IM/IV Injection

Azactum IM/IV Injection

1 gm/5 ml
1 gm vial: ৳ 400.00
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Indications

Azactum is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:
  • Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter species and Serratia marcescens.
  • Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species and Serratia marcescens.
  • Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens and Enterobacter species.
  • Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers and burns caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae and Citrobacter species.
  • Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii and Serratia species including S. marcescens.
  • Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae and Proteus mirabilis.
  • Adjunctive therapy to surgery in the management of infections caused by susceptible organisms.

Pharmacology

Aztreonam is a synthetic bactericidal monobactam antibiotic. It inhibits bacterial cell wall synthesis by blocking peptidoglycan crosslinking. The inhibition of bacterial cell wall synthesis occurs due to a high affinity of Aztreonam for penicillin binding protein 3 (PBP3). By binding to PBP3, Aztreonam inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that Aztreonam interferes with an autolysin inhibitor.

Dosage

Adults: The recommended dosage for Urinary tract infections , Moderately severe systemic infections and Severe systemic or life-threatening infections is 500 mg or 1 g , 1 g or 2 g, 2 g every 8 or 12, 8 or 12 and 6 or 8 hourly respectively.

Children: The recommended dosage for Mild to moderate infections (Over 1 week) and Moderate to severe infections (2 years or older) is 30 mg/kg and 50 mg/kg every 6 and 6 or 8 hourly respectively. Maximum recommended dose for adult is 8 g per day. Maximum recommended dose for pediatric patient is 120 mg/kg/day.

Pediatric use: Dosage information is not yet available for new born less than one week.

Administration

Intramuscular administration: The dose should be given by deep injection into a large muscle mass. Aztreonam is well tolerated and should not be administered with any local anesthetic agent. For each gram of Aztreonam add at least 3 ml water for injection BP and shake well.

Intravenous administration: A bolus injection may be used to initiate therapy. The dose should be slowly injected directly into a vein, or the tubing of a suitable administration set, over a period of 3 to 5 minutes.

For infusion: Each gram of Aztreonam should be initially constituted with at least 3 ml of water for injection BP. The resulting solution should be diluted with an appropriate infusion solution to a final concentration not exceeding 2% w/v (at least 50 ml solution per gram Aztreonam). The Aztreonam infusion should be administered over a 20-60 minute period. A number of intravenous solutions may be used as diluents for the administration of Aztreonam by intravenous infusion.These include sodium chloride injection, dextrose and mixed injections of sodium chloride and dextrose, Ringers and lactated Ringers injection,water for injection etc.

Interaction

Concomitant administration of probenecid or furosemide and Azactum causes clinically insignificant increases in the serum levels of Azactum.

Contraindications

This preparation is contraindicated in patients with known hypersensitivity to Aztreonam or any other component in the formulation.

Side Effects

Local reactions such as phlebitis/thrombophlebitis following IV administration and discomfort/swelling at the injection site following IM administration may occur. Systemic reactions like diarrhea, nausea and/or vomiting, and rash may occur. Other side effects include anaphylaxis, angioedema, bronchospasm, pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis, abdominal cramps, dermatitis, urticaria, pruritus, hypotension, flushing, seizure, weakness, headache, fever, malaise may occur.

Pregnancy & Lactation

Pregnancy Category B. Aztreonam crosses the placenta and enters the fetal circulation. So it should be used during pregnancy only if the potential benefit justifies the potential risk. Aztreonam is excreted in breast milk in concentrations that are less than 1% of concentrations determined in simultaneously obtained maternal serum. Temporary discontinuation of nursing is recommended.

Precautions & Warnings

In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy.

Therapeutic Class

Other beta-lactam Antibiotics

Storage Conditions

Store in a cool & dry place, protected from light & moisture. Keep all medicines out of reach of children.