SULFASALAZINE Oral suspension Ref.[7790] Active ingredients: Sulfasalazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Therapeutic indications

Induction and maintenance of remission of ulcerative colitis and treatment of active Crohn’s disease.

Posology and method of administration

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

Ulcerative Colitis

Adults and the Elderly

Severe attacks: 20 to 40 ml four times a day may be given in conjunction with steroids as part of an intensive management regime. Rapid passage of the suspension may reduce the effect of the drug.

The night time interval between doses should not exceed 8 hours.

Moderate attacks: 20 ml four times a day may be taken with or without steroids.

Maintenance therapy: With induction of remission, reduce the dose gradually to 40 ml per day. This dosage should be continued indefinitely, since discontinuance even several years after an acute attack is associated with a four-fold increase in relapse.

Children

The dose is reduced in proportion to body weight.

Acute attack or relapse: 0.8-1.2 ml/kg/day.

Maintenance dosage: 0.4-0.6 ml/kg/day.

Crohn’s Disease

In active Crohn’s Disease, sulfasalazine should be administered as in attacks of ulcerative colitis (see above).

Overdose

The drug has low acute per oral toxicity in the absence of hypersensitivity. There is no specific antidote and treatment should be supportive.

Shelf life

24 months.

1 month once open.

Special precautions for storage

Do not store at above 25°C.

Nature and contents of container

Bottle: Amber (Type III) glass.

Closure: HDPE, EPE wadded, tamper evident, child resistant closure.

Pack: 1 bottle containing 500ml of liquid.

Special precautions for disposal and other handling

Take the suspension with food.

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