Ceftriaxone Uses, Dosage, Side Effects & Price | DrugsAtlas
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Therapeutic Class
Antibacterial
Subclass
Third-Generation Cephalosporin
Speciality
Infectious Disease
Schedule (India)
Schedule H
Routes
Intravenous (IV), Intramuscular (IM)
Formulations
| Form | Strengths |
|---|---|
| Powder for Injection (IV/IM) | 250 mg; 500 mg; 1 g; 2 g per vial |
| Fixed-Dose Combinations | Ceftriaxone + Sulbactam (1 g + 500 mg; 1.5 g combination); Ceftriaxone + Tazobactam (1 g + 125 mg) |
Reconstitution Notes:
- IV: Reconstitute with Sterile Water for Injection or compatible IV fluid
- IM: Reconstitute with 1% Lidocaine (without adrenaline) to reduce injection pain ā Lidocaine-containing solution must NOT be used for IV administration
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Community-Acquired Pneumonia (CAP)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 g IV/IM once daily |
| Titration | Increase to 2 g once daily for severe pneumonia |
| Usual maintenance dose | 1ā2 g once daily |
| Maximum dose | 4 g/day (given as 2 g every 12 hours if >2 g/day required) |
| Duration | 5ā7 days; extend to 10ā14 days for severe or complicated cases |
Clinical Note: For severe CAP requiring ICU admission, consider combination with macrolide (azithromycin) or fluoroquinolone for atypical coverage.
2. Bacterial Meningitis
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2 g IV every 12 hours |
| Titration | Not applicable |
| Usual maintenance dose | 2 g IV every 12 hours (4 g/day total) |
| Maximum dose | 4 g/day |
| Duration | 7 days (meningococcal); 10ā14 days (pneumococcal); 21 days (Listeria ā add ampicillin) |
Clinical Note: Higher doses and shorter dosing intervals essential for adequate CSF penetration. Add dexamethasone before or with first antibiotic dose for suspected bacterial meningitis.
3. Enteric Fever (Typhoid/Paratyphoid)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2 g IV/IM once daily |
| Titration | Not applicable |
| Usual maintenance dose | 2 g once daily |
| Maximum dose | 2 g/day (some protocols allow up to 4 g/day in severe cases) |
| Duration | 10ā14 days; minimum until afebrile for 5 days |
Clinical Note: Preferred parenteral agent for multi-drug resistant (MDR) and fluoroquinolone-resistant typhoid, which is increasingly common in India. Blood culture before initiation recommended where feasible.
4. Uncomplicated Gonorrhoea (Urethritis/Cervicitis)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 250 mg IM as single dose (Indian practice) OR 500 mg IM single dose (per updated guidelines) |
| Titration | Not applicable |
| Usual maintenance dose | Not applicable (single-dose therapy) |
| Maximum dose | 500 mg single dose |
| Duration | Single dose |
Clinical Note: Always co-treat with azithromycin 1 g orally single dose (dual therapy) to cover potential chlamydial co-infection and reduce gonococcal resistance emergence. Higher dose (500 mg) increasingly recommended due to rising MICs.
5. Intra-Abdominal Infections (Including Peritonitis, Cholangitis)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 1ā2 g IV once daily |
| Titration | Not applicable |
| Usual maintenance dose | 2 g once daily |
| Maximum dose | 4 g/day (in severe infections) |
| Duration | 5ā14 days depending on source control and clinical response |
Clinical Note: Add metronidazole for anaerobic coverage in mixed intra-abdominal infections.
6. Skin and Soft Tissue Infections (Complicated)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 g IV/IM once daily |
| Titration | Increase to 2 g once daily for severe infections |
| Usual maintenance dose | 1ā2 g once daily |
| Maximum dose | 4 g/day |
| Duration | 7ā14 days |
7. Bone and Joint Infections (Osteomyelitis, Septic Arthritis)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2 g IV once daily |
| Titration | Not applicable |
| Usual maintenance dose | 2 g once daily |
| Maximum dose | 4 g/day (divided doses if >2 g) |
| Duration | 4ā6 weeks (osteomyelitis); 3ā4 weeks (septic arthritis) |
Clinical Note: Requires culture-guided therapy. Often used as empirical agent pending sensitivity results. Orthopaedic/infectious disease specialist input recommended for prolonged courses.
