Indications
Salazine Tablet is used for:
Inflammatory bowel disease, Rheumatoid arthritis
Adult Dose
Oral
Inflammatory bowel disease
Adult: Initially, 1-2 g 4 times daily until remission occurs. Maintenance: 2 g/day in divided doses.
Rheumatoid arthritis
Adult: As enteric-coated tablet: Initially, 500 mg daily for the 1st wk increased by 500 mg every wk. Max: 3 g daily in 2-4 divided doses.
Rectal
Inflammatory bowel disease
Adult: As suppository: 0.5-1 g in the morning and night, either alone or as an adjunct to oral treatment.
Hepatic impairment: Avoid use.
Child Dose
Oral
Inflammatory bowel disease
Child: >2 yr: 40-60 mg/kg/day in divided doses. Maintenance: 20-30 mg/kg/day in divided doses.
Rheumatoid arthritis
Child: For polyarticular juvenile rheumatoid arthritis: >6 yr: As enteric-coated tablet: 30-50 mg/kg/day in 2 divided doses. Begin treatment with 1/4 to 2/3 of expected maintenance dose and increase wkly to reach maintenance dose in 1 mth. Max: 2 g daily.
Rectal
Inflammatory bowel disease
Child: As suppository (may be given as divided doses): 5-8 yr: 500 mg bid; 8-12 yr: 500 mg in the morning and 1 g at night; 12-18 yr: 1 g bid.
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
10-30ml/min Admin twice daily.
<10ml/min Admin once daily.
Administration
Should be taken with food. Take after meals. Ensure adequate fluid intake.
Contra Indications
Hypersensitivity to sulphonamides or salicylates, porphyria, <2 yr of age, intestinal or urinary obstruction, blood dycrasias, history of leucopenia with gold therapy.
Precautions
Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.
Lactation: Excreted into human breast milk; caution with breastfeeding, some reports of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine
Pregnancy-Lactation
Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn
Oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and protection from neural tube defects
Lactation: Excreted into human breast milk; caution with breastfeeding, some reports of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine
Interactions
Plasma levels reduced by rifampicin and ethambutol. Interferes with absorption of folic acid. Additive leucopaenia with gold therapy for rheumatoid arthritis. Increased haematological toxicity with azathioprine. Reduced serum levels of digoxin.
Side Effects
Side effects of Sulfasalazine :
>10%
Anorexia (~33%), Headache (~33%), Nausea (~33%), Vomiting (~33%), Gastric distress (~33%), Apparently reversible oligospermia (~33%)
<1%
Skin rash, Pruritus, Urticaria, Fever, Heinz body anemia, Hemolytic anemia, Cyanosis
Potentially Fatal: Severe hypersensitivity reactions, blood dyscrasias, renal and hepatic toxicity, fibrosing alveolitis.
Mode of Action
Actual mechanism not determined. Sulphasalazine may have direct anti-inflammatory action in the colon. It also systemically interferes with secretion by prostaglandin synthesis inhibition.
Note
Salazine 500mg Tablet generic name is Sulfasalazine. Salazine 500mg Tablet is manufactured by Opsonin Pharma LimitedSalazine is availble in all over Bangladesh.
Mes BD drug index information on Salazine Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.