Timentin - instructions for use. Medicinal reference book geotar Description of the active ingredient

Included in the preparations

ATX:

J.01.C.R Combinations of penicillins (including beta-lactamase inhibitors)

Pharmacodynamics:

Ticarcillin

It has a bactericidal effect due to inhibition of the synthesis of bacterial cell walls. It disrupts the synthesis of peptidoglycan, a biopolymer, the main component of the bacterial cell wall. Inhibits peptidoglycan transpeptidase, suppresses the activity of the endogenous inhibitor, which leads to the activation of murein hydrolase, which breaks down peptidoglycan. Effective against dividing bacteria, in the walls of which peptidoglycan synthesis occurs.

Semi-synthetic antibiotic With wide range action from the penicillin group is destroyed by β-lactamases.

Has a bactericidal effect against gram-negative bacteria: Acinetobacter spp., Moraxella catarrhalis, Citrobacter spp.(including Citrobacter freundii, Citrobacter diversus, Citrobacter amalonaticas), Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp. ( including Klebsiella pneumoniae), Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas spp. ( in t. h . Pseudomonas aeruginosa, Pseudomonas maltophila), Salmonella spp., Serratia spp. ( including Serratia marcescens); And gram-positive bacteria : Staphylococcus aureus, Staphylococcus epidermidis ( coagulase - negative strains ), Staphylococcus saprophyticus, Streptococcus agalactiae ( group B ), Streptococcus bovis, Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes ( group A, beta hemolytic), Streptococcus viridans; anaerobic bacteria: Bacteroides spp., including Bacteroides fragilis group (Bacteroides fragilis, Bacteroides vulgatus, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides distasonis), and non-Bacteroides fragilis (beta melanogenic), Clostridium spp. (including Clostridium perfiingens, Clostridium difficile, Clostridium sporogenes, Clostridium ramosum, Clostridium bifermentans), Eubacterium spp., Fusobacterium spp. ( including Fusobacterium nucleatum and Fusobacterium necrophorum), Peptococcus spp., Peptostreptococcus spp., Veillonella spp.

Clavulanic acid

Does not have clinical effect meaningful action but having a β-lactam structure associated with penicillins, it competitively inhibits β-lactamase, preventing the inactivation of ticarcillin, expanding its spectrum of activity.

Pharmacokinetics:

Ticarcillin

After intravenous administration the maximum concentration in blood plasma is reached after 30 minutes. Communication with plasma proteins is 50%.

Therapeutic effect develops after starting treatment. Metabolism in the liver.

The half-life is 68 minutes. Elimination by the kidneys.

Clavulanic acid

After intravenous administration, the maximum plasma concentration is reached after 1 hour. The binding to plasma proteins is 25%. Penetrates the placental barrier and enters breast milk.

Metabolism in the liver.

The half-life is 64 minutes. Elimination by the kidneys.

The drug is removed by hemodialysis.

Indications:

Used for treatment infectious diseases caused by pathogens sensitive to the drug: bone and connective tissue, skin and subcutaneous tissue, lower respiratory tract, septicemia, peritonitis, infections urinary tract.

I.A30-A49.A41.9 Septicemia, unspecified

I.B99 Other infectious diseases

VIII.H60-H62.H60 Otitis externa

VIII.H65-H75.H66 Purulent and unspecified otitis media

VIII.H65-H75.H70 Mastoiditis and related conditions

X.J00-J06.J01 Acute sinusitis

X.J00-J06.J02.9 Acute pharyngitis unspecified

X.J00-J06.J03.9 Acute tonsillitis unspecified

X.J00-J06.J04 Acute laryngitis and tracheitis

X.J10-J18.J18 Pneumonia without specifying the pathogen

X.J20-J22.J22 Acute respiratory infection lower respiratory tract, unspecified

X.J40-J47.J40 Bronchitis, not specified as acute or chronic

XI.K65-K67.K65 Peritonitis

XI.K65-K67.K67* Peritoneal lesions with infectious diseases, classified in other headings

XII.L00-L08 Infections of the skin and subcutaneous tissue

XIII.M00-M03 Infectious arthropathy

XIII.M60-M63.M63.0* Myositis with bacterial diseases, classified in other headings

XIII.M65-M68.M65.0 Tendon sheath abscess

XIII.M70-M79.M71.0 Abscess of the bursa

XIII.M70-M79.M71.1 Other infectious bursitis

XIII.M86-M90.M86 Osteomyelitis

XIV.N00-N08.N00 Acute nephritic syndrome

XIV.N00-N08.N03 Chronic nephritic syndrome

XIV.N10-N16.N12 Tubulointerstitial nephritis, not specified as acute or chronic

XIV.N10-N16.N10 Acute tubulointerstitial nephritis

XIV.N10-N16.N11 Chronic tubulointerstitial nephritis

XIV.N10-N16.N15 Other tubulointerstitial kidney diseases

XIV.N30-N39.N30 Cystitis

XIV.N30-N39.N33* Defeats bladder for diseases classified elsewhere

XIV.N30-N39.N34 Urethritis and urethral syndrome

XIV.N30-N39.N39.0 Urinary tract infection without established localization

XIV.N40-N51.N49 Inflammatory diseases of the male genital organs, not elsewhere classified

XIV.N70-N77.N70 Salpingitis and oophoritis

XIV.N70-N77.N71 Inflammatory diseases of the uterus, except the cervix

XIV.N70-N77.N72 Inflammatory disease of the cervix

XIV.N70-N77.N73 Other inflammatory diseases women's pelvic organs

XIV.N70-N77.N74* Inflammatory diseases of the female pelvic organs in diseases classified elsewhere

XIV.N70-N77.N76 Other inflammatory diseases of the vagina and vulva

XIV.N70-N77.N77* Ulceration and inflammation of the vulva and vagina in diseases classified elsewhere

Contraindications:

Individual intolerance to β-lactam antibiotics: penicillins and cephalosporins.

