Azaktam (Aztreonam) por. for injection 1g 1 fl./pack. — Instructions

Azeonam is prescribed for the treatment of infections caused by sensitive anaerobic gram-negative microorganisms:

  • Urinary tract infections, including pyelonephritis and cystitis (initial and recurrent), asymptomatic bacteriuria, including those caused by pathogens resistant to aminoglycosides, cephalosporins or penicillins.
  • Gonorrhea: acute uncomplicated urogenital or anorectal infection caused by beta-lactamase-producing or non-beta-lactamase-producing strains of N.gonorrhoeae.
  • Lower respiratory tract infections, including pneumonia, bronchitis and lung infections in patients with cystic fibrosis.
  • Bacteremia/septicemia.
  • Meningitis due to Haemophilus influenzae and Neisseria Meningitidis. Because aztreonam affects only Gram-negative organisms, it should not be given as initial blind therapy only, but may be used in conjunction with an antibiotic active against Gram-positive organisms until the results of susceptibility tests are known.
  • Bone and joint infections.
  • Skin and soft tissue infections, including infections associated with surgical wounds, ulcers and burns.
  • Intra-abdominal infections: peritonitis.
  • Gynecological infections: pelvic inflammation, endometritis and parametritis.

Features of application

Prescribe antibiotics and other drugs with caution to patients with a history of allergic reactions to structurally related compounds. If an allergic reaction occurs, stop taking the drug and begin appropriate supportive therapy. Severe hypersensitivity reactions may require the administration of epinephrine and other emergency measures. Appropriate studies have shown no significant cross-sensitivity between aztreonam and antibodies to penicillins or cephalosporins. The incidence of hypersensitivity to aztreonam in clinical trials was low, but until further study results are available, caution should be exercised in patients with a history of hypersensitivity to beta-lactam antibiotics.

Pregnancy

Aztreonam is contraindicated during pregnancy. Aztreonam penetrates the placenta and enters the fetal bloodstream.

Children

Data on the safety and effectiveness of the drug in infants less than one week of age are limited, so the use of this drug in this population requires careful evaluation.

Drivers

No studies have been conducted on the effect on the ability to drive vehicles or use other machinery.

Aztreonam-DECO

Pharmacodynamics

Synthetic monocyclic beta-lactam antibiotic for parenteral use. Structurally different from other beta-lactam antibiotics (such as penicillins, cephalosporins). The core of the molecule is alpha-methyl-3-amino-mono-bactamic acid. Suppresses cell wall synthesis and has a bactericidal effect. Binds to transpeptidases and disrupts the final stages of bacterial cell wall synthesis. It has a high affinity for penicillin-binding protein 3. It is highly resistant to beta-lactamases (including penicillinases and cephalosporinases) of gram-negative bacteria. It has potent and specific in vitro activity against gram-negative aerobic pathogens, including Pseudomonas aeruginosa.

The bactericidal effect is manifested in a wide range of pH values ​​and under anaerobic conditions.

Active against the following microorganisms both in vitro and in vivo: Citrobacter spp., including Citrobacter freundii, Enterobacter spp., including Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant and other penicillinase-producing strains), Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp., including Serratia marcescens.

The following strains were sensitive in vitro, however, the clinical significance of these data is unknown: Aeromonas hydrophila, Morganella morganii, Neisseria gonorrhoeae (including penicillinase-producing strains), Pasteurella multocida, Proteus vulgaris, Providencia Stuartii, Providencia rettgeri, Yersinia enterocolitica.

Gram-positive aerobic cocci and bacteria, Acinetobacter spp., anaerobic microorganisms, mycoplasmas and other intracellular pathogens, Mycobacterium spp. are resistant to the drug.

Pharmacokinetics

Maximum serum concentrations (Cmax) after a single 30-minute intravenous infusion of 0.5 g and 1 g are observed immediately after administration and are approximately 54 mcg/ml and 90 mcg/ml, respectively. With an intravenous bolus injection over 3 minutes, Cmax is about 58 mcg/ml and 125 mcg/ml 5 minutes after administration.

After intramuscular injection of 0.5 g and 1 g, Cmax is determined after an hour and is about 21 μg/ml and 46 μg/ml, respectively.

