Expiration date: 01/2025

Composition and form of issue:

Tablets soluble. 1 tablet contains:

amoxicillin (as amoxicillin trihydrate) 125, 250, 500 or 1000 mg

inactive ingredients: dispersible cellulose MCC crospovidon the vanilla flavor, tangerine flavor, citric saccharin magnesium stearate 

in blistere 5 PCs., in box 4 blisters (125, 250, 500, 1000 mg), or blistere 7 PC., in box 2 blisters (125 mg).

Description of dosage form:

Tablets are dispersed from white to light yellow, oval shape with the logo of the company and a digital designation on one side and the risk that separates the tablet in half, on the other side. Digital signage: flemoksin soljutab (125 mg), — "231" flemoksin soljutab (250 mg) — "232" flemoksin soljutab (500 mg) — "234" flemoksin soljutab (1000 mg) — "236".

Characteristic:

Bactericidal acid-resistant broad-spectrum antibiotic from the group of semi-synthetic penicillins.

Pharmacokinetics:

Suction

After ingestion absorbed quickly and almost completely (about 93%), acid resistance. Once inside the dose of 500 mg Cmax of the active substance in plasma is about 5 ág/ml observed in plasma after 2 hours When increasing or decreasing the dose in 2 times Cmax in plasma is also changed 2 times. Eating practically does not affect the absorption of the drug.

Distribution

Plasma protein binding is about 20%. Amoxicillin penetrates well into the mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations. The concentration of amoxicillin in the bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical cord vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman.

Poor permeates through GEB, but the inflammation of the meninges concentration in cerebrospinal fluid is about 20% of the concentration in the blood plasma.

Metabolism

Partially metabolized, most of its metabolites are inactive against microorganisms.

Breeding

Eliminated primarily by the kidneys, about 80% by kanalzeva excretion, 20% — by clubockova filtering. In the absence of renal dysfunction T1 / 2 is 1-1. 5 hours in premature, newborn and children under 6 months-3-4 hours.

Pharmacokinetics in special clinical cases.

T1 / 2 amoxicillin does not change with impaired liver function.

In violation of kidney function (Cl creatinine & le15 ml / min), T1 / 2 amoxicillin can increase and reaches anuria 8, 5 no. 

Description of the pharmacological action:

Active against gram-positive and gram-negative microorganisms such as Streptococcus pyogenes, Streptococcus pneumonia, Clostridium tetani, C. welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamases), Bacillus anthracis, Listeria monocytogenes pylori. Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. Not active for micro-organisms producing beta-lactamases, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Indications:

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infection of the respiratory system
  
• organs of the genitourinary system
  
• of the digestive tract
  
• skin and soft tissue.
  

Contraindications:

• Hypersensitivity to the drug and other beta-lactam antibiotics.
  

With caution:

• polyvalent hypersensitivity to xenobiotics
  
• infectious mononucleosis
  
• lymphocytic leukaemia
  
• diseases of the gastrointestinal tract in history (especially colitis, associated with the use of antibiotics)
  
• renal failure
  
• pregnancy
  
• lactation.
  

Application for pregnancy and breastfeeding:

Possible use of the drug during pregnancy and lactation in the case if the expected positive results from the use of the drug greater than the risk of side effects. In small quantities, amoxicillin is excreted in breast milk, which can lead to the development of sensitization in the child.

Side effect:

From the digestive tract: rarely - changes in taste, nausea, vomiting, diarrhea in some cases — a moderate increase in liver transaminases very rarely — pseudomembranous and hemorrhagic colitis.

From the urinary system: rarely-the development of interstitial nephritis.

From the hematopoietic system: possible agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia, but they are also extremely rare.

Side effects from the nervous system when using amoxicillin tablets in the dosage form are not registered dispersible.

Allergic reactions: skin reactions, mainly in the form of a specific maculopapular rash rarely — multiform exudative erythema (Stevens-Johnson syndrome) in some cases — anaphylactic shock, angioedema.

Drug interaction:

Probenecid, phenylbutazone, oxyphenbutazone, to a lesser extent acetylsalicylic acid and sulfinpyrazone inhibit tubular secretion of penicillins, which leads to an increase in the half-life period and increase in the concentration of amoxicillin in blood plasma. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) while receiving have sinergidnyj effect possible antagonism when receiving some bacteriostatic drugs (e.g. chloramphenicol, sulfonamides). Simultaneous administration of èstrogensoderža?imi oral contraceptives may decrease their effectiveness and increase the risk of breakthrough bleeding). Simultaneous administration with allopurinol does not increase the frequency of skin reactions in contrast to the combination of allopurinol with ampicillin.

Method of application and doses:

Inside, before, during or after a meal. The tablet can be swallowed whole, divided into parts or chew, drinking a glass of water or diluted in water to form a syrup (20 ml) or suspension (100 ml).

Adults and children older than 10 years (with mild and moderate infections) — 500-750 mg 2 times a day or 375-500 mg 3 times a day.

Children from 3 to 10 years — 375 mg 2 times a day or 250 mg 3 times a day from 1 year to 3 years-250 mg 2 times a day or 125 mg 3 times a day. Daily dose for children (including children under 1 year) — 30-60 mg/kg/day, divided into 2-3 admission.

In the treatment of severe infections, as well as infections with hard-to-reach lesions (eg acute otitis media), a triple reception of the drug is preferred.

In chronic diseases, relapses, severe infections: adults — 0, 75-1 g 3 times a day, children — up to 60 mg/kg/day in 3 admission.

In acute uncomplicated gonorrhea-3 g, once, in combination with 1 g probenecid.

In case of mild and moderate infections, treatment is carried out for 5-7 days, with infections caused by Streptococcus pyogenes — not less than 10 days.

In the treatment of chronic diseases, infections, heavy doses of the drug should be determined by the clinical picture of the disease. The drug is continued for 48 hours after disappearance of symptoms.

Patients with Cl creatinine below 10 ml/min dose reduce to 15-50%.

Overdose:

Symptoms: nausea, vomiting, diarrhea, violation of water-electrolyte balance.

Treatment: gastric lavage, the appointment of activated charcoal, saline laxatives, correction of water-electrolyte balance.

Special instruction:

The presence of erythroderma in history is not a contraindication for Flemoxin Solutab.

Cross-resistance with penicillin and cephalosporins is possible.

As with other penicillin drugs, the development of superinfection is possible.

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

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