Ceftriaxone in Egypt: A Guide to Brands, Uses, and Safety Warnings

Disclaimer: This document is for educational and reference purposes only. It does not replace official prescribing information, clinical judgment, or institutional protocols. Always consult updated guidelines and product labeling before use.

Ceftriaxone: A Comprehensive Guide for the Egyptian Market

Summary

Ceftriaxone is a powerful, broad-spectrum, third-generation cephalosporin antibiotic administered via injection. It is widely used to treat serious bacterial infections such as meningitis, pneumonia, and gonorrhea. Due to its long half-life, it is typically dosed once daily. Key safety considerations include the risk of precipitation with IV calcium solutions (especially in neonates) and the potential for biliary sludging. This guide provides detailed information on its use, dosage, and the various brands available in Egypt.

Generic Name & Pharmacological Class

• Generic Name: Ceftriaxone Sodium.
• Class: Third-generation Cephalosporin Antibiotic.

Available Forms & Strengths

Ceftriaxone is available as a powder for solution for injection, which must be reconstituted before use. Common strengths include:

• 250 mg / vial
• 500 mg / vial
• 1 g (1000 mg) / vial

Mechanism of Action

Ceftriaxone is a bactericidal agent that works by inhibiting the synthesis of the bacterial cell wall. It binds to penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall, which prevents the final step of peptidoglycan synthesis. This leads to cell lysis and death.

Pharmacokinetics

• Absorption: 100% absorbed after intramuscular (IM) injection.
• Distribution: Widely distributed in body tissues and fluids, including excellent penetration into the cerebrospinal fluid (CSF), making it effective for meningitis.
• Protein Binding: Reversibly binds to plasma proteins (85-95%).
• Elimination: Excreted through a dual pathway: approximately 60% via the kidneys (urine) and 40% via the liver (bile).
• Half-life: Long elimination half-life of 6-9 hours, allowing for once-daily dosing in most cases.

Indications

Ceftriaxone is indicated for the treatment of the following serious infections caused by susceptible organisms:

• Lower respiratory tract infections, including community-acquired pneumonia.
• Bacterial meningitis.
• Complicated urinary tract infections and pyelonephritis.
• Skin and soft tissue infections.
• Intra-abdominal infections (e.g., peritonitis), often in combination with other antibiotics.
• Bone and joint infections.
• Bacterial septicemia.
• Uncomplicated gonorrhea.
• Surgical prophylaxis to reduce the risk of postoperative infections.

Dosage and Administration

Important: Ceftriaxone for IM injection is often reconstituted with 1% Lidocaine to reduce pain. Do not use Lidocaine for IV reconstitution.

• Adults: 1-2 g administered IV or IM once daily. In severe infections, the dose may be increased to 4 g per day (administered in two divided doses).
• Bacterial Meningitis: 100 mg/kg/day, usually 2 g IV every 12 hours (max 4 g/day).
• Uncomplicated Gonorrhea: 500 mg IM as a single dose (as per 2021 CDC guidelines).
• Pediatrics (1 month to 12 years): 50-75 mg/kg once daily (max 2 g/day).
• Neonates (up to 14 days): 20-50 mg/kg once daily. Do not exceed 50 mg/kg/day.

Contraindications

Ceftriaxone is contraindicated in patients with:

• Known severe hypersensitivity to ceftriaxone or any cephalosporin.
• A history of severe, immediate hypersensitivity reaction (e.g., anaphylaxis) to any penicillin antibiotic.
• Hyperbilirubinemic neonates, especially premature infants.
• Absolute Contraindication: Concomitant use of ceftriaxone and IV calcium-containing solutions in neonates (≤28 days of age).

Warnings & Precautions

• Precipitation with Calcium: Do not use calcium-containing diluents (e.g., Ringer's lactate) to reconstitute ceftriaxone vials or to dilute for IV administration.
• Immune-Mediated Hemolytic Anemia: A serious, and sometimes fatal, side effect. Discontinue if anemia develops.
• Clostridioides difficile-Associated Diarrhea (CDAD): Can range from mild diarrhea to fatal colitis. Consider in any patient who presents with diarrhea following antibiotic use.
• Biliary Pseudolithiasis (Sludging): Reversible precipitates in the gallbladder may occur, especially in children. Usually resolves after discontinuation.
• Renal and Hepatic Impairment: Monitor plasma concentrations in patients with severe renal impairment who are also hepatically impaired.

