Aztreobact (Powder) Instructions for Use

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

ATC Code

J01DF01 (Aztreonam)

Active Substance

Aztreonam (Rec.INN registered by WHO)

Dosage Forms

	Aztreobact	Powder for preparation of solution for intravenous and intramuscular administration 0.5 g
		Powder for preparation of solution for intravenous and intramuscular administration 1 g

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration

0.5 g – vials – cardboard packs – By prescription
0.5 g – vials (10 pcs.) – cardboard boxes – By prescription
0.5 g – vials (100 pcs.) – cardboard boxes – By prescription
0.5 g – vials (15 pcs.) – cardboard boxes – By prescription
0.5 g – vials (25 pcs.) – cardboard boxes – By prescription
0.5 g – vials (5 pcs.) – cardboard boxes – By prescription
0.5 g – vials (50 pcs.) – cardboard boxes – By prescription

Powder for preparation of solution for intravenous and intramuscular administration

1 g – vials – cardboard packs – By prescription
1 g – vials (10 pcs.) – cardboard boxes – By prescription
1 g – vials (100 pcs.) – cardboard boxes – By prescription
1 g – vials (15 pcs.) – cardboard boxes – By prescription
1 g – vials (25 pcs.) – cardboard boxes – By prescription
1 g – vials (5 pcs.) – cardboard boxes – By prescription
1 g – vials (50 pcs.) – cardboard boxes – By prescription

Clinical-Pharmacological Group

Antibiotic of the monobactam group

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; monobactams

Pharmacological Action

It is a monocyclic beta-lactam antibiotic. The core of the molecule is alpha-methyl-3-amino-monobactamic acid. It suppresses cell wall synthesis, 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. Rarely causes dysbacteriosis.

Pharmacokinetics

After intramuscular administration, absorption is rapid. T_max – 1 h. C_max after intravenous administration in doses of 0.5, 1 and 2 g is 54, 90 and 204 µg/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 case 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% – with 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, intravenously by bolus injection over 3-5 minutes, or by intravenous infusion over 20-60 minutes.

Determine the dose, route, and frequency of administration individually based on infection severity, causative pathogen susceptibility, renal function, and patient age.

For adults with normal renal function (creatinine clearance >50 mL/min), use a dosage range of 1 g to 2 g every 6 to 12 hours.

For severe systemic infections, including sepsis, hospital-acquired pneumonia, and complicated intra-abdominal infections, administer 2 g every 6 to 8 hours; do not exceed a total daily dose of 8 g.

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

For surgical prophylaxis, administer a single 1 g or 2 g dose intravenously 60 minutes before the procedure.

For pediatric patients over 9 months of age, administer 30 mg/kg every 6 to 8 hours; do not exceed the maximum adult dose.

Adjust the dosage regimen in patients with impaired renal function; for creatinine clearance 10-30 mL/min, administer the standard initial loading dose, then reduce subsequent doses by 50% at the standard interval.

For creatinine clearance less than 10 mL/min, administer the standard initial loading dose, then give 25% of the standard maintenance dose at the usual interval.

Administer a supplementary dose of one-half the usual dose after hemodialysis.

Reconstitute the 1 g vial with at least 3 mL of Sterile Water for Injection for intramuscular use; for intravenous bolus, reconstitute with 6 to 10 mL of Sterile Water for Injection.

For intravenous infusion, further dilute the reconstituted solution in a compatible IV fluid such as 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration not exceeding 20 mg/mL.

Use the prepared solution immediately; if stored under refrigeration, use within 48 hours; if stored at room temperature, use within 24 hours.

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 convulsions, diplopia, insomnia, dizziness, headaches, confusion.

From the musculoskeletal system myalgia, arthralgia.

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

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

Other breast engorgement, increased sweating.

Contraindications

Hypersensitivity to aztreonam; chronic renal failure (creatinine clearance less than 10 ml/min); hepatic insufficiency; 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 insufficiency.

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 dosing regimen is required.

Pediatric Use

Contraindicated for use in children under 9 months of age.

Geriatric Use

Use with consideration of renal function status.

Special Precautions

Use with caution in case of 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.