FELEXIN Powder for oral suspension Ref.[28224] Active ingredients: Cefalexin

Posology

Adults

The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis, and mild, uncomplicated urinary tract infections, the usual dosage is 250 mg every 6 hours, or 500 mg 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 4 g 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 (see section 4.4).

Paediatric population

Children: The usual recommended daily dosage for children is 25-50 mg/kg (10-20 mg/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 under 5 years: 125 mg every 8 hours.

Children 5 years and over: 250 mg 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 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.

Method of administration

Oral administration.

Symptoms of oral overdosage may include nausea, vomiting, diarrhoea, epigastric distress and haematuria.

In the event of severe overdosage, general supportive care is recommended, including close clinical and laboratory monitoring of haematological, renal, and hepatic functions, and coagulation status until the patient is stable. Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefalexin. It would be extremely unlikely that one of these procedures would be indicated.

Unless 5 to 10 times the normal total daily dose has been ingested, gastro-intestinal decontamination should not be necessary.

Paediatric Population

There have been reports of haematuria, without impairment of renal function, in children accidentally ingesting more than 3.5 g of cefalexin in a day. Treatment has been supportive (fluids) and no sequelae have been reported.

3 years.

Shelf life after reconstitution: store the reconstituted suspension up to 14 days in a refrigerator.

Store below 25°C. Protect from light and moisture.

Amber glass bottles with aluminium closure. A measuring spoon of 5 ml (graduated every 2.5 ml) is supplied with this pack. Pack-size of 100 ml oral suspension.

Directions for reconstitution:

Check that the bottle’s cap is intact before use. Shake to loosen powder. Add water up to the bottle line, invert the bottle, tap until the powder falls in the water and shake well. Allow the suspension to stand for a few seconds and when the suspension retreats below the bottle line, add more water up to the bottle line and shake again. Shake well before each use.