Sulindac

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, or gout.

Sulindac is available under the following different brand names: Clinoril, and Sulin.

Dosage Forms and Strengths

Tablets

• 150 mg
• 200 mg

Dosage Considerations – Should be Given as Follows:

Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis

• Adult and geriatric: 150-200 mg orally every 12 hours
• No more than 400 mg
• Use lowest effective dose for shortest possible duration

Shoulder Pain

• Adult and geriatric: 200 mg orally every 12 hours for 7-14 days

Gout

• Adult and geriatric: 200 mg orally every 12 hours for 7 days

Familial Adenomatous Polyposis (Off-label)

• Adult and geriatric: 150-200 mg orally every 12 hours

Renal Impairment

• Severe renal impairment: Not recommended; administer lower dose and monitor closely if administration necessary

Hepatic Impairment

• Administer lower dose; discontinue if toxicity occurs

Administration

• Take with food or 8-12 oz water to avoid gastrointestinal (GI) effects

Other Indications and Uses

• Bursitis/bursitis (shoulder), synovitis, tendonitis/tendonitis (shoulder), tenosynovitis

Pediatric

• Safety and efficacy not established

Common side effects of sulindac include:

• Gastrointestinal (GI)/stomach pain
• Constipation
• Diarrhea
• Dizziness
• Indigestion/heartburn
• Headache
• Nausea
• Rash
• Abdominal cramps
• Loss of appetite
• Swelling (edema)
• Nervousness
• Skin itching
• Ringing in the ears (tinnitus)
• Vomiting
• Upset stomach
• Gas
• Bloating
• Fatigue
• Dry mouth
• Increased sweating
• Runny nose
• Blurred vision

Less common side effects of sulindac include:

• Hypersensitivity reactions (including anaphylaxis, skin swelling, bronchospasm, shortness of breath) sulindac therapy should be discontinued and not reinstituted if unexplained fever or other evidence of hypersensitivity occurs
• Low blood platelet count (thrombocytopenia)
• Bruising
• Red or purple pinpoint spots on skin
• Low white blood cell count (leukopenia, neutropenia)
• Agranulocytosis
• Bone marrow depression
• Congestive heart failure
• Blood in the urine
• Renal impairment (including renal failure)
• Interstitial nephritis
• Nephrotic syndrome

Serious side effects of sulindac include:

• Swelling of the hands or feet (edema)
• Sudden or unexplained weight gain
• Mental/mood changes
• Difficult or painful swallowing
• Unusual tiredness

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

• Sulindac has no known severe interactions with other drugs.
• Serious interactions of sulindac include:
  • apixaban
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • ketorolac intranasal
  • lisinopril
  • methotrexate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril
  • ramipril
  • tacrolimus
  • trandolapril
• Sulindac has moderate interactions with at least 230 different drugs.
• Sulindac has mild interactions with at least 80 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

Cardiovascular Risk:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, heart attack (myocardial infarction [MI]), and stroke, which can be fatal
• Risk may increase with duration of use
• Patients with risk factors for or existing cardiovascular disease may be at greater risk
• NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI and stroke)

Gastrointestinal Risk:

• NSAIDs increase risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
• GI adverse events may occur at any time during use and without warning symptoms
• Elderly patients are at greater risk for serious GI events

This medication contains sulindac. Do not take Clinoril or Sulin if you are allergic to sulindac or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Absolute: acetylsalicylic acid (aspirin) allergy, nursing mother, hypersensitivity
• Relative: Bleeding disorder, duodenal/gastric/peptic ulcer, renal calculus, stomatitis, systemic lupus erythematosus (SLE), ulcerative colitis, upper gastrointestinal (GI) disease, late pregnancy (may cause premature closure of ductus arteriosus)

Effects of Drug Abuse

• Longer use can cause the bowels to stop functioning normally and might cause dependence on laxatives.
• Long-term use can cause changes in blood electrolytes that can cause heart function disorders, muscle weakness, liver damage, and other harmful effects.

Short-Term Effects

• See "What Are Side Effects Associated with Using Sulindac?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Sulindac?"

Cautions

Use caution in asthma (bronchial), cardiac disease, congestive heart failure, hepatic impairment, hypertension, renal impairment.

Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs.

Heart Failure (HF) risk:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
• NSAIDs should be avoided or withdrawn whenever possible
• American Heart Association (AHA)/American College of Cardiology (ACC) Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Sulindac may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• If used for prolonged periods, or near term, use sulindac during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk (may cause premature closure of ductus arteriosus).
• The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation. Each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions. Exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454).
• It is not known if sulindac is distributed in milk. Consult your doctor before breastfeeding.
• Sulindac is considered safe for use while breastfeeding.