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
Induction and maintenance of remission of ulcerative colitis and treatment of active Crohn’s disease.
The dose is adjusted according to the severity of the disease and the patient’s tolerance of the drug, as detailed below.
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.
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.
In active Crohn’s Disease, sulfasalazine should be administered as in attacks of ulcerative colitis (see above).
The drug has low acute per oral toxicity in the absence of hypersensitivity. There is no specific antidote and treatment should be supportive.
24 months.
1 month once open.
Do not store at above 25°C.
Bottle: Amber (Type III) glass.
Closure: HDPE, EPE wadded, tamper evident, child resistant closure.
Pack: 1 bottle containing 500ml of liquid.
Take the suspension with food.
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