Flemoxin Solutab - instructions for use, dose, side effects, contraindications

Excipients: Lemon flavor 1.4 / 2.8 / 5.6 / 11.1 mg; flavoring mandarin 1,1 / 2,3 / 4,5 / 9,1 mg; vanillin 0.13 / 0.26 / 0.5 / 1.0 mg; crospovidone 6.3 / 12.6 / 25.2 / 50.4 mg; magnesium stearate 0.76 / 1.5 / 3.0 / 6.0 mg; saccharin 1.6 / 3.3 / 6.6 / 13.1 mg; cellulose dispersible 4.3 / 8.7 / 17.4 / 34.8 mg; cellulose microcrystalline 6.3 / 12.6 / 25.2 / 50.5 mg.

Description:

Dispersible tablets from white to light yellow color, oval in shape with a company logo and a reference numeral on one side and the notch which separates the tablet in half, on the other side.

Numeric designation:

Tablets dispersible 125 mg - "231";

Tablets dispersible 250 mg - "232";

Tablets dispersible 500 mg - "234";

Tablets dispersible 1000 mg - "236".

Pharmacotherapeutic group:antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Flemoksin Solyutab® - antibacterial broad-spectrum antibiotic from the group of semisynthetic penicillins. Violates the synthesis of peptidoglycan (supporting polymer of the cell wall) in the period of division and growth, causing bacterial lysis. It is active against Gram-positive and Gram-negative microorganisms, such as Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium tetani, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. Less active at respect Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. He active at respect microorganisms, producing beta-lactamase, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp. Strains producing penicillinase are resistant to the action of amoxicillin.

Pharmacokinetics:

Suction

After oral administration amoxicillin absorbed quickly and almost completely (about 93%), not destroyed in the acidic environment of the stomach. The intake of food has practically no effect on the absorption of the drug. The maximum concentration of the active substance in the plasma is observed after 1-2 hours. After oral administration of 500 mg of amoxicillin, the maximum active substance concentration of 5 μg / ml is noted in the blood plasma after 2 hours. When the dose of the drug is increased or decreased by a factor of 2, the maximum concentration in Plasma also changes 2 times.

Distribution

The connection with plasma proteins is 17%. Amoxicillin well penetrates the mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations.The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin poorly penetrates the blood-brain barrier; However, with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma.

Metabolism

Amoxicillin is partially metabolized in the liver, most of its metabolites do not have microbiological activity.

Excretion

Amoxicillin is excreted 50-70% by kidneys in the unchanged form (by tubular secretion - 80% and glomerular filtration 20%), liver - 10-20%. In small amounts excreted in breast milk. In the absence of impaired renal function, the half-life of amoxicillin is 1-1.5 hours. Preterm, newborns and children younger than 6 months of age. - 3-4 hours.

Pharmacokinetics in special clinical cases

The half-life of amoxicillin does not change if the liver function is impaired. If the renal function is impaired (creatinine clearance <15 ml / min), the half-life of amoxicillin can increase and reaches an anuria of 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:

Infectious and inflammatory diseases caused by microorganisms sensitive to amoxicillin: infections of the respiratory system; infections of the urogenital system; infections of the gastrointestinal tract (GIT); infections of the skin and soft tissues.

Contraindications:

hypersensitivity to the drug and other beta-lactam antibiotics, incl. to other penicillins, cephalosporins, carbapenems.

Carefully:

Polyvalent hypersensitivity to xenobiotics, infectious mononucleosis, lymphocytic leukemia, a history of gastrointestinal disease (especially colitis associated with the use of antibiotics), kidney failure, pregnancy, lactation, allergic reactions, including. polyvalent hypersensitivity to xenobiotics (including in the anamnesis).

Pregnancy and lactation:

It is possible to administer the drug during pregnancy and lactation in the event that the expected positive result of the use of the drug in the mother exceeds the risk of side effects in the fetus and the baby. In small quantities amoxicillin excreted in breast milk, which can lead to the development of sensitization in the child.

Dosing and Administration:

Inside (oral).

The dose is set individually, taking into account the severity of the course of the disease, the age of the patient. In the case of infectious-inflammatory diseases of mild and moderate severity, the use of the drug according to the following scheme is recommended: adults and children over 10 years old prescribe 500-750 mg 2 times / day or 375-500 mg 3 times / day.

Children from 3 to 10 years appoint 375 mg 2 times / day or 250 mg 3 times / day.

Children aged from 1 to 3 years prescribe 250 mg 2 times / day or 125 mg 3 times / day. Daily dose of the drug for children (including children under 1 year) is 30-60 mg / kg / day, divided into 2-3 doses.

In the treatment of severe infections, as well as infections with hard-to-reach foci of infection (eg, acute otitis media), a three-time administration of the drug is preferred.

With chronic diseases, recurrent infections, severe infections, the dose of the drug can be increased: adults appoint 750 mg - 1 g 3 times / day; children before 60 mg / kg / day, divided into 3 doses.

