When choosing a treatment for a child, we try to use as little as possible pharmacy medicines... But there are times when the disease requires serious intervention. If the baby has coughing and temperature, and analyzes show the presence bacterial infection, doctors prescribe antibiotics. Flemoklav Solutab is one of them. Our review is dedicated to him.
Flemoklav Solutab - antibiotic wide range actions.
Composition and action
The active ingredients of the drug are amoxicillin and clavulanic acid.
The first is a broad-spectrum antibiotic with bactericidal properties. Thanks to him, the synthesis of a substance responsible for its protection is disrupted in the wall of a harmful cell, as a result, it dies.
Amoxicillin is a so-called beta-lactam antibiotic (the name is associated with its structure). And among the harmful bacteria there are those that are able to withstand the effects of antibiotics of this series. They contain enzymes called beta-lactamases. Amoxicillin will be ineffective against such bacteria.
The manufacturers of Flemoklav foresaw this and included in the composition of the product a second active ingredient - clavulanic acid, which increases the bactericidal capabilities of amoxicillin and contributes to the death of pathogenic microorganisms.
Additional components:
- microcrystalline cellulose;
- povidone;
- vanillin;
- apricot flavor;
- sweetener saccharin;
- filler magnesium stearate.
Manufacturers, prices, release forms
The drug is produced by the Dutch pharmaceutical company Astellas Pharma Europe in tablet form.
Pay attention to the dosage!
Depending on the concentration of active ingredients, there are 4 types of tablets. On the package, 2 numbers are indicated: the first is the concentration of amoxicillin, the second is clavulanic acid.
- 125 mg + 31.25 mg. Oblong tablets, easy dissolving in the mouth, marked 421.
- 250 mg + 62.5 mg. The same pills, but labeled 422.
- 500 mg + 125 mg. Here, every pill is labeled "424".
- 875 mg + 125 mg. Elongated tablets with the label "425".
The manufacturer's logo is embossed on the tablets. All forms of Flemoklav are packed in blisters of 4 pieces. The cardboard box contains 5 blisters. The cost of the drug is from 310 to 500 rubles.
What it treats
Flemoklav Solutab is prescribed for respiratory infections caused by bacteria:
An antibiotic will help with otitis media.
- Chronical bronchitis;
- chronic obstructive pulmonary disease;
- pneumonia.
With the help of Flemoklav, infectious lesions of the skin, soft tissues, kidneys and ureters are also treated.
Dosage and administration
According to the instructions for use (), the dosage of Flemoklav Solutab depends on the weight of the child and the severity of the infection. The treatment tactics should be chosen by the doctor.
You need to take the remedy before meals, to reduce the risk of bowel problems. The tablet can be swallowed whole and washed down with a glass of liquid. To give medicine to a child who cannot swallow tablets, dissolve a single dose in a small amount of water (at least 30 ml).
You can dissolve the tablet in a little water.
Prescribe the drug Flemoklav Solutab for children from 3 months. The table shows approximate scheme reception, where the amount of amoxicillin required for treatment is indicated in milligrams.
Give Flemoklav to a child under 3 months old in smaller doses, and only when there is an urgent need for it. The dosage will be calculated by the attending physician.
The dosage will be prescribed by the doctor!
The course of taking the drug should not last more than two weeks. It usually takes 5-7 days.
After treatment with any antibiotics, the child is required.
Contraindications
Flemoklav Solutab cannot be used with:
- hypersensitivity or intolerance to the components of the medication and to other antibiotics of the penicillin and cephalosporin group;
- infectious mononucleosis;
- lymphocytic leukemia.
The 875 ml / 125 ml form is contraindicated for use by children under 12 years of age and weighing less than 40 kg.
Side effects
Sometimes, on the part of the digestive tract, Flemoklav Solutab has undesirable reactions:
- nausea;
- abdominal pain;
- vomit;
Taking the drug may cause nausea, vomiting, or diarrhea.
- diarrhea;
- colitis;
- intestinal candidiasis.
From the side nervous system: the child may experience dizziness, sleep disturbance, hyperactivity, anxiety, aggressive behavior, headache.
Taking the drug can provoke malfunctions in the hematopoietic system and liver.
It is extremely rare during treatment with Flemoklav that itching and burning sensation is observed in groin area, interstitial nephritis.
The remedy can provoke allergies in the form of a rash, itching, dermatitis, hemolytic anemia, laryngeal edema, Quincke's edema, anaphylactic shock.
Allergy to the skin may appear at the first use of the medication.
When the first symptoms appear side effects stop using Flemoklav Solutab and see a doctor.
Overdose
If the dose of the medicine required for the child is exceeded, undesirable effects may appear in the form of nausea, vomiting and diarrhea, sometimes. Doctors recommend treatment with activated charcoal or other sorbents, as well as osmodiuretics - diuretics that channel fluid from the intercellular space into the blood.
Interaction with other medicinal products
Flemoklav is not combined with some anti-inflammatory drugs (aspirin, drugs that contain phenylbutazone, sulfinpyrazone, indomethacin, probenecid). When taken simultaneously, these drugs can cause an increase in the content of amoxicillin in the blood and bile, as they inhibit its excretion by the kidneys.
The anticancer drug Methotrexate, when taken together, is excreted from the body more slowly, which can cause symptoms of an overdose in a child.
Flemoklav enhances the effect of drugs that reduce blood clotting.
Do not use the drug in conjunction with other antibiotics.
Analogs
Many parents notice a significant outward resemblance of Flemoklav Solutab with. These funds really have a lot in common, including the manufacturer. The only and significant difference is that Flemoxin does not contain clavulanic acid. Although, in fact, it can be considered an analogue of Flemoklav. An antibiotic is also available in tablets. There are 4 types of the drug, and they differ in the concentration of the active substance: 125 mg, 250 mg, 500 mg and 1000 mg. The dosages are the same as those of Flemoklav. The price of Flemoxin ranges from 240 to 500 rubles, depending on the species.
sold in pharmacies in the form of tablets, capsules and granules for diluting the suspension. Dose it depending on the severity of the disease and the age of the patient. Average single dose for a child:
- up to 2 years - 20 mg per 1 kg of body weight;
- 2-5 years - 125 mg;
- 5-10 years - 250 mg;
- over 10 years old - 250 - 500 mg.
The cost of the drug is from 50 to 170 rubles.
- contains another active ingredient - azithromycin. This is a bacteriostatic drug, that is, it slows down the growth and reproduction of pathogenic bacteria, and in high concentration kills them. Designed for the treatment of children from 6 months. The price range is 220-560 rubles.
An analogue of Flemoklav Solutab is Sumamed.
- ... The active ingredient is clarithromycin. Available in the form of tablets, powder and lyophilisate. Children from 6 months of age are treated with it. Price - from 370 rubles.
- Wilprafen is available as tablets containing 500 or 1000 mg of josamycin, a natural bacteriostatic antibiotic. The drug is contraindicated in children weighing less than 10 kg. The dosage instructions are indicated only for adults and children over 14 years of age. You can buy the drug for an average of 540 rubles (500 mg) and 660 rubles (1000 mg). Dispensed by prescription.
- is available in the form of tablets and capsules of 250 and 500 mg of active substance, as well as powder for suspension of 100, 200 and 500 mg. The dosage of the medicine is calculated by the doctor based on the age, weight of the child and the severity of the disease. The average children's daily dose is 5-10 mg of azithromycin per 1 kg of body weight. Among the contraindications, only individual intolerance to the active substance and the like is indicated. The cost of packaging the medicine ranges from 35 to 190 rubles.
Before choosing an analogue, consult your pediatrician.
Registration number: P N016067 / 01-130114
Tradename: Flemoklav Solutab®
Dosage form: dispersible tablets
Composition:
Active ingredient: amoxicillin trihydrate (which corresponds to amoxicillin base) - 145.7 mg (125 mg), 291 mg (250 mg), 528.8 mg (0.5 g); potassium clavulanate (which corresponds to clavulanic acid) 37.2 mg (31.25 mg), 74.5 mg (62.5 mg), 148.9 mg (125 mg).
Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.
Description
Oblong tablets from white to yellow color with brown dotted spots without risks and marked: "421" - at a dosage of 125 mg + 31.25 mg; "422" - 250 mg + 62.5 mg; "424" - 0.5 g + 125 mg and the company logo.
Pharmacotherapeutic group: antibiotic, polysynthetic penicillin + beta-lactamase inhibitor.
ATX code: .
Pharmacological properties
Broad-spectrum antibiotic, combination drug amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Acts bactericidal, inhibits the synthesis of the bacterial wall. It is active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases). Clavulanic acid, which is part of the drug, inhibits types II, III, IV and V types of beta-lactamases, is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases and expands its spectrum of action.
Flemoklav Solutab® is active against:
Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including betalactamase-producing strains), Staphylococcus epidermidis (including beta-lactamase-producing strains), Enterococcus Lactamase.
Clostridium spp., Peptococcus spp., Peptostreptococcus spp.
Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including the strains of the above bacteria that produce lactic acid dermatitis) Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori.
Anaerobic gram-negative bacteria: Bacteroides spp., Including Bacteroides fragilis (including strains producing beta-lactamases).
Amoxicillin:
The absolute bioavailability of amoxicillin reaches 94%. Absorption is independent of food intake. The maximum plasma concentration is observed 1-2 hours after taking amoxicillin. After taking a single dose of 500 / 125mg (amoxicillin / clavulanic acid), the average concentration of amoxicillin (after 8 hours) is 0.3mg / l. Serum protein binding is approximately 17-20%. Amoxicillin crosses the placental barrier and passes into breast milk in small amounts.
Amoxicillin is metabolized in the liver (10% of the administered dose), for the most part excreted through the kidneys (52 ± 15% of the dose unchanged within 7 hours) and a small amount is excreted in the bile. Serum half-life in patients with normal function the kidney is approximately 1 hour (0.9-1.2 h), in patients with creatinine clearance in the range of 10-30 ml / min it is 6 hours, and in the case of anuria it ranges between 10 and 15 hours. The drug is excreted during hemodialysis.
Clavulanic acid:
The absolute bioavailability of clavulanic acid is approximately 60%. Absorption is independent of food intake. The maximum concentration of clavulanic acid in the blood is noted 1-2 hours after ingestion. After taking a single dose of 0.5 g / 125 mg (amoxicillin / clavulanic acid), the average maximum concentration of clavulanic acid reaches 0.08 mg / l after 8 hours. Plasma protein binding is 22%. Clavulanic acid crosses the placental barrier. There are no reliable data on penetration into breast milk.
Clavulanate is metabolized in the liver (50-70%) and about 40% is excreted through the kidneys (18-38% unchanged). The total clearance is approximately 260 ml / min. The half-life in patients with normal renal function is approximately 1 hour, in patients with creatine clearance of 20-70 ml / min - 2.6 hours, and in anuria - within 3-4 hours. The drug is excreted during hemodialysis.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- upper respiratory tract and ENT organs (incl. otitis media, sinusitis, tonsillitis, pharyngitis);
- lower respiratory tract: chronic bronchitis and its exacerbations, community-acquired pneumonia;
- skin and soft tissues;
- kidneys and lower urinary tract.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid or other components. Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins. Jaundice or liver dysfunction with a history of amoxicillin / clavulanate. In patients with infectious mononucleosis or lymphocytic leukemia increases the risk of exanthema, therefore, amoxicillin / clavulanic acid should not be prescribed in the presence of these diseases.
Carefully: heavy liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.
Pregnancy and lactation
There was no harmful effect of amoxicillin / clavulanate on the fetus and newborns when used by pregnant women. Use in the II and III trimesters of pregnancy is considered safe. During the first trimester, the drug should be administered with caution.
Amoxicillin is excreted in breast milk. There are no data on the excretion of clavulanic acid in breast milk. Harmful impact on a child while breastfeeding while taking a combination of amoxicillin and clavulanic acid was not noted.
Method of administration and dosage
To prevent dyspeptic symptoms, Flemoklav Solutab® is prescribed at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (at least 30 ml), stirring thoroughly before use.
The duration of treatment depends on the severity of the infection and should not exceed 14 days without special need.
Adults and children weighing more than 40 kg the drug is prescribed at 0.5 g / 125 mg 3 times / day. For severe, recurrent and chronic infections these doses can be doubled.
For children aged 3 months to 2 years(with a body weight of about 5-12 kg) the daily dose is 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. This is usually a dose of 125 / 31.25 mg 2 times / day.
For children aged 2 to 12(with a body weight of about 13-37 kg) the daily dose is 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. This is usually a dose of 125 / 31.25 mg 3 times / day for children aged 2 to 7 years (body weight about 13-25 kg) and 250 / 62.5 mg 3 times / day for children aged 7-12 years (weight body about 25-37 kg). In severe infections, these doses can be doubled (the maximum daily dose is 60 mg of amoxicillin and 15 mg of clavulanic acid per kg of body weight).
Patients with impaired renal function
In patients with renal insufficiency, excretion of clavulanic acid and amoxicillin through the kidneys is slow. Depending on the severity renal failure the total dose of Flemoklav Solutab® (expressed in the dose of amoxicillin) should not exceed the amounts presented in the table.
Patients with impaired liver function
The combination of amoxicillin / clavulanic acid should be used with caution in patients with liver damage. Liver function must be monitored constantly.
Side effects
Allergic skin reactions: urticaria, erythematous rash, rarely exudative erythema multiforme, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), in some cases the so-called "rash of the fifth day" (measles exanthema) appears. Reactions depend on the dose of the drug and the condition of the patient.
External reactions digestive system:
nausea, vomiting, diarrhea, liver dysfunction, increased activity of "hepatic" transaminases, in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. An increase in the activity of transaminases (AST and ALT), bilirubin and alkaline phosphatase is usually observed in males and in elderly patients, especially over 65 years of age. To prevent undesirable effects, the drug is recommended to be taken at the beginning of a meal. The risk of such changes increases when the drug is taken for more than 14 days. These phenomena are very rarely observed in children. The above changes usually appear during treatment or immediately after. Sometimes it can appear several weeks after the drug is discontinued. Basically, reactions from the digestive system are transient and insignificant, but sometimes they are pronounced.
Others: candidiasis, development of superinfection, reversible increase in prothrombin time.
The list below shows, in descending order, the possible side effects:
Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain
Immune reactions: hives
Leather and soft tissue:
exanthema
Blood and lymphatic system:
changes in blood composition (leukopenia, thrombocytopenia, hemolytic anemia)
Hepatobiliary system: cholestatic jaundice, hepatitis
The immune system: angioedema, vasculitis
Blood coagulation system: prolongation of prothrombin time
Urinary system: interstitial nephritis
Anaphylactic shock, angioedema, pseudomembranous colitis, erythema multiforme, exfoliative dermatitis
Overdose
Overdose can lead to these gastrointestinal symptoms like nausea, vomiting and diarrhea with possible violation water and electrolyte balance.
Treatment
Appoint Activated carbon... It is necessary to maintain water and electrolyte balances... For seizures, diazepam is prescribed. Other symptoms are treated symptomatically. In severe renal failure, hemodialysis should be performed.
Interaction with other medicinal products
Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; vitamin C increases absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.
Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor the indicators of blood clotting.
Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which para-aminobenzoic acid is formed, ethinylestradiol - the risk of bleeding "breakthrough".
Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
Allopurinol increases the risk of skin rashes.
Amoxicillin should not be administered with disulfiram.
The simultaneous use of amoxicillin and digoxin can lead to an increase in the concentration of digoxin in the blood plasma.
special instructions
When treated with penicillins, anaphylactic reactions may occur in patients with hypersensitivity to them. Treatment with Flemoklav Solutabom® in such cases should be stopped immediately and replaced with another suitable therapy. For the treatment of anaphylactic shock, urgent adrenaline, corticosteroids and the elimination of respiratory distress may be required.
Possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins exists. As in the case of the use of other broad-spectrum penicillins, superinfections of fungal or bacterial origin (in particular, candidiasis) may occur, especially in patients with chronic diseases and / or functional impairment immune system... In case of superinfection, the drug should be discontinued and / or appropriate therapy selected.
In patients with impaired renal function, the dose should be selected based on the severity of the condition.
In patients with impaired liver function, the combination of amoxicillin / clavulanic acid should be prescribed with caution and under constant medical supervision. Flemoklav Solutab® should not be used for more than 14 days without liver function assessment.
An increase in prothrombin time is rarely noted. Amoxicillin / clavulanic acid should be used with caution in patients receiving anticoagulation therapy.
Non-enzymatic methods for determining urine sugar, as well as a test for urobilinogen, can give false positive results.
At course treatment it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.
Release form
Dispersible tablets, 125 mg + 31.25 mg, or 250 mg + 62.5 mg, or 500 mg + 125 mg. 4 tablets (one dosage) in a blister made of polyamide and PVC films, which are laminated on both sides aluminum foil and a polyurethane adhesive. 5 blisters, together with instructions for use, are placed in a cardboard box.
Storage conditions
List B. Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life
3 years. Do not use after the expiration date printed on the package.
Conditions of dispensing from pharmacies
by prescription
Registration applicant (owner of RU)
Manufacturer
Astellas Pharma Europe B.V., Hogemaat 2, 7942 JG Meppel, The Netherlands
Pre-packaged and / or packaged
Astellas Pharma Europe B.V., Netherlands
or
CJSC "ORTAT", Russia
Active substance: amoxicillin (as amoxicillin trihydrate) - 125 mg (145.7 mg), 250 mg (291.4 mg), 500 mg (582.8 mg); clavulanic acid (as potassium clavulanate) - 31.25 mg (37.2 mg), 62.5 mg (74.5 mg), 125 mg (148.9 mg).
Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.
Description
Dispersible tablets oblong form from white to yellowish, without risks, labeled "421" for a dosage of 125 mg + 31.25 mg, "422" for a dosage of 250 mg + 62.5 mg or "424" for a dosage of 500 mg + 125 mg and a graphic drawing "".Brown dotted blotches are allowed.
Pharmacological properties
PharmacodynamicsMechanism of action
Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (known as penicillin-binding proteins) in the biosynthesis of bacterial peptidoglycan, which is a unifying structural component the cell wall of bacteria. Inhibition of peptidoglycan synthesis leads to a thinning of the cell wall, which subsequently leads to lysis and cell death. Amoxicillin is destroyed by β-lactamases produced by resistant bacteria, and therefore the spectrum of activity of amoxicillin itself does not include microorganisms that produce these enzymes.
Clavulanic acid is a β-lactamase inhibitor structurally related to penicillins. Clavulanic acid blocks the action of certain β-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid alone does not exhibit a clinically significant antibacterial effect.
Pharmacokinetic / Pharmacodynamic Relationship
The main factor determining the effectiveness of amoxicillin is the time it takes to exceed the minimum inhibitory concentration (T> MIC).
Mechanism of resistance formation
There are two main mechanisms for the formation of amoxicillin / clavulanic acid resistance:
Inactivation by those beta-lactamases that are not inhibited by clavulanic acid, including class B, C, and D beta-lactamases. Changes in penicillin-binding proteins that lead to a decrease in affinity antibacterial agent to a given target of action.
In addition, changes in the permeability of the membrane of the microorganism, as well as the expression of efflux pumps, can induce or contribute to the development of bacterial resistance, especially in gram-negative bacteria.
Bacteriological sensitivity to antibiotics varies by region and over time. It is advisable to take into account local sensitivity data, especially when it comes to the treatment of severe infections. Experts should be consulted if local resistance data calls into question efficacy medicinal product to treat certain types of infections.
Sensitive microorganisms
Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus, methicillin-sensitive *, coagulase-negative staphylococci (methicillin-sensitive), Streptococcus agalactiae, Streptococcus pneumoniae ***, Streptococcus pyogenes, Streptococcus pyogenes and other group of virgin streptococci
Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae ****, Moraxella catarrhalis, Pasteurella multocida
Anaerobic microorganisms:
Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp.
Microorganisms for which acquired resistance is possible
Aerobic gram-positive microorganisms:
Enterococcus faecium **
Aerobic gram-negative microorganisms:
Escherichia coli, Кlebsiella oxytoca, Кlebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris
Naturally resistant microorganisms
Aerobic gram-negative microorganisms
Acinetobacter sp., Citrobacter freundii, Enterobacter sp., Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia
Other microorganisms
Chlamydophilia pneumoniae, Chlamodophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae
* All methicillin-resistant staphylococci are resistant to amoxicillin / clavulanic acid.
** Naturally moderate sensitivity in the absence of an acquired resistance mechanism.
*** Tablets amoxicillin / clavulanic acid are not suitable for the treatment of infections caused by Streptococcus ppeumoniae resistant to penicillin (see sections "Dosage and Administration" and "Precautions").
**** In some countries, susceptible strains have been reported with a frequency of more than 10%.
Pharmacokinetics
Suction
Amoxicillin and clavulanic acid completely dissociate into aqueous solution at physiological values pH. Both active components of the drug, amoxicillin and clavulanic acid, are rapidly and completely absorbed from the gastrointestinal tract after oral administration. The absorption of active substances is optimal when taking the drug at the beginning of a meal. The oral bioavailability of amoxicillin and clavulanic acid averages 70%. The concentration profiles of both components are similar, and the time to reach maximum concentration in plasma (T max) in each case is about one hour.
Listed below are the pharmacokinetic data from a study in which amoxicillin / clavulanic acid (500 mg / 125 mg, tablet three times daily) was administered to a group of healthy volunteers on an empty stomach.
|
Mean (± standard deviation) pharmacokinetic parameters |
|||||
|
Dose |
WITH m Oh |
T max * |
AUC (0 - 24h) |
T ½ |
|
|
(mg) |
(μg / ml) |
00 |
(μg.h / ml) |
(h) |
|
|
Amoxicillin |
|||||
|
AMX / CA 500 mg / 125 mg |
7,19 ± 2.26 |
(1,0-2,5) |
53,5 ± 8.87 |
1,15 ± 0.20 |
|
|
Clavulanic acid |
|||||
|
AMX / CA 500 mg / 125 mg |
2,40 ± 0.83 |
(10-2,0) |
15,72 ± 3.86 |
0,98 ± 0.12 |
|
|
AMX- amoxicillin, CA- clavulanic acid * Median (range) |
|||||
Plasma concentrations of amoxicillin and clavulanic acid achieved with amoxicillin / clavulanate are similar to those with oral administration of equivalent doses of amoxicillin and clavulanic acid alone.
Distribution
About 18% of amoxicillin and 25% of clavulanic acid binds to blood plasma proteins. The apparent volume of distribution is 0.3-0.4 l / kg for amoxicillin and about 0.2 l / kg for clavulanic acid. Amoxicillin is poorly distributed into the cerebrospinal fluid.
In animal studies, no cumulation of the drug's components in tissues was detected.
Like most penicillins, amoxicillin passes into breast milk. Clavulanic acid is also found in human milk in trace concentrations. Amoxicillin and clavulanic acid cross the placental barrier (see sections "Pregnancy and lactation").
Biotransformation
10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid is extensively metabolized and excreted in urine, feces, and exhaled air in the form of carbon dioxide.
Withdrawal
Amoxicillin is eliminated mainly by the kidneys. Clavulanic acid is eliminated primarily through both renal and extrarenal mechanisms.
The half-life of amoxicillin and clavulanic acid in healthy individuals is on average 1 hour, and the total clearance is about 25 l / h.
Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted by the kidneys unchanged within the first 6 hours after taking 1 tablet of the drug 250/125 mg or 500/125 mg. Various studies have shown that up to 50-85% of amoxicillin and up to 27-60% of clavulanic acid are excreted through the kidneys within 24 hours. The largest number clavulanic acid is excreted within the first 2 hours after ingestion. Simultaneous reception probenecid delays the excretion of amoxicillin, but does not affect the renal excretion of clavulanic acid (see section "Interaction with other medicinal products").
Pharmacokinetics in special cases
Age features
The half-life of amoxicillin in children 3 months - 2 years does not differ from that in older children and adults. Children of the first week of life (including premature babies) should not be prescribed the drug more than 2 times a day due to the immaturity of the renal elimination pathway. Due to the possible decrease in renal function, the selection of the dose of the drug for elderly patients should be made with caution. Monitoring of kidney function may be required.
Sexual characteristics
At oral administration amoxicillin / clavulanic acid healthy men and women have not found a significant effect of the patient's gender on pharmacokinetics active ingredients drug.
Impaired renal function
The total clearance of amoxicillin / clavulanic acid decreases in proportion to the decrease renal function... The clearance of amoxicillin is especially noticeably impaired, since most of it is excreted by the kidneys. Thus, in case of impaired renal function, the dose of the drug should be adjusted in order to avoid excessive concentration of amoxicillin and to maintain the required level of clavulanic acid.
Liver dysfunction
In patients with impaired liver function, the drug should be prescribed with caution. It is necessary to regularly monitor liver function.
Indications for use
Flemoklav Solutab® is indicated for the treatment of the following infections in adults and children:Acute bacterial sinusitis (adequately diagnosed);
Acute otitis media;
Exacerbation of chronic bronchitis (adequately diagnosed);
Community-acquired pneumonia;
Cystitis;
Pyelonephritis;
Infections of the skin and soft tissues, in particular, phlegmon, animal bites, severe dental abscess with spreading phlegmon;
Bone and joint infections, in particular osteomyelitis.
Official guidelines for the rational use of antibacterial agents should be taken into account
Contraindications
Hypersensitivity to the active substances of the drug, antibiotics from the penicillin group or auxiliary components that are part of Flemoklav Solutab (see section "Composition").History of severe hypersensitivity reaction immediate type(eg, anaphylaxis) for prior administration of other beta-lactam antibiotics (cephalosporins, carbapenems, or monobactams).
History of jaundice or liver dysfunction with amoxicillin / clavulanic acid
Application during pregnancy and lactation
PregnancyAnimal studies have not revealed direct or indirect negative impact the drug for pregnancy, embryonic / fetal development, childbirth or postpartum development. Limited data on the use of amoxicillin / clavulanic acid in women during pregnancy have not been identified high risk congenital anomalies. In one study in women with premature rupture of the membranes, it was found that preventive therapy the combination of amoxicillin / clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in newborns.
You should avoid taking the drug during pregnancy, unless the doctor considers it necessary.
Lactation
Both active substances the drug penetrates into breast milk (the effect of clavulanavic acid on children fed with breast milk is not known). Because of this, there is a possibility of developing diarrhea or fungal infection of the mucous membranes in breastfed babies, so it may be necessary to stop lactation. The combination of amoxicillin / clavulanic acid can be used during breastfeeding only after a benefit / risk assessment by the attending physician.
Method of administration and dosage
DosageDoses are presented in terms of amoxicillin / clavulanic acid, except when doses are set depending on the content of the individual component.
The dosage regimen is set individually depending on the following factors:
the characteristics of the suspected pathogens, including their likely levels of antibiotic susceptibility (see the Precautions section);
the severity and localization of the infection;
age, body weight of the patient and renal function (see below).
It is necessary to keep in mind the presence of alternative forms of Flemoklav Solutab containing higher doses of amoxicillin and / or other ratios of amoxicillin and clavulanic acid (see section "Precautions" and "Pharmacodynamics").
For adults and children weighing 40 kg or more, the maximum daily dose of Flemoklav Solutab® 500 mg + 125 mg is 1500 mg amoxicillin / 375 mg clavulanic acid when taken in accordance with the recommendations below.
For children weighing less than 40 kg, the maximum daily dose of Flemoklav Solutab® 125 mg + 31.25 mg and 250 mg + 62.5 mg is 2400 mg amoxicillin / 600 mg clavulanic acid when taken in accordance with the recommendations below. If it is necessary to use higher doses of amoxicillin, use a drug with a different ratio of amoxicillin and clavulanic acid in order to avoid taking an excessive dose of clavulanic acid (see section "Precautions" and "Pharmacodynamics").
The duration of treatment depends on the severity of the infection. In some cases (in particular, in the treatment of osteomyelitis), it is required long-term therapy... Without assessing the patient's condition, the total duration of taking the drug should not exceed 14 days (see section "Precautions").
Recommended dose for adults and children weighing 40 kg or more:
One tablet 500 mg / 125 mg 3 times a day.
Recommended dose for children weighing less than 40 kg:
20 mg / 5 mg / kg / day up to 60 mg / 15 mg / kg / day in 3 divided doses;
Children are advised to prescribe the drug in (dispersible) tablets, suspensions or sachets. Lack of experience clinical use drugs with a ratio of amoxicillin and clavulanic acid 4: 1 in daily dose more than 40 mg / 10 mg / kg in children under 2 years of age.
Elderly patients
No dose adjustment required
Patients with impaired renal function
The dose adjustment is based on the maximum recommended dose of amoxicillin.
In patients with creatinine clearance (CC): more than 30 ml / min, dose adjustment is not required.
Adults and children ≥ 40 kg
Children< 40 кг
Patients with impaired liver function
Treatment is carried out with caution; liver function is monitored regularly. (see sections "Contraindications" and "Precautions")
Mode of application
Flemoklav Solutab® is taken orally.
To reduce possible side effects from the gastrointestinal tract and improve absorption, Flemoklav Solutab® is recommended to be taken at the beginning of a meal.
Always take Flemoklav Solutab® exactly as prescribed by your doctor. If you have any questions, please consult your doctor. Immediately before use, the Flemoklav Solutab® tablet should be dissolved in a small amount of water and mixed thoroughly until a uniform suspension is obtained. The resulting suspension must be taken immediately after preparation.
Skipping the next dose should be avoided medicinal product since this can lead to a decrease in therapeutic efficacy. If the next dose is missed, the dose must not be doubled; the drug must be resumed in the same dose and according to the same scheme.
Side effect
The most frequent adverse reactions are diarrhea, nausea and vomiting.Adverse events identified during clinical research and post-marketing surveillance are listed by body system and according to frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10000 и <1/1000), очень редко (<1/10000), частота неизвестна (частота не может быть оценена по имеющимся данным).
Infectious diseases
Often: candidiasis of the skin and mucous membranes;
frequency unknown: overgrowth of insensitive organisms.