Drug Interactions

• Calcium-Containing Solutions: Can form fatal precipitates in the lungs and kidneys of neonates. In older patients, do not administer simultaneously, even via different infusion lines.
• Warfarin: May increase the anticoagulant effect. Monitor INR.
• Aminoglycosides: Potential for additive nephrotoxicity. Monitor renal function.

Use in Specific Populations

• Pregnancy: Category B. Use only if clearly needed, as it crosses the placenta.
• Lactation: Excreted in low concentrations in breast milk. Generally considered compatible, but caution is advised.
• Pediatrics: See Contraindications for neonates. Effective for most pediatric infections.
• Geriatrics: Generally safe, but adjust dose in cases of severe combined renal and hepatic dysfunction.

Side Effects

• Local Reactions: Pain, induration, and tenderness at the IM injection site.
• Common: Diarrhea, rash, eosinophilia, thrombocytosis.
• Less Common: Elevated liver enzymes (AST, ALT), leukopenia.
• Rare but Serious: Anaphylaxis, immune-mediated hemolytic anemia, pseudomembranous colitis, biliary sludging, pancreatitis.

Storage

• Store un-reconstituted vials at controlled room temperature (below 30°C), protected from light.
• Follow manufacturer's instructions for stability after reconstitution, as it varies.

Brands & Manufacturers in Egypt

The Egyptian market features several brands of Ceftriaxone, with various manufacturing and marketing relationships:

• Direct Production:
  • CEFTRIAXONE-KAHIRA: (e.g., 1 g IM vial) - by KAHIRA.
  • CEFTRIAXONE-EVA: (e.g., 250 mg, 500 mg, 1 g IM/IV) - by EVA PHARMA.
  • CEFTRIAXONE-SEDICO: (e.g., 1 g IM) - by SEDICO.
• Co-Marketing / Tolling:
  • CEFTRIAXONE-SEDICO (IV): (e.g., 500 mg IV) - Manufactured by SEDICO, marketed by RAMEDA.
  • CEFTRIAXONE-SANDOZ: (e.g., 1 g, 500 mg IM/IV) - Manufactured by PHARCO B, marketed by SANDOZ.
  • CEFTRIAXONE-SANDOZ (250 mg): Manufactured by NOVARTIS, marketed by SANDOZ.

Note: The "X > Y" format indicates manufactured by X and marketed by Y, an important distinction in the market.

Frequently Asked Questions (FAQ)

Q1: Why can't ceftriaxone be given with IV calcium in babies?

A: It can form a solid precipitate (like tiny stones) in the lungs and kidneys, which can be fatal. This risk is highest in neonates (≤28 days old).

Q2: Does the dose need to be changed for kidney patients?

A: Not usually. Because ceftriaxone is cleared by both the kidneys and the liver, dose adjustment is typically only needed if a patient has severe impairment of both organs.

Q3: Is the single dose for gonorrhea still effective?

A: Yes, but due to increasing resistance, the CDC updated its guidelines in 2021 to recommend a higher single dose of 500 mg IM for uncomplicated gonorrhea.

Q4: Does ceftriaxone treat Pseudomonas infections?

A: No, ceftriaxone does not have reliable activity against Pseudomonas aeruginosa. Other antibiotics like ceftazidime, cefepime, or piperacillin-tazobactam are used instead.

References

1. Lexicomp®. "Ceftriaxone: Drug Information". UpToDate.
2. Centers for Disease Control and Prevention (CDC). "Sexually Transmitted Infections Treatment Guidelines, 2021".
3. World Health Organization (WHO). "Model List of Essential Medicines".
4. Official Product Leaflets from respective manufacturers (e.g., SEDICO, SANDOZ).