After intravenous and intramuscular administration, it is well distributed in many organs and tissues. Therapeutically significant concentrations exceeding the minimum inhibitory concentrations for sensitive microorganisms are determined in synovial fluid, bile, pericardial fluid, bronchial secretions, interstitial fluid, peritoneal exudate, kidneys, prostate gland, lungs, skin, bones, ovaries, endometrium, myometrium, skeletal muscles , liver tissue, the wall of the gallbladder, the wall of the small and large intestine. Passes through the placenta and passes into breast milk in low concentrations. When administered as part of a peritoneal dialysis fluid, it quickly reaches therapeutic concentrations in the blood serum.

The apparent volume of distribution at steady state is about 13 L, which is approximately equivalent to the volume of extracellular fluid.

The degree of binding to blood plasma proteins is 56%. It is excreted primarily by the kidneys by glomerular filtration and tubular secretion. Serum clearance is about 91 ml/min, renal clearance is about 56 ml/min. The half-life is 1.7 hours (range 1.5-2 hours). Slightly (less than 6% of the administered dose) is metabolized in the liver. 60-70% is excreted by the kidneys unchanged and as an inactive product of hydrolysis of the beta-lactam ring, 12% through the intestines.

In patients with reduced renal function, the half-life is markedly prolonged, and therefore dose adjustment is recommended. Serum concentrations decrease rapidly with hemo- and peritoneal dialysis.

Overdose

Use of beta-lactam therapy, including aztreonam, may cause encephalopathy (eg, confusion, impaired consciousness, epilepsy, movement disorders), especially in patients with impaired renal function and in combination with beta-lactam overdose.

No cases of overdose have been reported. If necessary, aztreonam can be removed from the blood serum by hemodialysis and/or peritoneal dialysis. Aztreonam can also be removed from the blood serum by continuous arteriovenous hemofiltration.

Azaktam (Aztreonam) por. for injection 1g 1 fl./pack. — Instructions

Compound

The drug contains 1 g of aztreonam and 780 mg of L-arginine.

Release form

The medicine is produced in powder form for the preparation of a solution for injections and infusions. Supplied in packages of one bottle each.

pharmachologic effect

The bactericidal activity of aztreonam is due to inhibition of bacterial cell wall synthesis due to aztreonam's high affinity for penicillin binding protein 3 (PBP3). By binding to PBP3, aztreonam inhibits the third and final stage of bacterial cell wall synthesis. Cell lysis is then mediated by autolytic enzymes in the bacterial cell wall, such as autolysins. In addition, it is possible that aztreonam interacts with an autolysin inhibitor.

Pharmacokinetics

When administered intramuscularly, the drug is completely absorbed.

Approximately 6 to 16% of the drug is metabolized to inactive metabolites by hydrolysis of the beta-lactam linkage to form a ring-opened compound.

In healthy people, aztreonam is excreted in the urine through active tubular secretion and glomerular filtration. Urinary excretion of a single parenteral dose was virtually complete 12 hours after injection.

Indications for use

Azactam is used to treat urinary tract infections (pyelonephritis), lower respiratory tract infections (pneumonia, exacerbation of COPD, cystic fibrosis). In addition, use is appropriate in the case of bacteremia, sepsis, skin and soft tissue infections, infections that prevent the healing of postoperative wounds, burns and ulcers, abdominal infections (peritonitis), gynecological infections (pelvic inflammatory disease, endometritis), gonorrhea, treatment of infections in surgery (abscesses, infections complicated by intestinal perforation), meningitis, infections of bones and joints.

Contraindications

Hypersensitivity to aztreonam is a contraindication to the use of the drug.

Side effects

Possible side effects of Azactam include respiratory, thoracic and mediastinal disorders. In addition, rashes often appeared and the temperature rose very often.

Drug interactions

Concomitant use of Azactam and other antiviral substances may enhance their effects and increase the risk of side effects.

Concomitant use with natural and synthetic estrogens may reduce the contraceptive effect of ethinyl estradiol.

Concomitant use of anticoagulants may enhance the anticoagulant effect of warfarin and thus increase the risk of bleeding and hemorrhage.

Application and dosage

The dosage range for Azactam is 1 to 8 g per day, divided equally. The usual dose is 3 to 4 g per day. The maximum recommended dose is 8 g per day. Dosage and route of administration should be determined by the susceptibility of the pathogen, the severity of the infection and the condition of the patient.

Overdose

To date, no cases of overdose have been reported.

special instructions

Particular caution should be exercised in patients with a history of allergic reaction to beta-lactam.

Use during pregnancy and breastfeeding

Appointment is not recommended.

Impact on the ability to drive vehicles and operate machinery

Based on an assessment of the safety profile and mechanism of action of the drug, it should not have a negative impact on the above-mentioned activities.

