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HSA Approval

UPHALEXIN CAPSULE 250 MG

SIN16584P

UPHALEXIN CAPSULE 250 MG

UPHALEXIN CAPSULE 250 MG

August 29, 2022

DUOPHARMA (SINGAPORE) PTE LTD

DUOPHARMA (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDUOPHARMA (SINGAPORE) PTE LTD
Licence HolderDUOPHARMA (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

CAPSULE

**DOSAGE AND ADMINISTRATION** Cephalexin is administered orally. Adults: 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 may be 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 Children: The usual recommended daily dosage for children is 25–50mg/kg (10–20mg/lb) in divided doses. For skin and soft tissue infections, streptococcal pharyngitis, and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours. For most infections, the following schedule is suggested - Children 5 years and over: 250mg every 8 hours In severe infections, the dosage may be doubled. 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** Cephalexin is indicated in the treatment of the following infections: - Respiratory tract infections - Otitis media - Skin and soft tissue infections - Bone and joint infections - Genito-urinary tract infections, including acute prostatitis - Dental infections

**CONTRAINDICATIONS** Contraindicated in patient hypersensitive to cephalosporin.

J01DB01

cefalexin

Manufacturer Information

DUOPHARMA (SINGAPORE) PTE. LTD.

KOTRA PHARMA (M) SDN. BHD.

Active Ingredients

CEPHALEXIN MONOHYDRATE EQV CEPHALEXIN

250 mg

Cephalexin

Documents

Package Inserts

Uphalexin Capsule 250mg PI.pdf

Approved: August 29, 2022

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