Adult: As conventional cap or oral susp: Usual dose: 250-500 mg 8 hourly; may double the dose for more severe cases or those caused by less susceptible organisms. Max: 4,000 mg daily. Child: >1 month As conventional cap or oral susp: Usual dose: 20 mg/kg daily in 2 or 3 divided doses; may increase to 40 mg/kg daily in divided doses for more serious cases or those caused by less susceptible organisms. Max: 1,000 mg daily. Continue therapy for at least 10 days in the treatment of β-haemolytic streptococcal infections.
Adult: As extended-release tab: 375 mg 12 hourly for at least 10 days.
Administration
cap & oral susp: May be taken with or without food. extended-release tab: Should be taken with food. Take w/in 1 hr of meals. Do not cut/crush/chew.
Reconstitution
Powder or granules for oral susp: Reconstitute with the appropriate volume of water as indicated on the label. The water may be added in 2 portions then shake the bottle well between each addition.
Contraindications
Hypersensitivity to cefaclor or any other cephalosporins.
Special Precautions
Patient with a history of allergy to penicillins; history of gastrointestinal disease especially colitis; anuria. Cefaclor is generally effective in eradicating streptococci from the nasopharynx; however, data that establish efficacy in subsequent prevention of either bacterial endocarditis or rheumatic fever are not available. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Anaphylactic reactions; bacterial or fungal superinfection (prolonged use); serum sickness-like reaction particularly in children. Blood and lymphatic system disorders: Eosinophilia. Gastrointestinal disorders: Diarrhoea, nausea, vomiting, dyspepsia. Immune system disorders: Hypersensitivity reactions (e.g. morbilliform eruptions, pruritus, urticaria). Investigations: Increased serum transaminases. Nervous system disorders: Headache. Reproductive system and breast disorders: Vaginitis, vulvovaginal candidiasis, genital pruritus. Skin and subcutaneous tissue disorders: Rash. Rarely, Stevens-Johnsons syndrome, toxic epidermal necrolysis. Potentially Fatal:Clostridium difficile-associated diarrhoea and pseudomembranous colitis.
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Assess the patient's allergy history to cefaclor, cephalosporin, penicillins, or other drugs before treatment initiation. Monitor renal function; signs and symptoms of anaphylaxis (during initial dose).
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, and epigastric distress. Management: Supportive treatment. May administer activated charcoal or perform gastric lavage if a large amount (approx 5 times the normal daily dose) is ingested. Protect the patient's airway; support ventilation and perfusion.
Drug Interactions
Probenecid inhibits the renal excretion of cefaclor. May increase the prothrombin time (with or without clinical bleeding) with warfarin. Mg hydroxide or Al hydroxide containing antacids may diminish the extent of absorption of cefaclor (extended-release tab).
Food Interaction
Conventional cap/oral susp: Food may delay the rate but does not affect the extent of absorption. Extended-release tab: Increased extent of absorption and peak plasma concentrations when taken with food.
Lab Interference
May lead to a positive direct Coombs' test. May cause false-positive urinary glucose test using cupric sulfate (e.g. Benedict's solution, Fehling's solution, Clinitest®).
Action
Description: Cefaclor, a semisynthetic 2nd generation cephalosporin, binds to 1 or more penicillin-binding proteins (PBPs) which block the final transpeptidation step of bacterial peptidoglycan cell wall synthesis, thus resulting in the inhibition of bacterial cell wall synthesis. Pharmacokinetics: Absorption: Well absorbed from the gastrointestinal tract. Conventional cap/oral susp: Food may delay the rate but does not affect the extent of absorption. Extended-release tab: Enhanced absorption when taken with food. Time to peak plasma concentration: 0.5-1 hour (conventional cap/oral susp); 2.5 hours (extended-release tab). Distribution: Widely distributed in the body tissues and fluid, including the bone, pleural and synovial fluid. Crosses the placenta; enters breast milk (small amounts). Plasma protein binding: Approx 25%. Excretion: Via urine (60-85% as unchanged drug). Elimination half-life: 0.6-0.9 hours.
Chemical Structure
Cefaclor Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 51039, Cefaclor. https://pubchem.ncbi.nlm.nih.gov/compound/Cefaclor. Accessed Mar. 29, 2022.
Storage
Store between 20-25°C. Protect from light. Reconstituted oral susp: Store between 2-8°C. Do not freeze. After reconstitution, the oral susp must be used within 14 days.
J01DC04 - cefaclor ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
References
Anon. Cefaclor. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/12/2021.Anon. Cefaclor. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/12/2021.Buckingham R (ed). Cefaclor. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/12/2021.Cefaclor 500 mg Capsules (Clydesdale Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 09/12/2021.Cefaclor Capsule (Hikma Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/12/2021.Cefaclor Tablet, Film Coated, Extended Release (Teva Pharmaceuticals USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/12/2021.Distaclor 125 mg/5 mL and 187 mg/5 mL Oral Suspension (A. Menarini Singapore Pte. Ltd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/12/2021.Distaclor 250 mg/5 mL Granules for Oral Suspension (Flynn Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/12/2021.Distaclor MR Tablets (Flynn Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/12/2021.Douglas Pharmaceuticals Ltd. Ranbaxy-Cefaclor 250 mg and 500 mg Capsules, 125 mg/5 mL and 250 mg/5 mL Granules for Oral Suspension, and Ranbaxy-Cefaclor SR 375 mg Modified Release Tablets data sheet 28 December 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 09/12/2021.Joint Formulary Committee. Cefaclor. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/12/2021.Vercef MR Tablets 375 mg (Ranbaxy [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/12/2021.
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