8. Urinary Tract Infections (Complicated/Pyelonephritis)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 g IV/IM once daily |
| Titration | Increase to 2 g once daily for severe pyelonephritis or urosepsis |
| Usual maintenance dose | 1ā2 g once daily |
| Maximum dose | 4 g/day |
| Duration | 10ā14 days; step-down to oral therapy when clinically stable |
9. Surgical Prophylaxis
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 g IV, 30ā60 minutes before surgical incision |
| Titration | Not applicable |
| Usual maintenance dose | Not applicable (single pre-operative dose) |
| Maximum dose | 2 g for high-risk or colorectal surgery |
| Duration | Single dose; redose if surgery prolonged (>4 hours) or significant blood loss |
Clinical Note: Appropriate for clean-contaminated procedures. Not routinely recommended for clean procedures unless prosthetic material involved.
10. Sepsis / Septicaemia (Empirical Therapy)
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2 g IV once daily (or 1 g every 12 hours) |
| Titration | Not applicable |
| Usual maintenance dose | 2 g once daily |
| Maximum dose | 4 g/day |
| Duration | As per culture-sensitivity and source; typically 7ā14 days |
Clinical Note: Empirical choice for community-acquired sepsis. Not effective against MRSA, Pseudomonas, or ESBL-producers ā escalate if these are suspected.
Secondary Indications ā Adults (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Spontaneous Bacterial Peritonitis (SBP) | 2 g IV once daily | 5 days | OFF-LABEL. Standard practice in Indian hepatology centres (AIIMS, PGI protocols). Culture ascitic fluid before starting. Step-down to oral fluoroquinolone if sensitive |
| Lyme Disease (Early disseminated/Late ā Neuroborreliosis) | 2 g IV once daily | 14ā28 days | OFF-LABEL. Rare in India; relevant for travellers returning from endemic areas |
| Infective Endocarditis (Native valve ā Streptococcal) | 2 g IV once daily | 4 weeks (with or without gentamicin) | OFF-LABEL. Specialist use only. Based on AHA/ESC guidelines adapted in tertiary centres |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
1. Bacterial Meningitis
Neonates (≤28 days):
| Parameter | Recommendation |
|---|---|
| Starting dose | 50 mg/kg IV once daily |
| Titration | Not applicable |
| Usual maintenance dose | 50 mg/kg once daily |
| Maximum dose | 50 mg/kg/day (do not exceed 2 g/day) |
| Duration | 14ā21 days depending on organism |
Infants and Children (>28 days to 12 years):
| Parameter | Recommendation |
|---|---|
| Starting dose | 50 mg/kg IV |
| Titration | Not applicable |
| Usual maintenance dose | 80ā100 mg/kg/day divided every 12 hours |
| Maximum dose | 4 g/day |
| Duration | 7ā14 days depending on pathogen |
2. Community-Acquired Pneumonia (Severe/Hospitalised)
Infants and Children:
| Parameter | Recommendation |
|---|---|
| Starting dose | 50 mg/kg IV/IM once daily |
| Titration | Not applicable |
| Usual maintenance dose | 50ā75 mg/kg once daily |
| Maximum dose | 2 g/day |
| Duration | 5ā10 days |
3. Enteric Fever (Typhoid)
Infants and Children:
| Parameter | Recommendation |
|---|---|
| Starting dose | 50 mg/kg IV/IM once daily |
| Titration | Not applicable |
| Usual maintenance dose | 75 mg/kg once daily |
| Maximum dose | 2 g/day |
| Duration | 10ā14 days; minimum until afebrile for 5 days |
Clinical Note: Preferred parenteral agent for MDR typhoid in children.
