Klamosar
Klamosar: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Klamosar
ATX code: J01CR02
Active ingredient: amoxicillin (Amoxicillin), clavulanic acid (Clavulanic acid)
Manufacturer: JSC "Biochemist" (Russia)
Description and photo update: 2019-08-07
Klamosar is a combined antibacterial drug containing semi-synthetic penicillin and a beta-lactamase inhibitor.
Release form and composition
The drug is available in the form of a powder for the preparation of a solution for intravenous (i / v) administration: a crystalline mass of white or white with a yellow tint, hygroscopic (in 10 ml vials, in a cardboard box of 1, 5 or 10 vials and instructions for using Klamosar; for hospitals - 50 vials in a cardboard box).
In one bottle, the content of active ingredients is:
- amoxicillin sodium: 500 or 1000 mg (in terms of amoxicillin);
- potassium clavulanate: 100 or 200 mg (in terms of clavulanic acid).
Pharmacological properties
Pharmacodynamics
Klamosar is a combined antibacterial drug with a broad spectrum of bactericidal action. Its active ingredients are amoxicillin - a bactericidal penicillin antibiotic and clavulanic acid - an irreversible inhibitor of beta-lactamases. Due to the high tropism of clavulanic acid to penicillinases, a stable complex with an enzyme is formed that prevents the enzymatic decomposition of amoxicillin under the influence of beta-lactamases of types II, III, IV and V. Type I beta-lactamases produced by Serratia speciales (spp.), Pseudomonas aeruginosa and Acinetobacter spp. Are not sensitive to clavulanic acid.
The clinical efficacy of Klamosar has been established for the treatment of diseases caused by the following aerobic bacteria: gram-positive (including strains producing beta-lactamase) - Staphylococcus aureus, gram-negative - Enterobacter spp., Klebsiella spp., Escherichia coli, Moraxella catarrhalis, Haemophilus influenza.
The following pathogens exhibit sensitivity to the drug only in vitro:
- aerobic gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus anthracis, Streptococcus viridans, Staphylococcus epidermidis, Enterococcus faecalis, Listeria monocytogenes, Corynebacterium spp.;
- anaerobic gram-positive bacteria: Peptococcus spp., Clostridium spp., Peptostreptococcus spp.;
- aerobic gram-negative bacteria (including beta-lactamase-producing strains): Salmonella spp., Proteus vulgaris, Proteus mirabilis, Shigella spp., Yersinia enterocolitica, Yersinia metocida (formerly Pasteurella), Bordetella pertussae, Gardnerella gillinia vaginalis, Neybioser., Haemophilus ducreyi;
- anaerobic gram-negative bacteria (including beta-lactamase-producing strains): Bacteroides spp. (including Bacteroides fragilis).
Pharmacokinetics
After intravenous administration of Klamosar at a dose of 500 mg + 100 mg, the maximum concentration (C max) of amoxicillin in blood plasma is 0.032 2 mg / ml, and of clavulanic acid - 0.010 5 mg / ml. After the introduction of the solution at a dose of 1000 mg + 200 mg, the value of C max of active components is 0.105 4 and 0.028 5 mg / ml, respectively.
The level of the maximum inhibitory concentration of 0.001 mg / ml for amoxicillin in adults and children is unchanged when using the drug 2 or 3 times a day.
The binding of amoxicillin to plasma proteins is 17–20%, clavulanic acid - 22–30%.
The metabolism of active substances occurs in the liver, 10% of amoxicillin, 50% of clavulanic acid undergoes from the administered dose of biotransformation.
The drug is excreted mainly through the kidneys: amoxicillin - by tubular secretion, clavulanic acid - by glomerular filtration.
Indications for use
The use of Klamosar is indicated for the treatment of the following diseases of bacterial etiology caused by sensitive pathogens:
- ENT infections: otitis media, sinusitis, tonsillitis;
- lower respiratory tract infections: bronchitis, pneumonia, pleural empyema, lung abscess;
- infections of the pelvic organs and genitourinary system: prostatitis, salpingitis, salpingo-oophoritis, cervicitis, endometritis, tubo-ovarian abscess, bacterial vaginitis, postpartum sepsis, septic abortion, pelvioperitonitis, pyelitis, cystitis, pyelonephritis, urethritis, chancre, goncreas
- infections of the skin and soft tissues: wound infection, abscess, impetigo, secondarily infected dermatoses, phlegmon, erysipelas;
- bone infections: osteomyelitis.
In addition, Klamosar is prescribed for the prevention and treatment of postoperative infections.
Contraindications
Absolute:
- infectious mononucleosis (including when a measles rash appears);
- dysfunction of the liver or episodes of jaundice against the background of the use of amoxicillin and clavulanic acid in history;
- period of pregnancy;
- breast-feeding;
- established individual intolerance to cephalosporins and other beta-lactam antibiotics;
- hypersensitivity to the components of Klamosar.
Precautions should be taken to prescribe the antibiotic Klamosar for chronic renal failure, severe liver failure, diseases of the gastrointestinal tract (including cases of a history of colitis due to the use of penicillins).
Klamosar, instructions for use: method and dosage
The finished Klamosar solution is administered intravenously by bolus (slowly over 3-4 minutes) or by drip.
When preparing a solution for bolus IV administration, to dissolve the powder, water for injection is used in a volume of 10 ml for vials at a dose of 500 mg + 100 mg, 20 ml - for vials at a dose of 1000 mg + 200 mg.
It is recommended to use a 20 ml syringe to dilute the 1000 mg + 200 mg dose. After taking 20 ml of water for injection from the syringe, 10 ml of the solvent is injected into the powder vial and its contents are dissolved without removing the needle. When diluted, the solution may temporarily acquire a pink color. Then the solution is taken into a syringe and shaken for 5-10 seconds to obtain a uniform concentration of the solution.
The ready-made solution for IV bolus administration is light yellow in color and must be used within 20 minutes after preparation.
The duration of the intravenous infusion should be 30-40 minutes. After dissolving the powder, the resulting solution must be immediately added to the infusion liquid.
A dose of 500 mg + 100 mg is dissolved in 50 ml, a dose of 1000 mg + 200 mg is dissolved in 100 ml of an infusion solution.
To maintain a sufficient concentration of antibiotics in the recommended volumes of infusion solutions at a temperature of 25 ° C, the standard period of stability of standard solutions for intravenous infusion should be observed.
At a temperature of 25 ° C, Clamosar's solution is stable in water for injection or 0.9% sodium chloride solution for 4 hours, in 1.85% sodium lactate solution for intravenous infusion, Ringer's solution, Hartman's solution (Ringer's lactate), 0, 3% potassium chloride solution and 0.9% sodium chloride solution for intravenous infusion - within 3 hours. Therefore, the infusion must be completed before the expiration of the indicated time frame.
The unused remainder of the antibiotic solution should be discarded.
The doctor sets the dose and dosage regimen individually, taking into account the severity of the disease, the localization of the infection and the sensitivity of the pathogen.
The dose is calculated using amoxicillin.
The recommended dosage has age restrictions:
- adults and adolescents over the age of 12 years (weighing more than 40 kg): 1000 mg 3-4 times a day, depending on the severity of the infection. The maximum daily dose is 6000 mg;
- children aged 3 months to 12 years: at the rate of 25 mg per 1 kg of the child's weight 3-4 times a day;
- infants under the age of 3 months (only as an intravenous infusion): 25 mg per 1 kg of body weight. The interval between procedures for children with a body weight of less than 4 kg is 12 hours, for children with a body weight of more than 4 kg - 8 hours.
The duration of the course of treatment is up to 14 days, with acute otitis media - up to 10 days. After the disappearance of clinical signs of the disease, treatment should be continued for another 2-3 days.
The dose for the prevention of postoperative infections depends on the duration of the operation. If the operation lasts less than one hour, then Klamosar is administered intravenously during induction of anesthesia at a dose of 1000 mg. With longer surgical interventions, the administration of the drug is indicated every 6 hours, 1000 mg. If the risk of infection is very high, then the antibiotic is continued for several days.
The dose adjustment for hemodialysis patients is based on the maximum recommended dose of amoxicillin.
Recommended dosage for patients on hemodialysis:
- adults: the initial dose is 1000 mg, then 500 mg every 24 hours and 500 mg at the end of the hemodialysis session in order to compensate for the decrease in the plasma concentration of amoxicillin;
- children: the initial dose is 25 mg per 1 kg of the child's weight with an interval of 24 hours and additionally at the end of the hemodialysis session - 12.5 mg per 1 kg of body weight. Further, 25 mg per 1 kg with an interval of 24 hours.
The dose and frequency of intravenous administration of Klamosar for chronic renal failure is prescribed taking into account creatinine clearance (CC):
- CC more than 30 ml / min: dose adjustment is not required;
- CC 10-30 ml / min: adults - an initial dose of 1000 mg, then 500 mg 2 times a day; children - 25 mg per 1 kg of the child's weight 2 times a day;
- CC less than 10 ml / min: adults - an initial dose of 1000 mg, then 500 mg once a day; children - 25 mg per 1 kg once a day.
In case of impaired liver function, no changes are made to the dosage regimen of Klamosar, treatment is carried out with regular monitoring of liver function.
Side effects
- on the part of the hematopoietic organs: a reversible increase in bleeding time and prothrombin time, eosinophilia, leukopenia, thrombocytopenia, thrombocytosis, hemolytic anemia, hyperbilirubinemia, agranulocytosis;
- from the digestive system: stomatitis, darkening of tooth enamel, nausea, vomiting, black "hairy" tongue, gastritis, diarrhea, glossitis, cholestatic jaundice, increased activity of hepatic transaminases, hepatitis, increased activity of alkaline phosphatase, enterocolitis, pseudomembranous and hemorrhagic colitis (in including after the end of therapy); in men, elderly patients or with long-term therapy - liver failure;
- from the nervous system: agitation, insomnia, headache, dizziness, anxiety, behavior change, hyperactivity, seizures;
- allergic reactions: pruritus, urticaria, angioedema, erythematous rashes, bullous exfoliative dermatitis, Stevens-Johnson syndrome (malignant exudative erythema), exudative erythema multiforme, toxic epidermal necrolysis, allergic vasculitis generalization, osteoarthritis generalization exanthema with serum sickness;
- local reactions: at the injection site - phlebitis;
- others: the development of superinfection, candidiasis, interstitial nephritis, hematuria, crystalluria.
