Amoksiklav 2X (Amoxicillin) 500mg/125mg 14 tablets — Made in Poland by Sandoz — Free Delivery

Product Description

Amoxiclav 2X is indicated for the treatment of bacterial infections caused by microorganisms sensitive to the preparation:

• acute bacterial sinusitis (confirmed)
• acute otitis media,
• exacerbation of chronic bronchitis was confirmed;
• community-acquired pneumonia
• cystitis;
• pyelonephritis;
• infections of the skin and soft tissues, including cellulite, animal bites, severe dentoalveolar abscesses with widespread cellulite;
• infections of bones and joints, including osteomyelitis.

Composition

• active ingredients: amoxicillin, clavulanic acid;
• 1 tablet contains 500 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of potassium salt;
• Excipients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose
• shell: hydroxypropyl methylcellulose, ethylcellulose, polysorbate, triethyl citrate, talc, titanium dioxide (E 171).

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins) in the biosynthetic metabolism of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the cell wall, resulting in lysis and cell death.

Amoxicillin is sensitive to the degradation of beta-lactamases produced by resistant bacteria, therefore, the spectrum of activity of amoxicillin as monotherapy does not include organisms that produce these enzymes.

Clavulanic acid is a beta-lactams structurally related to penicillins. It disables some of the beta-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid alone has no clinically beneficial antibacterial effect.

Contraindications

Hypersensitivity to the components of the preparation, to any antibacterial agents of the penicillin group.

A history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other beta-lactam agents (including cephalosporins, carbapenems or monobactams).

A history of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanate.

Method of administration and dosage

The preparation should be used according to the official recommendations for antibiotic therapy and local antibiotic susceptibility data. Sensitivity to amoxicillin / clavulanate differs in different regions and may change over time. If necessary, refer to the local sensitivity data and, if necessary, carry out a microbiological determination and a sensitivity test. The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial preparations, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient.

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

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

If large doses of amoxicillin are to be prescribed for treatment, other forms of the preparation should be used to avoid the appointment of unnecessary high doses of clavulanic acid.

The duration of treatment is determined by the physician based on the patient's clinical response to treatment. Some infections (such as osteomyelitis) require long-term treatment.

Adults and children weighing ≥ 40 kg 1 tablet 500 mg / 125 mg 3 times a day.

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

Since the tablet cannot be divided, children weighing less than 25 kg should not be given this form of the preparation.

Children aged 6 years with a body weight of 25 to 40 kg. Since the tablet cannot be divided, children over 6 years old with a body weight of 25 to 40 kg with creatinine clearance less than 30 ml / min or children on hemodialysis should not be prescribed this form of the preparation.

The tablet should be swallowed whole without chewing. For optimal absorption and to reduce possible side effects from the digestive tract, the preparation should be taken at the beginning of a meal.

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

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

Application features

Use during pregnancy or lactation

Pregnancy. Reproductive studies on animals of oral and parenteral forms of the preparation did not reveal a single teratogenic effect. One study in women with premature rupture of the membranes of the fetus reported that prophylactic use of the preparation may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other medicines, the use of the preparation during pregnancy, especially in the first trimester, should be avoided, unless, in the opinion of the doctor, such use is necessary.

Breastfeeding period. Both active components of the preparation are excreted in breast milk (there is no information on the effect of clavulanic acid on a breastfed infant). Accordingly, a breastfed infant may develop diarrhea and a fungal infection of the mucous membranes, so breastfeeding should be discontinued. Consideration should be given to the possibility of allergic reactions. The preparation can be used during lactation only when, in the opinion of the doctor, the benefit from the use will prevail the risk.

Children

The preparation in this dosage can be used in children aged 6 years and older with a body weight of at least 25 kg.

The ability to influence the reaction rate when driving or driving other mechanisms

Studies on the ability of the preparation to influence the reaction rate when driving vehicles or other mechanisms have not been carried out. However, adverse reactions (eg allergic reactions, dizziness, convulsions) may occur that may affect the ability to drive a car or other mechanisms.

Overdose

Symptoms Symptoms of gastrointestinal disorders and fluid and electrolyte imbalances may occur. Crystalluria was observed associated with the intake of amoxicillin, which in some cases led to renal failure.

In patients with impaired renal function and in patients taking high doses of the preparation, seizures may occur.

Amoxicillin sediments have been reported in bladder catheters, predominantly after high-dose administration. You should regularly check the patency of the catheters (see Section "Peculiarities of use").

Treatment. The gastrointestinal tract can be treated symptomatically by paying attention to fluid / electrolyte balance.

Amoxicillin / clavulanic acid can be removed from the bloodstream by hemodialysis.

Adverse Reactions

The most commonly reported adverse reactions to the preparation were diarrhea, nausea, and vomiting.

Interaction with other medicinal products and other types of interactions

Oral anticoagulants.

Oral anticoagulants and penicillin antibiotics are widely used in practice in the absence of reports of interactions. However, cases of an increase in the international normalization rate have been described in patients taking acenocoumarol or warfarin and how the course of treatment with amoxicillin was prescribed. If concomitant administration of preparations  is necessary, the prothrombin index or the international normalization factor should be carefully monitored when adding or discontinuing amoxicillin. In addition, it may be necessary to adjust the dose of anticoagulants for oral administration (see Sections "Peculiarities of use" and "Adverse reactions").

The simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. The simultaneous use of probenecid can lead to an increase in the level and duration of amoxicillin (but not clavulanic acid) in the blood.

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions. There are no data regarding the simultaneous use of allopurinol and Amoxiclav ® 2X.

Like other antibiotics, Amoxiclav 2X can affect the intestinal flora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives.

Amoxiclav ® 2X should not be used in conjunction with bacteriostatic chemotherapeutic agents / antibiotics (chloramphenicol, macrolides, tetracyclines or sulfonamides), since an antagonistic effect was observed in vitro with such combinations.

Methotrexate. Penicillins can reduce the excretion of methotrexate, causing a potential increase in toxicity.

Mofetila mycophenolate. In patients who are treated with mycophenolate mycophenolate, after the start of oral amoxicillin with clavulanic acid, the pre-dose concentration of the active metabolite of IFC may decrease by about 50%. This change in pre-dose level may not fully match the change in overall IFC exposure. Thus, a change in mycophenolate mofetil dosage is usually not required unless there is clinical evidence of graft dysfunction. However, close observation is necessary during joint use and for some time after antibiotic therapy.

Storage conditions

Store at a temperature not exceeding 25 ° C in its original packaging.

Keep out of the reach of children.

Shelf life is 2 years.