Medication info

Sarazopyrin EN Tablet (Sulfasalazine)

Prescription medicationExpired
Ingredient · strength
Sulfasalazine›Strength being verified
Manufacturer / importer
Il Sung IS Co., Ltd.
Appearance
Yellow, wide, flat oval enteric-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Expired

MFDS item code 199801373 · Notified 1998.10.20

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of rheumatoid arthritis and ulcerative colitis
Who uses it
Adults
Adult dosage
1. Rheumatoid arthritis 1) Initial dose: The usual adult dose is 500 mg of sulfasalazine orally once daily. 2) Maintenance dose: 500 mg of this medication 2–4 times daily. Depending on symptom improvement, increase the daily dose by 500 mg each week from the initial dose until the maintenance dose is reached. 2. Ulcerative colitis The usual adult dose is 1 g of this medication 4–6 times daily; as symptoms improve, the dose is 500 mg 4 times daily. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Il Sung IS Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis and ulcerative colitis

  • Rheumatoid arthritis
  • ulcerative colitis
View approved original text

Used for rheumatoid arthritis and ulcerative colitis that do not respond to non-steroidal anti-inflammatory drugs.

Dosage and Administration

Adult dosage

1. Rheumatoid arthritis 1) Initial dose: The usual adult dose is 500 mg of sulfasalazine orally once daily. 2) Maintenance dose: 500 mg of this medication 2–4 times daily. Depending on symptom improvement, increase the daily dose by 500 mg each week from the initial dose until the maintenance dose is reached. 2. Ulcerative colitis The usual adult dose is 1 g of this medication 4–6 times daily; as symptoms improve, the dose is 500 mg 4 times daily. Adjust the dose as appropriate according to age and symptoms.

Precautions

This drug should not be used in patients with specific allergic reactions or in women who are pregnant or breastfeeding, and in children under 2 years of age. Patients with severely impaired liver or kidney function or problems with hematopoietic system should also avoid this medication. Patients with blood disorders, liver disorders, kidney disorders, bronchial asthma, severe allergic reactions, and the elderly should use this drug with extra caution. This medication may cause various adverse reactions in the initial treatment phase of 3-6 months, so regular monitoring of blood status and liver and kidney function is necessary, and immediate consultation with a physician should be sought if any abnormal symptoms occur. Particular caution is needed for occurrences of hematologic abnormalities, gastrointestinal issues, neurological symptoms, skin rashes or severe skin reactions, hepatitis, kidney issues, hypersensitivity reactions, respiratory symptoms, etc. Sufficient hydration is necessary to prevent crystalluria and stone formation, and blood and liver and kidney function tests must be carried out before and during treatment. When used with other medications, interactions may occur, so any currently taken medications should be disclosed to a doctor or pharmacist. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication as it may harm the newborn. The elderly are at higher risk for side effects and should begin with a lower dose and be closely monitored during administration. In case of overdose, symptoms such as vomiting, diarrhea, and neurological symptoms may appear, so immediate medical attention is warranted if suspicion arises. This medication is enteric-coated, so do not chew or crush the tablets; they should be taken whole. If symptoms such as skin rash or severe allergic reactions, fever, sore throat, jaundice appear during the intake of this medication, stop taking it immediately and consult medical personnel.

Side effects

Aplastic anemia, agranulocytosis, leukopenia, megaloblastic anemia, purpura, hemolytic anemia, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, disseminated intravascular coagulation, immunoglobulin deficiency, atypical lymphocytes, eosinophilia, Heinz body anemia, myelodysplastic syndrome, pancytopenia, hepatitis, pancreatitis, hemorrhagic diarrhea, folate malabsorption, digoxin malabsorption, gastritis, diarrhea, enterocolitis, abdominal pain, loss of appetite, nausea, vomiting, peptic ulcer, cecal perforation, stomach pain, stomatitis, epigastric discomfort, constipation, abdominal bloating, cheilitis, glossitis, thirst, membrane colitis, exacerbation of ulcerative colitis, transverse myelitis, tremor, meningitis, transient lesions of the posterior spine, paralytic syndrome, Guillain-Barré syndrome, peripheral neuropathy, depression, dizziness, hearing loss, insomnia, ataxia, hallucinations, tinnitus, sedation, headache, altered consciousness, seizures, encephalopathy, amnesia, fever, rash, erythema, conjunctivitis, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, acute generalized exanthematous pustulosis, AGEP, erythroderma, systemic lupus erythematosus, SLE, hair loss, exfoliative dermatitis, itching, urticaria, lichen planus, cyanosis, marked elevation of AST/ALT, hepatitis, liver dysfunction, jaundice, liver necrosis, fulminant hepatitis, polyuria, anuria, nephritis, hematuria, crystalluria, proteinuria, toxic nephritis, acute renal failure, nephrotic syndrome, interstitial nephritis, urinary stones, edema, increased BUN, swelling, diabetes, urinary tract infection, hemolytic-uremic syndrome, pyelonephritis, rash, hypersensitivity syndrome, infectious mononucleosis, facial flushing, photosensitivity, serum sickness, anaphylaxis, vasculitis, pleuritis, pericarditis, allergic myocarditis, nodular polyarteritis, cutaneous form resembling smallpox, Mucha-Haberman syndrome, rhabdomyolysis, arthralgia, periorbital edema, vascular edema, lymphadenopathy, interstitial pneumonia, drug-induced pneumonia, eosinophilic pulmonary infiltration, fibrosing alveolitis, urine discoloration, skin depigmentation, lethargy, taste disturbance, smell disturbance, palpitations, myalgia, heartburn, goiter formation, diuretic effect, hypoglycemia, DRESS syndrome, nausea, vomiting, gastrointestinal disturbances, neuropsychiatric symptoms, strabismus, seizures, sedation, headache, dizziness, transient myopia, diarrhea

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. This will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

Yellow, wide, flat oval enteric-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.