Instruction for Flemoclav Solutab
You can buy Flemoclav Solutab here
The principle of the drug is based on the introduction of the active substance into the microbial cell, followed by blocking the synthesis of a particular compound (peptidoglycan), which is responsible for the construction of cell membranes. As a result of the deficiency of this compound, the growth and development of the microbial cell stops, and it dies.
Bactericidal action Flemoclav Solutab applies to most strains of pathogenic microflora, including gram-positive and gram-negative anaerobic and aerobic microorganisms.
Composition and release form
The dosage form of Flemoclav Solutab is dispersible tablets: oblong, from yellow to white with brown inclusions, labeled “421”, “422”, “424” or “425” and the company logo, without dividing risks (labeled “421” , "422", "424": 4 pieces in a blister, in a cardboard bundle 5 blisters; "425": 7 pieces in a blister, in a cardboard bundle 2 blisters).
Flemoclav Solutab tablets can be produced in four different dosages:
clavulanic acid (potassium clavulanate) - 31.25 mg, amoxicillin (amoxicillin trihydrate) - 125 mg;
clavulanic acid (potassium clavulanate) - 62.5 mg, amoxicillin (amoxicillin trihydrate) - 250 mg;
clavulanic acid (potassium clavulanate) - 125 mg, amoxicillin (amoxicillin trihydrate) - 500 mg;
clavulanic acid (potassium clavulanate) - 125 mg, amoxicillin (amoxicillin trihydrate) - 875 mg.
Auxiliary substances are: dispersed cellulose, MCC, vanillin, crospovidone, tangerine flavor, lemon flavor, saccharin, magnesium stearate.
Pharmacological effect
Flemoclav Solutab - a combination drug of amoxicillin and clavulanic acid. Bactericidal effect, inhibits the synthesis of the bacterial wall.
Active against aerobic gram-positive bacteria: Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp .; as well as aerobic Gram-negative bacteria (including beta-lactamase producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., ours, ours, ours, our companies, our companies, ours, ours, ours, ours, ours formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis.
Clavulanic acid inhibits type II, III, IV, and V beta-lactamase, not active against type I beta-lactamase, produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. It has a high tropic to penicillinases, forms a stable complex with the enzyme, prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamase.
Indications for use
What helps? Flemoclav Solutab is used in the treatment of infectious and inflammatory diseases that are caused by microorganisms that are susceptible to the action of the drug:
gonorrhea, which is caused by Neisseria gonorrhoeae;
infectious diseases of soft tissues and skin;
odontogenic infections (maxillary sinusitis, severe dental abscesses with spreading cellulitis, periodontitis);
infections of upper respiratory tract and upper respiratory tract (sinusitis, otitis media, recurrent tonsillitis);
infectious diseases of the lower respiratory tract (bronchopneumonia, lobar pneumonia, chronic bronchitis in the acute stage);
urinary tract infections (urethritis, pyelonephritis, cystitis, infectious diseases of the female genital organs);
infections of the joints and bones that are caused by Staphylococcus aureus and require long-term therapy (only for tablets at a dose of 875/125 mg);
step therapy for other mixed infections (postpartum and intra-abdominal sepsis, septic abortion) (only for tablets at a dose of 875/125 mg).
Contraindications for Flemoclav Solutab
Severe liver damage after taking the drug in the past.
Lymphocytic leukemia.
Infectious mononucleosis.
Renal failure (filtration below 30 ml per minute) - for tablets 875/125 mg.
Age less than 12 years and weight up to 40 kg - for tablets 875/125 mg.
Hypersensitivity to the components of the drug and any beta-lactam antibiotics (cephalosporins and penicillins).
To use Flemoclav Solutab with caution in severe forms of hepatic and renal failure, diseases of the digestive system.
Appointment during pregnancy and lactation
In the first trimester of pregnancy, taking the drug Flemoclav Solutab is contraindicated, since at this stage all organs and systems of the fetus are formed and laid, and the influence of drugs on the maternal organism can lead to failures of this fine process, respectively, the formation of anomalies and congenital malformations.
