Flemoklav soljutab tab dispersing. 125mg + 31.25mg 20 pc

$6.32

Flemoklav soljutab tab dispersing. 125mg + 31.25mg 20 pc

Quantity:

Description

Composition
Active substance:
1 tablet contains: Amoxicillin trihydrate (equivalent to amoxycillin base) – 145.7 mg (125 mg), 291 mg (250 mg), 528.8 mg (0.5 g); Potassium clavulanate (equivalent 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:
Tablets of elongated shape from white to yellow to brown dot blots without risks and having marking “421” – at a dose of 125 mg + 31.25 mg; “422” -250 mg + 62.5 mg; “424” – 0.5 g + 125 mg and company logo.
Product form:
Dispersible Tablets 125 mg + 31.25 mg, or 250 mg + 62.5 mg, or 500 mg + 125 mg. 4 tablets (same dosage) in a blister made of polyvinylchloride and polyamide films which are laminated on both sides of an aluminum foil and a polyurethane adhesive. 5 blisters together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid, or other components. Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins. Jaundice or liver dysfunction while taking amoxicillin / clavulanate history. Patients with infectious mononucleosis or lymphatic leukemia increases the risk of exanthema, therefore, amoxicillin / clavulanic acid should not be administered in the presence of these diseases.
Precautions: severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal insufficiency.
Dosage
125 mg + 31.25 mg
Indications
Infectious and inflammatory diseases caused by microorganisms susceptible to the drug: upper respiratory and ENT (including otitis media, sinusitis, tonsillitis, pharyngitis); lower respiratory tract: chronic bronchitis and acute, community-acquired pneumonia; skin and soft tissues; kidney and the lower urinary tract.
Interaction with other drugs
Antacids, glucosamine, laxatives, drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases the absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonistic.
Enhances effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). At the same time taking anticoagulants need to monitor the performance of blood clotting.
Reduces the effectiveness of oral contraceptives, medicines, which is formed during the metabolism of para-aminobenzoic acid, ethinyl estradiol – the risk of bleeding “breakthrough.”
Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory agents and other drugs that block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived largely by glomerular filtration).
Allopurinol increases the risk of skin rash.
Amoxicillin should not be administered with disulfiram.
The simultaneous use of amoxycillin and digoxin may increase the digoxin concentration in the blood plasma.
Overdose
Overdosing can lead to gastrointestinal symptoms such as nausea, vomiting and diarrhea with the possible violation of the water and electrolyte balance.
Treatment
Activated charcoal. It is necessary to maintain fluid and electrolyte balance. In convulsions diazepam prescribed. Other symptoms are treated symptomatically. In the case of severe renal insufficiency should be conducted hemodialysis.
pharmachologic effect
Pharmacological group:
An antibiotic, a semisynthetic penicillin + beta-lactamase inhibitor.
Pharmacodynamics:
pharmacodynamics
Broad-spectrum antibiotic, combined formulation of amoxycillin and clavulanic acid, – beta-lactamase inhibitor. Bactericidal effect, inhibits bacterial cell wall synthesis. Active against gram-positive and gram-negative microorganisms (including strains that produce beta-lactamase). Part of the preparation Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is inactive against beta-lactamase I type produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has high affinity for penicillinases, thereby forming a stable complex with the enzyme, thus preventing the enzymatic degradation of amoxicillin influenced by the beta-lactamase and extends the range of action.
Flemoklav Solyutab® is active against:
Grampolozhitelnyh Aerobic bacteria: Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including strains that produce beta-lactamase), Staphylococcus epidermidis (including strains that produce beta-lactamase) Enterococcus faecalis, Corynebacterium spp, Bacillus anthracis, Listeria monocytogenes.
Grampolozhitelnyh anaerobic bacteria: Clostridium spp, Peptococcus spp, Peptostreptococcus spp…
Aerobic gramotritsatelnyh bacteria: Escherichia coli, Klebsiella spp, Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp, Shigella spp, Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including strains of the above bacteria producing beta-lactamase), Neisseria meningitides… , Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori
Gramotritsatelnyh anaerobic bacteria:. Bacteroides spp, including Bacteroides fragilis (including strains that produce beta-lactamase).
Pharmacokinetics:
amoxicillin:
The absolute bioavailability is 94% of amoxicillin. The absorption is independent of food intake. The maximum plasma concentration observed 1-2 hours after administration of amoxicillin. After receiving a single dose of 500/125 mg (amoxicillin / clavulanic acid), the average concentration of amoxicillin (after 8 hours) is O. ZMG / l. Binding of serum proteins is approximately 17-20%. Amoxicillin crosses the placental barrier and penetrate in small quantities in breast milk.
Amoxicillin is metabolized in the liver (10% of the administered dose), for the most part eliminated via the kidneys (52 ± 15% of the dose in unchanged form within 7 hours) and a small amount excreted in bile. The half-life of blood serum in patients with normal renal function was approximately 1 hr (0.9-1.2 hours) in patients with a creatinine clearance in the range of 10-30 ml / min is 6 hours, while in the case of anuria ranges between 10 and 15 hours. The drug appears in hemodialysis.
Clavulanic acid:
The absolute bioavailability of clavulanic acid is about 60%. The absorption is independent of food intake. Maximum blood concentration of the clavulanic acid observed within 1-2 hours after ingestion. After a single dose of 0.5 g / 125 mg (amoxicillin / clavulanic acid) the mean maximum concentration of clavulanic acid up to 0.08 mg / l after 8 hours. Binding to plasma proteins is 22%. Clavulanic acid penetrates the placental barrier. There are no reliable data on the penetration of not breastfeeding.
