Flemoksin soljutab
Active material: Amoksiцillin
When ATH: J01CA04
CCF: Antibiotics penicillin broad spectrum, collapsing penicillinase
ICD-10 codes (testimony): A54, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J42, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, N10, N11, N30, N34, N41, N70, N71, N72
When CSF: 06.01.02.01.01
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)
Pharmaceutical form, composition and packaging
Dispersible tablets from white to light yellow in color, Oval, with company logo and brand name “231” on one side and Valium, dividing the tablet in half, on the other side.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 125 mg |
Excipients: dispersible cellulose, microcrystalline cellulose, krospovydon, vanillin, Flavors (Tangerine, lemon), saxarin, magnesium stearate.
5 PC. – blisters (4) – packs cardboard.
Dispersible tablets from white to light yellow in color, Oval, with company logo and brand name “232” on one side and Valium, dividing the tablet in half, on the other side.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 250 mg |
Excipients: dispersible cellulose, microcrystalline cellulose, krospovydon, vanillin, Flavors (Tangerine, lemon), saxarin, magnesium stearate.
5 PC. – blisters (4) – packs cardboard.
Dispersible tablets from white to light yellow in color, Oval, with company logo and brand name “234” on one side and Valium, dividing the tablet in half, on the other side.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 500 mg |
Excipients: dispersible cellulose, microcrystalline cellulose, krospovydon, vanillin, Flavors (Tangerine, lemon), saxarin, magnesium stearate.
5 PC. – blisters (4) – packs cardboard.
Dispersible tablets from white to light yellow in color, Oval, with company logo and brand name “236” on one side and Valium, dividing the tablet in half, on the other side.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 1 g |
Excipients: dispersible cellulose, microcrystalline cellulose, krospovydon, vanillin, Flavors (Tangerine, lemon), saxarin, magnesium stearate.
5 PC. – blisters (4) – packs cardboard.
Pharmacological action
Acid-bactericidal broad-spectrum antibiotic from the group of semisynthetic penicillins.
It is active against gram and gram microorganisms: Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium Dathan, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (не продуцирующие b-лактамазы), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori.
Less active against Enterococcus faecalis, Escherichia coli, Proteus is wonderful, Salmonella typhi, Shigella sonnei, Vibrio cholerae.
Not against microorganisms, продуцирующих b-лактамазы, Pseudomonas spp., Proteus spp. (indole-positive strains), Serratia spp., Enterobacter spp.
Pharmacokinetics
Absorption
After oral amoxicillin is absorbed rapidly and almost completely (93%), is acid. Eating has virtually no effect on the absorption of the drug. Once inside 500 mg amoxicillin Cmax active substance, component 5 ug / ml, It observed in plasma 2 no. By increasing or decreasing the dose in 2 times Cmax plasma also varies 2 times.
Distribution
About 20% Amoxicillin bound to plasma proteins. Amoxicillin penetrates the mucosal, bone, intraocular fluid and sputum in therapeutically effective concentrations. Amoxicillin concentration in the bile exceeding its concentration in blood plasma 2-4 times. The amniotic fluid and umbilical vessels of the concentration of amoxicillin 25-30% from its level in the blood plasma of pregnant women. Amoxicillin does not penetrate the blood-brain barrier; However, in inflammation of the meninges concentration in cerebrospinal fluid is approximately 20% concentration in blood plasma.
Metabolism
Amoxicillin partially metabolized in the liver, most of its metabolites are microbiologically inactive.
Deduction
Amoxicillin is eliminated primarily by the kidneys, about 80% by tubular excretion, 20% – through glomerular filtration.
In the absence of renal dysfunction T1/2 Amoxicillin is 1-1.5 no. Premature, infants and children under 6 Months – 3-4 no.
Pharmacokinetics in special clinical situations
T1/2 Amoxicillin does not change with abnormal liver function.
If the kidney function (CC ≤ 15 ml / min) T1/2 amoxicillin increases and reaches at anurii 8.5 no.
Testimony
Infectious-inflammatory diseases, caused by susceptible to malaria infections:
- Respiratory infections;
- Infections of the genitourinary system;
- Infections of the digestive tract;
- Infections of the skin and soft tissues.
