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HSA Approval

SOFIDROX CAPSULE 500 mg

SIN11665P

SOFIDROX CAPSULE 500 mg

SOFIDROX CAPSULE 500 mg

September 13, 2001

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

CAPSULE

**Dosage and Administration** To be administered orally. Adult and children (over 6 years), body weight more than 40 kg: _Urinary Tract Infections:_ For acute uncomplicated lower urinary tract infections (e.g. cystitis), the usual daily dosage is 1 or 2 grams per day in a single dose. In complicated or chronic urinary tract infections, the usual dose is 1 g every 12 hours for a minimum of 7 – 10 days. _Skin and Skin Structure Infections:_ The usual dosage is 1 gram per day in a single dose. _Upper Respiratory Tract Infections:_ The usual dosage is 500 mg every 12 hours. For group A β-haemolytic streptococcal pharyngitis and tonsillitis, 1 gram may be given as a single, daily dose. For any infections caused by Group A β-haemolytic streptococcus, treatment should be administered for 10 days. _Lower Respiratory Tract Infections:_ The recommended dosage is 500 mg to 1 gram every 12 hours. Doses should be reduced in patients with impaired renal function.

ORAL

Medical Information

**Indications** Infections due to sensitive Gram-positive and Gram-negative bacteria, including those of the biliary, respiratory, urinary tracts and of the skin.

**Contraindications** Cefadroxil is contraindicated in patients who are sensitive to cephalosporin and in patients with acute porphyria.

J01DB05

cefadroxil

Manufacturer Information

APEX PHARMA MARKETING PTE. LTD.

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Active Ingredients

CEFADROXIL

500 mg

Cefadroxil

Documents

Package Inserts

Sofidrox Cap PI.pdf

Approved: September 28, 2020

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