Flemoxin Solutab, pills 125mg, 20pcs

Composition

Active ingredient:

Amoxicillin trihydrate is 145.7 mg, which corresponds to the amoxicillin content of 125 mg.

Auxiliary substances:

dispersible cellulose – 4.3 mg,

microcrystalline cellulose-6.3 mg,

crospovidone-6.3 mg,

vanillin-0.13 mg,

tangerine flavor-1.1 mg,

lemon flavor-1.4 mg,

saccharin-1.6 mg,

magnesium stearate-0.76 mg

Pharmacological action

of Flemoxin Solutab-bactericidal, antibacterial.

Pharmacodynamics

It is active against gram-positive and gram-negative microorganisms such as:  Streptococcus pyogenes, Streptococcus pneumonia, Clostridium tetani, C. welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (that do not produce beta-lactamases), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. It is less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. It is not active against microorganisms producing beta-lactamases, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Pharmacokinetics

Suction

After oral use, it is absorbed quickly and almost completely (about 93%), acid-resistant. After oral use at a dose of 500 mg, the Cmax of the Active ingredient in plasma is 5 mcg / ml and is noted in blood plasma after 2 hours. When the dose of the drug is increased or decreased by 2 times, Cmax in blood plasma also changes by 2 times. Food intake practically does not affect the absorption of the drug.

Distribution

Binding to plasma proteins 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 bile exceeds its concentration in blood plasma by 2-4 times. In the amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman.

Poorly penetrates the BBB, but with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in blood plasma.

Metabolism

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

Deduction

It is eliminated mainly by the kidneys, about 80% by tubular excretion,20% by glomerular filtration. In the absence of impaired renal function, T1 / 2 is 1-1.5 hours. In preterm infants, newborns and children under 6 months-3-4 hours

. Pharmacokinetics in special clinical cases.

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

With impaired renal function (Cl creatinine ≤15 ml / min), T1 / 2 of amoxicillin may increase and reaches 8.5 hours in anuria.

Indications

Pneumonia, bronchitis, urinary tract infections, sinusitis, otitis media.

Contraindications

Hypersensitivity (including to other antibiotics-penicillins, cephalosporins, carbapenems), bronchial asthma, pollinosis, liver failure.

Side effects

From the digestive system: rarely-taste changes, nausea, vomiting, diarrhea, dysbiosis, stomatitis, glossitis; in some cases-a moderate increase in the activity of hepatic transaminases, cholestatic jaundice, hepatic cholestasis, acute cytolytic hepatitis, pseudomembranous and hemorrhagic colitis.

From the urinary system: development of interstitial nephritis, crystalluria.

From the hematopoietic system: leukopenia, neutropenia, thrombocytopenic purpura, eosinophilia, thrombocytopenia, agranulocytosis, hemolytic anemia.

Nervous system disorders: agitation, anxiety, insomnia, ataxia, confusion, behavior changes, depression, peripheral neuropathy, headache, dizziness, epileptic seizures.

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

Others: shortness of breath, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced body resistance).

Interaction

Probenecid, phenylbutazone, oxifenbutazone, diuretics, allopurinol, NSAIDs, to a lesser extent – acetylsalicylic acid and sulfinpyrazone inhibit the tubular secretion of penicillins, which leads to an increase in T1 / 2 and an increase in the concentration of amoxicillin in blood plasma.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) show synergy when taken simultaneously.

Antagonism is possible when taken with certain bacteriostatic drugs (for example, chloramphenicol, sulfonamides).

Concomitant use of amoxicillin with estrogen-containing oral contraceptives may reduce the effectiveness of the latter and increase the risk of acyclic bleeding.

Antacids, glucosamine, laxatives, aminoglycosides, and food reduce absorption. Ascorbic acid increases absorption.

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

Concomitant use of amoxicillin with allopurinol increases the risk of skin rash.

How to take, course of use and dosage

The drug is taken orally. 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 suspension (in 100 ml), which has a pleasant fruit taste.

The dosage regimen is set individually, taking into account the severity of the disease, the sensitivity of the pathogen to the drug, and the patient’s age.

In the case of infectious-inflammatory disease of mild to moderate severity, it is recommended the use of the drug according to the following scheme: adults and children over 10 years: 500-750 mg 2 times/day or 375-500 mg 3 times/day; children aged 3 to 10 years old it is administered 375 mg 2 times/day or 250 mg 3 times/day; children aged 1 to 3 years: 250 mg 2 times/day or 125 mg 3 times/day.

The 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 in hard-to-reach foci of infection (for example, acute otitis media), a triple dose is recommended.

For chronic diseases, recurrent infections, severe infections, adults are prescribed 0.75-1 g 3 times/day; children-60 mg / kg/day, divided into 3 doses.

In acute uncomplicated gonorrhea,3 g of the drug is prescribed in 1 dose in combination with 1 g of probenecid.

In patients with impaired renal function with creatinine clearance<10 ml / min, the dose of the drug is reduced by 15-50%.

In the case of mild to moderate infections, the drug is taken for 5-7 days. However, for Streptococcus pyogenes infections, the duration of treatment should be at least 10 days.

The drug should be continued for 48 hours after the disappearance of symptoms of the disease.

Overdose

Symptoms: disorders of the gastrointestinal tract – nausea, vomiting, diarrhea; vomiting and diarrhea may result in a violation of the water-electrolyte balance.

Treatment: prescribe gastric lavage, activated charcoal, saline laxatives; apply measures to maintain water and electrolyte balance, hemodialysis.

Special instructions

Prescribe the drug to patients with infectious mononucleosis and lymphocytic leukemia with caution, since there is a high probability of the appearance of non-allergic exanthema.

The presence of a history of erythroderma is not a contraindication for the appointment of Flemoxin Solutab®.

Possible cross-resistance with penicillin-type drugs and cephalosporins.

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

During the course of treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver and kidneys.

It is possible to develop superinfection due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibacterial therapy.

In the treatment of mild diarrhea, antidiarrheal medications that reduce intestinal motility should be avoided during the course of treatment; kaolin-or attapulgite-containing antidiarrheal medications can be used. Treatment must continue for another 48-72 hours after the disappearance of clinical symptoms of the disease.

If possible, other or additional methods of contraception should be used when using estrogen-containing oral contraceptives and amoxicillin at the same time.

Influence on the ability to drive motor vehicles and manage mechanisms

No adverse effects of the drug on the ability to drive vehicles or work with mechanisms have been reported.

Form of production

Dispersible tablets.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Amoxicillin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Pharyngitis, Respiratory tract infections, Tonsillitis, Otitis media, Urinary tract infections, Sore throat, Gastrointestinal infections caused by Helicobacter Pylori, Intestinal infections, Skin infections, Bronchitis, Biliary tract infections