With caution:

Imbalance of electrolytes or fluids, severe liver damage.

Pregnancy and lactation:

During pregnancy, prescribe with caution, weighing the potential benefits and potential risks. In trace quantities, the drug passes into breast milk, which can lead to sensitization of the newborn.

Directions for use and dosage:

Children

Premature infants weighing less than 2 kg: 75 mg/kg every 12 hours;

with a body weight of 2 kg: 75 mg/kg every 8 hours.

Children weighing less than 40 kg: 75 mg/kg every 6-8 hours.

Adults

Intravenous drip over 30 minutes.

Adults and children weighing over 40 kg: 3-5 g every 6-8 hours.

Higher daily dose: 20 g.

Highest single dose: 5 g.

Side effects:

Central and peripheral nervous system: rarely - convulsions.

Hematopoietic system: thrombocytopenia, eosinophilia, leukopenia, increased PTI and blood clotting time.

Digestive system: nausea, vomiting, diarrhea, increased activity of liver enzymes, hepatic or cholestatic jaundice, intestinal dysbiosis.

Dermatological reactions: local reactions - compaction at the injection site, candidal dermatitis, vulvovaginitis.

Urinary system: rarely - the development of hypokalemia.

Allergic reactions.

Overdose:

Symptoms: nausea, vomiting, diarrhea, neuromuscular irritability, seizures.

Treatment: symptomatic, hemodialysis.

Interaction:

Concomitant use with probenecid slows the renal excretion of ticarcillin.

Special instructions:

Clavulanic acid may cause nonspecific binding of albumin and immunoglobulin on red blood cell membranes, leading to false-positive Coombs test results.

Instructions

Description of the active component

Pharmacological action

A broad-spectrum antibiotic, it is a carboxypenicillin with a wide spectrum of bactericidal activity.

Active against a wide range of microorganisms (with the exception of strains producing β-lactamases), incl. aerobic gram-positive bacteria: Staphylococcus spp. (including Staphylococcus aureus and Staphylococcus epidermidis), Streptococcus spp. (including Streptococcus faecalis); anaerobic gram-positive bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Eubacterium spp.; aerobic gram-negative bacteria: Escherichia coli, Haemophilus spp. (including Haemophilus influenzae), Branhamella catarrhalis, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Proteus spp. (including indole-positive strains), Morganella morganii, Providencia rettgeri, Providencia stuartii, Pseudomonas spp. (including Pseudomonas aeruginosa and Stenotrophomonas maltophilia), Serratia spp. (including Serratia marcescens), Citrobacter spp., Acinetobacter spp., Yersinia enterocolitica, Salmonella spp., Neisseria gonorrhoeae, Neisseria meningitidis; anaerobic gram-negative bacteria: Bacteroides spp. (including Bacteroides fragilis), Fusobacterium spp., Veillonella spp.

Use in combination with clavulanic acid (a β-lactamase inhibitor) expands the spectrum of antimicrobial activity of ticarcillin.

Indications

Severe infectious and inflammatory diseases caused by sensitive microorganisms (in combination with clavulanic acid): sepsis, septicemia; bacteremia; intra-abdominal infections (including peritonitis); post-operative infections; gynecological infections (including endometritis); bone and joint infections; skin and soft tissue infections; respiratory tract infections; severe or complicated kidney and urinary tract infections (including pyelonephritis); ENT infections; established or suspected infections in patients with impaired or suppressed immunity.

Dosage regimen

Individual, depending on the indications, patient’s age, kidney function.

Side effect

Allergic reactions: skin rash, itching, urticaria, anaphylactic reactions; rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the outside digestive system: nausea, vomiting, diarrhea, moderate increase in AST and/or ALT; rarely - pseudomembranous colitis; very rarely - hepatitis, cholestatic jaundice.

From the side of the central nervous system: rarely – convulsions (especially in patients with impaired renal function and when the drug is prescribed in high doses).

From the hematopoietic system: rarely - thrombocytopenia, leukopenia, eosinophilia, decreased hemoglobin levels and signs of bleeding.

Local reactions: thrombophlebitis.

Others: rarely - hypokalemia.

Contraindications

Premature infants with impaired renal function, a history of hypersensitivity to ticarcillin, to beta-lactam antibiotics (for example, penicillins and cephalosporins).

Pregnancy and lactation

If it is necessary to use it during pregnancy and lactation, the expected benefits of therapy for the mother and the potential risk to the fetus should be carefully weighed.