From the hematopoietic and lymphatic system
Rarely: reversible leukopenia (including neutropenia), thrombocytopenia;
frequency unknown: reversible agranulocytosis, hemolytic anemia, prolongation of bleeding time and prothrombin time (see section "Precautions").
From the immune system (see sections "Precautions" and "Contraindications to use")
Frequency unknown: angioedema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis, acute coronary syndrome associated with a hypersensitivity reaction (Coonis Syndrome).
From the nervous system
Uncommon: dizziness, headache;
frequency unknown: reversible hyperactivity, seizures (see section "Precautions"), aseptic meningitis.
From the gastrointestinal tract
Very common: diarrhea; often: nausea, vomiting; infrequently: digestive disorders;
frequency unknown: antibiotic-induced colitis (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue.
Nausea is more common with ingestion of high doses. Gastrointestinal reactions may be reduced by taking the drug at the beginning of a meal.
From the liver and biliary tract
Uncommon: increased activity of aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT). A moderate increase in the activity of AST and ALT is observed in patients receiving therapy with beta-lactam antibiotics, but the clinical significance of this phenomenon is not known.
Frequency unknown: hepatitis and cholestatic jaundice. These adverse reactions have been observed during therapy with other penicillins and cephalosporins.
On the part of the skin and subcutaneous fat
Uncommon: rash, itching, urticaria; rarely: erythema multiforme;
Frequency unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (see sections "Contraindications" and "Precautions"), drug reactions with eosinophilia and systemic symptoms (DRESS syndrome: flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results, including elevated white blood cell counts (eosinophilia) and liver enzymes).
In the event of any allergic reactions, treatment with Flemoklav Solutab® must be discontinued.
From the kidneys and urinary tract
Frequency unknown: interstitial nephritis, crystalluria (see section "Overdose").
Overdose
Symptoms and SignsGastrointestinal and water-electrolyte disturbances may occur. Described amoxicillin crystalluria, in some cases leading to the development of renal failure (see section "Precautions").
When taking high doses of the drug or in patients with impaired renal function, convulsions may occur.
There are reports of amoxicillin deposition in urinary catheters, mainly after intravenous administration in large doses, therefore, regular check of the catheter patency should be carried out (see section "Precautions").
Treatment
Symptomatic correction of gastrointestinal disturbances can be carried out, with special attention to the normalization of the water-electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.
Interaction with other medicinal products
Oral anticoagulants: oral anticoagulants and penicillin antibiotics are widely used in clinical practice without reports of their interaction. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous use of prothrombin time or INR should be carefully monitored when prescribing or discontinuing amoxicillin. In addition, dose adjustment of oral anticoagulants may be required.Methotrexate: penicillins can reduce the excretion of methotrexate, leading to a potential increase in toxicity.
Probenecid: it is not recommended to use Flemoklav Solutab ® simultaneously with probenicid. Probenicid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Flemoklav Solutab® and probenicid can lead to a sustained and long-term increase in the blood concentration of amoxicillin, but not clavulanic acid.
Mycophenolate mofetil: in patients receiving mycophenolate mofetil, after the start of oral administration of a combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed for taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect general changes in mycophenolic acid exposure. In this regard, as a rule, no dose adjustment of mycophenolate mofetil is required in the absence of clinical signs of impaired graft function. However, close clinical monitoring should be carried out while taking the combination of drugs, and also shortly after the end of antibiotic treatment.
Precautionary measures
Before starting treatment with amoxicillin / clavulanic acid, it is necessary to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics (see sections "Contraindications to use" and "Side effects").Serious, sometimes fatal, hypersensitivity reactions (including anaphylactoid and severe skin reactions) to penicillins have been reported. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in those with atopy. In the event of an allergic reaction, it is necessary to discontinue treatment with amoxicillin / clavulanic acid and initiate alternative therapy.
If the infection has been confirmed to be caused by amoxicillin-susceptible organisms, consideration should be given to switching from amoxicillin / clavulanic acid therapy to amoxicillin therapy in accordance with official guidelines.
Flemoklav Solutab® tablets 500 mg / 125 mg, 250 mg / 62.5 mg and 125 mg / 31.25 mg are not suitable for use in cases where there is a high risk that the suspected pathogens have reduced sensitivity or resistance to beta-lactams which is not mediated by beta-lactamases inhibited by clavulanic acid. These dosage forms should not be used in the treatment of penicillin-resistant S. pneumoniae infections.
In rare cases, when using amoxicillin, hypersensitivity reactions have been reported (acute coronary syndrome associated with a hypersensitivity reaction, see the "Side Effects" section); in case of occurrence, it is necessary to apply appropriate treatment.
In patients with impaired renal function or when taking high doses of the drug, convulsions may occur (see section "Side effects").
The appointment of amoxicillin / clavulanic acid is not recommended if infectious mononucleosis is suspected, since such patients have a measles-like rash after taking amoxicillin.
The combined use of allopurinol and amoxicillin increases the risk of allergic skin reactions.
Long-term treatment can lead to overgrowth of insensitive microorganisms.
The appearance of pustules on erythematous areas of the skin with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. The occurrence of this adverse reaction requires discontinuation of the drug and is a contraindication to the further use of amoxicillin.
The combination of amoxicillin / clavulanic acid should be used with caution in patients with signs of hepatic insufficiency (see sections "Dosage and Administration", "Contraindications to use", "Precautions").
Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare in children. Signs and symptoms of liver dysfunction usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. They are usually reversible. Adverse events from the liver can be severe, in extremely rare cases, there have been reports of deaths. In almost all cases, these were persons with serious comorbidities or persons simultaneously receiving potentially hepatotoxic drugs.
Antibiotic-associated colitis has been reported with virtually all antibacterial agents. This adverse reaction can vary in severity from mild to life-threatening (see the "Side Effects" section). Therefore, the possibility of this diagnosis should be considered in patients who develop diarrhea during treatment or after administration of any antibiotics. If antibiotic-associated colitis occurs, the drug should be discontinued immediately. The patient should seek the advice of a doctor who will prescribe the appropriate treatment. In such a situation, the use of drugs that inhibit peristalsis is contraindicated.
