Zulfidin Tablet 500mg

Product Information

ZULFIDIN

Zulfidin

Sulfasalazine 500 mg

Presentation: Zulfidin 500 mg tablet: Yellow, oblong shaped; each contains Sulfasalazine BP 500 mg.

Description: In Crohn’s disease and ulcerative colitis, it is thought to be an anti-inflammatory drug that is essentially

providing topical relief inside the intestine. It does this via a number of mechanisms such as reducing the synrhesis f

inflammatory mediators known as eicosanoids and inflammatory cytokines.

Indication: Zulfidin is used in the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. It

is also indicated for use in rheumatoid arthritis and used in other types of inflammatory arthritis ( e.g. psoriatic arthritis)

where it has a beneficial effect.

Dosage and Administration: The dosage of Zulfidin tablet should be adjusted to each individual’s responses and tolerance. Adult

dose for crohn’s disease 500 mg orally 2 to 4 times a day with food.

Pediatric use: In case of Ulcerative Colitis 6 years or older the initial dose 40 to 60 mg/kg/day orally divided into 3 to 6

doses. In case of rheumatoid arthritis 6 years or older initial dose 10 mg/kg/day orally in 2 equally divided doses.

Adverse reactions: The most common adverse reactions associated with Sulfasalazine are anorexia, headache, nausea, vomiting,

gastric disturbance and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse

reactions are skin rash, pruritus, urticarial, fever, hemolytic anemia and cyanosis, which may occur at a frequency of one in

every thirty patients or less.

Contraindications: Sulfasalazine tablets are contraindicated in patients with intestinal or urinary obstruction, patients with

porphyria as sulfonamides have been reported to precipitate an acute attack, patients hypersensitivity to Sulfasalazine.

Drug interactions: Reduced absorption of folic acid and digoxin have been reported when those agents were administered

concomitantly with Sulfasalazine.

Precautions:  Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate

fluid must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase 

deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or

hypersensitivity reactions occur, the drug should be discontinued immediately.

Pregnancy: Pregnancy category B. However, there are no adequate and well controlled studies in pregnancy women.  

Nursing mothers: Caution should be exercised when sulfasalazine is administered to a nursing women. Sulfonamides are excreted

through milk. In the newborn, they compete with bilirubin for binding sites on the plasma proteins and may thus cause Kernicterus.

Pharmaceutical Precautions:  Store in a cool and dry place, protected from light.

Packaging Quantity: Zulfidin 500 mg tablet: Each box contains 30 tablets

Manufactured by: UniMed & UniHealth Manufacturers Ltd. B K Bari, Gazipur, Bangladesh.

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