Overdose
Symptoms: functional disorders of the gastrointestinal tract, changes in water and electrolyte balance.
Treatment: the appointment of symptomatic therapy. The use of hemodialysis is shown.
special instructions
When Klamosar is prescribed to patients with impaired liver function during treatment, it is necessary to regularly monitor liver function indicators.
It should be borne in mind that against the background of the use of amoxicillin and clavulanic acid, Coombs' test can give a false positive result. This is due to their ability to cause non-specific binding of immunoglobulins and albumin to the erythrocyte membrane.
With the introduction of high doses of amoxicillin, the patient should be advised to consume a sufficient amount of fluid, it is necessary to maintain adequate diuresis to reduce the risk of amoxicillin crystals.
If symptoms of an allergic reaction appear, treatment with Klamosar must be discontinued and continued treatment with an antibiotic of a different group. If serious hypersensitivity reactions occur, immediate action is required. The patient should be provided with airway patency (including intubation), if necessary - the introduction of epinephrine, intravenous administration of glucocorticosteroids, oxygen therapy.
With infectious mononucleosis, the use of amoxicillin can cause a measles-like skin rash, therefore, if you suspect mononucleosis, you should refrain from using Klamosar so as not to complicate the diagnosis.
Against the background of a course of treatment with Clamosar for mild diarrhea caused by Clostridium difficile, antidiarrheal drugs containing kaolin or attapulgite should be used, which do not reduce intestinal motility. Severe diarrhea should see a doctor.
With concomitant estrogen-containing oral contraception, the patient should be advised to use additional barrier contraceptives during the treatment with amoxicillin.
During the course of treatment, monitoring of the state of the liver function, hematopoietic organs, and kidneys is required.
In case of development of superinfection, it is necessary to make appropriate changes in antibiotic therapy.
It is necessary to take into account the receipt of false positive results when determining glucose in the urine, therefore, during the period of treatment with Klamosar, it is recommended to use the glucose oxidant method to determine the concentration of glucose in the urine.
With increased sensitivity to penicillins, patients may experience cross-allergic reactions with cephalosporin antibiotics.
Influence on the ability to drive vehicles and complex mechanisms
During the treatment period, care should be taken when driving vehicles and working with complex mechanisms. These measures are due to the possible development of side effects from the central nervous system, including dizziness.
Application during pregnancy and lactation
The appointment of Klamosar is contraindicated during gestation and lactation.
If it is necessary to prescribe the drug during lactation, breastfeeding for the period of treatment should be discontinued.
Pediatric use
According to clinical indications, the appointment of Klamosar in pediatrics is allowed.
With impaired renal function
It is recommended to use the antibiotic Klamosar with caution in patients with chronic renal failure.
The dosage regimen should be adjusted taking into account the patient's QC.
For violations of liver function
It is recommended to use Klamosar with caution in severe hepatic impairment.
Drug interactions
- tetracyclines, macrolides, lincosamides, sulfonamides, chloramphenicol and other agents with bacteriostatic activity: cause an antagonistic effect;
- indirect anticoagulants: suppress the intestinal microflora, reduce the prothrombin index and vitamin K synthesis, which leads to an increase in the effectiveness of anticoagulants (when they are combined, monitoring of blood clotting parameters is required);
- oral contraceptives: their contraceptive effect decreases;
- drugs that block tubular secretion (including diuretics, nonsteroidal anti-inflammatory drugs, allopurinol, phenylbutazone): increase the concentration of amoxicillin;
- allopurinol: increases the likelihood of developing a skin rash;
- ethinyl estradiol: increased risk of breakthrough bleeding.
Do not mix Klamosar solutions with infusion solutions containing sodium bicarbonate, dextrose or dextran.
Klamosar is pharmaceutically incompatible with blood preparations, protein hydrolysates and other similar protein fluids, lipid emulsions for intravenous administration.
Aminoglycoside antibiotics, when mixed with Klamosar in one syringe, lose their activity.
Analogs
The analogues of Klamosar are: Amoxicillin + Clavulanic acid, Amovikomb, Amoxiclav, Amoxiclav Kviktab, Amoxivan, Arlet, Augmentin, Verklav, Medoklav, Baktoklav, Novaklav, Panklav 2X, Fibell, Flemoklav Solutab, Ranklav and Dr. Rapklaviklav, Flemoclav
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 15 ° C, protected from moisture and light.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Klamosar
At the moment, there are no reviews of Klamosar from patients and specialists.
Price for Klamosar in pharmacies
The price for Klamosar for a package containing 5 bottles with a dosage of 500 mg + 100 mg can be from 127 rubles, 5 bottles with a dosage of 1000 mg + 200 mg - from 298 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
