TRIAXONE (IV) 1/G 1/VIAL+1/AMP

Indications

Approved Uses

Treatment of susceptible infections including: lower respiratory tract infections (including pneumonia), acute bacterial otitis media, skin and skin-structure infections, urinary tract infections (including pyelonephritis), intra-abdominal infections (typically with anaerobic coverage), bone and joint infections, bacterial septicemia, meningitis, gonorrhea, and perioperative (surgical) prophylaxis; pelvic inflammatory disease is also an accepted labeled/commonly approved indication in many references.

Off-Label Uses

Common off-label/region-dependent uses include: typhoid fever, disseminated gonococcal infection, serious Salmonella/Shigella infections when susceptible, Lyme disease (IV for neuro/late disease), neurosyphilis (alternative when penicillin cannot be used), and selected endocarditis regimens (in combination, organism-dependent).

Dosage & Administration

Dosing by Condition

Adults (typical): most infections 1-2 g IV once daily (or 1 g IV q12h for some infections); severe infections up to 4 g/day. Meningitis: 2 g IV q12h (max 4 g/day). Gonorrhea (current guideline-based): ceftriaxone 500 mg IM once (<150 kg) or 1 g IM once (≥150 kg) with chlamydia coverage if not excluded (note: this product is IV-only). Surgical prophylaxis: 1-2 g IV single dose within 30-60 minutes before incision (timing per procedure/institution). Intra-abdominal infection: 1-2 g IV daily plus anaerobic coverage (e.g., metronidazole) when indicated.

Initial Dose

1g IV once daily

Maintenance Dose

1-2g IV or IM once daily. For severe infections like meningitis, 2g IV every 12 hours.

Maximum Dose

4g per day (meningitis); 2g per day for most other indications

Children's Dosage

50-75mg/kg/day IV once daily (max 2g/day for most infections); Meningitis: 100mg/kg/day divided every 12-24 hours (max 4g/day); Neonates >41 weeks corrected gestational age without hyperbilirubinemia: 20-50mg/kg/day

Dose Adjustment Notes

No dosage adjustment is usually required for renal impairment or hepatic impairment alone. If severe renal impairment and significant hepatic dysfunction coexist, limit total daily dose to a maximum of 2 g/day and monitor clinical response and adverse effects.

How to Take

IV use only for this product (ceftriaxone 1 g vial for IV reconstitution). Administer either as slow IV injection over 2-4 minutes (commonly up to 5 minutes) or as IV infusion over at least 30 minutes after reconstitution/dilution per institutional protocol. Do NOT mix or co-infuse with calcium-containing IV solutions; in neonates avoid any concomitant IV calcium and use separate lines with thorough flushing in others per policy.

How to Prepare

Reconstitute 1 g vial with 10 mL Water for Injection (as supplied); for IV infusion, further dilute in a compatible fluid (e.g., 0.9% NaCl or 5% dextrose) and administer over ~30 minutes; avoid mixing/co-infusing with calcium-containing solutions

Side Effects

Common Side Effects

Common: diarrhea, nausea/vomiting, rash/hypersensitivity reactions, injection-site reactions (pain, induration, phlebitis), and laboratory abnormalities such as elevated liver enzymes; hematologic changes (eosinophilia, thrombocytosis) can occur.

Side Effect Frequency

Common (≥1%): diarrhea, rash, injection-site reactions; laboratory changes such as eosinophilia, thrombocytosis, and transaminase elevations are also commonly reported; uncommon/rare: nausea/vomiting, headache/dizziness, biliary sludge/pseudolithiasis, hypersensitivity (including anaphylaxis), C. difficile-associated colitis, severe cutaneous reactions, hemolytic anemia, seizures

Safety & Warnings

Contraindications

Known hypersensitivity to ceftriaxone/cephalosporins; history of immediate/severe hypersensitivity to beta-lactams (e.g., anaphylaxis to penicillins) as a practical contraindication; premature neonates up to PMA 41 weeks; hyperbilirubinemic neonates; concomitant IV calcium-containing solutions in neonates ≤28 days (including calcium-containing infusions/TPN).

Warnings & Precautions

Assess for beta-lactam allergy/cross-reactivity; avoid mixing/co-infusing with calcium-containing IV solutions (especially contraindicated in neonates ≤28 days); monitor for C. difficile diarrhea; risk of biliary sludge/pseudolithiasis and renal precipitates (hydration/monitoring with prolonged/high-dose therapy); monitor CBC for hemolytic anemia; monitor INR/prothrombin time in at-risk patients (malnutrition, liver disease, prolonged therapy, anticoagulants); superinfection with prolonged use; caution in seizure disorders/renal dysfunction due to neurotoxicity risk.

Age Restriction

Contraindicated in premature neonates up to a postmenstrual age of 41 weeks and in hyperbilirubinemic neonates (especially ≤28 days); avoid/contraindicated with IV calcium in neonates ≤28 days.

Drug Interactions

Drug Interactions

MAJOR: IV calcium-containing solutions/infusions (precipitation risk; contraindicated in neonates ≤28 days; avoid Y-site mixing in all ages). MODERATE: Warfarin/other anticoagulants (↑INR/bleeding risk), probenecid (may increase levels), aminoglycosides/other nephrotoxins (additive nephrotoxicity risk-monitor). OTHER: Live oral bacterial vaccines (e.g., typhoid) may have reduced efficacy; oral contraceptive failure is not a reliable/clinically significant interaction but counsel about GI upset affecting absorption if applicable.

Interaction Severity

MAJOR: IV calcium-containing solutions (risk of precipitation; contraindicated in neonates and avoid co-infusion/ensure line separation and flushing in others). MODERATE: warfarin/vitamin K antagonists (increased INR/bleeding risk-monitor). Other clinically relevant: live oral bacterial vaccines (e.g., cholera/typhoid) may have reduced efficacy; additive nephrotoxicity is mainly a concern with aminoglycosides in general practice though ceftriaxone itself is not strongly nephrotoxic.

Food Interaction

No food restrictions (parenteral administration).

Special Populations

Children

50-75mg/kg/day IV once daily (max 2g/day for most infections); Meningitis: 100mg/kg/day divided every 12-24 hours (max 4g/day); Neonates >41 weeks corrected gestational age without hyperbilirubinemia: 20-50mg/kg/day

Kidney Impairment

No adjustment for renal impairment alone for usual dosing; if severe renal impairment coexists with significant hepatic dysfunction, do not exceed 2 g/day and monitor.

Storage & Patient Advice

Preparation Instructions

Reconstitute 1 g vial with 10 mL Water for Injection (as supplied); for IV infusion, further dilute in a compatible fluid (e.g., 0.9% NaCl or 5% dextrose) and administer over ~30 minutes; avoid mixing/co-infusing with calcium-containing solutions

Missed Dose

Because this is administered by healthcare professionals, if a scheduled dose/appointment is missed, contact the treating team promptly to reschedule; do not double doses without clinician direction.

Stopping the Medicine

Complete the full prescribed course; do not stop early unless advised by the prescriber (e.g., serious adverse reaction).

Patient Counseling

Explain it is an IV antibiotic given by healthcare professionals; stress completing the prescribed course. Seek urgent care for allergy symptoms (rash, swelling, breathing difficulty). Report severe/persistent diarrhea (possible C. difficile). Inform clinicians about all medicines, especially anticoagulants, and discuss vaccines (live oral bacterial vaccines may be less effective during antibiotics).

Monitoring Requirements

Monitor clinical response and hypersensitivity. With prolonged therapy and/or high doses: CBC, liver function tests, and renal function. Monitor INR/prothrombin time in patients on anticoagulants or with low vitamin K stores; watch for C. difficile-associated diarrhea and superinfection.

Pharmacology

Mechanism of Action

Beta-lactam cephalosporin that binds penicillin-binding proteins, inhibiting the final transpeptidation (cross-linking) step of peptidoglycan cell-wall synthesis, leading to bacterial cell lysis and death.

Onset of Action

Rapid after IV administration (clinical effect begins as therapeutic levels are achieved immediately; symptomatic improvement typically within 24-72 hours depending on infection).

Duration of Effect

Approximately 24 hours (supports once-daily dosing for many indications).

Half-Life

Approximately 5.8-8.7 hours in healthy adults (average elimination half-life approximately 4.3-4.6 hours reported in some studies)

Bioavailability

IV: 100% (by definition); IM: high/near-complete (~100%) but not strictly 100% in all references

Product Information

Available Dosage Forms

Powder for solution for injection/infusion in a vial for IV use (this SFDA-registered product includes a 10 mL water-for-injection ampoule for reconstitution).

Composition per Dose

Each vial: 1g ceftriaxone as ceftriaxone sodium, reconstituted with 10mL water for injection

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Cephalosporin

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