Yes

Nonsteroidal Anti-Inflammatory Agent (NSAID)

Management of inflammatory disease, rheumatoid disorders, acute gouty arthritis, structurally similar to indomethacin but acts like aspirin; safest NSAID for use in mild renal impairment

B (D in 3rd trimester)

Hypersensitivity to sulindac, any component, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Use with caution in patients with peptic ulcer disease, GI bleeding, bleeding abnormalities, dehydration, impaired renal or hepatic function, congestive heart failure, hypertension, and patients receiving anticoagulants

>10%:

Central nervous system: Dizziness

Dermatologic: Rash

Gastrointestinal: Abdominal cramps, heartburn, indigestion, nausea

1% to 10%:

Central nervous system: Headache, nervousness

Dermatologic: Itching

Endocrine & metabolic: Fluid retention

Gastrointestinal: Vomiting

Otic: Tinnitus

<1%: Congestive heart failure, hypertension, arrhythmias, tachycardia, confusion, hallucinations, aseptic meningitis, mental depression, drowsiness, insomnia, urticaria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, polydipsia, hot flashes, gastritis, GI ulceration, cystitis, polyuria, agranulocytosis, anemia, hemolytic anemia, bone marrow suppression, leukopenia, thrombocytopenia, hepatitis, peripheral neuropathy, toxic amblyopia, blurred vision, conjunctivitis, dry eyes, decreased hearing, acute renal failure, allergic rhinitis, shortness of breath, epistaxis

Symptoms of overdose include dizziness, vomiting, nausea, abdominal pain, hypotension, coma, stupor, metabolic acidosis, leukocytosis, renal failure

Management of a nonsteroidal anti-inflammatory drug (NSAID) intoxication is primarily supportive and symptomatic. Fluid therapy is commonly effective in managing the hypotension that may occur following an acute NSAID overdose, except when this is due to an acute blood loss. Seizures tend to be very short-lived and often do not require drug treatment; although, recurrent seizures should be treated with I.V. diazepam.

Decreased effect of diuretics, beta-blockers, hydralazine, ACE inhibitors

Increased toxicity with probenecid, NSAIDs; increased toxicity of digoxin, methotrexate, lithium, aminoglycosides antibiotics (reported in neonates), cyclosporine (increased nephrotoxicity), potassium-sparing diuretics (hyperkalemia), anticoagulants

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclo-oxygenase, which results in decreased formation of prostaglandin precursors

Onset of effect: Analgesic: ~1 hour

Duration: 12-24 hours

Absorption: 90%

Metabolism: Sulindac is a prodrug and, therefore, requires metabolic activation; requires hepatic metabolism to sulfide metabolite (active) for therapeutic effects; also metabolized in the liver to sulfone metabolites (inactive)

Half-life: Parent drug: 7 hours; Active metabolite: 18 hours

Elimination: Principally in urine (50%) with some biliary excretion (25%)

Maximum therapeutic response may not be realized for up to 3 weeks

Children: Dose not established

Adults: 150-200 mg twice daily or 300-400 mg once daily; not to exceed 400 mg/day

Dosing adjustment in hepatic impairment: Dose reduction is necessary

Food: May decrease the rate but not the extent of oral absorption. Drug may cause GI upset, bleeding, ulceration, perforation; take with food or milk to minimize GI upset.

Liver enzymes, BUN, serum creatinine, CBC, blood pressure

chloride (S), sodium (S), bleeding time

Dizziness is common; may cause nervousness; may rarely cause drowsiness, confusion, insomnia, hallucinations, or depression

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; may decrease lithium clearance (evidence suggests that this effect may be less than with other NSAIDs) resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

No information available to require special precautions

NSAID formulations are known to reversibly decrease platelet aggregation via mechanisms different than observed with aspirin. The dentist should be aware of the potential of abnormal coagulation. Caution should also be exercised in the use of NSAIDs in patients already on anticoagulant therapy with drugs such as warfarin (Coumadin®).

Take this medication exactly as directed; do not increase dose without consulting prescriber. Take with food or milk to reduce GI distress. Maintain adequate fluid intake (2-3 L/day of fluids unless instructed to restrict fluid intake). Do not use alcohol, aspirin, or aspirin-containing medication, and all other anti-inflammatory medications without consulting prescriber. You may experience dizziness, nervousness, or headache (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or heartburn (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help). GI bleeding, ulceration, or perforation can occur with or without pain; discontinue medication and contact prescriber if persistent abdominal pain or cramping, or blood in stool occurs. Report breathlessness or difficulty breathing; unusual bruising/bleeding; blood in urine, stool, mouth, or vomitus; unusual fatigue; skin rash or itching; change in urinary pattern; or change in hearing or ringing in ears. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Observe for edema and fluid retention; monitor blood pressure

Tablet: 150 mg, 200 mg

A suspension of sulindac can be prepared by triturating 1000 mg sulindac (5 x 200 mg tablets) with 50 mg of kelco and 400 mg of Veegum® until a powder mixture is formed; then add 30 mL of sorbitol 35% (prepared from 70% sorbitol) to form a slurry; finally add a sufficient quantity of 35% sorbitol to make a final volume of 100 mL; the final suspension is 10 mg/mL and is stable for 7 days

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