During long-term therapy with Flemoklav Solutab®, it is recommended to periodically assess the function of the kidneys, liver and hematopoiesis.
In patients who received a combination of amoxicillin and clavulanic acid, in rare cases, an increase in prothrombin time was observed. With a joint appointment
the combination of amoxicillin and clavulanavic acid with anticoagulants should be monitored accordingly. To maintain the desired level of anticoagulation, it may be necessary to adjust the dose of the anticoagulant (see the section "Interaction with other medicinal products" and "Side effects").
In patients with impaired renal function, the dose of Flemoklav Solutab® should be changed according to the degree of impairment (see section "Dosage and Administration").
In patients with reduced diuresis, in very rare cases, the development of crystalluria has been reported, mainly with parenteral administration of the drug. While taking high doses of amoxicillin, it is recommended to take enough fluids and maintain adequate urine output to reduce the likelihood of amoxicillin crystals forming. In patients with urinary catheters, catheter patency should be checked regularly (see Overdose section).
During treatment with amoxicillin, if it is necessary to test for the presence of glucose in the urine, enzymatic methods for determining glucose oxidase should be used due to the possibility of obtaining a false-positive result when using non-enzymatic methods.
The presence of clavulanic acid in the preparation can cause non-specific binding of lgG and albumin to erythrocyte membranes, which can lead to a false-positive Coombs test result.
Patients taking the amoxicillin / clavulanic acid combination may have a false positive test result for Aspergillus infection when using the Platelia Aspergillus EIA tests. There have been reports of cross-reactions between the Platelia Aspergillus EIA test and non-Aspergillus polysaccharides and polyfuranoses. Therefore, positive test results in patients taking amoxicillin / clavulanic acid combination should be interpreted with caution and confirmed by other diagnostic methods.
The development of inflammation caused by infection requires antibiotic therapy. In pediatric practice, Flemoklav Solutab is often prescribed - a medication that shows high efficiency and causes a minimum of side effects. If the dosage and the rules for using the medicine are observed, the child's condition improves already on days 2–3 of treatment.
Forms of release, composition and action Flemoklav Solutab
The antibiotic is available in the form of elongated yellowish tablets with brown dots, which are packed in blisters of 4 or 7 pieces. The preparation contains two active substances:
- Antibiotic amoxicillin. Possesses a wide spectrum of activity. There are pills on sale containing 125, 250, 500 and 875 mg of amoxicillin.
- Clavulanic acid. The substance increases the bactericidal properties of the antibiotic, contributing to the rapid destruction of microorganisms.
The product also contains auxiliary components: dispersed cellulose, saccharin, flavor (lemon, vanilla, tangerine and apricot). They ensure the normal dissolution of the pill in the liquid and the pleasant taste of the medicine.
The drug belongs to the group of penicillins and actively affects the pathogenic flora, destroying the integrity of the walls of bacteria, which leads to their early death. The tool is especially effective against staphylococci and streptococci.
Indications for use
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The antibacterial agent is used to treat infectious and inflammatory diseases that are caused by microorganisms that are sensitive to amoxicillin. It is indicated for use in the following diseases:
- infections of ENT organs - otitis media, sinusitis, bronchitis, tonsillitis, pneumonia, sinusitis, etc.;
- inflammatory processes in the organs of the genitourinary system - cystitis, pyelonephritis, urethritis, bacterial vaginitis, etc.;
- skin infections - dermatosis, erysipelas, abscess, purulent wounds;
- osteomyelitis and other infections of bones and joints;
- dental infections that cause the destruction of bone tissue;
- postoperative sepsis or prevention of bacterial complications after surgery.
In what cases is the drug contraindicated?
Flemoklav Solutab should be used with extreme caution in severe renal or hepatic failure and gastrointestinal diseases. The medication is low-toxic and is not prescribed only for the following diseases and conditions:
- mononucleosis;
- lymphocytic leukemia;
- hypersensitivity to substances of the penicillin series or other components of the medication;
- violations of the liver when using the drug in the past;
- renal failure (with filtration less than 30 ml / min);
- the child has not reached the age of 12 or his body weight is less than 40 kg.
Possible side effects
Children well tolerate taking Flemoklav, but in some cases, adverse reactions may occur. Allergies appear in less than 0.1% of patients in the form of rashes and itching of the skin. Severe manifestations of an allergic reaction in the form of Quincke's edema or anaphylactic shock occur only in 0.001% of people. If side effects occur, you should immediately stop using the medication and contact the pediatrician to change the therapy regimen and replace the drug.
Also, children may experience other undesirable reactions:
A negative response of the body to the use of a medication occurs in children immediately during treatment, but there is a possibility of side effects appearing a few days after the end of therapy. Parents should promptly notify the doctor of the problem.
Dosage and administration of the drug
Pills
The dosage of the drug Flemoklav Solutab is prescribed for children, taking into account their weight and the severity of the disease. The medication is approved for admission from the age of 3 months. The treatment regimen is chosen by the pediatrician. According to the instructions, the standard dosages are as follows:
To reduce the risk of bowel problems, it is advisable to drink the drug before meals. The tablet should be swallowed without chewing or breaking, and washed down with a glass of water.
During treatment, it is important to observe the intervals between the use of the medication - to maintain the concentration of the active substance, it is drunk at regular intervals (every 7–8 or 12 hours). It is forbidden to exceed the dose of 60 mg of amoxicillin per 1 kg of body weight per day. The minimum duration of antibiotic therapy is 5 days. Without revising the clinical situation, treatment cannot last longer than 2 weeks.
Suspension preparation
The term "dispersible tablet" means that it has the property of rapidly dissolving in a small amount of liquid, resulting in a suspension. It is in this form that it is recommended to use the remedy for the treatment of babies who cannot yet swallow a pill. The dosage of the medication depends on the age of the child.
For example, it is recommended to give a tablet of 125 mg to a baby with a body weight of no more than 5 kg. It is dissolved in at least 30 ml of boiled water and the mixture is thoroughly stirred until a homogeneous syrup is obtained. The solution can be stored in the refrigerator for 24 hours.
Kids easily drink liquid with a fruity or vanilla flavor - Flemoklav Solutab, unlike many antibiotics, does not cause disgust in children. The baby should be given the medicine from a bottle with a large-bore nipple.
