Branch 3 - Imexpharm Corporation in Binh Duong Province

Imexpharm Pharmaceutical Joint Stock Company

Cephalexin (as Cephalexin monohydrat powder)

250 mg

24 months

Powder for oral suspension

Box of 12 sachets x 1,5g

VD-32837-19

01/08/2019

Antibiotics

Cefalexin is a semi synthetic cephalosporin antibiotic for oral administration.
Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms:
- Respiratory tract infections,
- Otitis media,
- Skin and soft tissue infections,
- Bone and joint infections;
- Genito-urinary tract infections, including acute prostatitis
- Dental infections.

Adults
-Common dose: 1 - 4 g/day divided into several doses depending on the location and severity of infection:
+ Most infections will respond to a dosage of 500 mg (2 sachets) every 8 hours.
+ For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250 mg (1 sachet) every 6 hours, or 500 mg (2 sachets) every 12 hours.
-For more severe infections, or those caused by less susceptible organisms larger doses may be needed. If daily doses of cefalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Elderly:
As for adults. Reduce dosage if renal function is markedly impaired.
Paediatric population
The usual recommended daily dosage for children is 25-50 mg/kg 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.
In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75-100 mg/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.
Patients with renal impairment: Use with caution because the safe dose may be lower than the usual dose. Close clinical and laboratory monitoring is required:
- No need to reduce the dose for patients with creatinine clearance > 40 ml/min.
- If creatinine clearance =<40 ml/min, the first dose is the usual dose, then adjust the dose according to creatinine clearance:
Creatinine clearance 11-40 (ml/min): 500 mg (equivalent to 2 sachets), Every 8-12 hours
Creatinine clearance 5-10 (ml/min): 250 mg (equivalent to 1 sachet), Every 12 hours
Creatinine clearance <5 (ml/min): 250 mg (equivalent to 1 sachet), every 12 - 24 hours
Hemodialysis patients:
Hemodialysis: take 1 additional dose usually used after each hemodialysis.
Continuous peritoneal dialysis at home: use the same dose as patients with renal failure.