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The information provided in this report is intended for educational and professional reference purposes only and does not replace professional medical judgment, diagnosis, or treatment.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
Bacticlor® is an oral second-generation cephalosporin antibiotic containing cefaclor. It is indicated for the treatment of mild to moderate bacterial infections caused by susceptible organisms, particularly infections of the respiratory tract, urinary tract, and skin and soft tissues. Cefaclor exerts bactericidal activity through inhibition of bacterial cell wall synthesis. Clinical use should be guided by culture results, antimicrobial susceptibility patterns, and local resistance data.
3. Brand Name
Bacticlor®
4. Category
- Antibiotic
- Second-Generation Cephalosporin (β-lactam antibiotic)
5. Active Ingredient
Cefaclor
(Semi-synthetic cephalosporin)
6. Pharmaceutical Form & Strength
Capsules:
- 250 mg
- 375 mg
- 500 mg
Powder for Oral Suspension (after reconstitution):
- 125 mg / 5 mL
- 250 mg / 5 mL
Final bottle volume: 60 mL
7. Manufacturer & Marketing Authorization Holder
- Local Manufacturer / Distributor: Pharco B International (Egypt)
- Original License Holder (historical): Ranbaxy Laboratories
Note: Ranbaxy Laboratories was acquired by Sun Pharmaceutical Industries Ltd. in 2014. Current marketing authorization and licensing arrangements may vary by country and should be verified with local regulatory authorities.
8. Mechanism of Action
Cefaclor is a bactericidal β-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This action prevents peptidoglycan cross-linking, leading to weakening of the bacterial cell wall and subsequent cell lysis. Cefaclor is stable against some β-lactamases but is not effective against ESBL- or AmpC-producing organisms.
9. Spectrum of Activity
Gram-Positive (susceptible strains):
- Streptococcus pyogenes
- Streptococcus pneumoniae (penicillin-susceptible strains)
- Staphylococcus aureus (methicillin-susceptible strains, MSSA)
Gram-Negative (susceptible strains):
- Haemophilus influenzae (non–β-lactamase producing)
- Moraxella catarrhalis
- Escherichia coli
- Proteus mirabilis
- Klebsiella pneumoniae
Not active against:
- MRSA
- ESBL- or AmpC-producing Enterobacteriaceae
- Pseudomonas spp.
- Acinetobacter spp.
- Most anaerobes (e.g., Bacteroides fragilis)
10. Pharmacokinetics
- Absorption: Well absorbed orally; food may delay peak concentration but does not significantly reduce bioavailability
- Time to Cmax: Approximately 0.5–1 hour
- Protein Binding: ~25%
- Distribution: Good penetration into middle ear fluid, sinus secretions, bronchial secretions, and skin tissues; poor CSF penetration
- Metabolism: Minimal hepatic metabolism
- Excretion: Primarily renal; approximately 80–85% excreted unchanged in urine
- Elimination Half-life: ~0.6–0.9 hours (prolonged in renal impairment)
11. Indications
Treatment of infections caused by susceptible organisms, including:
- Otitis media
- Pharyngitis and tonsillitis
- Acute bacterial sinusitis
- Acute bacterial exacerbations of chronic bronchitis
- Secondary bacterial infection of acute bronchitis
- Mild community-acquired pneumonia
- Urinary tract infections (cystitis, uncomplicated pyelonephritis)
- Skin and skin structure infections
12. Administration
- Administer orally at evenly spaced intervals.
- For β-hemolytic streptococcal infections, treatment should be continued for at least 10 days to reduce the risk of acute rheumatic fever.
13. Method of Preparation (Oral Suspension)
- Shake bottle to loosen powder
- Add purified water in two portions to the indicated mark (approximately 40 mL total)
- Shake well after each addition
- The reconstituted suspension is typically strawberry-flavored
- Shake well before each dose
- Store refrigerated and discard after 14 days
14. Contraindications
- Known hypersensitivity to cefaclor or other cephalosporins
- History of severe immediate hypersensitivity reactions (e.g., anaphylaxis) to β-lactam antibiotics
15. Warnings & Precautions
- Possible cross-reactivity in patients with penicillin allergy
- Risk of Clostridioides difficile–associated diarrhea
- Prolonged use may result in superinfection with non-susceptible organisms
- Serum sickness–like reactions, particularly in pediatric patients
- Dose adjustment required in significant renal impairment
- Discontinue immediately if severe hypersensitivity occurs
16. Drug Interactions
Probenecid: Increases cefaclor plasma concentrations by reducing renal excretion
Antacids: May slightly reduce absorption if taken simultaneously
Warfarin: Rare reports of increased INR; monitor coagulation parameters if used concomitantly
Laboratory Tests:
- False-positive urine glucose with copper reduction methods
- False-positive direct Coombs’ test
17. Side Effects
Common:
- Diarrhea
- Nausea, vomiting
- Abdominal discomfort
- Skin rash, pruritus, urticaria
Uncommon/Rare:
- Elevated hepatic enzymes
- Dizziness, headache
- Vaginal candidiasis
- Serum sickness–like reactions
- Pseudomembranous colitis
- Hemolytic anemia (very rare)
18. Use in Special Populations
- Pregnancy: FDA Pregnancy Category B; use only if clearly needed
- Lactation: Low concentrations in breast milk; generally considered compatible with breastfeeding, monitor infant for GI disturbances
- Pediatrics: Approved for use in infants ≥1 month; higher incidence of serum sickness–like reactions
- Geriatrics: No dosage adjustment unless renal function is impaired
- Renal Impairment: Dose adjustment recommended
- Hepatic Impairment: No dosage adjustment necessary
19. Storage Conditions
- Store below 25°C
- Protect from moisture
- Keep out of reach of children
- Reconstituted suspension: store at 2–8°C and discard after 14 days
- Do not freeze
20. Additional Sections
Overdose Management:
Supportive and symptomatic treatment. Activated charcoal may be considered in recent ingestion. Hemodialysis can remove cefaclor, though clinical benefit is usually limited.
21. Frequently Asked Questions (FAQ)
Q: Can Bacticlor be taken with food?
A: Yes. Food does not significantly affect overall absorption.
Q: Is Bacticlor effective against viral infections?
A: No. It is active only against susceptible bacterial infections.
Q: Can it be used in penicillin-allergic patients?
A: Use with caution; contraindicated in patients with a history of anaphylaxis to β-lactams.
Q: What is the usual duration of therapy?
A: Typically 7–14 days, depending on infection type; at least 10 days for streptococcal infections.
22. References
- FDA Drug Label – Cefaclor Capsules and Oral Suspension
- Lexicomp® Drug Monograph: Cefaclor (2024)
- Micromedex® Solutions – Cefaclor (2024)
- British National Formulary (BNF)
- CLSI M100 – Antimicrobial Susceptibility Testing Standards (2024)
- Product Information Leaflet – Bacticlor® (Pharco B / Ranbaxy)
