SALAZOPYRIN Suppository Ref.[7793] Active ingredients: Sulfasalazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Therapeutic indications

Ulcerative colitis or Crohn’s Disease affecting the rectum.

Posology and method of administration

The dose is adjusted according to the severity of the disease and the patient’s tolerance of the drug.

Acute attack or relapse – Adults and the Elderly

Two suppositories are to be inserted in the morning and two at bedtime after defecation. After three weeks the dosage is gradually reduced as improvement occurs.

Adjustment to oral therapy – Adults and the Elderly

In severe generalised ulcerative colitis of the rectum or recto sigmoid, or in cases who are responding slowly to oral therapy, one or two suppositories may be given in the morning and at bedtime additional to oral therapy.

Children

The adult dose is reduced on the basis of body weight.

Overdose

Overdose with suppositories is unlikely. In the event, evacuate the bowel and treat supportively. The toxicity of sulphasalazine is low in acute dosage. There is no specific antidote.

Shelf life

Five years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC/Polyethylene laminate moulds.

Special precautions for disposal and other handling

As the suppositories melt at body temperature they should be kept below 25°C and handled as little as possible before insertion so that they are firm.

Sulfasalazine is an orange dye, and care should thus be taken with clothing, bedding etc with regard to seepage or spillage.

Insertion

Empty the bowel if possible. Push the suppository through the anus with a finger, as far as possible. The urge to expel them will pass in a few minutes, once they have melted.

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