Full Prescribing Info
Cefaclor monohydrate.
Capsule: Each capsule contains: Cefaclor (as monohydrate) 500 mg.
Granules for Suspension: Each 5 mL (1 teaspoonful) contains: Cefaclor (as monohydrate) 125 mg.
Each 5 mL (1 teaspoonful) contains: Cefaclor (as monohydrate) 250 mg.
Oral Drops: Each mL contains: Cefaclor (as monohydrate) 50 mg.
Cefaclor is a semisynthetic second generation cephalosporin antibiotic. It is chemically designed as 3-Chloro-7-D (2-phenylglycinamido)-3-cephem-4 carboxylic acid monohydrate. Its empirical formula is C15H14ClN3O4S·H20 and its molecular formula is 385.8.
Pharmacology: Pharmacodynamics: Mechanism of Action: Cefaclor is a bactericidal cephalosporin and like other cephalosporins is an inhibitor of bacterial cell wall synthesis. It acylates membrane-bound transpeptidase enzymes thus preventing the cross-linking of peptidoglycan necessary for bacterial cell wall strength and rigidity.
Pharmacokinetics: Cefaclor is well absorbed after oral administration. The presence of food may delay the absorption of cefaclor, but the total amount absorbed remains unchanged. Serum levels of 6 mg/1 mcg and 13 mg/1 mcg are obtained after 250 mg and 500 mg of cefaclor respectively. Peak serum concentrations are obtained in 0.5 hour to 1 hour. About 25% is protein bound. Cefaclor is widely distributed in the body. It is rapidly excreted by the kidneys, up to 85% of a dose appears unchanged in the urine within two hours. The plasma elimination half life cefaclor is about 30 minutes to 1 hour.
Cefaclor is indicated in the treatment of respiratory tract infection, acute bronchitis and acute exacerbation of chronic bronchitis, pneumonia, otitis media, pharyngitis, tonsillitis, sinusitis, urinary tract infections and skin and soft tissue infections.
Dosage/Direction for Use
Adult: 500 mg capsule: 1 capsule every 8 hours or as prescribed by the physician.
250 mg capsule: 1 to 2 capsules every 8 hours or as prescribed by the physician.
125 mg/5 mL Granules for Suspension & 250 mg/5mL Granules for Suspension: Over 5 years: 2 teaspoonful (10 mL) every 8 hours.
1-5 years: 1 teaspoonful (5 mL) every 8 hours.
Under 1 year: ½ teaspoon (2.5 mL) every 8 hours or as prescribed by the physician.
50 mg/mL Granules for Suspension (Oral Drops): Children: Over 1 month of age: 20 mg/kg body-weight daily in three divided doses, increased if necessary to 40 daily, but not exceeding a total daily dose 1 g or as prescribed by the physician.
Direction For Reconstitution: To make 10 mL suspension, add 6 mL water.
To make 60 mL suspension, add 42 mL water.
Mix thoroughly until all granules are evenly suspended. After reconstitution, suspension retains potency for 7 days at temperatures not exceeding 30°C and 14 days under refrigeration (2-8°C).
Special Precautions
Risk versus benefit should be carefully considered when history of bleeding disorders, ulcerative colitis, regional enteritis or pseudomembranous colitis exist.
Side Effects
The most common are hypersensitivity reaction, including skin rashes, urticaria, eosinophilia, fever reactions resembling serum sickness and anaphylaxis.
Store at temperatures not exceeding 30°C.
Shake well before using.
MIMS Class
ATC Classification
J01DC04 - cefaclor ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Cap 500 mg x 100's. Granules for oral susp 125 mg/5 mL x 60 mL. 250 mg/5 mL x 60 mL. Oral drops 50 mg/mL x 10 mL.
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