SYNTOLEXIN Capsule Ref.[28270] Active ingredients: Cefalexin

Posology

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 cefalexin 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 (see section 4.4).

Paediatric population

• 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 under 5 years: 125mg every 8 hours.
• 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.

Method of administration

Syntolexin is administered orally.

Symptoms

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

Management

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.

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

36 months.

Store below 25°C in the original package, in order to protect from light.

Syntolexin Capsules: PVC-Aluminium blisters in cartons of 16, 30 and 100 capsules and in plastic containers of 500 and 1000 capsules with a patient information leaflet.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.