Use for liver dysfunction

Use for renal impairment

The dosage regimen depends on renal function.

Application for children

Contraindicated in premature infants with impaired renal function.

Special instructions

If any hypersensitivity reactions occur, treatment should be discontinued.

Use with caution in patients with severe liver dysfunction.

Bleeding, which has been reported in rare cases during treatment with beta-lactam antibiotics (including penicillins, cephalosporins and carbapenems), may be associated with impaired blood clotting, in particular such indicators as clotting time, platelet aggregation and prothrombin time, and more likely in patients with impaired renal function. If signs of bleeding occur, antibiotic treatment should be stopped and appropriate therapy should be instituted.

Ticarcillin is not used in premature newborns with impaired renal function.

Drug interactions

Probenecid reduces the secretion of ticarcillin by the renal tubules. Concomitant use with probenecid leads to a slowdown in the renal excretion of ticarcillin.

Ticarcillin exhibits synergism with aminoglycosides against a number of microorganisms (including Pseudomonas spp.).

Catad_pgroup Antibiotics penicillins

Timentin - instructions for use

Currently, the drug is not listed in the State Register of Medicines or the specified registration number has been excluded from the register.


Registration number:

P N012635/01-070807

Trade name: Timentin

International nonproprietary name:

not assigned.
Combination drug: ticarcillin with clavulanic acid

Dosage form:

lyophilisate for the preparation of solution for infusion

Description
Powder from white to light yellow.

Compound
Active substances: ticarcillin disodium equivalent to ticarcillin 1.5 g or 3 g; Potassium clavulanate equivalent to clavulanic acid 100 mg or 200 mg.

Pharmacotherapeutic group:

Semi-synthetic antibiotic penicillin + beta-lactamase inhibitor

ATX code.

Pharmacological properties
Pharmacodynamics
Timentin is combination drug ticarcillin sodium, a semi-synthetic carboxypenicillin with a wide spectrum of bactericidal activity, and potassium clavulanate, a β-lactamase inhibitor. β-lactamases are produced by many gram-negative and gram-positive bacteria. The action of β-lactamases can lead to the destruction of some antibacterial drugs even before their impact on pathogens begins. Potassium clavulanate disrupts this defense mechanism by blocking the action of enzymes, making bacteria susceptible to ticarcillin. Potassium clavulanate does not have antibacterial activity, but its combination with ticarcillin as part of the drug Timentin makes it possible to obtain a broad-spectrum antibiotic that is insensitive to β-lactamases.

Timentin has a bactericidal effect in vitro against a wide range of microorganisms.

Gram-negative bacteria:

  • Acinetobacter species
  • Moraxella catarrhalis
  • Citrobacter species, including C. freundii, C. diversus and C. amalonaticus
  • Enterobacter species (although many strains of Enterobacter species are resistant in vitro, it has been demonstrated clinical effectiveness Ticarcillinia with clavulanic acid for urinary tract infections)
  • Escherichia coli
  • Haemophilus influenzae
  • Klebsiella species, including K. pneumoniae
  • Morganella morganii
  • Neisseria gonorrhoeae
  • Neisseria meningitidis#
  • Proteus mirabilis
  • Proteus vulgaris
  • Providencia rettgeri
  • Providencia stuartii
  • Pseudomonas aeruginosa
  • Pseudomonas including P. maltophilia
  • Salmonella species
  • Serratia species, including S, marcescens
  • Gram-positive bacteria:

  • Staphylococcus aureus
  • Staphylococcus epidermidis (coagulase-negative)
  • Staphylococcus saprophyticus
  • Streptococcus agalactiae# (group B)
  • Streptococcus bovis#
  • Enterococcus faecalis#
  • Streptococcus pneumoniae# (Dipplococcus pneumoniae)
  • Streptococcus pyogenes# (group A, beta-hemolytic)
  • Viridans streptococci group
  • Anaerobic bacteria:

  • Bacteroides species, including the B. fragilis group (B. fragilis, B. vulgatus, B. thetaiotaomicron, B. ovatus, B. distasonis), and non-B. fragilis (beta-melanogenic)
  • Clostridium species including C. perfringens, C. difficile, C. sporogenes, C. ramosum and C. bifermentans#
  • Eubacterium species
  • Fusobacterium species including F. nucleatum and F. necrophorum#
  • Peptococcus species#
  • Peptostreptococcus species#
  • Veillonella species
  • Ticarcillin-sensitive strains that do not produce beta-lactamase are marked with #.

    Pharmacokinetics
    The mean area under the concentration-time curve for ticarcillin is 485 mcg/ml/h after administration of 3.1 g and 3.2 g. The corresponding values ​​for clavulanic acid are 8.2 mcg/ml/h and 15.6 mcg/ml/h. After intravenous infusion of ticarcillin in doses of 3.1 g and 3.2 g over 30 minutes, maximum plasma concentrations are achieved immediately after completion of the infusion and are 330 mcg/ml for both doses. In this case, the pharmacokinetic parameters of clavulanic acid are 8 μg/ml (for 3.1 g of ticarcillin) and 16 μg/ml (for 3.2 g of ticarcillin).

