Sulfasalazine Delayed-release
Loading...Sulfasalazine Delayed-release Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Only after critical appraisal should sulfasalazine delayed release 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 delayed release tablets (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.
Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue sulfasalazine delayed release tablets if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with sulfasalazine delayed release tablets. For a patient who develops a new infection during treatment with sulfasalazine delayed release tablets, perform a prompt and complete diagnostic workup for infection and myelosuppression. Caution should be exercised when considering the use of sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections.
Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of sulfasalazine. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms have been reported in patients taking sulfasalazine. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sulfasalazine delayed release tablets, USP are indicated:
- in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;
- for the prolongation of the remission period between acute attacks of ulcerative colitis;
- in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and
- in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.
Sulfasalazine delayed release tablets, USP are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.
In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, sulfasalazine delayed release tablets, USP do not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of sulfasalazine delayed release tablets, USP is apparent.
History
There is currently no drug history available for this drug.
Other Information
Sulfasalazine delayed release tablets, USP contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.
Sulfasalazine delayed release tablets, USP are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa.
Anti-inflammatory agent and/or immunomodulatory agent.
5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.
Inactive ingredients: Carnauba wax, cellulose acetate phthalate, croscarmellose sodium, diethyl phthalate, microcrystalline cellulose, povidone, pregelatinized starch, sodium stearyl fumarate, talc.
Anti-inflammatory agent and/or immunomodulatory agent.
Chemical Designation:5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.
Chemical Structure:Sources
Sulfasalazine Delayed-release Manufacturers
-
Qualitest Pharmaceuticals
![Sulfasalazine Delayed-release (Sulfasalazine) Tablet, Delayed Release [Qualitest Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sulfasalazine Delayed-release | Qualitest Pharmaceuticals
The dosage of sulfasalazine delayed release tablets should be adjusted to each individual's response and tolerance.
Patients should be instructed to take sulfasalazine delayed release tablets in evenly divided doses, preferably after meals, and to swallow the tablets whole.
Initial TherapyAdults: 3 to 4 g daily in evenly 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. If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.
Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.
Maintenance TherapyAdults: 2 g daily.
Children, six years of age and older: 30 mg/kg of body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to sulfasalazine delayed release 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 satisfactory improvement, dosage of sulfasalazine delayed release tablets should be reduced to a maintenance level. If diarrhea recurs, dosage should be increased to previously effective levels.
Sulfasalazine delayed release tablets are particularly indicated in patients who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance (e.g., anorexia, nausea). If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine delayed release tablets, they are probably due to increased serum levels of total sulfapyridine, and may be alleviated by halving the daily dose of sulfasalazine delayed release tablets and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.
Adult Rheumatoid Arthritis2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage of sulfasalazine delayed release tablets, e.g., 0.5 to 1 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given below.
In rheumatoid arthritis, the effect of sulfasalazine delayed release tablets can be assessed by the degree of improvement in the number and extent of actively inflamed joints. A therapeutic response has been observed as early as 4 weeks after starting treatment with sulfasalazine delayed release tablets, but treatment for 12 weeks may be required in some patients before clinical benefit is noted. Consideration can be given to increasing the daily dose of sulfasalazine delayed release tablets to 3 g if the clinical response after 12 weeks is inadequate. Careful monitoring is recommended for doses over 2 g per day.
Suggested Dosing Schedule for Adult Rheumatoid Arthritis: Number of sulfasalazine delayed release tablets Week of
Treatment
Morning
Evening 1 – One 2 One One 3 One Two 4 Two Two Juvenile Rheumatoid Arthritis – polyarticular courseChildren, six years of age and older: 30 to 50 mg/kg of body weight daily in two evenly divided doses. Typically, the maximum dose is 2 g per day. To reduce possible gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until reaching the maintenance dose at one month.
Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,8 7 of 8 patients,9 and 19 of 20 patients.10 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine delayed release tablets should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.
Initial TherapyAdults: 3 to 4 g daily in evenly 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. If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.
Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.
Maintenance TherapyAdults: 2 g daily.
Children, six years of age and older: 30 mg/kg of body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to sulfasalazine delayed release 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 satisfactory improvement, dosage of sulfasalazine delayed release tablets should be reduced to a maintenance level. If diarrhea recurs, dosage should be increased to previously effective levels.
Sulfasalazine delayed release tablets are particularly indicated in patients who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance (e.g., anorexia, nausea). If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine delayed release tablets, they are probably due to increased serum levels of total sulfapyridine, and may be alleviated by halving the daily dose of sulfasalazine delayed release tablets and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.
Adult Rheumatoid Arthritis2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage of sulfasalazine delayed release tablets, e.g., 0.5 to 1 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given below.
In rheumatoid arthritis, the effect of sulfasalazine delayed release tablets can be assessed by the degree of improvement in the number and extent of actively inflamed joints. A therapeutic response has been observed as early as 4 weeks after starting treatment with sulfasalazine delayed release tablets, but treatment for 12 weeks may be required in some patients before clinical benefit is noted. Consideration can be given to increasing the daily dose of sulfasalazine delayed release tablets to 3 g if the clinical response after 12 weeks is inadequate. Careful monitoring is recommended for doses over 2 g per day.
Suggested Dosing Schedule for Adult Rheumatoid Arthritis: Number of sulfasalazine delayed release tablets Week of
Treatment
Morning
Evening 1 – One 2 One One 3 One Two 4 Two Two Juvenile Rheumatoid Arthritis – polyarticular courseChildren, six years of age and older: 30 to 50 mg/kg of body weight daily in two evenly divided doses. Typically, the maximum dose is 2 g per day. To reduce possible gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until reaching the maintenance dose at one month.
Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,8 7 of 8 patients,9 and 19 of 20 patients.10 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine delayed release tablets should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.
Login To Your Free Account