Flemoxin SoluTab pills 250mg №20

Active ingredient and dosage form

Pills white, flat-oval shape, with a chamfer, with a label of 125 mg- "181"; 250 mg- "182"; 500 mg- "gbr 184" on one side and a risk on the other side.

1 pill contains Amoxicillin (in the form of trihydrate) 125, 250 or 500 mg;
Excipients: MCC, hydroxypropylcellulose poorly substituted, vanillin, flavoring agent, saccharin, colloidal dioxin silicone, Magnesium stearate;
5 pieces. in a blister, in a box of 4 blisters.

P №013650 / 01-2002 01.24.02

Mechanism of action

A broad-spectrum antibiotic of a group of semi-synthetic penicillins. Bactericidal effect.
Active against Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium tetani, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus, Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori.
Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae.
To drugare resistant beta-lactamase producing bacteria, Pseudomonas spp., Proteus spp. (indole-positive), Serratia spp., Enterobacter spp.

Suction
After ingestion, amoxicillin is absorbed quickly and almost completely (93%), acid resistant. Eating almost no effect on the absorption of the drug. C_max active substance in plasma is observed after 1-2 hours. After oral administration, 500 mg of amoxicillin C_max active substance, component 5 mcg / l, is noted in the blood plasma after 2 h.With increasing or decreasing the dose of the drug in 2 times C_max in blood plasma also changes 2 times.
Distribution
About 20% of amoxicillin binds to plasma proteins. Amoxicillin penetrates mucous membranes, bone tissue and intraocular fluid, sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in the blood plasma by 2-4 times. In amniotic fluid and umbilical cord vessels, amoxicillin concentration is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin poorly penetrates the BBB; however, in inflammation of the meninges (for example, meningitis), the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma.
Metabolism
Amoxicillin is partially metabolized, most of its metabolites are inactive against microorganisms.
Removal
Amoxicillin is eliminated predominantly by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration.
In the absence of renal dysfunction T_1/2 Amoxicillin is 1-1.5 hours. In premature babies, newborns and children younger than 6 months - 3-4 hours.
Pharmacokinetics in special clinical situations
T_1/2 Amoxicillin does not change in violation of liver function.
In case of impaired renal function (CC is equal to or less than 15 ml / min) T_1/2 Amoxicillin increases and reaches 8.5 hours during anuria.

Indications and usage

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- respiratory infections;
- infections of the genitourinary system;
- infections of the digestive tract;
- infections of the skin and soft tissues.

Dosage and administration

Set individually, taking into account the severity of the disease, the sensitivity of the pathogen to the drug, the patient's age.
Wheninfectious and inflammatory diseases of mild to moderate severity It is recommended to use the drug according to the following scheme:
adults and children over 10 years appoint 500-750 mg 2 times / day or 375-500 mg 3 times / day.
Children aged 3 to 10 years appoint 375 mg 2 times / day or 250 mg 3 times / day.
Children aged 1 to 3 years appoint 250 mg 2 times / day or 125 mg 3 times / day.
The average daily dose for children is 30 mg / kg of body weight, 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.
In chronic diseases, relapses, severe infections The dose of the drug may be increased:for adults appoint 0.75-1 g 3 times / day; for children - 60 mg / kg / day, divided into 3 doses.
With acute uncomplicated gonorrhea prescribe 3 g of the drug in 1 reception in combination with 1 g of probenecid.
Patients with impaired renal function atQC below 10 ml / min the dose of the drug is reduced by 15-50%.
In case of mild to moderate infections, the drug is taken for 5-7 days. However, for infections caused by streptococcus, the duration of treatment should be at least 10 days.
In the treatment of chronic diseases, infections of the severe course of the drug dose should be determined by the clinical picture of the disease.
The drug should be continued for 48 hours after the disappearance of the symptoms of the disease.
The drug is prescribed regardless of the meal. The pill can be swallowed whole, divided into parts or chewed, washed down 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 apricot flavor.

Adverse reactions

Gastrointestinal: rarely - diarrhea, itching in the anus; dyspepsia is possible; very rarely, pseudomembranous and hemorrhagic colitis.
Urogenital: rarely - the development of interstitial nephritis.
Hemic and lymphatic: rarely - agranulocytosis, thrombocytopenia.
Allergic reactions: skin reactions, mainly in the form of a specific maculopapular rash; rarely erythema multiforme, Stevens-Johnson syndrome; in some cases - anaphylactic shock, angioedema. Allergic skin reactions with the use of amoxicillin are more common than with other drugs of the penicillin group, but less frequently than with ampicillin.

Contraindications

- infectious mononucleosis and lymphocytic leukemia;
- Hypersensitivity to the drug or other beta-lactam antibiotics.

Pregnancy and breastfeeding

The use of the drug Flemoxin Solutab during pregnancy and lactation is possible if the expected positive result from the use of the drug outweighs the risk of side effects.
In small quantities, amoxicillin is excreted in breast milk, which can lead to the development of sensitization phenomena in a child.

The presence of erythroderma in history is not a contraindication for the appointment of Flemoxin Solutab.
Simultaneous use with Allopurinol does not increase the frequency of skin reactions in contrast to the combination of allopurinol with ampicillin.
There is cross-resistance and cross-hypersensitivity to penicillin-type drugs, cephalosporins.
As with the use of other penicillin preparations, the development of superinfection is possible.
The appearance of severe diarrhea, characteristic of pseudomembranous colitis, is an indication for discontinuation of the drug.
The purpose of the drug for patients with infectious mononucleosis and lymphocytic leukemia is contraindicated, because high probability of the appearance of exanthema non-allergic genesis.

Overdosage

Symptoms: dysfunction of the digestive tract - nausea, vomiting, diarrhea; vomiting and diarrhea can be a violation of water and electrolyte balance.
Treatment: designate gastric lavage, Activated carbon, saline laxatives; apply measures to maintain water and electrolyte balance.

Drug Interactions

Probenecid, phenylbutazone, oxyphenbutazone, to a lesser extent - Acetylsalicylic acid, Indomethacin and sulfinpyrazone inhibit the tubular secretion of penicillin preparations, which leads to an increase in the half-life and an increase in the concentration of amoxicillin in the blood plasma.
Drugs that have a bacteriostatic effect (tetracycline antibiotics, macrolides, chloramphenicol) can neutralize the bactericidal effect of amoxicillin.
With simultaneous appointment with aminoglycosides synergism of interaction is possible.
Simultaneous intake of amoxicillin with oral contraceptives may reduce the effectiveness of the latter.

List B. The drug should be stored in a dry, dark place, out of the reach of children at a temperature of 15 ° to 25 ° C.

- 5 years.
Pharmacy sales terms
The drug is available on prescription.