Flemoclav Solutab (Amoxicillin) 500mg/125mg 20 tablets — Made in Netherlands — Free Delivery

Product description

Flemoclav Solutab is prescribed for the treatment of bacterial infections caused by sensitive microorganisms:

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

Composition

active ingredients: amoxicillin, clavulanic acid

• 1 tablet contains amoxicillin (in the form of amoxicillin trihydrate) 875 mg, clavulanic acid (in the form of potassium clavulanate) 125 mg
• Excipients: microcrystalline cellulose, dispersed cellulose, crospovidone, vanillin, saccharin, magnesium stearate, tangerine and lemon flavor.

Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and degrades under its influence, therefore the spectrum of activity of amoxicillin does not include microorganisms synthesizing this enzyme. Clavulanic acid has a β-lactam structure similar to penicillins, and can also inactivate β-lactamase enzymes characteristic of microorganisms resistant to penicillins and cephalosporins. In particular, it has a pronounced activity against the clinically important plasmid β-lactamases, which are often responsible for the onset of antibiotic cross-resistance. The presence of clavulanic acid in the preparation protects amoxicillin from degradation under the action of β-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin,

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 antibiotics (in particular cephalosporins, carbapenems or monobactams).

A history of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanate (see Section "Adverse Reactions").

Method of administration and dosage

The dose is indicated according to the content of amoxicillin / clavulanic acid.

When choosing a dose of amoxicillin / clavulanic acid for the treatment of certain infections, one should take into account: expected pathogens and possible sensitivity to antibacterial preparations; the severity and localization of the infectious process; age, body weight and kidney function as indicated below.

If high doses of amoxicillin are required for treatment, other forms of amoxicillin / clavulanic acid should be used to avoid unnecessary high doses of clavulanic acid.

For children weighing from 25 kg to 40 kg

This dosage form provides a maximum daily dose of 1000-2800 mg amoxicillin / 143-400 mg clavulanic acid when used as described below.

If large doses of amoxicillin are required for treatment, other forms of amoxicillin / clavulanic acid should be used to avoid unnecessary high doses of clavulanic acid.

The duration of treatment is determined by the patient's response to treatment. Some infections (such as osteomyelitis) require treatment for a long time. Treatment should not be continued for more than 14 days without assessing the patient's condition.

Adults and children weighing ≥ 40 kg

Recommended doses:

• Standard doses (for all indications) 875/125 mg 2 times a day

Higher doses: (especially for infections such as otitis media, sinusitis, lower respiratory tract infections, and urinary tract infections) 875 mg / 125 mg 3 times daily

Children weighing from 25 kg to 40 kg

From 25 mg / 3.6 mg / kg / day to 45 mg / 6.4 mg / kg / day, divided into 2 doses

Up to 70 mg / 10 mg / kg / day, divided into 2 doses for the treatment of certain infections (such as otitis media, sinusitis, lower respiratory tract infections).

Since the tablet cannot be divided, children weighing less than 25 kg are not prescribed this form of Flemoclav Solutab ® 875/125 mg.

Mode of application

Flemoclav Solutab ® is intended for oral administration.

Flemoclav Solutab® should be taken with food to reduce potential gastrointestinal side effects.

Treatment can begin with parenteral administration of amoxicillin / clavulanic acid in the appropriate dosage form according to the instructions for use, followed by a transition to oral administration of tablets, dispersed.

Tablets, dispersed, should be dissolved in a small amount of water before taking.

Children

The preparation in this dosage form can be used for children weighing more than 9 kg at the rate of a daily dose of 40 mg / 10 mg / kg / day, divided into 3 doses.

Application features

Use during pregnancy or lactation

Pregnancy

Animal studies have not shown any direct or indirect deleterious effects on pregnancy, embryo / fetal development, or postnatal development. Limited data on the use of amoxicillin / clavulanic acid during pregnancy did not show an increased risk of congenital malformations. One study in women with premature rupture of the membranes of the fetus reported that prophylactic use of amoxicillin / clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in newborns. The use of the preparation during pregnancy 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. The possibility of allergic reactions should be taken into account.

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

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

There was no study of the effect on the ability to drive a car and other mechanisms. However, side effects (eg allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive a car or other mechanisms (see the section "Side effects").

Overdose

Overdose may be accompanied by symptoms from the gastrointestinal tract and an imbalance in water and electrolyte balance. Cases of crystalluria due to intake of amoxicillin have been reported, which can sometimes cause renal failure. Seizures may occur in patients with impaired renal function or when taking high doses. In patients with a catheter in the bladder, it is necessary to periodically change the catheter in a timely manner due to the fact that amoxicillin in high concentrations can settle on the walls of the urinary catheter.

Treatment. Gastrointestinal symptoms are treated symptomatically, with attention to correcting fluid and electrolyte balance. Amoxicillin / clavulanic acid is cleared from the blood by hemodialysis.

Adverse Reactions

The most commonly reported adverse reactions are diarrhea, nausea and vomiting.

Interaction with other medicinal products and other types of interactions

Oral anticoagulants.

In practical medicine, both oral anticoagulants and penicillins have not been reported to interact.

Individual cases of an increase in the level of the international normalized ratio (INR) in patients who simultaneously took amoxicillin and acenocoumarol or warfarin are described. If such use is necessary, prothrombin time or INR should be carefully monitored with the addition or discontinuation of amoxicillin treatment. In addition, it may be necessary to adjust the dose of oral anticoagulants (see Sections "Peculiarities of use" and "Adverse reactions").

Methotrexate.

Penicillins can reduce the excretion of methotrexate, which can lead to an increase in the toxicity of the latter.

Probenecid.

The simultaneous use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. The simultaneous use of probenecid with amoxicillin can lead to an increase in the level and a longer stay of the preparation in the blood, but does not affect the level of clavulanic acid.

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

In patients who are treated with mycophenolate mofetil, after starting the use of oral amoxicillin with clavulanic acid, the pre-dose concentration of the active metabolite of mycophenolic acid may decrease by about 50%. This change in pre-dose level may not accurately correspond to a change in total mycophenolic acid 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 3 years.