Aztreobol (Powder) Instructions for Use

ATC Code

J01DF01 (Aztreonam)

Active Substance

Aztreonam (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the monobactam group

Pharmacotherapeutic Group

Antibiotic, monobactam

Pharmacological Action

Monocyclic beta-lactam antibiotic. The core of the molecule is alpha-methyl-3-amino-monobactamic acid. It suppresses the synthesis of the cell wall, acts bactericidally, 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, Enterobacter spp., Citrobacter spp.).

Not active against gram-positive microorganisms and anaerobes.

There is cross-resistance between aztreonam and aminoglycosides. It rarely causes dysbacteriosis.

Pharmacokinetics

After IM administration, absorption is rapid. T_max – 1 h. C_max after IV administration in doses of 0.5, 1, and 2 g is 54, 90, and 204 mcg/ml, respectively. It passes through histohematic barriers and penetrates tissues well. T_1/2 – 1.7 h (with normal renal function); it is prolonged in cases of impaired excretory function and in old age.

It penetrates the blood-brain barrier during inflammation of the meninges, crosses the placental barrier, and is excreted in breast milk. It is minimally metabolized in the liver. 60-75% is excreted by the kidneys unchanged, 12% is excreted in bile. During hemodialysis, the blood concentration decreases by 30-60%.

Indications

Sepsis, endocarditis, meningitis, peritonitis, lower respiratory tract infections (pneumonia, lung abscess, pleural empyema, bronchitis), gastrointestinal tract infections, biliary tract infections (cholangitis, cholecystitis, enterocolitis), kidney and urinary tract infections, urogenital sphere infections (pyelonephritis, urethritis, cystitis, endometritis), gonorrhea, bone, skin and soft tissue infections, localized parenchymal abscesses, infected burns and wounds, infections or threat of infections in patients with reduced immunity, postoperative infections (including prophylaxis).

ICD codes

Dosage Regimen

Administer intramuscularly or intravenously as a bolus or infusion.

Determine the dose and frequency individually based on the infection severity, causative pathogen, and patient’s renal function.

For adults with normal renal function, use a dose of 0.5 g to 2 g every 6 to 12 hours.

For severe systemic infections, including sepsis or hospital-acquired pneumonia, administer 1 g to 2 g every 6 to 8 hours.

The maximum daily dose for life-threatening conditions is 8 grams.

For uncomplicated urinary tract infections, administer 0.5 g to 1 g every 8 to 12 hours.

For gonorrhea, administer a single 1 gram intramuscular dose.

For pediatric patients over 9 months, use 30 mg/kg per dose every 6 to 8 hours.

Adjust the regimen in patients with renal impairment based on creatinine clearance.

If creatinine clearance is 10-30 mL/min, administer the standard initial dose, then reduce subsequent doses by 50% at the standard interval.

If creatinine clearance is below 10 mL/min, administer the standard initial dose, then give 25% of the standard dose at the standard interval.

Administer intravenous bolus injections over 3 to 5 minutes.

Infuse intravenous solutions over 20 to 60 minutes.

Reconstitute the powder for injection with an appropriate volume of Sterile Water for Injection.

Further dilute the resulting solution in a compatible IV fluid such as 0.9% Sodium Chloride or 5% Dextrose for infusion.

Adverse Reactions

Allergic reactions skin rash, skin itching, multiform exudative erythema, petechiae, urticaria.

From the digestive system diarrhea, nausea, vomiting, stomatitis, taste alteration, candidiasis.

From the nervous system seizures, diplopia, insomnia, dizziness, headaches, confusion.

From the musculoskeletal system myalgia, arthralgia.

Laboratory indicators eosinophilia, thrombocytopenia, increased prothrombin time, anemia, neutropenia, increased activity of “hepatic” transaminases (ALT and AST) and ALP.

Local reactions : with IV administration – phlebitis, thrombophlebitis, discomfort at the IM injection site.

Other breast enlargement, increased sweating.

Contraindications

Hypersensitivity to aztreonam; chronic renal failure (creatinine clearance less than 10 ml/min); hepatic failure; pregnancy, lactation period, children under 9 months of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Hepatic Impairment

Contraindicated for use in hepatic failure.

Use in Renal Impairment

Contraindicated for use in chronic renal failure (creatinine clearance less than 10 ml/min).

In mild and moderate renal failure, adjustment of the dosage regimen is required.

Pediatric Use

Contraindicated for use in children under 9 months of age.

Geriatric Use

Use with consideration of the state of renal function.

Special Precautions

Use with caution in cases of a history of allergic reactions to other beta-lactam antibiotics.

It can be prescribed for allergies to penicillins, cephalosporins, and carbapenems.

Drug Interactions

Pharmaceutically incompatible with heparin and metronidazole.

It has a synergistic effect with vancomycin, clindamycin, aminoglycosides, penicillins, cephalosporins, carbapenems, metronidazole.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.