Cefaclor (Ceclor), a second-generation cephalosporin that can be used orally, is recommended for treating infections brought on by the following microorganisms.:

• Treatment with the (extended-release formulation only) of Acute bacterial exacerbations of chronic bronchitis caused by:

  • Haemophilus influenzae excluding beta-lactamase-negative, ampicillin-resistant strains

  • Moraxella catarrhalis, or

  • Streptococcus pneumoniae.

• Treatment of Lower respiratory tract infections including pneumonia (oral suspension and capsules only) caused by:

  • S. pneumoniae

  • H. influenzae

  • Streptococcus pyogenes.

• Treatment of Otitis media (capsules and oral suspension only) caused by:

  • S. pneumoniae

  • H. influenzae

  • staphylococci

  • S. pyogenes.

• Treatment of Pharyngitis and tonsillitis caused by:

  • S. pyogenes.

• Treatment of Secondary bacterial infections of acute bronchitis (extended-release tablets only) caused by:

  • H. influenzae excluding beta-lactamase negative, ampicillin-resistant strains

  • M. catarrhalis

  • S. pneumoniae.

• Uncomplicated Skin and soft tissue infections caused by:

  • Methicillin-susceptible Staphylococcus aureus

  • S. pyogenes.

• Treatment of Urinary tract infections including pyelonephritis and cystitis (capsules and oral suspension only) caused by:

  • Escherichia coli

  • Proteus mirabilis

  • Klebsiella spp

  • coagulase-negative staphylococci.

Cefaclor Dose in Adults

Treatment of cefaclor susceptible infections:

• Immediate-release oral formulations:

  • 250 - 500 mg thrice daily.

• Extended-release:

  • 500 mg twice daily.

Indication-specific dosing:

Note: Clinically, a 250 mg, three-times-daily dose of an immediate-release capsule is equivalent to a 500 mg, twice-daily dose of an extended-release tablet.

Use in the treatment of Acute bacterial exacerbations of chronic bronchitis:

• Extended-release formulation:
  • 500 mg twice daily for a week.

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Use in treatment of Secondary bacterial infection of acute bronchitis: 

• Extended-release formulation:
  • 500 mg twice daily for a week. 

Cefaclor Dose in Children

(Note: Clinically, a 250 mg immediate-release capsule taken three times a day is similar to a 500 mg extended-release pill taken twice daily. ).

General dosing for susceptible infection:

Mild to moderate infection:

• Infants, Children, and Adolescents:
  • Immediate-release:
    • 20–40 mg/kg/day, divided two–three times daily, with a daily dose cap of 1,500 mg.

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Acute bacterial exacerbations of chronic bronchitis:

• Dose in Adolescents 16 years of age or older:
  • Extended-release:
    • • For 7 days, take 500 mg twice day orally.

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Use in treatment of Lower respiratory tract infections:

• Infants, Children, and Adolescents:
  • Immediate-release oral formulation:
    • 20 to 40 mg/kg/day orally divided 8 hourly to a maximum daily dose of 1,000 mg/day.
    • Treat for at least ten days if beta-hemolytic streptococcus or S. pyogenes is suspected

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Use in the treatment of Otitis media:

• Infants, Children, and Adolescents:
  • immediate-release formulations:
    • 40 mg/kg/day orally divided two or three times a day(oral suspension) or three times a day (capsule) to a maximum daily dose of 1,000 mg/day.
    • Treat for at least ten days if beta-hemolytic streptococcus or S. pyogenes is suspected

Note: Cefaclor is not a recommended treatment option in the AAP guidelines.

Use in treatment of Pharyngitis & tonsillitis:

• Infants, Children, and Adolescents:
  • Oral immediate-release formulations:
    • 20 mg/kg/day orally divided into two or three doses throughout the day (oral suspension) or three doses throughout the day (capsule), with a daily dose cap of 1,000 mg.
    • Treat for at least ten days if beta-hemolytic streptococcus or S. pyogenes is suspected.

Note: Cefaclor is not a recommended and preferred treatment option in the IDSA guidelines.

Use in treatment of uncomplicated Skin and soft tissue infections:

• Infants, Children, and Adolescents:
  • Immediate-release oral formulations:
    • 20 to 40 mg/kg/day orally divided three times a day to a maximum daily dose of 1,000 mg/day.
    • Treat for at least ten days if beta-hemolytic streptococcus or S. pyogenes is suspected.

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Use in the treatment of Urinary tract infections:

• Infants, Children, and Adolescents:
  • Immediate-release oral formulation:
    • 20 - 40 mg/kg/day orally divided three times a day to a maximum daily dose of 1,000 mg/day.

Pregnancy Risk Factor B

• Cefaclor can be used during pregnancy as there have been no adverse fetal outcomes.

Cefaclor use during breastfeeding:

• Cefaclor can be excreted in small amounts into breastmilk. 
• You should not use it if you are lactating as there may be dose-related GI adverse reactions due to the modification of the neonatal bowel flora.

Cefaclor Dose in Rneal Disease:

Cefaclor dose according to the Manufacturer’s labeling:

According to the manufacturer's labeling, there is no dosage adjustment for the immediate or extended-release formulations, however, in severe renal impairment and anuric patients, it should be used with caution.

As off-label recommendations (by the American Association of Family Physicians):

Immediate-release oral tablets:

• Mild to severe impairment:

  • Dosage adjustment not necessary.

• End-stage renal disease (ESRD) on intermittent hemodialysis (IHD):

  • Supplement with 250 - 500 mg after dialysis.

• Peritoneal dialysis:

  • Administer 250 to 500 mg thrice daily.

Cefaclor Dose in Liver Disease:

The manufacturer has not recommended any dose adjustment in patients with liver disease. 

Common Side Effects Of Cefaclor Include:

• Dermatologic:

  • Rash
    • Erythematous rash
    • Maculopapular rash
    • Morbilliform rash

• Gastrointestinal:

  • Diarrhea

• Genitourinary:

  • Vaginitis
  • Vulvovaginal candidiasis

• Hematologic & oncologic:

  • Eosinophilia

• Hepatic:

  • Increased serum transaminases

Contraindication to Cefaclor include:

Allergic reaction to cefaclor, other cephalosporins, or any component of the formulation.

Warnings and Precautions

• Hypersensitivity
  • Anaphylactic reactions can occur.
  • It is important to stop using the drug and immediately start treatment with antihistamines, epinephrine and steroids.
• Penicillin allergy
  • Patients who experience IgE-mediated responses like anaphylaxis, urticaria, or angioedema should use cefaclor with caution.
• Superinfection
  • Cefaclor treatment for more than two months may result in superinfections, including fungal or bacterial superinfections. 
  • C. difficile-associated diarrhea, (CDAD), and pseudomembranous collitis can occur.
• Gastrointestinal Disease:
  • Patients who have had colitis in the past should not take this drug.
• H. influenzae infections:
  • Cefaclor should not be used to treat infections caused by Beta-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae as they are likely to be resistant to cefaclor.
• Renal impairment
  • Patients with impaired renal function should be cautious when taking the drug.

Cefaclor: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitor:

• Renal function
• Clinical features of hypersensitivity reactions and anaphylaxis during first dose.

How to take Cefaclor?

• It should be administered round the clock to avoid variations in the peak and trough levels.
• The extended-release tablets should be taken with or within an hour of a meal, but the capsules and oral solution can be taken regardless of when you eat.
• The Oral suspension should be shaken well prior to use. The extended-release tablets should not be chewed, crushed, or split.

Mechanism of action of Cefaclor:

• Cefaclor blocks the formation of bacterial proteins, peptidoglycans and penicillin-binding protein ligases.
• This eventually leads to cell lysis through the use of autolytic enzymes. It is well-suited for acidic environments.

absorbedIt can be taken orally. It isdistributedIn tissues and fluids, including bone, synovial, and pleural fluid. 25% of the drug has proteins bound. 

Thehalf-life eliminationIt ranges from 0.6 to 0.9 hours, and can be increased to approximately 2.5 hours for those with renal impairment. TheTime required to achieve peak serum concentrationAfter swallowing the capsules, the oral suspension takes between 30 and 60 minutes. It takes approximately 2.5 hours to digest the extended-release tablets. It isexcretedPrimarily (60-85%) via urine, unchanged drug 

International Brands of Cefaclor:

• APO-Cefaclor
• CO Cefaclor
• DOM-Cefaclor
• NOVO-Cefaclor
• PMS-Cefaclor 125
• PMS-Cefaclor 250
• PMS-Cefaclor BID
• PMS-Cefaclor
• Abaclor
• Achlor
• Ackfa
• Aclor
• Aczebri
• Alclor
• Alfatil LP
• Bacticlor
• Bearclor
• Beinuoke
• Bioclocel
• CEC
• Cec
• CEC 500
• Ceclobid
• Ceclodyne
• Ceclor
• Ceclor AF
• Ceclor CD
• Ceclor DS
• Ceclor MR
• Ceclor PDR
• Ceclor Retard
• Cecrun
• Cefabac
• Cefacle
• Cefacloren
• Cefaloc
• Cefclor
• Cefkor
• Ceflacid
• Cefmed
• Cektin
• Celormed
• Cephlor
• Ceracl
• Cero
• Cevacl
• Cleancef
• Clex
• Clocef
• Cloracef
• Cloracef MR
• Clorcef
• Distaclor
• Dorocor
• Eurocefix
• Forbatec
• Forifek
• Forticef
• Haxifal
• Karlor CD
• Kefaclor
• Keflor
• Keflor CD
• Kefolor
• Keftid
• Kemocin
• Kerfenmycin
• Lanaclor
• Locef
• Lorcef
• Medacef
• Medoclor
• Metiny
• Miclor
• Midocef
• Ozcef
• Panacef
• Panoral
• Panoral Forte
• Pharmaclor
• Pinaclor
• Qualiphor
• Ranclor
• Sefaclor
• Seporin
• Serviclor
• Sifaclor
• Soclor
• Soficlor
• Surecef
• Swiflor
• U-Clor
• Vefarol
• Vercaf
• Vercef MR
• Versef
• Wonclor
• Xelent
• Xeztron
• Zaike

Ceclor brands in Pakistan: