Sulfasalazine 500 mg/1
Sulfasalazine · TABLET, DELAYED RELEASE · Mylan Pharmaceuticals Inc.
Sulfasalazine is a tablet, delayed release containing sulfasalazine at 500 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Sulfasalazine
- Generic Name
- Sulfasalazine
- NDC Code (Product)
59762-0104- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 500 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA007073
- Drug Class
- Aminosalicylate [EPC]
- Marketing Start
- 05/05/2005
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.
Aidapak Services, LLC
Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sulfasalazine Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of Sulfasalazine Tablets should be adjusted to each individual’s response and tolerance. Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses. Maintenance Therapy: Adults: 2 g daily. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to Sulfasalazine Tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisf…
Warnings
WARNINGS Hepatic, Renal, and Hematologic Toxicity or Other Conditions Only after critical appraisal should Sulfasalazine Tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving sulfasalazine (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and Infertility Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Serious Infections Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were ass…
Contraindications
CONTRAINDICATIONS Sulfasalazine Tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.
Adverse Reactions
ADVERSE REACTIONS The most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of one in every thirty patients or less. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 μg/mL, the incidence of adverse reactions tends to increase. Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when Sulfasalazine Tablets are administered. Less common or rare adverse reactions include: Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome. Hypersensitivity reactions: erythema multiforme, epidermal necro…
Frequently Asked Questions
What is Sulfasalazine used for?
Sulfasalazine contains Sulfasalazine. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Sulfasalazine a controlled substance?
Sulfasalazine is not classified as a controlled substance by the DEA.
What is the generic name for Sulfasalazine?
The generic name for Sulfasalazine is Sulfasalazine. There are 1 other brand versions of Sulfasalazine.
What is the NDC code for Sulfasalazine 500 mg/1?
The NDC (National Drug Code) for Sulfasalazine 500 mg/1 is 59762-0104, listed by Mylan Pharmaceuticals Inc..
Other Sulfasalazine Dosages
- Sulfasalazine500 mg/171610-706
- Sulfasalazine500 mg/111534-200
- Sulfasalazine500 mg/111534-201
- Sulfasalazine500 mg/150090-6936
- Sulfasalazine500 mg/170518-1829
- Sulfasalazine500 mg/116571-261
- Sulfasalazine500 mg/10093-3234
- Sulfasalazine500 mg/163629-9715
- Sulfasalazine500 mg/150090-0086
- Sulfasalazine500 mg/162135-960
Other Sulfasalazine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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