Aciphin (Inj) 500mg vial i.v

Aciphin 500mg IV Injection — Ceftriaxone 500mg Intravenous

1. Indications

Aciphin® 500mg IV contains ceftriaxone — a third-generation cephalosporin for once-daily parenteral treatment of moderate to severe bacterial infections. Indicated for: lower respiratory tract infections (pneumonia, bronchitis); complicated and uncomplicated urinary tract infections (UTI, pyelonephritis); septicaemia; skin, soft tissue, bone and joint infections; intra-abdominal infections; bacterial meningitis; uncomplicated gonorrhoea (250mg single IM dose); pelvic inflammatory disease (PID); ENT infections; acute bacterial otitis media; bacterial endocarditis; surgical prophylaxis; typhoid fever; and infections in immunocompromised patients. The 500mg IV dose is commonly used for paediatric infections and as a step-down from higher adult doses.

Diabetes relevance: Essential for hospitalised diabetic patients with diabetic foot infections, complicated UTIs, and systemic bacterial infections. Ceftriaxone's dual hepatic-renal elimination and absence of nephrotoxicity make it safe in diabetic patients with renal impairment.

2. Mechanism of Action

Ceftriaxone inhibits bacterial cell wall synthesis by binding penicillin-binding proteins (PBPs), preventing peptidoglycan cross-linking. This causes osmotic lysis and rapid bacterial death. Active against beta-lactamase-producing organisms. Bactericidal against: S. pneumoniae, H. influenzae, E. coli, K. pneumoniae, Neisseria spp., Salmonella typhi, and many other Gram-positive and Gram-negative pathogens.

3. Dosage & Administration

Adults: 1–2g once daily (every 24h). Severe infections: 2–4g/day. Children (15 days–12 years): 20–50 mg/kg/day; up to 80 mg/kg in severe infections. Neonates: 20–50 mg/kg/day IV infusion over 60 minutes (max 50 mg/kg).
IV Reconstitution: Dissolve 500mg in 5ml Water for Injection BP. Give by slow IV push over minimum 5 minutes. Reconstituted solution stable 6h at room temperature, 24h at 5°C.
Renal/hepatic impairment: No dose adjustment needed for CrCl >10 ml/min. If CrCl <10 ml/min: maximum 2g/day. No change needed for hepatic impairment if renal function intact.
Duration: Continue 2–3 days after signs and symptoms resolve (typically 4–14 days).

4. Side Effects

Generally well tolerated. GI: nausea, vomiting, diarrhoea (2–4%). C. difficile-associated diarrhoea possible. Haematological: eosinophilia, thrombocytosis/thrombocytopenia, leucopaenia. Hepatic: transient elevated liver enzymes. Biliary sludge/pseudolithiasis (reversible on discontinuation — especially children on high doses). Rarely: convulsions, dizziness, fever. IV site: phlebitis. Hypersensitivity: rash, urticaria; rarely anaphylaxis (cross-reaction with penicillin in 1–2% penicillin-allergic patients). CRITICAL: Never mix with calcium-containing IV solutions — fatal precipitation.

5. Contraindications

Hypersensitivity to ceftriaxone, cephalosporins, or history of penicillin anaphylaxis; hyperbilirubinaemic or premature neonates; concurrent calcium-containing IV solutions in neonates.

6. Warnings & Precautions

Perform test dose and monitor 30 minutes for anaphylaxis — have epinephrine ready. Monitor for CDAD if diarrhoea develops. Neonates: do not use with hyperbilirubinaemia or calcium IV fluids. Diabetic patients with CrCl <10 ml/min: cap at 2g/day. Screen for penicillin allergy before administration.

7. Drug Interactions

Aminoglycosides: synergistic (administer separately). Warfarin: may potentiate (monitor INR). Calcium-containing IV solutions: NEVER mix (fatal precipitate). No nephrotoxicity with frusemide or aminoglycosides per ACI official data. Separate IV line required for all concomitant infusions.

8. Pharmacokinetics

100% IV bioavailability. Protein binding 85–95%. Half-life 6–9h (once-daily dosing). Dual elimination: ~50% renal, ~50% biliary (unchanged). Excellent penetration: CSF, bone, lung, bile, peritoneum. Safe in renal impairment — unique advantage over aminoglycosides.

9. Storage

Store dry powder below 30°C, protected from light. After reconstitution: stable 6h at room temperature, 24h at 5°C. Use freshly prepared solutions whenever possible.

10. Course Completion

Complete the full prescribed course. Continue 2–3 days after full resolution of symptoms. Never stop early — risk of relapse and antibiotic resistance.

11. Overdose

No specific antidote. Not removed by haemodialysis. Supportive care and neurological monitoring.

12. Clinical Evidence

WHO Essential Medicine. Standard of care globally for pneumonia (BTS/IDSA), bacterial meningitis (WHO), typhoid, and sepsis. Once-daily dosing confirmed equivalent to twice-daily in multiple RCTs. Preferred parenteral antibiotic for Bangladeshi diabetic patients due to dual hepatic-renal elimination and absence of nephrotoxicity.

13. Patient Counselling

Requires healthcare professional administration. Report rash, breathing difficulty, or swelling immediately (allergy signs). Complete the full course. Report diarrhoea during treatment. This IV box contains Water for Injection solvent — NOT to be confused with Aciphin IM which uses lidocaine (Xylone 1%) solvent. Never interchange.

Frequently Asked Questions (FAQ)

Q1. What is the difference between Aciphin IV and Aciphin IM formulations?
Aciphin IV is reconstituted with Water for Injection BP and given by intravenous route. Aciphin IM is reconstituted with Xylone 1% (lidocaine hydrochloride 1%) and given deep intramuscular. The lidocaine IM preparation must NEVER be given IV — cardiac toxicity risk. Each kit contains the correct solvent for its route.

Q2. Can ceftriaxone be given to children?
Yes — ceftriaxone is widely used in children (15 days and older) at 20–80 mg/kg/day depending on severity. Neonates (up to 14 days) can receive ceftriaxone only if they are not hyperbilirubinaemic — ceftriaxone displaces bilirubin from albumin, risking kernicterus. Always use weight-based dosing for children.

Q3. Why must ceftriaxone never be mixed with Ringer's Lactate?
Ringer's Lactate (and other calcium-containing IV fluids including Hartmann's solution) forms an insoluble precipitate with ceftriaxone in the IV line or bag. This precipitate can block blood vessels, causing embolism — fatalities have been reported in neonates. Always use 0.9% NaCl or 5% dextrose as the flush solution, and administer ceftriaxone via a separate IV line from calcium-containing infusions.

Q4. Is ceftriaxone effective for typhoid fever in Bangladesh?
Yes — ceftriaxone is a first-line treatment for typhoid fever (Salmonella typhi infection) in Bangladesh, especially for multidrug-resistant (MDR) typhoid strains. Typical dose: 2g/day IV for 10–14 days (50–75 mg/kg/day for children). Compared to oral ciprofloxacin, IV ceftriaxone provides faster defervescence for severe typhoid and is effective against fluoroquinolone-resistant strains increasingly prevalent in Bangladesh.

⚕ Medical Disclaimer: Aciphin® is a prescription parenteral antibiotic for administration by trained healthcare professionals only. Product information sourced from ACI Pharmaceuticals Ltd. official prescribing data. Educational purposes only.