Sulcolon® Enteric coated caplet 500 mg, each enteric coated caplet contains : Sulfasalazine 500 mg.
Sulcolon® with Sulfasalazine as active ingredient is available in enteric coated caplet 500 mg.
Sulcolon® is used for the treatment of ulcerative colitis
DOSAGE AND ADMINISTRATIONS :
- Adults : 2 – 4 enteric coated caplets daily in divided doses, maximum 3000 mg a day.
- Children : Dosage should be adjusted according to the body weight, usually 40 – 60 mg/kgBW a day. Maintenance therapy 20 – 30 mg/kgBW a day.
- Patients whose hypersensitive to Sulfasalazine, its metabolites and Sulfonamide or Salicylates.
- Patients with urinary and gastrointestinal tract obstruction.
- Patients with porphyria as it may cause sedimentation of Sulfonamides.
- Children < 2 years of age.
WARNINGS AND PRECAUTIONS :
- In people with kidney and liver function disorders, blood dyscrasias, Sulfasalazine only given if circumstances so compel. Giving these drugs should be done carefully or it can be stopped if there is possibility of clinical symptoms occur,blood disorders, such as fever, purpurea, or jaundice. Liver function tests should be performed within 1 month intervals for at least the first 3 months of therapy, also recommended to monitoring of kidney function periodically.
- Blood tests should be done at the beginning of therapy and at least 1 time a month for a minimum of the first 3 months of treatment. If the suspected blood disorder, treatment should be discontinued and the blood examination performed. Patients or the nearest person should be informed about how to recognize symptoms of blood poisoning and should be advised to seek immediate medical help in case of fever, sore throat, ulceration of the mouth, bruises or bleeding.
- Administration should be carefully in patients with bronchial asthma or allergies.
- Patients recommended to drink more water to prevent crystalluria and stone formation.
- Symptoms of haemolytic anemia should observed in patients with glucose-6-phosphate dehydrogenase deficiency as this may be associated with the amount of dosage taken. Treatment must be discontinued if toxic or hypersensitivity reactions occur.
- Use in pregnant women : use this medicine only if absolutely necessary.
- Do not prescribe to nursing mother.
- Safety and effectiveness of Sulfasalazine in pediatric patients under 2 years with ulcerative colitisis unknown.
Sulcolon® Enteric coated caplet 500 mg Box, 10 strips @10 enteric coated caplets
Reg. No. DKL9002315107A1
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia