Treatment of bacterial infections caused by microorganisms sensitive to Amoxiclav Quicktab:
1 tablet contains 500 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of a potassium salt;
Excipients: aspartame (E 951), colloidal silicon dioxide, iron oxide yellow (E 172), "tropical mixture" flavoring, sweet orange flavoring, talc, hydrogenated castor oil, microcrystalline silicate cellulose.
Hypersensitivity to amoxicillin, clavulanic acid or other components of the drug, allergic reactions in history 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).
A history of jaundice or liver dysfunction associated with the use of amoxicillin/clavulanate.
Anticoagulants for oral use. Anticoagulants for oral use and antibiotics of the penicillin series are widely used in practice in the absence of reports of interactions. However, cases of an increase in the international normalization coefficient have been described in patients who took acenocoumarol or warfarin and who were prescribed a course of treatment with amoxicillin. If simultaneous administration of drugs is necessary, prothrombin index or international normalization coefficient should be carefully monitored when adding or stopping amoxicillin. In addition, dose adjustment of oral anticoagulants may be required (see sections "Particulars of use" and "Adverse reactions").
Before starting therapy with amoxicillin/clavulanic acid, information about previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam drugs should be carefully collected.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactic reactions and cutaneous adverse reactions) have been reported in patients treated with penicillin. Such reactions are more likely in patients with a history of increased sensitivity to penicillin and patients with atopic diseases. If an allergic reaction occurs, the use of amoxicillin/clavulanic acid should be discontinued and an appropriate alternative therapy initiated.
If the infection is proven to be caused by an organism(s) sensitive to amoxicillin, consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin according to generally accepted guidelines.
This dosage form of Amoxiclav Quicktab is not suitable for use in the presence of a high risk that the possible causative agents of the disease have reduced sensitivity or resistance to beta-lactam drugs, not mediated by beta-lactamases sensitive to inhibition by clavulanic acid. This dosage form should not be used to treat penicillin-resistant S. pneumoniae.
Convulsions may occur in patients with impaired renal function and in patients taking high doses of the drug.
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected, as a measles-like rash has been associated with the use of amoxicillin in this case.
Simultaneous use of allopurinol during treatment with amoxicillin increases the likelihood of allergic skin reactions.
Long-term use can lead to excessive reproduction of microorganisms insensitive to the drug.
in fatal cases. Such phenomena were almost always observed in patients with a severe underlying disease or in those who simultaneously took drugs with a known potential effect that could lead to complications from the liver (see the section "Adverse reactions").
Use during pregnancy or breastfeeding
Pregnancy. Animal reproduction studies of oral and parenteral forms of Amoxiclav did not reveal any 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 the use of other medicines, the use of the drug should be avoided during pregnancy, especially in the first trimester, except when, in the opinion of the doctor, such use is necessary.
Breastfeeding period. Both active components of the drug 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. The possibility of allergic reactions should be taken into account. Amoxiclav 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
Studies on the ability of the drug to influence the speed of reaction when driving a motor vehicle or other mechanisms were not conducted. However, side effects (such as allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive or operate machinery.
Method of application and dosage
The drug should be used in accordance with the official recommendations for antibiotic therapy and data of local sensitivities to the antibiotic. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. If necessary, local susceptibility data should be consulted and microbiological determination and susceptibility testing should be performed as appropriate.
The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, the patient's age, body weight and kidney function.
Adults and children with body weight ≥ 40 kg. 1 tablet 3 times a day (the daily dose is 1500 mg of amoxicillin/375 mg of clavulanic acid).
Children over 6 years of age with a body weight of 25 to 40 kg.
The dose is from 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day, divided into 3 doses. The maximum daily dose is 2400 mg of amoxicillin/600 mg of clavulanic acid (4 tablets).
Since the tablet cannot be given to children with a body weight of less than 25 kg, this dosage form should not be prescribed.
Elderly patients. Dose correction is not required. If necessary, adjust the dose depending on kidney function.
Children over 6 years of age with a body weight of 25 to 40 kg. Since the tablet cannot be divided, children over 6 years of age with a body weight of 25 to 40 kg, a creatinine clearance of less than 30 ml/min or children undergoing hemodialysis should not be prescribed this dosage form.
Violation of liver function. Apply carefully; it is necessary to monitor liver function at regular intervals.
For optimal absorption and reduction of 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.
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 (for example, osteomyelitis) require long-term treatment.
If large doses of amoxicillin are required for treatment, dosage forms with a different amoxicillin/clavulanic acid ratio should be used to avoid excessively high doses of clavulanic acid.
Treatment can be started with parenteral administration and then continued with oral administration.
Children. This medicinal form should be used by children over 6 years of age with a body weight of at least 25 kg.
Overdose
Symptoms
Symptoms of gastrointestinal disorders and fluid and electrolyte imbalance may be observed. Amoxicillin-related crystalluria was observed, which in some cases led to renal failure.
Convulsions may occur in patients with impaired renal function and in patients taking high doses of the drug.
Precipitation of amoxicillin in bladder catheters has been reported, mainly after high-dose administration. The patency of catheters should be checked regularly.
Treatment
From the side of the gastrointestinal tract, it is possible to treat symptomatically, taking into account the fluid/electrolyte balance.
Amoxicillin/clavulanic acid can be removed from the bloodstream by hemodialysis.
Adverse reactions
Adverse reactions when using Amoxiclav Quicktab are usually mild and pass quickly. Most often, disorders of the digestive tract (diarrhea, nausea) occur. These reactions can be prevented if the drug is taken with food.
Generally accepted classification of adverse reactions by frequency: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, < 1/1000), rare (<1/10000), not known (frequency cannot be estimated due to lack of data).
Infections and invasions: often - candidiasis of the genitals (discharge and itching of the vagina), skin and mucous membranes, the frequency is unknown - the development of superinfection, excessive growth of insensitive microflora.
From the side of the blood: single - reversible leukopenia (including neutropenia) and thrombocytopenia, rare - reversible agranulocytosis and hemolytic anemia, eosinophilia, pancytopenia, myelosuppression, increased bleeding time and prothrombin index.
From the side of the nervous system: often - dizziness, headache, convulsions (mainly in patients with impaired kidney function or when using high doses of the drug); rare - reverse 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 separate reports of a change in the color of the surface of the teeth, but these reports refer to the use of the drug in the form of a suspension. Oral hygiene should be observed to prevent these phenomena. Rarely - coloring of the tongue in black color, "black hairy tongue".
From the urinary system: rarely - interstitial nephritis, hematuria, crystalluria.
On the part of the skin: often - rash, itching, urticaria; infrequent - polymorphic erythema rare - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, drug reaction in the form of eosinophilia and systemic manifestations (DRESS syndrome), Lai syndrome With the appearance of any allergic dermatitis, further use of the drug should be stopped.
From the side of the immune system: often - angioneurotic edema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis, medicinal fever; rare - severe anaphylactoid reactions, requiring urgent therapy with the use of adrenaline and other means.
Hepatobiliary system: infrequently - a moderate increase in AST and ALT is noted in patients who are treated with antibiotics of the beta-lactam group; rare - hepatitis and cholestatic jaundice. These phenomena occur with the use of other penicillins and cephalosporins. On the part of the liver, they are noted mainly in men and elderly patients and are associated with long-term use of the drug (more than 14 days). Such phenomena occurred very rarely in children.
These phenomena can be severe, but are usually reversible. They develop during treatment or immediately after treatment, although sometimes they do not appear until several weeks after stopping the drug. Very rarely, fatal cases have been observed in patients with a severe underlying disease or in patients who are simultaneously treated with drugs that have a negative effect on the liver.
Storage conditions
Store at a temperature not higher than 25 °C in a dry place. Keep out of the reach of children. Quick validity - 3 years.