FELEXIN Hard capsule Ref.[28223] Active ingredients: Cefalexin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Cefalexin is a semisynthetic cephalosporin antibiotic for oral administration.

Felexin 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.

4.2. Posology and method of administration

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 Felexin 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, ‘Special warnings and precautions for use’).

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

Felexin is administered orally.

4.9. Overdose

Symptoms of oral overdose 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.

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.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

Felexin 250 mg hard capsules:

PVC/Aluminium Blisters. Pack sizes of 20 and 100 hard capsules.

PP containers with PE closures. Pack sizes of 500 and 1000 hard capsules.

Felexin 500 mg hard capsules:

PVC/Aluminium Blisters. Pack sizes of 16, 20, 100 and 1000 hard capsules.

PP containers with PE closures. Pack sizes of 500 and 1000 hard capsules.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.