4. Sepsis / Severe Bacterial Infections
Neonates:
| Age | Dose | Frequency | Maximum |
|---|---|---|---|
| 0ā7 days | 50 mg/kg | Once daily | 50 mg/kg/day |
| 8ā28 days | 50ā75 mg/kg | Once daily | 75 mg/kg/day |
Infants and Children:
| Parameter | Recommendation |
|---|---|
| Starting dose | 50 mg/kg IV |
| Usual maintenance dose | 50ā80 mg/kg/day in 1ā2 divided doses |
| Maximum dose | 4 g/day |
5. Uncomplicated Gonorrhoea (Adolescents ≥45 kg)
| Parameter | Recommendation |
|---|---|
| Dose | 250ā500 mg IM single dose |
| Duration | Single dose |
Clinical Note: Co-treat with azithromycin. NACO STI guidelines applicable.
6. Surgical Prophylaxis (Paediatric)
| Parameter | Recommendation |
|---|---|
| Dose | 50 mg/kg IV (max 1 g) 30ā60 minutes before incision |
| Duration | Single dose |
Secondary Indications ā Paediatrics (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| SBP in Paediatric Liver Disease | 50ā75 mg/kg IV once daily (max 2 g) | 5ā7 days | OFF-LABEL. Specialist hepatologist only. Monitor for biliary sludging |
Age Restrictions and Special Neonatal Precautions
| Population | Recommendation |
|---|---|
| Preterm neonates (<41 weeks postmenstrual age) | Use with extreme caution; risk of bilirubin displacement and kernicterus |
| Hyperbilirubinaemic neonates | AVOID ceftriaxone; use alternative cephalosporin (cefotaxime preferred) |
| Neonates receiving calcium-containing IV fluids | CONTRAINDICATED due to fatal ceftriaxone-calcium precipitation |
| Term neonates (>41 weeks) without hyperbilirubinaemia | May use with caution; avoid concurrent calcium infusions |
Safety Monitoring in Paediatrics:
- Bilirubin levels in neonates at risk
- Ultrasound if prolonged therapy (>14 days) ā assess for biliary sludging/pseudolithiasis
- Renal and hepatic function in prolonged courses
- Signs of superinfection (oral thrush, diarrhoea)
Renal Adjustments
| eGFR (mL/min) | Recommendation |
|---|---|
| >10 | No dose adjustment required |
| ≤10 (without hepatic impairment) | No dose adjustment required; monitor closely |
| ≤10 (with concurrent hepatic impairment) | Maximum 2 g/day |
| Haemodialysis | Not significantly removed; no supplemental dose required post-dialysis |
| Peritoneal dialysis | No supplemental dose required |
| CRRT | Standard dosing; monitor clinical response |
Clinical Note: Ceftriaxone has dual elimination (hepatic and renal). Dose reduction only needed when both routes are severely impaired.