In acute uncomplicated gonorrhea, adults are prescribed 3 g of the drug in a single dose in combination with 1 g of probenecid.

Patients with impaired renal function with creatinine clearance below 10 ml / min dose of the drug reduce by 15-50%.

The drug is prescribed before, during or after a meal.The tablet can be swallowed whole, divided into parts or chewed with a glass of water, and can also be diluted in water to form a syrup (in 20 ml) or a suspension (in 100 ml) with a pleasant fruit taste.

In the case of infections of mild and moderate severity, the drug is taken within 5-7 days. However, with infections caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.

Taking the drug should be continued within 48 hours after the disappearance of the symptoms of the disease.

Side effects:

From the gastrointestinal tract; change in taste, nausea, vomiting, diarrhea, dysbiosis, stomatitis, glossitis; in some cases - a moderate increase in the activity of "liver" transaminases, cholestatic jaundice, hepatic cholestasis, acute cytolytic hepatitis; pseudomembranous and hemorrhagic colitis.

From the side of the urinary system: development of interstitial nephritis.

From the hemopoietic system; leukopenia, neutropenia, thrombocytopenic purpura, eosinophilia, agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia.

From the nervous system: excitement, anxiety, insomnia, ataxia,confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, epileptic seizures.

Allergic reactions: skin reactions, mainly in the form of a specific maculopapular rash, hives, skin hyperemia, erythematous rashes, rhinitis, conjunctivitis; multiforme exudative erythema (Stevens-Johnson syndrome), fever, arthralgia, eosinophilia, exfoliative dermatitis, reactions similar to serum sickness; toxic epidermal necrolysis, allergic vasculitis, acute generalized exanthematous pustules; in some cases - anaphylactic shock, angioedema.

Other: shortness of breath, tachycardia, interstitial nephritis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced resistance of the body), crystalluria.

Overdose:

Symptoms: a violation of the function of the gastrointestinal tract - nausea, vomiting, diarrhea; the consequence of vomiting and diarrhea may be a violation of the water-electrolyte balance.

Treatment: a gastric lavage is prescribed, Activated carbon, salt laxatives; apply measures to restore the water-electrolyte balance, hemodialysis.

Interaction:

Probenecid, phenylbutazone, oxyphenbutazone, diuretics, allopurinol, non-steroidal anti-inflammatory drugs, to a lesser degree acetylsalicylic acid and sulfinpyrazone, and other drugs that block the tubular secretion of penicillins, which leads to an increase in the half-life and an increase in the concentration of amoxicillin in the blood plasma. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) with simultaneous administration have a synergistic effect; Possible antagonism in admission with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides). Simultaneous reception with estrogen-containing oral contraceptives can lead to a decrease in their effectiveness and an increased risk of bleeding "breakthrough"). Simultaneous administration with allopurinol does not increase the incidence of cutaneous reactions, unlike the combination of allopurinol with ampicillin.

Antacids, glucosamine, laxatives, food, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); increases absorption of digoxin. Allopurinol increases the risk of skin rash.

Special instructions:

The presence of erythrodermia in an anamnesis is not a contraindication for the administration of Flemoxin Solutab®.

Possible cross-resistance with penicillin series and cephalosporins.

As with other penicillin drugs, superinfection may develop.

The appearance of severe diarrhea, characteristic of pseudomembranous colitis, is an indication for the withdrawal of the drug.

Prescribe the drug to patients with infectious mononucleosis and lymphocytic leukemia with caution. the probability of occurrence of exanthema of non-allergic genesis is high.

In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys. It is possible to develop superinfection by increasing the microflora insensitive to the drug, which requires an appropriate change in antibacterial therapy.In the treatment of mild diarrhea against the background of course treatment, anti-diarrheal drugs should be avoided, which reduce intestinal peristalsis; it is possible to use kaolin- or attapulgite-containing antidiarrhoeal drugs. Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease. When using estrogen-containing oral contraceptives and amoxicillin concomitantly, other or additional methods of contraception should be used whenever possible.

Effect on the ability to drive transp. cf. and fur:

There was no reported adverse effects on the ability to drive vehicles or work with machinery.

Form release / dosage:Dispersible tablets 125 mg, 250 mg, 500 mg, 1000 mg.

Packaging:

Tablets dispersible 125 mg - 5 or 7 tablets in a blister made of polyvinyl chloride film and aluminum foil. For 4 or 2 blisters together with instructions for use are placed in a cardboard box.

Tablets dispersible 250 mg, 500 mg and 1000 mg - 5 tablets in a blister made of polyvinyl chloride film and aluminum foil. For 4 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:5 years. Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001852

Date of registration:19.08.2011

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

ASTELLAS PHARMA EUROPE, B.V. Netherlands

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp01.04.2014

Illustrated instructions

Instructions

Flemoxin Solutab® (Flemoxin Solutab®)