Cephalexin

Visa No.: VD-23202-15

Product: Cefatam 750

API: Cephalexin

Product Category: Antibiotics

Version approved leaflet: 277/QĐ-QLD_23/05/2022_175.1

INDICATIONS

Cephalexin is a cephalosporin antibiotic indicated for the treatment of infections caused by susceptible organisms, including:

• Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes
• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
• Skin and soft tissue infections caused by Gram-positive organisms, including Staphylococcus aureus and Streptococcus pyogenes
• Bone and joint infections caused by Staphylococcus aureus and Proteus mirabilis
• Genitourinary tract infections, including prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
   

DOSAGE AND ADMINISTRATION

Adults and adolescents ≥ 15 years

• The usual dose is 250 mg every 6 hours, or alternatively 500 mg every 12 hours, for 7–14 days.
• In severe infections, the dose may be increased to up to 4 g per day, administered in 2–4 equally pided doses.

Children ≥ 1 year

• The usual recommended dose for most infections is 25–50 mg/kg/day, pided into equally spaced doses, for 7–14 days.
• For mild to moderate infections, treatment for at least 10 days is recommended.
• In severe infections, the dose may be increased to 50–100 mg/kg/day, pided into equally spaced doses.
• Otitis media: 75–100 mg/kg/day, pided into equally spaced doses.

Dose adjustment in patients with renal impairment (Adults and children ≥ 15 years)

• Creatinine clearance > 60 ml/min: No dose adjustment required
• Creatinine clearance 39–59 ml/min: No dose adjustment required; maximum daily dose should not exceed 1 g
• Creatinine clearance 15–29 ml/min: 250 mg every 8 or 12 hours
• Creatinine clearance 5–14 ml/min, not on dialysis: 250 mg every 24 hours
• Creatinine clearance 1–4 ml/min, not on dialysis: 250 mg every 48 or 60 hours

*Insufficient data to provide dose adjustment recommendations for patients undergoing haemodialysis
 

CONTRAINDICATIONS

Hypersensitivity to cephalexin or 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.