Hepatic adjustment
Contraindications
- Known hypersensitivity to ceftriaxone or any cephalosporin antibiotic
- History of severe (anaphylactic) hypersensitivity reaction to any beta-lactam antibiotic
- Hyperbilirubinaemic neonates, especially preterm infants (<41 weeks postmenstrual age)
- Neonates requiring (or expected to require) calcium-containing IV infusions including parenteral nutrition
- Full-term neonates (<28 days) if concomitant IV calcium administration is anticipated
- Reconstitution with calcium-containing diluents (e.g., Ringer's lactate, Hartmann's solution)
Cautions
- History of non-severe penicillin allergy ā cross-reactivity risk approximately 1ā2% (higher with aminopenicillins); observe for allergic reactions
- Prolonged therapy (>14 days) ā risk of biliary sludging/gallbladder pseudolithiasis (especially in children, fasting patients, those on TPN)
- Dehydration or restricted fluid intake ā increased risk of biliary precipitation
- History of gastrointestinal disease, particularly colitis ā risk of Clostridioides difficile-associated diarrhoea
- Concurrent aminoglycoside use ā additive nephrotoxicity; administer separately and monitor renal function
- Premature neonates ā use cefotaxime preferentially to avoid bilirubin displacement risk
- IM administration ā painful injection; use lidocaine 1% for reconstitution (never for IV use)
Pregnancy
| Parameter | Recommendation |
|---|---|
| Overall safety | Generally considered safe; widely used in pregnancy |
| Risk category | Category B (US legacy); no formal India classification; extensive clinical experience supports safety |
| Preferred alternatives | Ceftriaxone is often preferred parenteral cephalosporin in pregnancy for serious infections |
| When to use | For serious infections (typhoid, pneumonia, pyelonephritis, sepsis) when parenteral therapy required |
| Monitoring | Hypersensitivity reactions; CBC and LFTs if prolonged use; standard foetal monitoring |
Lactation
| Parameter | Recommendation |
|---|---|
| Compatibility | Compatible with breastfeeding |
| Drug levels in milk | Low (approximately 3ā4% of maternal dose); clinically insignificant |
| Preferred alternatives | None required; ceftriaxone acceptable during breastfeeding |
| Infant monitoring | Observe for loose stools, oral thrush, or rash (rare) |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | Standard adult dosing; no age-related reduction required |
| Titration | Not applicable |
| Specific considerations | Assess renal function (serum creatinine may underestimate impairment); ensure adequate hydration to reduce biliary precipitation risk |
| Additional risks | Higher risk of Clostridioides difficile infection; increased susceptibility to biliary complications if malnourished or prolonged fasting |
| Monitoring | Renal function; hepatic function in prolonged therapy; signs of superinfection |
Major drug interactions
| Drug | Interaction | Recommendation |
|---|---|---|
| Calcium-containing IV solutions (Ringer's lactate, Hartmann's, calcium gluconate, TPN with calcium) | Risk of ceftriaxone-calcium precipitate formation ā can be fatal in neonates; lung/kidney precipitation reported | CONTRAINDICATED in neonates. In adults/children, administer through separate lines; flush between infusions; do not mix in same bag/syringe |
| Warfarin/Acenocoumarol | Enhanced anticoagulant effect; mechanism includes vitamin K antagonism via gut flora disruption and possible direct effect | Monitor INR closely during and for several days after ceftriaxone course; adjust anticoagulant dose as needed |
| Aminoglycosides (Amikacin, Gentamicin) | Additive nephrotoxicity; also physical incompatibility if mixed | Administer separately via different lines/sites; monitor serum creatinine and aminoglycoside levels |
Moderate drug interactions
| Drug | Interaction | Recommendation |
|---|---|---|
| Loop diuretics (Furosemide) | Theoretical increased nephrotoxicity risk | Generally safe; monitor renal function, especially in dehydrated patients |
| Probenecid | Decreases renal tubular secretion of ceftriaxone; increases plasma levels | Usually not clinically significant due to hepatic elimination; no dose adjustment typically needed |
| Oral contraceptives | Theoretical reduction in efficacy via gut flora alteration | Advise additional barrier contraception during antibiotic course and for 7 days after (precautionary) |
| Chloramphenicol | Potential antagonism (bacteriostatic vs bactericidal) | Avoid combination where possible; if used, monitor clinical response closely |
