Cefaclor monohydrate is indicated for the treatment of the following infections:

• Respiratory tract infections such as pneumonia and bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
• Pharyngitis and tonsillitis caused by Streptococcus pyogenes
• Urinary tract infections including pyelonephritis and cystitis caused by Escherichia coli, Proteus mirabilis, Klebsiella species, and coagulase-negative staphylococci
• Skin and soft tissue infections caused by Staphylococcus aureus and Streptococcus pyogenes

Cefaclor is a second-generation cephalosporin antibiotic with resistance to β-lactamase degradation and a broad spectrum of antibacterial activity. It is active against a wide range of organisms including alpha- and beta-hemolytic streptococci, staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes, Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species, and Haemophilus influenzae (including ampicillin-resistant strains). Cefaclor is effective in eradicating streptococci from the nasopharynx.

Capsule: Adult dose: The usual dose is 250 mg every 8 hourly. For severe infections or those caused by less susceptible organisms, doses may be doubled with a maximum dosage of 4 g/day. In case of β-hemolytic Streptococcal infections, therapy should be administered for at least 10 days.

Powder for suspension & Pediatric drops: Children: The usual daily dosage for paediatric patients over 1 month is 20 mg/kg/day in divided doses every 8 hours. In serious infections such as otitis media and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. Safety and effectiveness of Cefaclor for use in infants less than 1 month of age have not been established.

<1 year (9 kg):

• Powder for suspension: ½ tsp three times daily
• Pediatric drops: 0.625 ml three times daily

1-5 years (9 kg-18 kg):

• Powder for suspension: 1 tsp three times daily
• Pediatric drops: 1.25 ml three times daily

Over 5 years:

• Powder for suspension: 2 tsp three times daily

In renal impairment: Cefaclor may be administered in the presence of impaired renal function. Dose adjustments for patients with moderate or severe renal impairment are not usually required.

In patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 25-30%. In patients undergoing haemodialysis, a predialysis loading dose of 250 mg-1 g is recommended. A maintaining dose of 250-500 mg every 6 hourly during interdialytic period may be used.

Geriatric use: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Cefaclor may produce false-positive results for urinary glucose when tested using Benedict’s or Fehling’s solutions. Concomitant use with oral anticoagulants has been associated with enhanced anticoagulant effects and rare cases of prolonged prothrombin time, with or without bleeding. In patients receiving both cefaclor and anticoagulants (e.g., warfarin), regular monitoring of prothrombin time is recommended, and dosage adjustments may be required.

Cefaclor is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.

Gastrointestinal disturbances such as diarrhea, nausea, and vomiting may occur. Similar to other penicillins and cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Other possible effects include fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, elevated LDH, and pancytopenia.

There are no adequate and well-controlled studies in pregnant women. Cefaclor should be used during pregnancy only if clearly needed. Small amounts of cefaclor are excreted in breast milk, and its effects on nursing infants are not well established. Therefore, caution should be exercised when administering cefaclor to breastfeeding women.

Cefaclor should not be prescribed in the absence of a confirmed or strongly suspected bacterial infection, as unnecessary use may increase the risk of developing drug-resistant organisms.

Prolonged therapy with cefaclor may lead to overgrowth of non-susceptible organisms; if superinfection occurs, appropriate measures should be taken. When used with other β-lactam antibiotics, renal excretion of cefaclor may be reduced by probenecid. Cephalosporins should be used cautiously in patients with a history of gastrointestinal disease, especially colitis.

Before initiating therapy, a thorough history should be taken to assess any previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins, or other drugs. Caution is advised when administering cefaclor to penicillin-sensitive patients and to individuals with any known allergic tendency.

Symptoms of cefaclor overdose may include nausea, vomiting, epigastric discomfort, and diarrhea.

Second generation Cephalosporins

Store at room temperature and protect from light. After reconstitution, the suspension should be used within 7 days if kept at room temperature and within 14 days if refrigerated (2–8°C). Keep the bottle tightly closed.