Use of Flemoclav Solutab in the second and third trimesters of pregnancy is possible according to indications. Before prescribing pills to the future mother, the doctor carefully assesses the balance of risks and benefits. The treatment is carried out in the minimum effective dosage under the supervision of a physician.
Use of the drug Flemoclav Solutab during breastfeeding is possible. Despite the fact that the active active components are excreted in milk, in the course of the studies, no negative or toxic effect of the drug on the child's body was detected.
Use in childhood
In chronic renal insufficiency, dose adjustment and frequency of administration are carried out depending on QC: if QC is more than 30 ml / min, dose adjustment is not required; at CC 10-30 ml / min: orally - 250-500 mg / day every 12 hours; in / in - 1 g, then 500 mg /; when QA is less than 10 ml / min - 1 g, then 500 mg / day i.v. or 250-500 mg / day by mouth in one step. For children, doses should be reduced in the same way. When QA is less than 30 ml / min, the use of tablets 875 mg / 125 mg is contraindicated.
Patients on hemodialysis - 250 mg or 500 mg orally in a single dose or 500 mg IV, an additional 1 dose during dialysis and another 1 dose at the end of the dialysis session.
Dosage and method of use
As indicated in the instructions for use, tablets are taken orally before meals, swallowing whole and squeezed 200 ml of water or dissolved in 100 ml of water and thoroughly stirred before administration.
The recommended dosing for adults and children weighing more than 40 kg:
Flemoclav Solutab 875 mg + 125 mg: one tablet 2 times a day (every 12 hours);
Flemoclav Solutab 500 mg + 125 mg: one tablet 3 times a day (every 8 hours). For the treatment of chronic, recurrent, severe infections, you can double this dose.
The daily dose for children under 12 years old with a body weight of up to 40 kg is usually prescribed at the rate of 20–30 mg of amoxicillin and 5–7.5 mg of clavulanic acid per 1 kg of child weight.
Recommended dosage for children:
7–12 years old (25–37 kg): Flemoclav Solutab 250 mg + 62.5 mg - one tablet 3 times a day;
2–7 years (13–25 kg): drug 125 mg + 31.25 mg - one tablet 3 times a day;
3 months - 2 years (5–12 kg): 125 mg tablets + 31.25 mg - in one piece. 2 times a day.
For severe clinical indications, the indicated doses for children can be doubled, provided that the daily dose does not exceed 60 mg of amoxicillin and 15 mg of clavulanic acid per 1 kg of body weight.
The duration of treatment is not more than 14 days. If you need a longer use of Flemoclav Solutab should consult a doctor.
Amoxicillin dosing regimen for patients with renal insufficiency is adjusted for GFR:
10–30 ml / min: adults — 500 mg 2 times a day, children — 15 mg per 1 kg 2 times a day;
less than 10 ml / min: adults - 500 mg per day, children - at a dose of 15 mg per 1 kg per day.
Patients on hemodialysis are advised to take Flemoclav Solutab in a dose: adults - 500 mg per day and 500 mg during and after dialysis, children - 15 mg per 1 kg of body weight per day and 15 mg per 1 kg of weight during and after dialysis.
Adverse reactions
While taking the tablets Flemoclav Solutab in patients with hypersensitivity to the drug may develop side effects:
skin and subcutaneous tissue: infrequently - itching, urticaria, rash; rarely, erythema multiforme; very rarely - the development of acute generalized exantmatous pustus, toxic epidermal necrolysis, Stevens-Johnson syndrome, bullous exfoliative dermatitis;
circulatory and lymphatic systems: rarely - reversible leukopenia (including neutropenia), reversible thrombocytopenia; very rarely - eosinophilia, prolongation of prothrombin time, anemia (including reversible hemolytic), reversible agranulocytosis, prolongation of bleeding time, thrombocytosis;
nervous system: infrequently - headache, dizziness; very rarely - insomnia, reversible hyperactivity, behavior change, agitation, anxiety, convulsions (in case of impaired renal function and intake of high doses);
immune system: very rarely - allergic vasculitis, anaphylactic reactions, angioedema, the development of a syndrome similar to serum sickness;
kidneys and urinary tract: very rarely - crystalluria, hematuria, interstitial nephritis;
parasitic and infectious diseases: often - the development of candidiasis of the mucous membranes and skin;
liver and biliary tract: infrequently - a moderate increase in the activity of ALT and / or ACT (in patients taking beta-lactam antibiotics); very rarely, cholestatic jaundice and hepatitis (in patients receiving penicillin-type antibiotics and cephalosporins in patients), an increase in the concentration of alkaline phosphatase (alkaline phosphatase) and bilirubin. Side effects from the liver are mainly observed in men and elderly patients and may be associated with long-term treatment. Such reactions in children are very rare. The above symptoms are reversible and often develop during or immediately after the completion of treatment, but in some cases they may appear within a few weeks after the end of therapy. The side effects of the liver can be quite severe, up to and including fatal outcomes in extremely rare cases (mainly those with serious comorbidities or patients taking potentially hepatotoxic drugs at the same time).
Also, when taking the drug Flemoclav Solutab, the following undesirable reactions of the digestive system are observed:
children: often - nausea, diarrhea, vomiting;
adults: very often diarrhea; often - vomiting, nausea;
common for both categories: often - the appearance of nausea and other reactions from the gastrointestinal tract when taking large doses of Flemoclav Solutab (these effects usually disappear when using tablets at the beginning of a meal); infrequently - digestive disorders; very rarely - antibiotic-induced colitis (including hemorrhagic and pseudomembranous), gastritis, stomatitis, black "hairy" tongue.
Overdose
With a significant excess of the recommended dose or prolonged uncontrolled intake of the drug, the patient develops signs of overdose, which are clinically manifested by increased side effects described above, impaired water and electrolyte balance, indomitable vomiting and diarrhea.
Treatment of overdose consists in washing the stomach, administering activated carbon and performing symptomatic treatment. With the development of renal failure, the patient is hemodialysis.
special instructions
Before you start using Flemoclav Solutab, read the specific instructions:
After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.
In the course of treatment it is necessary to monitor the state of the function of the blood-forming organs, liver and kidneys.
In order to reduce the risk of side effects from the gastrointestinal tract should take the drug during meals.
Superinfection may develop due to the growth of microflora insensitive to it, which requires a corresponding change in antibacterial therapy.
May give false positive results in the determination of glucose in the urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine.
In patients with hypersensitivity to penicillins, allergic cross-reactions with cephalosporin antibiotics are possible.
Cases of necrotizing enterocolitis have been identified in newborns and pregnant women with premature rupture of the membranes.
Since tablets contain the same amount of clavulanic acid (125 mg), it should be borne in mind that 2 tablets of 250 mg each (for amoxicillin) are not equivalent to 1 tablet for each 500 mg (for amoxicillin).
Compatibility with other drugs
When using Flemoclav Solutab, you must consider the interaction with other drugs:
Allopurinol increases the risk of skin rash.
Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is derived mainly by glomerular filtration).
Bacteriostatic drugs (macrolides, chloramphenicol, linkosamides, tetracyclines, sulfonamides) have an antagonistic effect.
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). At the same time taking anticoagulants, it is necessary to monitor blood clotting indicators.
Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces PABK, ethinyl estradiol - the risk of bleeding "breakthrough".
Reviews
We offer you to read the reviews of people who used Flemoclav Solutab:
Alina
The child was 4 years old, the doctor prescribed Flemoclav, with a dosage of 500. A very strong drug, after two days of taking, improvements were noticeable, on the 5th day of taking the symptoms of the disease was no longer. Cured quickly. Conveniently, the tablet can be dissolved in water and drunk; it is convenient for children, since the tablet itself is rather big in size, and it is difficult for children to swallow it.
Dina
I underwent a Flemoclav treatment several times, as I have had chronic bronchitis for more than five years. Of course, now I try not to run to the deep stage, when only antibiotics already help, but sometimes it happens. It fights bronchitis perfectly. For a week, you can almost recover. But there are some "but." This is really a very strong antibiotic, so it gives side effects to other organs. After taking this drug, I had frustration, pain in the intestines and kidneys. Then we had to take Essentiale and Linex for recovery. Recently, I have been taking this drug only as a last resort, when lighter drugs no longer help.
Terms of sell
You don't need a prescription to buy Flemoclav Solutab.