Flemoxin Solutab, 250 mg 20 pcs

Flemoxin Solutab bactericidal, antibacterial.

Pharmacodynamics

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-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori.

Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. It is not active against beta-lactamase-producing microorganisms, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Pharmacokinetics

Absorption

After oral administration is quickly and almost completely absorbed (about 93%), acid resistant. After an oral dose of 500 mg, the C_max of the active substance in plasma is 5 µg/mL and is noted in blood plasma after 2 hours. When the drug dose is increased or decreased by a factor of 2, the C_max in plasma also changes by a factor of 2. Food intake has almost no effect on absorption of the drug.

Distribution

The binding to plasma proteins is about 20%. Amoxicillin penetrates well into the mucous membranes, bone tissue, intraocular fluid and sputum at 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 amoxicillin concentration is 25-30% of its level in the blood plasma of a pregnant woman.

Poorly penetrates through the BBB, but in inflammation of the cerebral membranes, the concentration in the cerebrospinal fluid is about 20% of the plasma concentration.

Metabolism

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

Elimination

Eliminated mainly by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, T_1/2 is 1-1.5 h. In premature infants, newborns and children younger than 6 months – 3-4 hours.

Pharmacokinetics in special clinical cases.

T_1/2 amoxicillin is not altered in impaired liver function.

In impaired renal function (creatinine Cl ≤15 ml/min), the T_1/2 of amoxicillin may increase and reach 8.5 h in anuria.

Indications

Pneumonia, bronchitis, urinary tract infections, maxillitis, otitis.

Active ingredient

Composition

Active ingredient:

amoxicillin trihydrate;

Excipients:

dispersible cellulose – 34.8 mg,

microcrystalline cellulose – 50.5 mg,

crospovidone – 50.4 mg,

vanillin – 1 mg,

tangerine flavoring – 9.1 mg,

lemon flavoring – 11.1 mg,

saccharin – 13.1 mg,

magnesium stearate – 6 mg.

How to take, the dosage

The drug is taken orally. The drug is taken before, during or after meals. The tablet may be swallowed whole, divided into parts or chewed with a glass of water, or it may be diluted in water to form a syrup (20 ml) or suspension (100 ml) having a pleasant fruity taste.

The dosing regimen is determined individually, taking into account the severity of the disease, the sensitivity of the causative agent to the drug and the age of the patient.

In case of infectious-inflammatory diseases of mild to moderate severity, the following regimen is recommended: For adults and children over 10 years of age, 500-750 mg 2 times a day or 375-500 mg 3 times a day; for children aged 3 to 10 years, 375 mg 2 times a day or 250 mg 3 times a day; for children aged 1 to 3 years, 250 mg 2 times a day or 125 mg 3 times a day are indicated.

The daily dose of the drug for children (including children under 1 year of age) 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 (e.g., acute otitis media), three doses are recommended.

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

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

In patients with impaired renal function at CK≤10 ml/min, the drug dose is reduced by 15-50%.

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

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

Interaction

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

The bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) exhibit synergism when taken simultaneously.

Possible antagonism when taken with some bacteriostatic drugs (e.g., chloramphenicol, sulfonamides).

The concomitant use of amoxicillin with estrogen-containing oral contraceptives may decrease the effectiveness of the latter and increase the risk of acyclic bleeding.

Antacids, glucosamine, laxative drugs, aminoglycosides, food reduce absorption. Ascorbic acid increases absorption.

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

The concomitant use of amoxicillin with allopurinol increases the risk of skin rash.

Special Instructions

The drug should be used with caution in patients with infectious mononucleosis and lymphatic leukemia because of the high probability of exanthema of non-allergic genesis.

The history of erythrodermia is not a contraindication for administration of Flemoxin Solutab®.

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

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

The state of hematopoietic, hepatic and renal function should be monitored during the course of treatment.

The development of superinfection due to growth of microflora insensitive to the drug is possible, which requires appropriate change in antibiotic therapy.

In the treatment of mild diarrhea, anti-diarrheal medications that reduce intestinal peristalsis should be avoided; kaolin- or attapulgit-containing anti-diarrheal medications may be used. Treatment necessarily continues for another 48-72 h after the clinical symptoms of the disease have disappeared.

When concomitant use of estrogen-containing oral contraceptives and amoxicillin, other or additional methods of contraception should be used, if possible.

Impact on driving and operating machinery

No adverse effects of the drug on driving or operating machinery have been reported.

Contraindications

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

Side effects

The digestive system: rarely – change of taste, nausea, vomiting, diarrhea, dysbacteriosis, stomatitis, glossitis; in some cases – moderate increase in liver transaminase activity, cholestatic jaundice, hepatic cholestasis, acute cytolytic hepatitis, pseudomembranous and hemorrhagic colitis.

Urinary system disorders: development of interstitial nephritis, crystalluria.

Hematopoietic system disorders: leukopenia, neutropenia, thrombocytopenic purpura, eosinophilia, thrombocytopenia, agranulocytosis, hemolytic anemia.

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

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

Others: difficulty breathing, vaginal candidomycosis, superinfection (especially in patients with chronic diseases or reduced body resistance).

Overdose

Symptoms: Gastrointestinal disorders – nausea, vomiting, diarrhea; consequence of vomiting and diarrhea can be a violation of water-electrolyte balance.

Treatment: Gastric lavage, activated charcoal, saline laxatives; measures to maintain water-electrolyte balance, hemodialysis are used.

Similarities