Aciphin IM 250 mg

Aciphin IM 250mg Injection — Ceftriaxone 250mg Intramuscular

1. Indications

Aciphin® IM 250mg is the intramuscular formulation of ceftriaxone for outpatient or clinic-based treatment of bacterial infections not requiring IV access. The 250mg IM dose is specifically indicated for: uncomplicated gonorrhoea (single 250mg IM dose — WHO recommended); paediatric infections (weight-based dosing); step-down from IV ceftriaxone in patients discharged from hospital; moderate UTIs and pyelonephritis (outpatient setting); community-acquired pneumonia (outpatient); skin and soft tissue infections; ENT infections (otitis media, sinusitis, pharyngitis); bone and joint infections (combination with oral therapy); and infections in patients without IV access.

Diabetes relevance: Used in outpatient treatment of mild-to-moderate diabetic foot infections, community-acquired UTIs in diabetic patients, and clinic-based management of infections where IV access is not available. IM route avoids phlebitis risk.

2. Mechanism of Action

Ceftriaxone inhibits bacterial cell wall synthesis by binding penicillin-binding proteins (PBPs), blocking peptidoglycan cross-linking and causing osmotic bacterial lysis (bactericidal). The IM route achieves serum levels within 1–2h that are therapeutically equivalent to IV dosing for most indications due to near-complete IM bioavailability (~100%). Active against: Streptococcus pneumoniae, H. influenzae, E. coli, K. pneumoniae, Neisseria gonorrhoeae, Salmonella typhi, S. aureus (MSSA), and many Enterobacteriaceae.

3. Dosage & Administration

Uncomplicated gonorrhoea: 250mg single IM dose. Adults — general infections: 1–2g once daily IM. Children: 20–80 mg/kg/day IM (max 50 mg/kg for non-meningitis).
IM Reconstitution: Using the 5ml syringe and baby needle provided, draw up the 2ml Xylone 1% (lidocaine HCl) from the ampoule. Inject into the vial containing ceftriaxone 250mg powder. Mix gently until completely dissolved — solution should be clear to slightly yellow. Inject deep intramuscular into the upper outer quadrant of the gluteus maximus or vastus lateralis. Aspiration recommended to confirm non-vascular placement.
NEVER administer the lidocaine-reconstituted solution intravenously.
Duration: Complete prescribed course. Typically 5–14 days depending on infection.

4. Side Effects

IM injection site: pain (reduced by lidocaine reconstitution), induration, local reaction. GI: nausea, vomiting, diarrhoea (2–4%). CDAD possible (report persistent diarrhoea). Haematological: eosinophilia, thrombocytopenia, leucopaenia. Hepatic: transient elevated liver enzymes. Biliary pseudolithiasis (reversible). Hypersensitivity: rash, urticaria; anaphylaxis (rare). Lidocaine-related (IM use): none expected at this low dose in healthy patients; caution in known lidocaine sensitivity or cardiac conduction disorder.

5. Contraindications

Hypersensitivity to ceftriaxone, cephalosporins, or lidocaine; penicillin anaphylaxis history; hyperbilirubinaemic or premature neonates; known cardiac conduction disorders (lidocaine component). Never given intravenously.

6. Warnings & Precautions

Screen for cephalosporin, penicillin, AND lidocaine allergy before use. Aspirate before IM injection to confirm non-intravascular placement. Have epinephrine ready for anaphylaxis. Monitor for CDAD if diarrhoea develops. Caution in patients with known cardiac arrhythmia (lidocaine). Keep this IM pack strictly separate from IV packs to avoid route error.

7. Drug Interactions

Aminoglycosides: synergistic, administer separately. Warfarin: may potentiate (monitor INR). Lidocaine component: additive cardiac effect with other antiarrhythmics at high systemic doses (not clinically significant at 2ml 1% lidocaine for IM reconstitution). No significant interaction with common diabetes medications.

8. Pharmacokinetics

IM bioavailability ~100% (near-complete). Peak serum concentration: 1–2h after IM injection. Half-life 6–9h (allows once-daily IM dosing). Dual elimination: ~50% renal, ~50% biliary. Excellent tissue penetration: lungs, bone, bile, peritoneum. Lidocaine 2ml 1% = 20mg absorbed systemically — safe at this dose.

