Description
Indications
Rheumatoid arthritis and juvenile arthritis: Sulfasalazine is used to treat individuals with rheumatoid arthritis and pediatric children with polyarticular-course juvenile rheumatoid arthritis who have not responded to salicylates or other non-steroidal anti-inflammatory medications (NSAIDs).
Crohn’s disease and ulcerative colitis: As a supplement to the standard supportive and nutritional measures in the treatment of ulcerative colitis. In individuals with aggressive Crohn’s disease, especially those who have colonic involvement.
Pharmacology
Sulfasalazine’s mode of action is unknown, but it could be related to its anti-inflammatory and/or immunomodulatory properties, which have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver, and intestinal walls, as shown in autoradiographic studies in animals. Clinical trials using rectal administration of Sulfasalazine, Sulfapyridine, and 5-Aminosalyclic Acid in ulcerative colitis have suggested that the 5-Aminosalyclic Acid moiety may have the most therapeutic effect.
Dosage & Administration
The dosage of Salazine tablets should be individually adjusted according to the patient’s tolerance and response to the treatment and taken in evenly divided doses preferably after meals.
Adult dose for crohn’s disease: 500 mg orally 2 to 4 times a day with food.
Pediatric use (6 years or older) for Ulcerative Colitis: The initial dose 40 to 60 mg/kg/day orally divided into 3 to 6 doses.
Adult dose for rheumatoid arthritis: 2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage e.g. 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given bellow:
- First week: One tablet in the evening
- Second week: One tablet in the morning & One tablet in the evening
- Third week: One tablet in the morning & two tablet in the evening
- Forth week: Two tablet in the morning & two tablet in the evening
In case of rheumatoid arthritis 6 years or older: initial dose 10 mg/kg/day orally in 2 equally divided doses.
Juvenile rheumatoid arthritis-polyarticular course: Children 6 years of age and older: 30 to 50 mg/kg/day in two evenly divided doses. Typically the maximum dose is 2 g per day.
For other indications:
Initial therapy:
- Adults: 3 to 4 g daily in divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage e.g. 1 to 2 g daily to reduce possible gastrointestinal intolerance.
- Children 6 years of age and older: 40 to 60 mg/kg/day in to 3 to 6 divided doses.
Maintenance therapy:
- Adults: 2 g daily.
- Children 6 years of age and older: 30 mg/kg/day in 4 divided doses.
Interaction
When folic acid and digoxin were given at the same time as sulfasalazine, there was a reduction in folic acid and digoxin absorption.
Contraindications
Patients with intestinal or urinary blockage, as well as porphyria, are hypersensitive to Sulfasalazine, its metabolites, sulfonamides, or salicylates.
Side Effects
Anorexia, headache, nausea, vomiting, stomach discomfort, dyspepsia, abdominal pain, disorientation, seemingly reversible oligospermia, and other unpleasant effects are frequent.
Pregnancy & Lactation
Use during pregnancy: Category B pregnancy. This medication should only be taken during pregnancy if absolutely necessary. When sulfasalazine is provided to a nursing mother, it should be done with caution.
Precautions & Warnings
Lactation, hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, and hepatic/renal impairment
Therapeutic Class
Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis
Storage Conditions
Store in a cold, dry, and light-protected location.
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