    Serum concentrations in adults after a 30-minute infusion of ticarcillin 3.2 g

    Distribution
    Ticarcillin is distributed in organs and tissues when administered parenterally. Ticarcillin has been shown to penetrate bile, pleural fluid, cerebrospinal fluid. The plasma half-life is inversely proportional to creatinine clearance. Plasma protein binding is 50% for ticarcillin and 25% for clavulanic acid.

    Removal
    The mean serum half-lives determined in healthy volunteers for ticarcillin and clavulanic acid are 68 minutes and 64 minutes, respectively. Approximately 60-70% of ticarcillin and 35-45% of clavulanic acid are excreted unchanged by the kidneys during the first hours after administration of a single dose of the drug (in healthy volunteers with normal function kidney). Two hours after intravenous infusion of 3.2 g of the drug, the concentration of ticarcillin in the urine exceeds 1500 mcg/ml, and the concentration of clavulanic acid exceeds 70 mcg/ml. 4-6 hours after administration of the drug at a dose of 3.2 g, the concentration in the urine is 2 mcg/ml.

    Patients with impaired renal function
    Ticarcillin can be eliminated by dialysis, with the rate of elimination depending on the type of dialysis.

    Indications for use
    Timentin is indicated for the treatment of infections caused by pathogens with known or suspected susceptibility, such as:

  • Bone and connective tissue infections caused by beta-lactamase-producing strains of Staphylococcus aureus
  • Infections in gynecology, including endometritis caused by beta-lactamase-producing strains of Bacteroides melaninogenicus#, Enterobacter species (including E. cloacae#), Escherichia coli, Klebsiella pneumoniae#, Staphylococcus aureus and Staphylococcus epidermidis
  • Intra-abdominal infections, including peritonitis caused by beta-lactamase-producing strains of Escherichia coli, Klebsiella pneumoniae and Bacteroides fragilis#
  • Lower respiratory tract infections caused by beta-lactamase-producing strains of Staphylococcus aureus, Haemophilus influenzae# and Klebsiella species#
  • Septicemia, including bacteremia, caused by beta-lactamase-producing strains of Klebsiella species#, E. coli#, Staphylococcus aureus#, Pseudomonas aeruginosa# (and other Pseudomonas species#)
  • Infections of the skin and subcutaneous tissue caused by beta-lactamase-producing strains of Staphylococcus aureus, Klebsiella species# and E. coli#
  • Urinary tract infections (uncomplicated and complicated) caused by beta-lactamase-producing strains of E. coli, Klebsiella species, Pseudomonas aeruginosa# (and other Pseudomonas species#), Citrobacter species#, Enterobacter cloacae#, Serratia marcescens# and Staphylococcus aureus#
  • Efficacy against microorganisms marked with # was shown for less than 10 infections in each nosological group.

    Contraindications
    Hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins). The drug is contraindicated in premature infants with impaired renal function.

    With caution
    Very rarely, the development of hypokalemia has been reported during the use of the drug. Therefore, caution must be exercised when prescribing to patients with electrolyte or fluid imbalances. Periodic monitoring of serum potassium concentrations is recommended in patients receiving the drug for a long time. In some patients, during treatment with Timentin, a moderate increase in alanine and aspartic aminotransferases was observed. In this regard, patients with severe liver dysfunction should be prescribed Timentin with caution.

    pregnancy and lactation
    Pregnancy
    In animal studies, no teratogenic effects of the drug were found. There is limited data on its use during pregnancy. The decision to prescribe the drug during pregnancy should be made with extreme caution. In this regard, when prescribing Timentin to pregnant women, the doctor must carefully weigh the potential benefits and potential risks associated with the use of this drug.

    Breastfeeding period
    Timentin can be prescribed during breastfeeding, but taking into account that trace amounts of the drug pass into breast milk, the risk of sensitization in the newborn should be taken into account.

    Directions for use and doses
    Timentin is administered intravenously: in a slow stream (over 3-4 minutes) or by drip (over 20-30 minutes).
    The intervals between infusions should be at least 4 hours.
    Treatment should be continued for 48-72 hours after the disappearance of clinical symptoms.

    The drug is not intended for intramuscular injections!


    - maximum dose per day
    3 g every 6 hours or 5 g every 8 hours
    3 g every 4 hours
    - normal mode dosage per day
    - maximum dose and frequency of administration
    75 mg/kg every 8 hours
    75 mg/kg every 6 hours
    Premature newborns:
    - body weight less than 2 kg
    - body weight more than 2 kg
    75 mg/kg every 12 hours
    75 mg/kg every 8 hours
    Elderly patients
    No dosage regimen adjustment is required.
    Dosage regimen for renal impairment:
    Adults and children weighing more than 40 kg:

    1. Creatinine clearance more than 60 ml/min

    3 g every 4 hours

    2. Creatinine clearance 30-60 ml/min 2 g every 4 hours or 3 g every 8 hours
    3. Creatinine clearance 10-30 ml/min 2 g every 8 hours or 3 g every 12 hours
    4. Creatinine clearance less than 10 ml/min
    5. Creatinine clearance less than 10 ml/min (with concomitant liver dysfunction) 1 g every 12 hours or 2 g every 24 hours
    6. Patients on peritoneal dialysis 1 g every 6 hours or 2 g every 12 hours or 3 g every 24 hours
    7. Hemodialysis patients 1 g every 6 hours or 2 g every 12 hours or 3 g every 24 hours, adding 3 g each time after dialysis
    Children weighing less than 40 kg:
    1 Creatinine clearance more than 30 ml/min75 mg/kg every 8 hours
    2 Creatinine clearance 10-30 ml/min37.5 mg/kg every 8 hours
    3 Creatinine clearance less than 10 ml/min37.5 mg/kg every 12 hours
    4 Premature newbornsthere is no precise data to recommend a dosage regimen

    Liver dysfunction
    There is no precise data to recommend a dosage regimen

    Preparation of the solution
    Intravenous drip infusion.
    To prepare the solution, it is recommended to use water for injection or a glucose solution intended for intravenous administration as a solvent (no more than 5%).

    Before dilution in infusion containers, sterile powder (from bottles containing 1.6 g and 3.2 g of the drug) is dissolved in approximately 10 ml of solvent. After this, it is recommended to use the following volumes of solvents:

    Each dose of Timentin is administered intravenously over 30-40 minutes. It is not recommended to administer the drug for a longer period of time, because this may result in subtherapeutic concentrations at which its effectiveness is reduced.

    Intravenous jet injection.
    The sterile powder is dissolved in 10 ml (bottle containing 1.6 g of the drug) or 20 ml (bottle containing 3.2 g of the drug) water for injection.

    The solution is administered slowly over 3-4 minutes. Timentin can be injected directly into a vein or through an IV.

    When Timentin dissolves, heat is released. The prepared solution usually has a light straw color.

    Unused solution cannot be used for further use!

    Stability of solutions and their storage
    It is recommended to prepare the solution immediately before use.

    Although Timentin solution must be used immediately after preparation, solutions prepared using various solvents have been reported to remain stable at 25°C for the following periods of time:

    Solvent Stability period at 25°C
    Water for injections24 hours
    Glucose solution for intravenous infusion (5% w/v)12 o'clock
    Solutions for intravenous infusion of sodium chloride (0.18% w/v) and glucose (4% w/v)24 hours
    Sodium chloride solution for intravenous infusion (0.9% w/v)24 hours
    Dextran 40 for intravenous infusion (10% w/v) in glucose solution for intravenous infusion (5%)6 hours
    Dextran 40 for intravenous infusion (10% w/v) in sodium chloride solution for intravenous infusion (0.9%)24 hours
    Glucose solution for intravenous infusion (10% w/v)6 hours
    Sorbitol solution for intravenous infusion (30% w/v)6 hours
    Sodium lactate solution for intravenous infusion (M/6)12 o'clock
    Combined sodium lactate solution for intravenous infusion (Ringer's lactate solution, Hartmann's solution)12 o'clock

    SIDE EFFECTS
    Hypersensitivity reactions
    Skin rash, itching, urticaria, anaphylactic reactions.
    Very rarely - bullous reactions (including: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
    If any hypersensitivity reactions occur, use of Timentin should be discontinued.

    From the outside gastrointestinal tract
    Nausea, vomiting and diarrhea. In very rare cases - pseudomembranous colitis.

    From the hepatobiliary system
    Moderate increase in serum concentrations of aspartic aminotransferase and/or alanine aminotransferase in patients receiving ampicillin antibiotics. Very rarely - hepatitis and cholestatic jaundice. These phenomena were also observed with the use of other penicillin and cephalosporin antibiotics.

    From the excretory system
    Rarely - hypokalemia. Very rarely - hemorrhagic cystitis.

    From the central side nervous system
    Rarely - convulsions, in particular in patients with impaired renal function and when prescribing high doses of the drug.

    From the blood system
    Rarely - thrombocytopenia, leukopenia, eosinophilia, decreased hemoglobin levels, prolongation of prothrombin time and bleeding time. Increased bleeding may occur.

    Local reactions
    Pain, burning sensation, redness and thickening at the injection site and thrombophlebitis with intravenous use.

    Overdose
    Symptoms
    In case of an overdose of the drug, the patient may experience symptoms such as nausea, vomiting, diarrhea. It is also possible to develop an imbalance of fluid volume and electrolytes. In case of overdose, some patients may develop increased neuromuscular irritability and seizures.

    Treatment
    If the clinical picture of a drug overdose develops, it is recommended to symptomatic therapy. In case of overdose, ticarcillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

    Interaction with other drugs and other interactions
    Concomitant use with probenecid is not recommended. Probenecid reduces the tubular secretion of ticarcillin. Concomitant use with probenecid slows down the excretion of ticarcillin, but does not affect the excretion of clavulanic acid.

    Timentin exhibits synergism with aminoglycosides against a number of microorganisms, including Pseudomonas. In this regard, it is recommended to prescribe Timentin in combination with aminoglycosides for the treatment life-threatening infections, especially in patients with impaired immunity. In this case, these drugs are administered separately in recommended doses.

    Clavulanic acid may cause nonspecific binding of IgG and albumin to red blood cell membranes, leading to false-positive Coombs test results.

