Clinoril

Clin·o·ril (kln-rl)

A trademark for the drug sulindac.

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sulindac

Apo-Sulin (CA), Clinoril, Novo-Sundac (CA), Nu-Sulindac (CA)

Pharmacologic class: Cyclooxygenase-1 (COX-1) enzyme inhibitor

Therapeutic class: Antirheumatic, nonsteroidal anti-inflammatory drug (NSAID)

Pregnancy risk category B (first and second trimesters), D (third trimester)

FDA Boxed Warning

• Drug may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke (which can be fatal). Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for it may be at greater risk.
• Drug increases risk of serious GI adverse events, including bleeding, ulcers, and stomach or intestinal perforation (which can be fatal). These events can occur at any time during use and without warning. Elderly patients are at greater risk.
• Drug is contraindicated for treatment of perioperative pain in setting of coronary artery bypass graft surgery.

Action

Unknown. Thought to inhibit prostaglandin biosynthesis by interfering with activity of the COX-1 enzyme.

Availability

Tablets: 150 mg, 200 mg

⊘Indications and dosages

➣ Rheumatoid arthritis; osteoarthritis; acute gouty arthritis; ankylosing spondylitis; painful shoulder (bursitis or tendinitis)

Adults: 150 to 200 mg P.O. b.i.d. Don't exceed 400 mg/day.

Contraindications

• Hypersensitivity to drug or other NSAIDs (including aspirin)
• Asthma
• Severe renal disease
• Pregnancy (third trimester)

Precautions

Use cautiously in:
• severe cardiovascular, renal, or hepatic disease; bleeding disorders; GI disorders; hyperkalemia
• history of ulcer disease
• concurrent use of other NSAIDs or methotrexate
• pregnant (first and second trimesters) or breastfeeding patients
• children (use not recommended).

Administration

• Give with food, milk, or antacids.

Route	Onset	Peak	Duration
P.O. (analgesic)	Unknown	2 hr	12 hr
P.O. (anti-inflamm.)	Unknown	Unknown	Unknown

Adverse reactions

CNS: dizziness, headache, nervousness

EENT: tinnitus

GI: nausea, vomiting, diarrhea, constipation, abdominal pain or cramps, flatulence, dyspepsia, anorexia, GI bleeding

Metabolic: hyperkalemia

Skin: rash, pruritus

Other: edema

Interactions

Drug-drug. Acetaminophen (long-term use), cyclosporine, gold compounds: increased risk of adverse renal effects

Antacids: decreased blood level and reduced efficacy of sulindac

Anticoagulants, cefamandole, cefoperazone, cefotetan, clopidogrel, eptifibatide, plicamycin, thrombolytics, ticlopidine, tirofiban, valproic acid: increased risk of bleeding

Antihypertensives, diuretics: decreased response to these drugs

Antineoplastics: increased risk of hematologic toxicity

Aspirin: decreased sulindac efficacy

Aspirin, corticosteroids, and other NSAIDs: additive GI adverse reactions

Dimethyl sulfoxide (DMSO): increased risk of peripheral neuropathy, reduced blood levels of sulindac and its metabolite

Insulin, oral hypoglycemics: increased risk of hypoglycemia

Lithium: increased lithium blood level and risk of toxicity

Methotrexate: inhibited renal elimination of methotrexate, increased risk of severe or fatal toxicity

Drug-diagnostic tests. Potassium: increased level

Drug-herbs. Dong quai: increased risk of bleeding

Patient monitoring

• Monitor liver and kidney function tests in patients on long-term therapy.
• Monitor potassium level and watch for signs and symptoms of hyperkalemia.
• Monitor hearing and vision.

Patient teaching

• Tell patient to take with food, milk, or antacid to reduce GI effects.
• Inform patient that drug increases risk of GI problems, and that ulcers and bleeding can occur without causing symptoms.
☞ Instruct patient to immediately report persistent abdominal pain or black or bloody stools.
• Explain that drug can cause swelling. Tell patient to report swelling or significant weight gain.
• Advise patient to monitor his hearing and report significant changes.
• Tell female patient to inform prescriber if she is pregnant. Caution her not to take drug during last 3 months of pregnancy or when breastfeeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.