SULFASALAZINE

The dose is adjusted according to the severity of the disease and the patient's tolerance to the drug, as detailed below. Elderly Patients No special precautions are necessary. A) Ulcerative colitis Adults Severe Attacks Sulfasalazine 2-4 tablets four times a day may be given in conjunction with steroids as part of an intensive management regime.

Rapid passage of the tablets may reduce effect of the drug. Night-time interval between doses should not exceed eight hours. Moderate Attack 2-4 tablets four times a day may be given in conjunction with steroids. Maintenance Therapy With induction of remission reduce the dose gradually to 4 tablets 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 risk of relapse. Paediatric population The dose is reduced in proportion to body weight Acute Attack or Relapse 40 - 60 mg / kg per day Maintenance Dosage 20 - 30 mg / kg per day Sulfasalazine suspension may provide a more flexible dosage form.

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

Overall, about 75% of ADRs occur within 3 months of starting therapy, and over 90% by 6 months. Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose. General Sulfasalazine is split by intestinal bacteria to sulfapyridine and 5-amino salicylate so ADRs to either sulfonamide or salicylate are possible.

Patients with slow acetylator status are more likely to experience ADRs related to sulfapyridine. The most commonly encountered ADRs are nausea, headache, rash, loss of appetite and raised temperature. Specific The adverse reactions observed during clinical studies conducted with Sulfasalazine have been provided in a single list below by class and frequency (very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1000 to < 1/100).

Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported. Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in the list below.

4 Special Warnings and precautions for use Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Serious infections associated with myelosuppression, including sepsis and pneumonia, have been reported. Patients who develop a new infection while undergoing treatment with sulfasalazine should be monitored closely. Administration of sulfasalazine should be discontinued if a patient develops a serious infection.

Caution should be exercised when considering the use of sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions which may predispose patients to infections. Complete blood counts, including differential white cell count, and liver function tests, should be performed before starting sulfasalazine, and every second week during the first three months of therapy.

During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Baseline assessment of renal function (including urinalysis) is required to be performed in all patients initiating treatment with sulfasalazine.

For patients with baseline renal impairment, treatment with sulfasalazine should only be initiated if the benefits are considered to outweigh the risk. Thereafter, periodic renal function monitoring, especially in the early months of treatment should be conducted based on clinical judgment taking baseline renal function into account.

Treatment should be discontinued if renal function deteriorates. The patient should also be counselled to report immediately with any sore throat, fever, malaise, pallor, purpura, jaundice or unexpected non-specific illness during sulfasalazine treatment, this may indicate myelosuppression, haemolysis or hepatoxicity.

Treatment should be stopped immediately while awaiting the results of blood tests. 4. “Interference with laboratory testing”. Sulfasalazine should not be given to patients with impaired hepatic or renal function or with blood dyscrasias, unless the potential benefit outweighs the risk.

Sulfasalazine is contraindicated in:

Infants under the age of 2 years. Patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients as well as sulfonamides or salicylates. Patients with porphyria.