    Like other antibiotics, ticarcillin can change its composition intestinal microflora, which leads to low estrogen reabsorption and, as a result, reduced effectiveness of combined oral contraceptives.

    Pharmaceutical incompatibility
    When using Timentin in combination with aminoglycosides, antibiotics should not be mixed in the same syringe, containers or intravenous infusion systems, because this may result in decreased aminoglycoside activity.

    Timentin is not stable enough in infusion fluids containing bicarbonate. It is not recommended to mix Timentin with blood products and other protein-like liquids, such as protein hydrolysates, or with intravenous lipid emulsions.

    Special instructions
    Due to the fact that serious, in some cases fatal, hypersensitivity reactions (including anaphylactic reactions) have been observed in patients who have previously received beta-lactam antibiotics, it is necessary to accurately establish the absence of a history of such reactions before prescribing Timentin. If allergic reactions occur, you should stop using the drug and carry out maintenance therapy; the development of anaphylactic reactions requires emergency measures according to accepted regimens.

    Despite the fact that Timentin has low toxicity, characteristic of penicillin antibiotics, during long-term therapy it is recommended to periodically evaluate the functions of the kidneys, liver and hematopoiesis.

    Increased bleeding was observed in patients receiving beta-lactam antibiotics. Such reactions may be associated with impaired coagulation, platelet aggregation and prolongation of prothrombin time (mainly in patients with renal failure). If bleeding develops, the drug should be discontinued and appropriate therapeutic measures should be taken.

    When prescribing Timentin to patients on a salt-free diet, it is necessary to take into account the sodium content of the drug.

    Long-term use of the drug can lead to the growth of insensitive strains of the pathogen.

    In patients with impaired renal function, the dose of Timentin is adjusted in accordance with the recommendations in the section "Dosage regimen for impaired renal function." When treating mixed infections caused by strains sensitive to ticarcillin (including those producing beta-lactamase), additional prescription of other antibiotics is not required.

    In order to ensure adequate therapy it is necessary to carry out appropriate tests for the sensitivity of the pathogen to the antibiotic. But given the wide range of bactericidal activity against gram-positive and gram-negative strains, the combination of ticarcillin and clavulanic acid is used as first-line therapy for the treatment of mixed infections until the pathogen is identified. The combination of ticarcillin and clavulanic acid has been shown to be effective as monotherapy for some severe infections that are usually treated with combinations of antibiotics. In vitro test results showed a synergistic effect of aminoglycosides and the combination of ticarcillin with clavulanic acid against certain strains of Pseudomonas aeruginosa, which suggests the effectiveness of such combination therapy (especially in immunocompromised patients). In this case, both drugs should be prescribed in recommended therapeutic doses. After receiving the results of sensitivity tests, therapy should be adjusted, if necessary.

    Release forms
    Lyophilisate for preparing a solution of 1.5 g +100 mg or 3.0 g +200 mg in a transparent glass bottle, sealed with a rubber stopper, crimped with an aluminum cap. 10 bottles along with instructions for use are placed in a cardboard box.

    Storage conditions
    Store at +2-8°C
    Keep out of the reach of children.

    Best before date
    3 years.
    Do not use after the expiration date stated on the packaging.

    Conditions for dispensing from pharmacies
    According to the recipe.

    Manufacturer
    SmithKline Beecham Pharmaceuticals, UK.

    Legal address
    SmithKline Beecham Pharmaceuticals, Clarendon Road, Worthing, West Sussex, BN14 8QH United Kingdom / SmithKline Beecham Pharmaceuticals, UK, BN14 8QH West Sussex, Worthing, Clarendon Road.

    For more information contact
    CJSC GlaxoSmithKline Trading, 121614, Moscow, st. Krylatskaya, house 17, bldg. 3, fl. 5, Business Park "Krylatskie Hills".

    International name:
    Ticarcillin+Clavulanic acid – Ticarcillin + Clavulanic acid.

    Group affiliation:
    Penicillin antibiotic of semi-synthetic origin + beta-lactamase inhibitor.

    Description active substance(INN):
    Ticarcillin + Clavulanic acid.

    Dosage form:
    Form of lyophilisate for obtaining a solution for infusion.

    Trade names(synonyms):
    Ticarcillin/clavulanate("Smith Klein Beecham" (UK)), Timentin(SmithKline Beecham Pharma (UK)).

    Pharmacological action:
    Is a combination of ticarcillin ( penicillin antibiotic with antibacterial effect and a wide spectrum of influence) and clavulanic acid (beta-lactamase inhibitor). Clavulanic acid promotes the action of ticarcillin on most gram-positive pathogens that both produce and do not produce beta-lactamase: Streptococcus viridans; Streptococcus pyogenes; Streptococcus faecalis; Streptococcus bovis; Streptococcus pneumoniae; Staphylococcus saprophyticus; Staphylococcus aureus, Staphylococcus epidermidis; gram-negative microorganisms that both produce and do not produce beta-lactamase: Morganella morganii; Providencia stuartii; Proteus vulgaris; Providencia rettgeri; Proteus mirabilis; Pseudomonas aeruginosa, other species of Escherichia coli, Pseudomonas; some Enterobacter species; Neisseria meningitidis; Neisseria gonorrhoeae, Moraxella catarrhalis (Branhamella); Serratia; Acinetobacter; some strains of Salmonella; Haemophilus influenzae; Klebsiella (including Klebsiella pneumoniae); Citrobacter spp.; anaerobic microorganisms: Bacteroides spp. (along with Bacteroides fragilis); some species of Clostridium spp. (along with Clostridium sporogenes, Clostridium difficile and Clostridium perfringens); Peptostreptococcus spp.; Fusobacterium spp.; Eubacter spp.

