Indications of Sulfacol 500 mg
Sulfacol 500 mg is indicated in:
Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs). ... Read moreSulfacol 500 mg is indicated in:
Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
Ulcerative colitis and Crohn's Disease: As adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. In the treatment of active Crohn's disease, especially in patients with colonic involvement.
Theropeutic Class
Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis
Pharmacology
The mode of action of Sulfacol 500 mg is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that 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 demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfacol 500 mg, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.
Dosage & Administration of Sulfacol 500 mg
The dosage of Sulfacol 500 mg 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.
Dosage of Sulfacol 500 mg
The dosage of Sulfacol 500 mg 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
Fourth 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 of Sulfacol 500 mg
Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with Sulfacol 500 mg.
Contraindications
Hypersensitivity to Sulfacol 500 mg, its metabolites, sulfonamides or salicylates, patients with intestinal or urinary obstruction and porphyria.
Side Effects of Sulfacol 500 mg
The common adverse reactions are anorexia, headache, nausea, vomiting, gastric distress, dyspepsia, abdominal pain, dizziness, apparently reversible oligospermia etc.
Pregnancy & Lactation
Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.Use in lactation: Caution should be exercised when Sulfacol 500 mg is administered to a nursing mother.
Precautions & Warnings
Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.
Storage Conditions
Store in a cool and dry place, protected from light.
Drug Classes
Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis
Mode Of Action
The mode of action of Sulfacol 500 mg is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that 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 demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfacol 500 mg, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.
Pregnancy
Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.Use in lactation: Caution should be exercised when Sulfacol 500 mg is administered to a nursing mother.