Leading the way to safer medication
 Crosscheck  Recommender

DISTACLOR Capsules (2018)

Therapeutic indications

Distaclor is indicated for the treatment of the following infections due to susceptible micro-organisms:

  • Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis.
  • Otitis media.
  • Skin and soft tissue infections.
  • Urinary tract infections, including pyelonephritis and cystitis.
  • Distaclor has been found to be effective in both acute and chronic urinary tract infections.
  • Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.

Posology and method of administration

Posology

Adults

The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.

Distaclor may be administered in the presence of impaired renal function. Under such conditions dosage is usually unchanged (see “Special Warning and Special Precautions for Use”).

Patients undergoing haemodialysis

Haemodialysis shortens serum half-life by 25-30%. In patients undergoing regular haemodialysis, a loading dose of 250mg-1g administered prior to dialysis and a therapeutic dose of 250-500mg every six to eight hours maintained during interdialytic periods is recommended.

The elderly

As for adults.

Paediatric population

The usual recommended daily dosage for children is 20mg/kg/day in divided doses every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses administered 3 times daily. For otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not been established for use in infants aged less than one month.

Distaclor Suspension:

 125mg/5m1250mg/5m1
<1 year (9kg) 2.5m1 tid 
1-5 years (9-18kg) 5.0ml tid 
Over 5 years 5.0ml tid

In more serious infections, otitis media, sinusitis and infections caused by less susceptible organisms, 40mg/kg/day in divided doses is recommended, up to a daily maximum of 1g.

In the treatment of beta-haemolytic streptococcal infections, therapy should be continued for at least 10 days.

Method of administration

Distaclor is administered orally.

Overdose

Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment

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

General management may consist of supportive therapy.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C. Keep the container tightly closed in order to protect from light.

Nature and contents of container

High density polyethylene bottles with screw caps containing 20, 50 or 100 capsules

or

UPVC/Aluminium foil blister packs containing 14 or 21 capsules or

PVC/PCTFE/Aluminium foil blister packs containing 14 or 21 capsules or

PVC/PCTFE/PE/Aluminium foil blister packs containing 14 or 21 capsules.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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