Classifications: analgesic, nonsteroidal antiinflammatory drug (nsaid); antipyretic; Therapeutic: nsaid, analgesic; antipyretic
Pregnancy Category: B (D in third trimester)
150 mg, 200 mg tablets
Mechanism of antiinflammatory action thought to result from inhibition of prostaglandin synthesis. Comparable to aspirin
in antiinflammatory activity with longer half-life.
Exhibits antiinflammatory, analgesic, and antipyretic properties.
Acute and long-term symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis; acute painful
shoulder (acute subacromial bursitis or supraspinatus tendinitis); acute gouty arthritis.
Hypersensitivity to sulindac; hypersensitivity to aspirin (patients with "aspirin triad": acute asthma, rhinitis,
nasal polyps), other NSAIDs, or salicylates; significant kidney or liver dysfunction; CABG perioperative pain; pregnancy
(category B; category D in third trimester), lactation. Safety in children is not established.
History of upper GI tract disorders; anticoagulant therapy; CHF; moderate or mild renal impairment; compromised cardiac
function, hypertension, hemophilia or other bleeding tendencies.
Route & Dosage
|Arthritis, Ankylosing Spondylitis, Acute Gouty Arthritis
Adult: PO 150200 mg b.i.d. (max: 400 mg/d)
- Crush and give mixed with liquid or food if patient cannot swallow tablet.
- Administer with food, milk, or antacid (if prescribed) to reduce possibility of GI upset. Note: Food retards absorption
and delays and lowers peak concentrations.
Adverse Effects (≥1%)CNS:
Drowsiness, dizziness, headache,
anxiety, nervousness. CV:
Palpitation, peripheral edema, CHF, (patients with marginal cardiac function). Special Senses:
Blurred vision, amblyopia, vertigo, tinnitus, decreased hearing. GI: Abdominal pain, dyspepsia, nausea, vomiting, constipation, diarrhea
, ulceration, flatulence, anorexia; stomatitis
, sore or dry mucous membranes, dry mouth; GI bleeding, gastritis
Prolonged bleeding time, aplastic anemia, thrombocytopenia
, eosinophilia. Body as a Whole:
Angioneurotic edema, fever, chills, anaphylaxis. Skin:
, toxic epidermal necrolysis syndrome,
rash, pruritus. Urogenital: Renal
Diagnostic Test Interference
Abnormalities in liver function tests may occur.
InteractionsDrug: Heparin, oral anticoagulants
may prolong bleeding time; may increase lithium toxicity
s add to ulcerogenic effects; may increase methotrexate toxicity
; dimethylsulfoxide (DMSO)
may decrease effects of sulindac. Herbal: Feverfew, garlic, ginger, ginkgo
may increase bleeding potential.
90% from GI tract. Peak:
2 h without food, 34 h with food. Duration:
1012 h. Distribution:
Minimal passage across placenta; distributed into breast milk. Metabolism:
In liver to active sulfide metabolite
75% in urine, 25% in feces. Half-Life:
7.8 h sulindac, 16.4 h sulfide metabolite
Assessment & Drug Effects
- Lab tests: Obtain baseline and periodic evaluations of Hgb, kidney and liver function.
- Schedule auditory and ophthalmic examinations in patients receiving prolonged or high-dose therapy.
- Recommend an ophthalmoscopic examination if patient has eye complaints.
Patient & Family Education
- Do not drive or engage in potentially hazardous activities until response to drug is known.
- Report any incidence of unexplained bleeding or bruising immediately to physician (e.g., bleeding gums, black and tarry stools,
- Report onset of skin rash, itching, hives, jaundice, swelling of feet or hands, sore throat or mouth, shortness of breath,
or night cough to physician.
- Be aware that adverse GI effects are relatively common. Report abdominal pain, nausea, dyspepsia, diarrhea, or constipation.
- Note: Initial effect may take up to 7 d; peak effect is usually experienced in 23 wk (relief of joint pain and stiffness,
reduction in joint swelling, increase in grip strength, and improved mobility).
- Avoid alcohol and aspirin as they may increase risk of GI ulceration and bleeding tendencies.
- Inform dentist or surgeon of drug regimen because bleeding time may be prolonged.