COMPOSITION :
Sulfasalazine Enteric coated caplet 500 mg, each enteric coated caplet contains : Sulfasalazine 500 mg.
DESCRIPTIONS :
Sulfasalazine with Sulfasalazine as active ingredient is available in enteric coated caplet 500 mg.
INDICATION :
Sulfasalazine 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.
CONTRAINDICATIONS :
- 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. 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 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 colitis is unknown.
DRUG INTERACTIONS :
- Reduced absorption of folic acid and Digoxin have been reported when those agents were administered concomitantly with Sulfasalazine.
- Daily doses of Sulfasalazine 2 g (max. 3 g) and weekly doses of Methotrexate 7.5 mg (max. 15 mg), the overall toxicity profile of the combination revealed an increased incidence of gastrointestinal adverse events, especially nausea.
ADVERSE REACTIONS :
- Hypersensitive reactions : Pruritus, urticaria, rash, erythema multiforme (Steven-Johnson syndrome), exfoliative dermatitis, serum sickness syndrome, Lupus erythematosus-like syndrome.
- Blood dyscrasias : Aplastic anemia, agranulocytosis, megaloblastic anemia, purpura, hypoprothrombinemia, methemoglobinemia, congenital neutropenia and myelodysplastic syndrome.
- CNS reactions : Headache, convulsion, mental depression, vertigo, hearing loss, ataxia.
- Renal reactions : Toxic nephrosis with oliguria dan anuria, nephritis, crystalluria and proteinuria.
- Genitor-urinary reactions : Oligospermia, reversible on withdrawal of Sulfasalazine.
- Cardiovascular reactions : Myocarditis.
- Gastrointestinal reactions : Nausea, vomiting, gastric distress, dyspepsia, abdominal pain, stomatitis, abnormal liver function tests, hepatitis, diarrhea, pancreatitis, impaired folic acid absorption, impaired Digoxin absorption and neutropenic enterocolitis.
- Hair reactions : Alopecia.
PRESENTATION :
Sulfasalazine Enteric coated caplet 500 mg Box, 10 strips @10 enteric coated caplets Reg. No. : GKL0702339907A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia