Classes
DEA Class; Rx
Common Brand Names; Clinoril, Sulin
NSAIDs
Description
Acetic acid NSAID; has analgesic and antipyretic properties; reported efficacy in the regression of colorectal polyps associated with familial adenomatous polyposis; causes an increased risk of serious gastrointestinal adverse effects; may cause an increased risk of serious cardiovascular events; use lowest effective dose for the shortest possible duration.
Indications
Contraindications
Hypersensitivity to drug or excipients
In the setting of CABG surgery
History of asthma, urticaria, or any other type of reaction after taking aspirin or other NSAIDs
Adverse Effects
1-10%
GI pain (10%)
Constipation (3-9%)
Diarrhea (3-9%)
Dizziness (3-9%)
Dyspepsia (3-9%)
Headache (3-9%)
Nausea (3-9%)
Rash (3-9%)
Abdominal cramps (1-3%)
Anorexia (1-3%)
Edema (1-3%)
Nervousness (1-3%)
Pruritus (1-3%)
Tinnitus (1-3%)
Vomiting (1-3%)
<1%
Hypersensitivity reactions (including anaphylaxis, angioedema, bronchospasm, dyspnea) Sulindac therapy should be discontinued & not reinstituted if unexplained fever or other evidence of hypersensitivity occurs
Thrombocytopenia
Ecchymosis
Purpura
Leukopenia
Agranulocytosis
Neutropenia
Bone marrow depression
Warnings
Sulindac metabolites have been reported rarely as the major or a minor component in renal stones in association with other calculus components; the drug should be used with caution in patients with a history of renal lithiasis, and they should be kept well hydrated while receiving therapy
Pancreatitis has been reported in patients receiving therapy; should pancreatitis be suspected, the drug should be discontinued and not restarted, supportive medical therapy instituted, and patient monitored closely with appropriate laboratory studies (eg, serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, lipase, etc.); a search for other causes of pancreatitis as well as those conditions which mimic pancreatitis should be conducted
Because of reports of adverse eye findings with non-steroidal anti-inflammatory agents, it is recommended that patients who develop eye complaints during treatment have ophthalmologic studies
In patients with poor liver function, delayed, elevated and prolonged circulating levels of the sulfide and sulfone metabolites may occur; such patients should be monitored closely; a reduction of daily dosage may be required
Pregnancy and Lactation
Pregnancy Category: B; D if used for prolonged periods, or near term (may cause premature closure of ductus arteriosus)
Lactation: not known if distributed in milk
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
6 mg/kg/day PO or 400 mg/day PO, whichever is less, has been suggested. However, data are limited.
6 mg/kg/day PO or 400 mg/day PO, whichever is less, has been suggested. However, data are limited.
How supplied
Tablet
- 150mg
- 200mg