Overdose
With a significant excess of the dosage or uncontrolled intake of the medication, the side effects increase in patients, as well as nausea, vomiting and diarrhea appear. In rare cases, seizures and kidney failure occur. The child's water-electrolyte balance is disturbed.
There is no specific antidote for antibiotic poisoning. The patient should wash the stomach and try to prevent dehydration.
Treatment for an overdose of amoxicillin is symptomatic:
- reception of sorbents - activated carbon and Polysorb;
- the use of diuretics to direct fluid from the intercellular space into the blood.
Interaction with other drugs
Analogs and prices
The price of Flemoklav depends on the dosage of the active substance and varies depending on the region of the country. On average, the cost varies between 260-650 rubles. The drug has many analogues. One of the drugs that repeat its chemical composition is Amoxiclav. The product contains similar active substances and is produced not only in the form of dissolving pills, but also in the form of conventional tablets and powder for preparing a suspension and an injection solution.
Due to the fact that Amoxiclav has several forms of release, the scope of its application is significantly expanding. In childhood, it is recommended to use a suspension, and an injection solution is used to treat even newborn patients. The price of the Amoxiclav product varies depending on the form of release and the amount of the antibacterial component, ranging from 120 to 850 rubles (we recommend reading:).
There are other analogues of Flemoklav:
Name of the medication Release form Price in rubles Augmentin tablets, powder for preparation of suspension 70–400 Amoxicillin tablets, granules for suspension and capsules 50–170 Sumamed capsules, suspension 220–560 Azithromycin tablets, capsules, powder to create a syrup 40-190 Wilprafen pills from 540 Ecoclave tablets, powder for syrup dilution from 160 Amovikomb suspension and powder for preparation of injection solution
Antibiotics are the drugs that raise the most questions for parents. The only person who can dot the i's is the doctor. Flemoklav Solutab tablets for children, the instructions for the use of which are written in great detail and clearly, are no exception. Only a doctor is able to determine if this medication is right for your child, what dosage to prescribe and how long to treat. It is strictly forbidden to give antibiotics to children without the agreement of a doctor.
Dr. Komarovsky, whose opinion is being listened to by more and more parents, pays close attention to the fact that antibiotics themselves are not so much harmful as their incorrect use. Self-medication, non-observance of terms and dosages, the use of the same medicine in case of a repeated case of the disease - these are the main mistakes of moms and dads, which lead to very serious consequences for the health of the child. The doctor urges you to remember that the instructions for using the drug are just a classic scheme for using the drug, but in each case, the decision is made by the attending physician.
When Flemoklav Solutab is appointed
The drug belongs to broad-spectrum antibiotics. Its principle of action is to prevent the reproduction of pathogenic microbes. A doctor can prescribe Flemoklav Solutab to a child from 3 months of age with the following diseases:
- Bacterial Respiratory Tract Infections
- Bacterial ENT infections
- Skin or soft tissue infections
- Diseases of the urinary system of a bacterial nature
- Infectious damage to joints and bones
Among the diseases for which Flemoklav Solutab can be prescribed for a child are otitis media, tonsillitis, pyelonephritis, community-acquired pneumonia, sinusitis, chronic bronchitis in the acute stage, pharyngitis, cystitis and others.
Release form and storage of the drug
The antibiotic comes in tablets that contain two active ingredients - amoxicillin and clavulanic acid. Depending on their concentration, 4 types of tablets are produced (in the first place is the dosage of amoxicillin, in the second - clavulanic acid):
- 125 mg / 31.25 mg
- 250 mg / 62.5 mg
- 500 mg / 125 mg
- 875 mg / 125 mg
Oblong tablets, packed in blisters, are white or yellowish in color, as well as brown blotches. The first three types contain 4 tablets in a blister and 5 blisters in a pack (the total number of tablets is 20 pieces). At a concentration of active substances of 875/125, the pack contains two blisters of 7 tablets each (14 pieces in total).
Flemoklav Solutab is stored at a temperature not exceeding 25 ° C for 3 years. Children should not have free access to the drug.
Contraindications
For tablets with any concentration of active substances, there are the following contraindications:
- Individual intolerance to active ingredients, as well as antibiotics of the penicillin group
- Liver dysfunction
- Lymphocytic leukemia
- Infectious mononucleosis
Flemoklav Solutab with a concentration of active substances 875/125 is not suitable for a child with renal failure. Children under 12 years old and weighing less than 40 kg also cannot take these tablets.
In diseases of the gastrointestinal tract, the drug is prescribed with caution.
How to take Flemoklav Solutab
First, consider the general rules for taking the drug. The tablets are taken at the beginning of a meal. Children should not chew them. If, due to age, the child cannot swallow a tablet, then it can be dissolved in water - at least 30 ml of water is taken for 1 tablet, it is better to take 100 ml. The drug must be taken after an equal number of hours. For example, if it is prescribed to drink 2 tablets daily, then the interval between taking the medicine is 12 hours.
The table shows the classic regimen for taking the drug, depending on the age and weight of the child, while only the doctor decides how to take Flemoklav Solutab in each case.
| Child's age, years | Child's weight, kg | Dosage (amoxicillin / clavulanic acid), mg | Number of tablets at a time | Number of times a day |
| 3 months - 2 years | 5 - 12 | 125/31,25 | 1 | 2 |
| 2 - 7 | 13 - 25 | 125/31,25 | 1 | 3 |
| 7 - 12 | 25 - 37 | 250/62,5 | 1 | 3 |
| over 12 years old | > 40 kg | 500/125 or 800/125 | 11 | 32 |
In severe infectious processes, the dosage can be doubled by the attending physician.
Typically, antibiotic therapy lasts 14 days. The doctor decides whether it is possible to give Flemoklav Solutab over 2 weeks.
What to do in case of drug overdose
If you suspect an overdose and the appearance of characteristic symptoms - nausea, diarrhea, vomiting, dehydration, abdominal pain - activated carbon is prescribed and the water-electrolyte balance is restored. If convulsions occur, diazepam is taken. With the development of severe renal failure, hemodialysis is performed.
Side effects
Flemoklav Solutab has many side effects, but most of them are rare.
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