Dosage regimen
The drug is taken orally. The drug is administered regardless of meals. The tablet can be swallowed whole, divided into parts or chew, with a glass of water, and can be diluted in water to form a syrup (in 20 ml) or suspension (in 100 ml), It has a pleasant fruity taste.
The mode set individually, taking into account the severity of the disease, susceptibility to the drug, the patient's age.
When infectious and inflammatory diseases mild to moderate It recommends the use of the preparation according to the following scheme: adult and older children 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 daily dose for children (including children under 1 year) is 30-60 mg / kg / day, razdelennaya of 2-3 admission.
At difficult foci of infection (eg, acute otitis media) recommended three-time reception.
At chronic diseases, recurrent infections, severe infections adult appoint 0.75-1 g 3 times / day; children – 60 mg / kg / day, divided by 3 admission.
At acute uncomplicated gonorrhea appointed 3 g in 1 taken in combination with 1 g probenecid.
Patients with impaired renal function at KK≤10 ml / min dose is reduced to 15-50%.
When infections of mild to moderate severity take medication for 5-7 days. However, infections, caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.
When treating chronic disease, severe infections duration of drug administration should be determined by the clinical picture of the disease.
The drug must be continued for 48 hours after the disappearance of symptoms.
Side effect
From the digestive system: rarely – change in taste, nausea, vomiting, diarrhea; in some cases – a moderate increase in liver transaminases; rarely – pseudomembranous colitis and haemorrhagic.
From the urinary system: rarely – development of interstitial nephritis.
From the hematopoietic system: rarely – agranulocytosis, neutropenia, thrombocytopenia, gemoliticheskaya anemia.
Allergic reactions: skin reactions, mainly, a particular maculo-papular rash; rarely – erythema multiforme exudative (Stevens-Johnson syndrome); in some cases – anaphylactic shock, angioedema.
Side effects in the nervous system when using amoxicillin in the form of dispersible tablets are not logged in.
Contraindications
- Hypersensitivity to the drug or to other beta-lactam antibiotics.
FROM caution use in patients with polyvalent hypersensitivity to xenobiotics, infectious mononucleosis, lymphocytic leukemia, gastrointestinal diseases in history (especially in cars, associated with the use of antibiotics), renal failure, Pregnancy and lactation.
Pregnancy and lactation
Use of the drug Flemoksin Soljutab® during pregnancy and lactation is possible in the case, if the expected benefits of the drug outweigh the risks of side effects.
Small amounts of amoxicillin is excreted in breast milk, which can lead to sensitization phenomena child.
Cautions
Prescribe drugs to patients with infectious mononucleosis and lymphocytic leukemia with caution, because of the high probability of exanthema nonallergic genesis.
It has a history of erythroderma is not a contraindication for appointment flemoksin Soljutab®.
The possibility of cross resistance and cross-hypersensitivity to penicillin drugs, cephalosporins.
As with other drugs penicillin, may develop superinfection.
The emergence of severe diarrhea, characteristic of pseudomembranous colitis, It is an indication for discontinuation of the drug.
Overdose
Symptoms: dysfunction of the gastrointestinal tract – nausea, vomiting, diarrhea; a consequence of vomiting and diarrhea can be a violation of water-electrolyte balance.
Treatment: prescribe gastric lavage, Activated carbon, saline laxatives; apply measures to maintain water and electrolyte balance.
Drug Interactions
Probenecid, phenylbutazone, oksifenʙutazon, less – acetylsalicylic acid and sulfinpyrazone inhibit tubular secretion of penicillin drugs, which leads to an increase in T1/2 and increasing concentrations of amoxicillin in plasma.
Bactericidal antibiotics (incl. aminoglikozidy, cephalosporins, vancomycin, rifampicin) while admission exhibit synergy.
Chance of antagonism when taken with certain medications bacteriostatic (eg, chloramphenicol, sulfonamides).
Simultaneous treatment with amoxicillin estrogensoderjath oral contraceptives can reduce the effectiveness of the latter and increase the risk of bleeding acyclic.
Concomitant use with amoxicillin allopurinol does not increase the incidence of skin reactions in contrast to the combination of allopurinol ampicillin.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 5 years.