Common Adverse effects
- Injection site pain and induration (IM route)
- Phlebitis/thrombophlebitis (IV route)
- Diarrhoea
- Nausea and vomiting
- Skin rash (maculopapular)
- Transient elevation of liver enzymes (AST, ALT)
- Eosinophilia
- Biliary sludging/pseudolithiasis (especially with prolonged use, higher doses, or fasting)
- Positive direct Coombs test (usually without haemolysis)
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
| Anaphylaxis | Rare but potentially fatal; discontinue immediately; manage with adrenaline and supportive care |
| Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis | Very rare; discontinue immediately; requires hospitalisation |
| Immune haemolytic anaemia | Rare; can be severe; discontinue ceftriaxone permanently |
| Clostridioides difficile-associated diarrhoea (CDAD) | May occur during or after therapy; discontinue ceftriaxone if confirmed; treat with oral vancomycin or metronidazole |
| Biliary obstruction (from pseudolithiasis) | Usually reversible upon drug discontinuation; ultrasound for diagnosis |
| Ceftriaxone-calcium precipitation (neonates) | Fatal cardiopulmonary reactions reported; strictly avoid concurrent calcium infusions in neonates |
| Seizures | Rare; reported with very high doses or in renal impairment |
| Interstitial nephritis | Rare; presents with fever, rash, eosinophilia, rising creatinine |
| Agranulocytosis / Neutropenia | Rare; monitor CBC in prolonged therapy |
Monitoring requirements
| Phase | Parameters |
|---|---|
| Baseline | Serum creatinine, LFTs, CBC, allergy history (especially to penicillins/cephalosporins); bilirubin in neonates |
| During treatment | Clinical response; signs of hypersensitivity; GI tolerance; injection site (for phlebitis/pain) |
| Prolonged therapy (>7 days) | LFTs weekly; CBC; renal function; ultrasound abdomen if >14 days (especially in children) to assess for biliary sludging |
| If on anticoagulants | INR monitoring during and after ceftriaxone course |
| Neonates | Bilirubin levels; avoid concurrent calcium; monitor for precipitation-related complications |
Brands in India
| Brand Name | Manufacturer |
|---|---|
| Monocef | Aristo |
| Ceftriaxone (Generic) | Multiple manufacturers |
| Taxim | Alkem |
| Oframax | Unidentified |
| Xone | Alkem |
| Cefaxone | Lupin |
| LupiCef | Lupin |
| Ceftriax | Cadila |
| Monotax | Zydus |
Fixed-Dose Combinations:
- Monocef-SB, Magnex (Ceftriaxone + Sulbactam)
- Intacef Tazo (Ceftriaxone + Tazobactam)
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| 250 mg vial | ā¹15āā¹40 |
| 500 mg vial | ā¹25āā¹60 |
| 1 g vial | ā¹30āā¹80 |
| 2 g vial | ā¹70āā¹150 |
| Ceftriaxone + Sulbactam 1.5 g | ā¹80āā¹180 |
Regulatory Note: Listed under NLEM 2022. Prices regulated by NPPA for scheduled strengths. Available through government supply (NRHM, hospital pharmacies) at significantly lower rates.
Clinical pearls
- Once-daily dosing advantage: Long half-life (6ā8 hours) allows once-daily administration for most indications except meningitis, simplifying inpatient and outpatient parenteral therapy.
- Calcium contraindication in neonates is absolute: Fatal cardiopulmonary precipitation reported. If ceftriaxone essential, ensure 48-hour gap from any calcium-containing infusion. Cefotaxime is safer alternative in neonates.
- IM injection technique: Reconstitute with 1% lidocaine (without adrenaline) for IM use to reduce pain. Never use lidocaine-containing solution for IV administration.
- Biliary sludging is reversible: If gallbladder pseudolithiasis occurs (more common with >14 days therapy or fasting patients), it typically resolves spontaneously after stopping ceftriaxone.
- Empirical typhoid therapy: Ceftriaxone is preferred parenteral agent in India given high fluoroquinolone resistance. Continue for 10ā14 days for optimal cure rates.
- Not effective against: MRSA, Pseudomonas aeruginosa, Enterococcus species, ESBL-producing Enterobacteriaceae, Acinetobacter. Escalate therapy if these organisms suspected.
Version
RxIndia v1.0 ā 20 Apr 2025
Reference
-
- CDSCO Drug Database and Product Inserts
- Indian Pharmacopoeia 2022
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine (11th Edition)
- AIIMS Antibiotic Guidelines and Treatment Protocols
- IAP Antimicrobial Guidelines for Paediatric Practice
- ICMR Guidelines for Antimicrobial Use
- NACO STI/RTI Treatment Guidelines
- ILBS/PGI Hepatology Protocols (for SBP)
- WHO Essential Medicines List (supportive reference)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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