Product Classification

• Type: Broad-spectrum antibiotic.

• Drug Category: Beta-lactam antibiotic (Cephalosporin).

• Therapeutic Class: Anti-infective / Antibacterial.

Active Ingredient and Composition

• Ceftriaxone Sodium equivalent to 1 g Ceftriaxone.

• Formulation: Sterile powder for solution (intravenous or intramuscular injection).

• Excipients: Pharmaceutical-grade stabilizers (as per pharmacopeia standards).

Mechanism of Action

• Ceftriaxone is a third-generation cephalosporin antibiotic.

• Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).

• Results in bactericidal effect against both Gram-positive and Gram-negative bacteria.

• Stable against many beta-lactamases, providing broad coverage.

Indications and Benefits

• Primary Uses: Treatment of moderate to severe bacterial infections, including:

  • Respiratory tract infections (pneumonia, bronchitis).

  • ENT infections (otitis media, sinusitis, tonsillitis).

  • Urinary tract infections (UTIs).

  • Skin and soft tissue infections.

  • Bone and joint infections.

  • Abdominal infections (peritonitis, biliary tract infections).

  • Septicemia and meningitis.

  • Gonorrhea (single-dose treatment).

• Surgical Prophylaxis: Pre-operative prevention of infections.

Dosage and Administration

(Must be prescribed and supervised by a healthcare professional)

• Adults & children >12 years: 1–2 g once daily, or divided into two doses.

• Severe infections: Up to 4 g daily.

• Children <12 years: 20–80 mg/kg daily, depending on infection severity.

• Neonates: Max 50 mg/kg/day (avoid calcium-containing solutions).

• Route of Administration: IV infusion, slow IV injection, or deep IM injection.

• Duration: Based on infection type and severity (usually 4–14 days).

Contraindications and Warnings

• Hypersensitivity to ceftriaxone, other cephalosporins, or beta-lactams.

• Contraindicated in neonates requiring calcium treatment (risk of precipitation).

• Use with caution in patients with history of severe penicillin allergy.

• Monitor in patients with renal or hepatic impairment.

• Avoid alcohol during therapy (risk of disulfiram-like reaction).

• Pregnancy & Breastfeeding: Use only if benefits outweigh risks; consult physician.

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Possible Side Effects

• Common: Pain at injection site, rash, diarrhea.

• Uncommon: Nausea, vomiting, dizziness, candidiasis.

• Rare but serious: Severe allergic reactions, pseudomembranous colitis, hematologic changes (anemia, leukopenia, thrombocytopenia).

Packaging and Presentation

• Triamerican 1 g Vial: Sterile glass vial containing powder for reconstitution.

• Supplied in cartons with patient information leaflet.

• Pack sizes: single vial or hospital packs (5–10 vials).

Storage and Shelf-Life

• Store below 25 °C, protected from light and moisture.

• Reconstituted solution should be used within recommended time (usually 6–24 hours depending on solvent).

• Shelf life: 24–36 months (unopened vials).

Manufacturer and Brand

• Manufacturer: Paxal Pharma, Egypt (GMP-certified).

• Distributor/Marketer: Paxal Pharma.

• Brand Positioning: Reliable broad-spectrum injectable antibiotic trusted by hospitals and physicians.

Unique Selling Points (USPs)

• High efficacy broad-spectrum coverage against major Gram-positive and Gram-negative pathogens.

• Convenient once-daily dosing for many infections.

• Trusted hospital antibiotic widely used in critical care and emergency settings.

• Available in multiple strengths (including 500 mg and 1 g) for tailored therapy.

• Cost-effective alternative without compromising on quality.

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