Cromobact — Aztreonam for Injection USP 1 g, 1 Vial

Cromobact is supplied as a combination pack containing a powder vial and a solvent ampoule.

Qualitative and Quantitative Composition:

• • Active Substance: Aztreonam (sterile grade complying with USP standards) — 1 g.
• • Excipients: L-arginine (utilized as a buffering agent to optimize pH and solubility).
• • Included Solvent: Ampoule containing Sterile Water for Injection.

Presentation and Packaging: White to off-white powder supplied in a 1 g glass vial accompanied by a solvent ampoule. The outer carton displays official Fusion Health Care regulatory details, batch number (e.g., CMBT-23), manufacturing date, and expiration date.

Pharmacodynamics:
Aztreonam is a synthetic bactericidal antibiotic belonging to the monobactam class. Due to its unique monocyclic beta-lactam ring structure, it binds preferentially to penicillin-binding protein 3 (PBP-3) of gram-negative bacteria, inhibiting bacterial cell wall synthesis, compromising cell wall integrity, and leading to rapid bacterial lysis and cell death. Aztreonam is highly active against gram-negative aerobic bacilli, including Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter species, Citrobacter species, Serratia marcescens, and Haemophilus influenzae. It lacks activity against gram-positive organisms and anaerobes.

Pharmacokinetics:

• • Absorption: Rapidly and completely absorbed following intramuscular injection, reaching peak plasma concentrations within 60 to 90 minutes.
• • Distribution: Widely distributed into body tissues and fluids, including cerebrospinal fluid (during meningeal inflammation), bile, bone, and pelvic organs. Plasma protein binding ranges from 56% to 60%.
• • Metabolism: Minimally metabolized (approximately 6–12% of a dose is converted to an inactive open-ring metabolite).
• • Elimination: Excreted primarily by the kidneys via glomerular filtration and tubular secretion. The elimination half-life (T1/2) in patients with normal renal function is approximately 1.5 to 2 hours.

Cromobact is indicated for the treatment of moderate to severe infections caused by susceptible gram-negative microorganisms:

• • Urinary tract infections (complicated and uncomplicated, including pyelonephritis and cystitis).
• • Lower respiratory tract infections (pneumonia, bronchitis, lung abscess).
• • Intra-abdominal infections (peritonitis, intra-abdominal abscesses — combined with anti-anaerobic agents).
• • Gynecological infections (endometritis, pelvic cellulitis).
• • Skin and skin structure infections.
• • Septicemia (sepsis).
• • Bone and joint infections.
• • Prophylaxis and treatment of infections in immunocompromised patients.

Cromobact is administered via intravenous (IV bolus or infusion) or intramuscular (IM) injection. Dosage and route depend on infection severity, pathogen susceptibility, and renal function.

Preparation of Solutions:

• • For Intramuscular Administration: Reconstitute the 1 g vial with at least 3 ml of Sterile Water for Injection. Inject deeply into a large muscle mass (upper outer quadrant of the gluteus maximus).
• • For Intravenous Bolus Injection: Reconstitute the 1 g vial with 6 to 10 ml of Sterile Water for Injection and administer slowly over 3 to 5 minutes.
• • For Intravenous Infusion: Dilute the reconstituted solution in 50 to 100 ml of a compatible infusion fluid (0.9% Sodium Chloride Injection, 5% Dextrose Injection) and infuse over 20 to 60 minutes.

Adult Dosing Guidelines:

• • Mild to moderate systemic infections: 1 g to 2 g every 8 to 12 hours.
• • Severe or life-threatening systemic infections (including pseudomonal infections): 2 g every 6 to 8 hours. Maximum daily dose is 8 g.
• • Renal impairment requires strict dosage adjustment based on creatinine clearance values.

Administration of Cromobact is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to aztreonam or any inactive excipients.
• • Beta-Lactam Allergy: History of severe allergic reactions to other beta-lactam antibiotics (although cross-reactivity with penicillins is low, clinical caution is warranted).
• • Neonatal Population: Use in neonates and premature infants requires extreme caution and strict medical justification.

Potential drug interactions must be considered when administering aztreonam:

• • Aminoglycosides (gentamicin, tobramycin): Exhibit synergistic bactericidal activity against certain gram-negative strains (including Pseudomonas aeruginosa). However, they must never be mixed in the same syringe or infusion container.
• • Loop Diuretics (furosemide): May increase the risk of nephrotoxicity when co-administered with beta-lactam antimicrobials.
• • Anticoagulants / Antithrombotic Agents: Potential risk of bleeding complications if hepatic or renal impairment coexists.
• • Chloramphenicol: Antagonistic effects have been observed; concurrent use should be avoided.

Pregnancy:
Aztreonam crosses the placental barrier. Adequate and well-controlled studies in pregnant women are lacking. Cromobact should be used during pregnancy only if clearly needed and prescribed by a physician.

Lactation:
Aztreonam is excreted in human breast milk in low concentrations. Temporary discontinuation of breastfeeding is advised during maternal treatment.

Cromobact is generally well tolerated; however, adverse events may occasionally occur:

• • Local Reactions: Pain, phlebitis, or thrombophlebitis at the IV site; discomfort and induration following IM injection.
• • Gastrointestinal Tract: Nausea, vomiting, diarrhea, abdominal cramps, pseudomembranous colitis (with prolonged therapy), transient elevations in serum transaminases (ALT, AST) and alkaline phosphatase.
• • Allergic Reactions: Rash, pruritus, urticaria, erythema; rarely anaphylaxis, angioedema, toxic epidermal necrolysis.
• • Hematologic System: Eosinophilia, thrombocytopenia, neutropenia, anemia.
• • Renal System: Transient increases in serum creatinine and blood urea nitrogen.
• • Nervous System: Headache, dizziness, general malaise, insomnia.

Symptoms:
Accidental overdose may result in an exacerbation of adverse events, potentially leading to neurological complications such as seizures or encephalopathy, particularly in patients with renal impairment.

Treatment:
There is no specific antidote. Symptomatic and supportive care should be administered. Aztreonam is effectively cleared from circulation via hemodialysis or peritoneal dialysis.

Storage Requirements for Cromobact:

• 🌡️ Temperature Range: Store in a dry place protected from light at temperatures not exceeding 25 °C.
• 💧 Reconstituted Solution Stability: Reconstituted solutions should be used promptly. Stable for up to 48 hours at room temperature or up to 7 days refrigerated (2–8 °C).
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on packaging. Do not use past expiration date. Prescription medicine.

To verify the authenticity of original Cromobact manufactured by Fusion Health Care, check the following security features:

• ✅ Fusion Corporate Logo: Official red circular emblem featuring a stylized white "F" (Fusion Health Care) located at the bottom of the carton face.
• ✅ Product Branding Typography: The brand name "Cromobact™" printed in green lettering with a stylized red bacterial/letter graphic accent, accompanied by Hindi subtext ("क्रोमोबाक्ट").
• ✅ Color Layout: Upper face panel features a green accent block carrying white text "Aztreonam for Injection USP", while the lower section is white with "For IM / IV Use" and dosage "1g".
• ✅ Batch Identification: Side panel clearly displays stamped batch number (e.g., CMBT-23), manufacturing date (12/2025), expiration date (11/2027), along with manufacturer corporate details (Banjara Hills, Hyderabad, India).