A-Z Drug Facts > Sulindac

Sulindac

Pronouncation: (SUL-in-dak)
Class: NSAID

Trade Names:
Clinoril
- Tablets 200 mg

APO-Sulin (Canada)
Novo-Sundac (Canada)
Nu-Sulindac (Canada)

Pharmacology

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Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Pharmacokinetics

Absorption

T _max is 3 to 4 h. Approximately 90% of the drug is absorbed after oral administration.

Distribution

93% bound to plasma proteins. Sulindac does penetrate the blood-brain and placental barriers.

Metabolism

Recirculation of sulindac and its sulfone metabolite is more active and extensive than that of the active sulfide metabolite.

Elimination

The t _½ is 7.8 h. The main route of excretion is via the urine. Approximately 25% is found in feces, primarily as the sulfone and sulfide metabolites. Renal clearance is 68 to 74 mL/min.

Special Populations

Renal Function Impairment

A lower daily dose should be anticipated to avoid excessive drug accumulation.

Hepatic Function Impairment

Plasma concentrations have been reported to be higher in patients with alcoholic liver disease; patients with acute and chronic hepatic disease may require reduced doses.

Indications and Usage

Treatment of acute and chronic rheumatoid and osteoarthritis, ankylosing spondylitis, acute gouty arthritis, and acute painful shoulder (tendonitis, bursitis).

Contraindications

Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in setting of coronary artery bypass graft (CABG) surgery; hypersensitivity to any component of the product.

Dosage and Administration

Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
Adults

PO 150 mg twice daily. Adjust dose as needed.

Acute Painful Shoulder, Acute Gouty Arthritis
Adults

PO 200 mg twice daily for 7 to 14 days.

General Advice

• Max dose is 400 mg/day
• Administer dose with food.

Storage/Stability

Store at room temperature (15° to 30° C [59° to 86° F]).

Drug Interactions

ACE inhibitors (eg, captopril), angiotensin II antagonists (eg, losartan)

The antihypertensive effect may be decreased by sulindac.

Anticoagulants

May increase effect of anticoagulants because of decreased plasma protein binding. May increase risk of gastric erosion and bleeding.

Aspirin

Risk of GI adverse reactions may be increased; plasma levels of active sulindac metabolite may be reduced.

Bile acid sequestrants (eg, cholestyramine)

Plasma levels of sulindac may be reduced.

Cimetidine

Sulindac has increased cimetidine bioavailability.

Cyclosporine

Risk of cyclosporine toxicity may be increased.

Diflunisal

Plasma level of active sulindac metabolite may be reduced.

Dimethyl sulfoxide

Dimethyl sulfoxide may decrease formation of active metabolite of sulindac, possibly resulting in decreased therapeutic effect. Also, topical dimethyl sulfoxide with sulindac has resulted in severe peripheral neuropathy.

Diuretics

Decreased diuresis may result.

Lithium

May decrease lithium clearance.

Methotrexate

May increase methotrexate levels.

NSAIDs (eg, ibuprofen)

Coadministration with other NSAIDs may increase the risk of GI toxicity.

Probenecid

Sulindac plasma levels may be elevated.

Ranitidine

Sulindac has increased ranitidine bioavailability.

Laboratory Test Interactions

May prolong bleeding time.

Adverse Reactions

Cardiovascular

Arrhythmia (postmarketing).

CNS

Dizziness, headache (3% to 9%); nervousness (1% to 3%); neuritis (postmarketing).

Dermatologic

Rash (3% to 9%); pruritus (1% to 3%).

EENT

Tinnitus (1% to 3%); disturbances of the retina and its vasculature (postmarketing).

GI

GI pain (10%); constipation, diarrhea, dyspepsia, nausea with or without vomiting (3% to 9%); anorexia, flatulence, GI cramps (1% to 3%).

Genitourinary

Gynecomastia (postmarketing).

Metabolic-Nutritional

Hyperglycemia (postmarketing).

Miscellaneous

Edema.

Precautions

Warnings NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Sulindac is contraindicated for treatment of perioperative pain in the setting of CABG surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.

Monitor Monitor for fever, chills, and joint pain (symptoms of acute hypersensitivity reaction); withhold medication if noted. Monitor BP, LFTs, and renal function. Monitor vision, CBC, and chemistry profile in patients on long-term treatment. Monitor all patients for GI bleeding.

Pregnancy

Category C . Avoid in late pregnancy. Premature closure of ductus arteriosus may occur if sulindac is used in late pregnancy.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Increased risk of adverse reactions.

Hypersensitivity

May occur; use caution in aspirin-sensitive individuals because of possible cross-sensitivity. Potentially fatal reaction. Fever and other evidence of hypersensitivity, including LFT abnormalities, skin reactions, and death have occurred.

Renal Function

Not recommended in patients with advanced renal disease.

Hepatic Function

Delayed, elevated, and prolonged levels of sulindac may occur.

Anaphylactic/anaphylactoid reactions

May occur in patients without known prior exposure to sulindac.

Asthma

Use with caution in patients with preexisting asthma.

CHF

Fluid retention and edema may occur.

Hematologic effects

Inhibition of platelet aggregation and prolongation of bleeding time may occur. Anemia, resulting from fluid retention, or occult or gross GI blood loss may occur.

Hypertension

Onset of new hypertension or worsening of pre-existing hypertension may occur.

Renal lithiasis

Use with caution in patients with a history of renal lithiasis.

Overdosage

Symptoms

Coma, death, diminished urine output, hypotension, stupor.

Patient Information

• Advise patients who become pregnant to avoid use in late pregnancy because of possible premature closure of the ductus arteriosus.
• Instruct patient to promptly report signs of symptoms of unexplained weight gain or edema to their health care provider.
• Advise patient to take medication with food or after meals.
• Tell patient to take medication with full glass of water to prevent medication from lodging in esophagus.
• Emphasize importance of regular medical follow-up, even in absence of adverse reactions or problems related to drug therapy.
• Instruct patient to report the following symptoms of toxicity to health care provider immediately: ringing in ears, blurred vision, change in urine (pattern, blood in urine).
• Tell patient to avoid intake of alcoholic beverages or other NSAIDs/acetylsalicylic acid during therapy (increases risk of GI irritation/GI bleeding), especially during long-term therapy.
• Advise patient that drowsiness or dizziness may occur and to use caution while driving or performing other activities requiring mental alertness.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to prevent photosensitivity reaction.

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