    Indications:
    Effective in the treatment of infectious diseases caused by sensitive pathogens: bronchitis, pneumonia, infections of joints and bones, sepsis, infections of the pelvic organs, infections of soft tissues and skin, abdominal infections, urinary tract infections; mixed infections. Also used as empirical therapy before identifying the pathogen.

    Contraindications:
    Do not prescribe in case of hypersensitivity (including to beta-lactam antibiotics); premature babies; suffering from impaired renal function. Women should be extremely careful during pregnancy and breastfeeding; in case of administration to children under 3 months; in case of severe liver dysfunction.

    Side effects:
    Abdominal pain, diarrhea, flatulence, vomiting, nausea, disturbances of taste and smell, convulsions, overexcitability, dizziness, headache; cholestatic jaundice, hepatitis, increased activity of “liver” transaminases, in rare cases – pseudomembranous enterocolitis; fever, chills, thrombophlebitis, burning, pain, compaction and swelling at the injection site, anaphylactic reactions, urticaria, itching, skin rash, myalgia, arthralgia, increased bleeding time and prothrombin time, anemia, eosinophilia, neutropenia, leukopenia, thrombocytopenia, hypercreatinine , increased concentration activity uric acid in the blood, hypokalemia, hypernatremia.
    Symptoms of overdose: convulsions, increased neuromuscular excitability. Treatment: stop taking the drug, perform hemodialysis and symptomatic therapy.

    Directions for use and dosage:
    IV administration, for adult patients weighing over 60 kg - administer 3.1 g 4-6 times a day, for patients weighing up to 60 kg - from 200 to 300 mg/kg per day (4-6 injections). Treatment of pelvic organ infections with moderate severity course – 6 times/day, 300 mg/kg. Patients with impaired renal function take the first dose of 3.1 g. Then, depending on the CC: if the CC is more than 60 ml/min - 6 times / day, 3.1 g, if the CC is 30-60 ml/min - 6 times / day, 2 g, if CK is 10-30 ml/min - 3 times a day, 2 g, if CK is up to 10 ml/min - 2 times / day, 2 g, if CK is up to 10 ml/min, plus dysfunction liver - 1 time / day, 2 g. Patients who need hemodialysis should take 2 g of the drug 2 times a day, and after the end of the hemodialysis procedure - another 3.1 g. Patients who are on peritoneal hemodialysis, take 2 times /day 3.1 g. The duration of therapy is from 10 to 14 days, but if necessary (the course of the disease is severe), therapy can be extended. After the symptoms of the disease have disappeared, you should take the drug for two more days, and the treatment ends. Children aged 3 months and older. and those weighing up to 60 kg receive a dose of 50 mg per 1 kg of weight. In the case of treatment of infections of moderate and mild degree during the course of the course, the dose is 200 mg per day (divided into four doses), if the infection is severe, then the dose is 300 mg/kg per day (divided into 6 doses). Children weighing over 60 kg receive 3.1 g every 6 hours; if the infection is severe, 3.1 g every 4 hours. How to prepare the solution: IV administration - add 13 to the bottle (3.1 g). ml 0.9% sodium chloride solution or water for injection, shake vigorously until completely dissolved; intravenous drip administration - mix the pre-dissolved drug with 0.9% sodium chloride or 5% dextrose solution to ultimately obtain a solution with a concentration of 10-100 mg/ml. The resulting solution should be pale to dark yellow (depending on concentration, temperature and shelf life).

    Special instructions:
    With long-term treatment, increased growth of microorganisms exhibiting resistance may be observed. Taking the drug may result in a false-positive Coombs test and a false-positive test for protein in the urine.

    Interaction:
    When taken in tandem with drugs that block tubular secretion, the process of excretion of ticarcillin slows down and its concentration in the blood increases. A synergistic effect is manifested in the treatment of diseases caused by Pseudomonas aeruginosa, if the drug is taken simultaneously with amikacin, tobramycin or gentamicin. Pharmaceutical incompatibility with solutions of other drugs is observed; when mixed, the activity of the aminoglycoside solution decreases.

    Self-medication with Ticarcillin/clavulanate is not allowed. The information is provided for informational purposes only. medical workers and employees of pharmaceutical companies.

    And potassium clavulanate.

    Release form

    The drug Amoxicillin + Clavulanate is produced in the form of a lyophilisate intended for the preparation of an injection solution, drops for internal use or suspension.

    Pharmacological action

    This drug is characterized by antibacterial And bactericidal action.

    Pharmacodynamics and pharmacokinetics

    Combined medicine amoxicillin and clavulanate are beta-lactamase inhibitors. Thanks to his bactericidal effect the drug is able to inhibit the synthesis of the bacterial wall. Its activity is manifested against the main aerobic gram-positive bacteria and their strains that produce beta-lactamases, for example: Staphylococcus aureus, Streptococcus pyogenes, Staphylococcus epidermidis, Streptococcus anthracis, Streptococcus viridans, Streptococcus pneumoniae, Enterococcus faecalis and others, as well as some anaerobic gram-positive bacteria , aerobic gram-negative bacteria, anaerobic gram-negative bacteria and so on.

    At the same time, clavulanate has an inhibitory effect on types II, III, IV and V beta-lactamases, but is inactive against type I beta-lactamases, which are synthesized by Enterobacter spp., Serratia spp., Pseudomonas aeruginosa, Acinetobacter spp. This substance is characterized by high tropism towards the main penicillinases, forming a stable complex with the enzyme, preventing the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

    Indications for use

    The main indication for the use of Amoxicillin + Clavulanate is the treatment of bacterial infections:

    • ENT organs – , ;
    • lower respiratory tract – pneumonia, pleural empyema, lung abscess;
    • soft and integumentary tissues – impetigo, abscess, secondary infected dermatoses, phlegmon;
    • genitourinary system - , pyelitis, salpingitis, and so on ;
    • and also as a prophylaxis against infections in surgical interventions, and other violations.

    Contraindications for use

    The use of the drug is contraindicated in:

    • infectious mononucleosis ;
    • hypersensitivity;
    • jaundice or disturbances in liver function during treatment.

    The medicine is prescribed with extreme caution when , , heavy liver failure, gastrointestinal diseases and other abnormalities.

    Side effects

    When treated with Amoxicillin + Clavulanate, disturbances in the functioning of the digestive and nervous systems, hematopoietic organs, allergic and local reactions, and other violations.

    Therefore, treatment may be accompanied by: nausea, vomiting, hyperactivity, anxiety, convulsions, hematopoietic disorders, thrombocytopenia, thrombocytosis, eosinophilia and so on.

    For locals and allergic reactions characteristic: development phlebitis at the injection site, urticaria, erythematous rashes, etc. In addition, it is possible that candidiasis, superinfections, interstitial nephritis, crystalluria And hematuria .

    Amoxicillin + Clavulanate, instructions for use (Method and dosage)

    It should be noted that this drug can be used for oral administration and injection. In this case, the therapeutic regimen, dosage and duration of use are determined individually. According to the instructions for use of the drug, it depends on the severity of the disease, the location of the infection and the characteristics of the patient.

    For adult patients and children over 12 years of age it is prescribed daily dosage 250 mg for 3 times a day. Heavy current infections allows increasing the dosage to 500 mg or 1 g to 2 one-time use. Children under 12 years of age are recommended to take the drug in the form of syrup, suspension or drops. A single dosage is set depending on the age of the child: for 9 months-2 years - 62.5 mg, 2-7 years - 125 mg, 7-12 years - 250 mg for 3 doses. Severe cases of disease allow an increase in dosage.

    The average duration of treatment is 10-14 days.

    Overdose

    In cases of overdose, the development of such undesirable symptoms as disruption of the gastrointestinal tract and water-electrolyte balance cannot be ruled out.

    In this case, symptomatic treatment is performed, possibly with hemodialysis.

    Interaction

    Combined treatment with this drug and antacids, laxatives, aminoglycosides – often leads to slower and decreased absorption. Simultaneous use with ascorbic acid – increases absorption.

    For bactericidal antibioticsaminoglycosides, cephalosporins, and is characterized by a synergistic effect. Some bacteriostatic agents, e.g. macrolides, lincosamides And sulfonamides exhibit an antagonistic effect. There is also an increase in the effectiveness of indirect anticoagulants, leading to suppression of intestinal microflora, a decrease in the synthesis of vitamin K or the prothrombin index.

    Simultaneous treatment with anticoagulants requires monitoring of blood clotting parameters. The effect of oral contraceptives is reduced, , which increases the risk of severe bleeding. , diuretics, Phenylbutazone – can increase the concentration of amoxicillin. In addition, allopurinol may cause a rash and skin irritation.

    Special instructions

    During antibiotic therapy, careful monitoring of the state of the functions of the hematopoietic organs, kidneys and liver is necessary. Reduce the risk of developing unwanted effects associated with the functioning of the gastrointestinal tract, will allow taking the drug with food. It is also possible that a superinfection may develop due to the growth of microflora insensitive to the drug, requiring a change in the treatment regimen. Increased sensitivity to leads to crosstalk allergic reactions With cephalosporin antibiotics.

    Terms of sale

    Antibiotics are available in pharmacies by prescription.

    Storage conditions

    The optimal place to store the medicine is dry, cool, protected from children and light.

    Best before date

    Analogs

    The main analogues include the following drugs: Amoklavin, Clavocin, Ticarcillin Clavulanate, Medoclav, Moxiclav, Ranclave, Rapiclav and.

    Alcohol

    When treating with antibiotics, it is necessary to refrain from drinking alcohol, as this reduces the effectiveness of therapy and increases the likelihood of side effects.