Clavulanate is metabolized in the liver (50-70%) and about 40% is excreted via the kidney (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 20 – 70 ml / min – 2.6 hours, and at anuria – within 3 to 4 hours. The drug appears in hemodialysis.
Pregnancy and breast-feeding
There were no harmful effects of amoxicillin / clavulanic acid on the fetus and the newborn when used by pregnant women. Application in II and III trimester of pregnancy is considered safe. During the I trimester of the drug should be administered with caution.
Amoxicillin is excreted in breast milk. clavulanic acid data on the allocation of breast milk does not. Harmful effects on the baby during breastfeeding in patients receiving the combination of amoxicillin and clavulanic acid was observed.
Conditions of supply of pharmacies
By prescription.
side effects
Allergic skin reactions: urticaria, erythematous rash, erythema -multiformnaya rarely, very rarely – exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), in some cases, there is the so-called “fifth day rash” (korevidnaya rash). Reactions depend on the dose and the patient’s condition.
The reactions of the digestive system: nausea, vomiting, diarrhea, abnormal liver function, increased activity of “liver” transaminases, in rare cases – cholestatic jaundice, hepatitis, pseudomembranous colitis. Increase in transaminases (ACT and ALT), bilirubin and alkaline phosphatase is usually seen in males, and in elderly patients, especially those older than 65 years. To prevent unwanted phenomena are advised to take the drug at the beginning of the meal. The risk of such changes is increased while taking the drug for more than 14 days. These phenomena are rarely observed in children. The above changes usually appear during or immediately after treatment. Sometimes it may appear several weeks after discontinuation of the drug. In general, the reaction of the digestive system are transitory and minor character, but sometimes severe.
Other: candidiasis, superinfection development, reversible increase of prothrombin time.
The following list shows, in descending order of possible side effects:
Often
Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain
Immune reactions: urticaria
Skin and soft tissue: rash
Seldom
Blood and lymphatic system: changes in the blood (leucopenia, thrombocytopenia, hemolytic anemia)
Hepato-biliary system: cholestatic jaundice, hepatitis
Immune System: angioedema, vasculitis
blood coagulation system: prolonged prothrombin time
Mochevydelitelnaya system: interstitial nephritis
isolated cases
Anaphylaxis, angioedema, pseudomembranous colitis, erythema multiforme, exfoliative dermatitis.
special instructions
In the treatment of penicillin in patients with hypersensitivity to it may experience an anaphylactic reaction. Treatment Flemoklav Solyutabom® in such cases should be immediately discontinued and replaced with other suitable therapy. For the treatment of anaphylactic shock may require an emergency epinephrine, corticosteroids, and elimination of respiratory failure.
There is a possibility of cross-resistance and hypersensitivity to other penicillins and cephalosporins. As in the case of using other broad-spectrum penicillins may occur superinfection fungal or bacterial origin (in particular – candidiasis), especially in patients with chronic diseases and / or disorders of immune system function. In case of superinfection taking the drug supersede and / or selected an appropriate therapy.
Patients with impaired renal function the dose should be selected, based on the severity of the condition.
Patients with impaired liver function the combination of amoxicillin / clavulanic acid should be administered with caution and under constant medical supervision. Flemoklav Solyutab® should not be applied more than 14 days without assessing liver function.
Occasionally there is an increase in prothrombin time. Amoxicillin / clavulanic acid should be used with caution in patients receiving anticoagulant therapy.
Non-enzymatic methods for determining urinary sugar, as well as the test results can give a false positive on urobilinogen.
Storage conditions
Store at a temperature not higher than 25 C, the reach of children.
Dosing and Administration
To prevent diarrheal symptoms Flemoklav Soljutab appointed at the beginning of the meal. A tablet is swallowed whole, a glass of water, or it is dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use.
The duration of treatment depends on the severity of the infection and should not unnecessarily exceed 14 days.
Adults and children weighing more than 40 kg drug prescribed to 0.5 g / 125 mg 3 times / day. In severe, recurrent and chronic infections, these doses can be double.
For children aged between 3 months to 2 years old (weighing about 5-12 kg) daily dose is 20-30 mg 5-7.5 mg of amoxicillin and clavulanic acid per kg body weight. Usually this dose of 125 / 31.25 mg of 2 times / day.
Children aged 2 to 12 years (body weight about 13-37 kg) daily dose is 20-30 mg 5-7.5 mg of amoxicillin and clavulanic acid per kg body weight. Usually this dose of 125 / 31.25 mg 3 times / day for children ages 2 to 7 years (body weight around 13-25 kg) and 250 / 62.5 mg 3 times / day for children aged 7-12 years (mass body about 25-37 kg). In severe infections, these doses can be double (maximum daily dose of 60 mg of amoxicillin and 15 mg of clavulanic acid per kg body weight).
In patients with renal insufficiency the excretion of clavulanic acid and amoxicillin via the kidneys slowly. Depending on the severity of renal insufficiency Flemoklav Solyutab® total dosage (expressed in dose of amoxicillin) should not exceed the number shown in the table:
Glomerular filtration rate Adults Children 10-30 ml / min with 0.5 g of 2 times / day to 15 mg / kg 2x / day
Hemodialysis 0.5 g per day, and 0.5 g of a 15 mg / kg per day and 15 mg / kg during or during and after dialysis after dialysis
Patients with impaired liver function
The combination of amoxicillin / clavulanic acid should be used with caution in patients with liver disease. Liver function should be under constant supervision.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Astellas

There are no reviews yet.

Add your review