Cefaclor


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Cystitis, Lower respiratory tract infections, Otitis media, Pneumonia, Pyelonephritis, Skin and skin structure infections, Streptococcal pharyngitis, Streptococcal tonsillitis, Upper respiratory tract infections, Urinary tract infections
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.

Oral
Pneumonia
Adult: As extended-release tab: 750 mg 12 hourly.

Oral
Asymptomatic bacteriuria, Cystitis, Uncomplicated lower urinary tract infections
Adult: As extended-release tab: 375 mg bid or 500 mg once daily.

Oral
Skin and skin structure infections
Adult: As extended-release tab: 375 mg 12 hourly for 7-10 days.

Oral
Acute bacterial exacerbation of chronic bronchitis
Adult: As extended-release tab: 375-750 mg 12 hourly.

Oral
Streptococcal pharyngitis, Streptococcal tonsillitis
Adult: As extended-release tab: 375 mg 12 hourly for at least 10 days.
Cách dùng
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.
Hướng dẫn pha thuốc
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.
Chống chỉ định
Hypersensitivity to cefaclor or any other cephalosporins.
Thận trọng
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.
Tác dụng không mong muốn
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.
Chỉ số theo dõi
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).
Quá liều
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.
Tương tác
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).
Tương tác với thức ăn
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.
Ảnh hưởng đến kết quả xét nghiệm
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®).
Tác dụng
Description:
Mechanism of Action: 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.
Đặc tính

Chemical Structure Image
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.

Bảo quản
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.
Phân loại MIMS
Cephalosporin
Phân loại ATC
J01DC04 - cefaclor ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Tài liệu tham khảo
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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