Regulatory Information
KOTRA PHARMA MARKETING
KOTRA PHARMA MARKETING
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**DOSAGE AND ADMINISTRATION:** For oral administration only. _Adult:_ The adult dosage ranges from 1 – 4g daily in divided doses; most infections will respond to a dosage of 500mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250mg every 6 hours, or 500mg every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses maybe needed. If daily doses of Cephalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered. _The elderly and patients with impaired renal function:_ As for adults. Reduce dosage if renal function is markedly impaired (refer Precaution section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Children:_ The usual recommended daily dosage for children is 25 – 50mg/kg/day in divided doses. For skin and soft tissues infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the total daily dose maybe divided and administered every 12 hours. For most infections the following schedule is suggested: 5 to 12 years : 250mg 3 times daily. In severe infections, the dosage maybe doubled. The maximum daily dose is 4g daily. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100mg/kg/day in 4 divided doses is required. In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
ORAL
Medical Information
**INDICATIONS:** Axcel Cephalexin Capsule is indicated in the treatment of the following infections: - Respiratory tract infection - Otitis media - Skin and soft tissue infections - Bone and joint infections - Genito-urinary tract infections, including acute prostatitis - Dental infections
**CONTRAINDICATION:** Contraindicated in patient with known allergy to the cephalosporin group of antibiotics.
J01DB01
cefalexin
Manufacturer Information
KOTRA PHARMA MARKETING
KOTRA PHARMA (M) SDN. BHD.
Active Ingredients
Documents
Package Inserts
AXCEL CEPHALEXIN PI.pdf
Approved: November 21, 2022