Cefaclor

Visa No.: 893110107224

Product: Cefaclor Stada 500mg Capsules

API: Cefaclor

Product Category: Antibiotics

Version approved leaflet: 90/QĐ-QLD_31/01/2024_192

INDICATIONS

Cefaclor is indicated for the treatment of infections caused by susceptible organisms, including:

• Upper and lower respiratory tract infections, including pneumonia, bronchitis, acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis, otitis media, and sinusitis
• Skin and soft tissue infections
• Urinary tract infections, including pyelonephritis and cystitis

The clinical efficacy of cefaclor in the treatment of acute and chronic urinary tract infections has been established.
Cefaclor is generally effective in the treatment of streptococcal pharyngitis; however, no data are available regarding its effectiveness in the prevention of rheumatic fever or in bacterial endocarditis.
 

DOSAGE AND ADMINISTRATION

Dosage

Adults The usual adult dose is 250 mg every 8 hours. In severe infections or infections caused by less susceptible organisms, the dose may be doubled.
A total daily dose of 4 g has been administered safely to adults with normal renal function for up to 28 days. The total daily dose should not exceed this amount.
Cefaclor may be administered to patients with impaired renal function, and dosage adjustment is generally not required (see Warnings and Precautions).

Patients undergoing haemodialysis Haemodialysis reduces the serum half-life of cefaclor by approximately 25–30%. For patients undergoing haemodialysis 2–3 times per week, an initial dose of 250 mg to 1 g is recommended, followed by a maintenance dose of 250–500 mg every 6–8 hours between dialysis sessions.

Elderly patients: Dosage is the same as for adults.

Children
The usual recommended daily dose for children is 20 mg/kg/day, pided every 8 hours. Otitis media and pneumonia: 20 mg/kg/day, pided into three doses Otitis media and sinusitis: doses up to 40 mg/kg/day, pided every 12 hours, may be used The safety and efficacy of treatment beyond one month have not been established.
In severe infections, otitis media, sinusitis, and infections caused by less susceptible organisms, a dose of 40 mg/kg/day pided into multiple doses is recommended, with a maximum daily dose of 1 g.
In infections caused by beta-haemolytic streptococci, treatment should be continued for at least 10 days.

Method of administration: For oral use.
 

CONTRAINDICATIONS

Hypersensitivity to cefaclor or any excipients
Hypersensitivity to other cephalosporin antibiotics
 

WARNINGS AND PRECAUTIONS

This medicine is for prescription use only.
Read the instructions for use carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.