Terms of sale

As prescribed by a doctor.

Storage conditions

It is important to store the drug in its original packaging and in a dry and cool place, away from children.

Side effects

From the blood and lymphatic system:

Rarely: pancytopenia, thrombocytopenia, thrombocythemia, leukocytosis, neutropenia, eosinophilia, anemia, increased prothrombin time, increased activated partial thromboplastin time.

From the organs of hearing and labyrinth

Rarely: vertigo, tinnitus.

From the nervous system

Rarely: convulsions, paresthesia, dizziness, headache.

Frequency unknown: encephalopathy (confusion, altered consciousness, epilepsy, movement disorders).

From the skin and subcutaneous tissue

Frequency unknown: toxic epidermal necrolysis, angioedema, erythema multiforme, exfoliative dermatitis, hyperhidrosis, petechiae, purpura, urticaria, rash, itching.

Aztreons

INSTRUCTIONS for using the product

Aztreons

Release form

Bottle

Pharmacological properties

Monocyclic beta-lactam antibiotic. The core of the molecule is alpha-methyl-3-amino-mono-bactamic acid. Suppresses cell wall synthesis, has a bactericidal effect, and is resistant to beta-lactamases of gram-negative bacteria. Active against gram-negative aerobic pathogens (Salmonella spp., Shigella spp., Proteus spp., Escherichia coli, Klebsiella spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Pseudomonas aeruginosa, Entero-Citrobacter spp.), has no effect on gram-positive microorganisms and anaerobes. Prescription is possible for allergies to penicillins, cephalosporins and carbapenems. Cross-resistance exists between aztreonam and aminoglycosides. Rarely causes dysbacteriosis.

Indications

Urinary tract infections: pyelonephritis, cystitis, etc.; lower respiratory tract infections: pneumonia, bronchitis, etc.; septicemia; skin and soft tissue infections; intra-abdominal infections, including peritonitis; gynecological infections: endometritis, parametritis, etc.; prevention of infectious postoperative complications, including abscess, infectious complications during perforation of hollow organs, infections of the skin and serous surfaces.

Contraindications

Individual intolerance; children up to 9 months; breast-feeding.

Use during pregnancy and breastfeeding

Contraindicated during breastfeeding.

Directions for use and doses

The drug is prescribed intramuscularly, intravenously (stream or drip). The dosage is selected individually in each specific case, depending on a number of factors (the disease and the severity of its course, the patient’s well-being, etc.).

For adults, a single dose is 0.5-2 g (dose reduction required for kidney disease) every 8-12 hours (that is, 2-3 times a day), the maximum daily dose is 8 g.

For children 9 months - 2 years - 30 mg/kg, over 2 years - 50 mg/kg every 6-8 hours (3-4 times a day).

Side effects

Nervous system and sensory organs: malaise and weakness, confusion, dizziness and headache, insomnia, vertigo, paresthesia, convulsions, tinnitus, numbness of the tongue, double vision, ulceration of the oral mucosa, perversion of taste.

From the cardiovascular system and blood (hematopoiesis, hemostasis): decreased blood pressure, transient changes on the ECG (ventricular bigemy and premature ventricular contraction), flushing, pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis.

From the respiratory system: wheezing, shortness of breath, chest pain.

Digestive system: cramping abdominal pain, hepatitis, jaundice, diarrhea, pseudomembranous colitis, gastrointestinal bleeding.

Skin: purpura, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, petechiae, profuse sweating.

Allergic reactions: anaphylaxis, angioedema, bronchospasm, itching, urticaria.

Others: sneezing, nasal congestion, bad breath, muscle pain, vaginal candidiasis, vaginitis, changes in biochemical blood test, breast tenderness, fever, positive Coombs test, hypercreatininemia.

Local reactions: with intravenous administration - phlebitis, thrombophlebitis, discomfort at the site of intramuscular injection.

Interaction with other drugs

When used simultaneously, the effects of penicillins, cephalosporins, aminoglycosides, clindamycin, and metronidazole mutually enhance. Pharmaceutically incompatible with heparin, cefradine and metronidazole.

Overdose

Overdose is characterized by nonspecific manifestations. Treatment is symptomatic, hemo- or peritoneal dialysis is prescribed.

Storage conditions

Store away from direct sunlight at temperatures between 15 and 25 degrees Celsius.

Best before date

3 years.

Note!

Description of the drug Azeonam por. d/r-ra d/in./inf. 1g fl. No. 1 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

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