Amoxiclav Quicktab dispersible tablets 875 mg/125 mg blister 14 pcs.

Composition

amoxicillin, clavulanic acid;

1 tablet contains 875 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of potassium salt;

Excipients: aspartame (E 951), colloidal silicon dioxide, yellow iron oxide (E 172), tropical blend flavor, sweet orange flavor, talc, hydrogenated castor oil, silicified microcrystalline cellulose.

Release form

Dispersible tablets.

Pharmacodynamics.

Amoxiclav Quicktab is a combination of amoxicillin, a penicillin antibiotic with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor that forms an inactive complex with enzymes and protects amoxicillin from destruction. Potassium clavulanate has weak antibacterial activity and does not affect the mechanism of action of amoxicillin.

Since clavulanic acid inhibits beta-lactamases, which normally inactivate amoxicillin, their combination is effective against many beta-lactamase-producing microorganisms resistant to amoxicillin.

The combination is active both in vitro and in clinical infections against penicillinase-nonproducing and penicillinase-producing Gram-positive and Gram-negative microorganisms:

Gram-positive aerobes: penicillin-sensitive strains of Streptococcus pneumoniae, Streptococcus spyogenes, methicillin-sensitive strains of Staphylococcus aureus, Listeria spp., Enterococcus faecalis, Enterococcus fae;

Gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium perfringens, Actinomyces israelli;

gram-negative aerobes: Haemophillus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Salmonella spp., Salmonella spp.

Gram-negative anaerobes: Bacteroides spp., Fusobacterium spp., Prevotella spp.

Pseudomonas aeruginosa, methicillin-resistant strains of Staphylococcus aureus, Legionella spp., Chlamydia spp., Mycoplasma spp. are resistant to the drug.

Pharmacokinetics.

The main pharmacokinetic properties of amoxicillin and clavulanic acid are similar. Both components are well absorbed after administration; food does not affect the level of absorption. The maximum concentration in serum is reached 1-2 hours after taking the drug. Both components are distributed in most liquid media and tissues of the body (lungs, middle ear exudate, maxillary sinus secretion, nasal sinus secretion, pleural and peritoneal fluid, uterus, ovaries, sputum, bronchial secretion, liver, gallbladder, uterus, ovaries, synovial fluid). Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier in non-inflamed meninges.

Both components cross the placental barrier and are present in small amounts in breast milk.

Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins.

Both components are excreted by the kidneys; amoxicillin is metabolized by 10-20%, and clavulanic acid – by almost 50%. A small amount can be excreted through the intestines and lungs. The half-life of the drug and clavulanic acid is 1-1.5 hours, increasing to 7.5 hours and 4.5 hours, respectively, in patients with severe renal impairment. Both substances are well excreted by hemodialysis, but insignificantly by peritoneal dialysis.

Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the combination of amoxicillin/clavulanic acid:

• 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;
• bone and joint infections, including osteomyelitis.

Hypersensitivity to amoxicillin, clavulanic acid or other components of the drug, history of allergic reactions to any penicillin antibiotic, infectious mononucleosis and lymphocytic leukemia.

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.

The product should be used in accordance with official antibiotic treatment guidelines and local antibiotic susceptibility data. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. Local susceptibility data should be consulted and microbiological determination and susceptibility testing should be performed as appropriate.

The suggested dose range depends on the expected pathogens and their susceptibility to antibacterial drugs, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient.

Adults and children weighing ≥ 40 kg: 1 tablet of 875 mg/125 mg twice daily (daily dose is 1750 mg amoxicillin/250 mg clavulanic acid).

Children weighing <40 kg: Dose 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day, divided into 2 doses. Maximum daily dose 1000–2800 mg amoxicillin/143–400 mg clavulanic acid.

If high doses of amoxicillin are required for treatment, formulations with a different amoxicillin/clavulanic acid ratio should be used to avoid unnecessarily high doses of clavulanic acid.

The duration of treatment is determined individually and should not exceed 14 days without assessment of the patient’s condition. The duration of treatment will be determined by the patient’s clinical response to treatment. Some infections (e.g. osteomyelitis) require prolonged treatment.

Elderly patients. No dose adjustment is required. If necessary, adjust the dose depending on renal function.

Hepatic impairment. Use with caution; liver function should be monitored at regular intervals. Insufficient data to make dosage recommendations.

Kidney dysfunction.

Amoxiclav Quicktab 875 mg/125 mg is prescribed only for the treatment of patients with creatinine clearance of 30 ml/min. In renal failure with creatinine clearance less than 30 ml/min. Amoxiclav Quicktab 875 mg/125 mg should not be used.

For optimal absorption and to reduce possible side effects from the digestive tract, the drug should be taken at the beginning of a meal. Dissolve the tablet in 1/2 glass of water (at least 100 ml), mix thoroughly before taking or chew before swallowing.

Treatment can be initiated with parenteral administration and then continued with oral administration.

Children. The drug in this dosage is not recommended for the treatment of children under 12 years of age.

Before initiating therapy with Amoxiclav Quicktab, it is necessary to accurately determine the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens. Serious and sometimes fatal cases (including anaphylactoid) most often occur in patients with a history of hypersensitivity to penicillins. In the event of allergic reactions, the drug should be discontinued and appropriate alternative therapy should be initiated. Serious anaphylactic reactions require immediate treatment with adrenaline. Oxygen therapy, steroid administration and respiratory support, including intubation, may also be necessary.

