SULFASALAZINE

The dose is adjusted according to the severity of the disease and the patient's tolerance of the drug, as detailed below. A) 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. 2 ml/kg/day. 6 ml/kg/day. 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 three months of treatment and over 90% by six months. Some unwanted 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); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from available data)).

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 for further information Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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 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 should be given with caution to patients with severe allergy or bronchial asthma. , pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration.

Use in children with the concomitant condition systemic onset juvenile rheumatoid arthritis may result in a serum sickness like reaction; therefore sulfasalazine is not recommended in these patients. Since sulfasalazine may cause haemolytic anaemia, it should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency.

g. macrocytosis and pancytopenia), this can be normalised by administration of folic acid or folinic acid (leucovorin). Because sulfasalazine causes crystalluria and kidney stone formation, adequate fluid intake should be ensured during treatment.

Oligospermia and infertility may occur in men treated with sulfasalazine. Discontinuation of the drug appears to reverse these effects within 2 to 3 months. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely in association with the use of sulfasalazine.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first month of treatment. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Severe, life-threatening, systemic hypersensitivity reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients taking various drugs including sulfasalazine. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.

If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine should be discontinued if an alternative aetiology for the signs or symptoms cannot be established. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug.

Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of sulfasalazine, sulfasalazine must not be re-started in this patient at any time. Sulfasalazine may colour the urine orange-yellow.

Interference with laboratory testing Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.

Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength.

Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose. It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK- MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses.

Consult with the testing laboratory regarding the methodology used. Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine. Results should be interpreted in conjunction with clinical findings.

Excipient warnings - This medicine contains 5 mg sodium benzoate in each 5ml. - This medicine contains less than 1 mmol sodium (23 mg) per […]

Sulfasalazine is contraindicated in: • Infants under the age of two years. • Patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients as well as sulfonamides, salicylates or the sodium benzoate preservative.

• Patients with porphyria.