9. Storage

Store below 30°C, protected from light. Use reconstituted solution immediately — lidocaine-reconstituted ceftriaxone is stable only 6h at room temperature. Do not refrigerate reconstituted IM solution.

10. Course Completion

Complete the full prescribed course. For gonorrhoea: single dose only. For other infections: continue 2–3 days after symptom resolution (minimum 5 days). Early stop risks treatment failure and resistance.

11. Overdose

No specific antidote. Ceftriaxone: not dialyzable, supportive management. Lidocaine overdose (unlikely at 20mg dose): monitor for CNS symptoms (tinnitus, perioral numbness) and cardiac arrhythmia if inadvertently given IV.

12. Clinical Evidence

WHO Essential Medicine. Standard single-dose IM treatment for uncomplicated gonorrhoea per WHO STI guidelines. Used widely in Bangladesh outpatient settings for moderate infections requiring parenteral therapy without hospitalisation. IM route demonstrated therapeutically equivalent to IV for most infections (multiple pharmacokinetic studies).

13. Patient Counselling

Inform healthcare professional of any allergy to local anaesthetics (lidocaine), penicillin, or cephalosporins. Injection will be into muscle — mild soreness is normal. Report rash, breathing difficulty, or chest discomfort immediately. Complete the full course of injections. Do not attempt self-administration — trained healthcare provider required.

Frequently Asked Questions (FAQ)

Q1. Why does the Aciphin IM pack contain Xylone 1% instead of Water for Injection?
Xylone 1% is lidocaine hydrochloride 1% solution — a local anaesthetic. When ceftriaxone powder is reconstituted in lidocaine, the injection into the muscle is significantly less painful. This is the standard WHO-recommended reconstitution solvent for IM ceftriaxone. The lidocaine itself is absorbed from the IM site at a low dose (20mg) and does not cause systemic effects at this concentration. Critically, the lidocaine-containing solution must NEVER be given intravenously as even small IV doses of lidocaine affect cardiac conduction.

Q2. Is Aciphin IM 250mg effective as a single dose for gonorrhoea?
Yes — a single 250mg IM dose of ceftriaxone is the WHO and CDC-recommended first-line treatment for uncomplicated urogenital, anorectal, and pharyngeal gonorrhoea (Neisseria gonorrhoeae). A single deep IM injection achieves serum concentrations that far exceed the MIC for susceptible and most resistant gonorrhoea strains. In Bangladesh, where fluoroquinolone-resistant gonorrhoea is prevalent, ceftriaxone IM remains the most effective single-dose treatment.

Q3. How do I distinguish the Aciphin IM pack from the Aciphin IV pack at the bedside?
Three differences to check: (1) Pack label — IM packs state "Intramuscular" and IV packs state "Intravenous"; (2) Solvent ampoule — IM pack contains Xylone 1% (lidocaine, opaque/white label), IV pack contains Water for Injection (clear label); (3) Needle/syringe — IM packs contain a baby needle for deep IM injection, IV packs contain a butterfly needle for slow IV push. Always read the pack label and solvent ampoule before reconstitution — route errors are dangerous.

Q4. Can Aciphin IM be given to diabetic patients with nephropathy?
Yes — the IM route and dose are safe in diabetic patients regardless of renal function for CrCl >10 ml/min. Since ~50% of ceftriaxone is eliminated via bile (hepatic pathway), standard dosing applies even in moderate-to-severe diabetic nephropathy. Only in severe renal failure (CrCl <10 ml/min) is the maximum daily dose capped at 2g. Lidocaine reconstitution at 2ml 1% (20mg) poses no renal risk. IM route avoids IV line complications in patients with difficult venous access.

⚕ Medical Disclaimer: Aciphin® IM 250mg is a prescription antibiotic for administration by trained healthcare professionals only. Information sourced from ACI Pharmaceuticals Ltd. official prescribing data. Educational purposes only. Never administer the lidocaine-reconstituted IM solution intravenously.