Use with caution in patients with severe allergies or a history of asthma.

Convulsions may occur in patients with impaired renal function or in those who have received high doses.

Use during pregnancy or breastfeeding

Animal reproduction studies (at doses 10 times the human dose) of oral and parenteral forms of Amoxiclav Quicktab did not reveal any teratogenic effects. In one study involving women with premature rupture of membranes, it was reported that prophylactic use of Amoxiclav Quicktab 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 the benefit of the drug outweighs the potential risk.

Both active components of the drug are excreted in breast milk (there is no information on the effects of clavulanic acid on breast-fed infants). Accordingly, diarrhea and fungal infection of the mucous membranes may occur in breast-fed infants, so breastfeeding should be discontinued.

Amoxiclav Quicktab can be used during breastfeeding only if, in the opinion of the doctor, the benefit of use outweighs the risk.

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.

Overdose may be accompanied by gastrointestinal symptoms and disturbances of water and electrolyte balance. These phenomena are treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, sometimes leading to renal failure. Convulsions may occur in patients with impaired renal function or in those receiving high doses of the drug. Amoxiclav Quicktab can be removed from the bloodstream by hemodialysis.

Side effects of Amoxiclav Quicktab are usually mild and resolve quickly. The most common side effects are gastrointestinal (diarrhea, nausea). These reactions can be prevented by taking the drug with food.

The generally accepted classification of adverse reactions by frequency is: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), rare (<1/10000), unknown (frequency cannot be estimated due to lack of data).

• Infections and infestations: common – candidiasis of the genitals (vaginal discharge and itching), skin and mucous membranes; frequency unknown – development of superinfection, excessive growth of insensitive microflora.
• On the part of the blood: rare – reversible leukopenia (including neutropenia) and thrombocytopenia; rare – reversible agranulocytosis and hemolytic anemia, eosinophilia, pancytopenia, myelosuppression, increased bleeding time and prothrombin index.
• Nervous system: infrequently – dizziness, headache, convulsions (mainly in patients with impaired renal function or when using high doses of the drug); rare – reversible hyperactivity; frequency unknown – aseptic meningitis.
• Mental disorders: rarely – hyperactivity, anxiety, insomnia, confusion, agitation, aggressive behavior.
• From the digestive tract: very often – diarrhea; often – nausea (more often associated with high doses of the drug), vomiting, abdominal pain, anal itching; infrequently – dyspepsia, indigestion, flatulence, glossitis, stomatitis associated with taking antibiotics, antibiotic (including hemorrhagic and pseudomembranous colitis). There are individual reports of discoloration of the surface of the teeth, but these reports relate to the use of the drug in the form of a suspension. Oral hygiene should be observed to prevent these phenomena. Rarely – staining of the tongue in black, “black hairy tongue”.
• From the urinary system: rarely – interstitial nephritis, hematuria, crystalluria.
• Skin: often – rash, itching, urticaria; infrequently – erythema multiforme; rare – Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Lyme syndrome. With the appearance of any allergic dermatitis, further use of the drug should be discontinued.
• On the part of the immune system: often – angioedema, anaphylaxis, serum sickness-like syndrome, allergic vasculitis, drug fever; rare – severe anaphylactoid reactions requiring emergency therapy with adrenaline and other agents.
• Hepatobiliary system: infrequently – moderate increase in AST and ALT is noted in patients treated with beta-lactam antibiotics; rare – hepatitis and cholestatic jaundice. These phenomena occur when using other penicillins and cephalosporins. On the part of the liver, they are noted mainly in men and elderly patients and are associated with prolonged use of the drug (more than 14 days). Such phenomena occurred very rarely in children.

These events may be severe but are usually reversible. They develop during or immediately after treatment, although sometimes they do not appear until several weeks after discontinuation of the drug. Very rarely, fatalities have been reported in patients with severe underlying disease or in patients receiving concomitant medications that have a negative effect on the liver.

The drug should be used together with bacteriostatic chemotherapeutic agents/antibiotics (chloramphenicol, macrolides, tetracyclines or sulfonamides, rifampicin), since antagonistic effects have been observed in in vitro reactions with such combinations.

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions. There are no data on the simultaneous use of Amoxiclav Quicktab and allopurinol.

Penicillins may reduce the excretion of methotrexate, which may increase the toxicity of the latter (leukopenia, thrombocytopenia, skin ulceration).

Concomitant use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Its simultaneous use with Amoxiclav Quicktab may lead to an increase in the level of the drug in the blood for a long time, but does not affect the level of clavulanic acid.

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

In some cases, when taking Amoxiclav Quicktab with oral anticoagulants, an increase in prothrombin time (increased INR level) is possible, therefore their simultaneous use requires caution.

Amoxicillin may reduce the plasma concentration of sulfasalazine.

When used simultaneously with digoxin, the degree of absorption of the latter may increase.

The drug should not be used together with disulfiram.

According to the literature, there are also 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 international normalized ratio should be carefully monitored with the addition or withdrawal of Amoxiclav Quicktab treatment.

In patients treated with mycophenolate mofetil, the overdosage concentration of the active metabolite MPA may decrease by approximately 50% after initiation of oral amoxicillin/clavulanic acid. This change in overdosage level may not correspond to a change in total MPA exposure.

Store at a temperature not exceeding 25 °C in a dry place. Keep out of reach of children. Shelf life – 3 years.