Amoxiclav® Quiktab

Amoxiclav® Quiktab and Amoxiclav® powder for oral suspension

From the side of the hematopoietic organs and the lymphatic system: rarely – reversible leukopenia (including neutropenia), thrombocytopenia; very rarely – eosinophilia, thrombocytosis, reversible agranulocytosis, an increase in bleeding time and a reversible increase in PT, anemia, incl. reversible hemolytic anemia.

From the immune system: the frequency is unknown – angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.

From the nervous system: infrequently – dizziness, headache; very rarely – insomnia, agitation, anxiety, behavior change, reversible hyperactivity, convulsions; convulsions may occur in patients with impaired renal function, as well as in those receiving high doses of the drug.

From the digestive tract: often – loss of appetite, nausea, vomiting, diarrhea. Nausea is more commonly observed when high doses are ingested. If gastrointestinal disorders are confirmed, they can be eliminated if the drug is taken at the beginning of a meal; infrequently – indigestion; very rarely – antibiotic-associated colitis induced by antibiotics (including pseudomembranous and hemorrhagic colitis), black “hairy” tongue, gastritis, stomatitis. In children, a change in the color of the surface layer of tooth enamel was very rarely noted. Oral care helps prevent discoloration of tooth enamel.

On the part of the skin: infrequently – skin rash, itching, urticaria; rarely – erythema multiforme exudative; frequency unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

From the urinary system: very rarely – crystalluria, interstitial nephritis, hematuria.

From the side of the liver and biliary tract: infrequently – increased activity of ALT and / or AST (this phenomenon is observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown); Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases there have been reports of death. In almost all cases, these were patients with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs. Very rarely – an increase in the activity of alkaline phosphatase, an increase in the level of bilirubin, hepatitis, cholestatic jaundice (noted with concomitant therapy with other penicillins and cephalosporins).

Other: often – candidiasis of the skin and mucous membranes; frequency unknown – growth of non-susceptible microorganisms.