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sulindac (Rx)Brand and Other Names:Clinoril, Sulin

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 150mg
  • 200mg
more...

Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis

150-200 mg PO q12hr

No more than 400 mg

Use lowest effective dose for shortest possible duration

Shoulder Pain

200 mg PO q12hr for 7-14 days

Gout

200 mg PO q12hr for 7 days

Familial Adenomatous Polyposis (Off-label)

150-200 mg PO q12hr

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 GI effects

Other Indications & Uses

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

Safety & efficacy not established

Ankylosing spondylitis, osteoarthritis, rheumatoid arthritis

150-200 mg PO q12hr

No more than 400 mg

Use lowest effective dose for shortest possible duration

Shoulder Pain

200 mg PO q12hr for 7-14 days

Gout

200 mg PO q12hr for 7 days

Familial Adenomatous Polyposis (Off-label)

150-200 mg PO q12hr

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Interactions

Interaction Checker

sulindac and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            GI pain (10%)

            Constipation (3-9%)

            Diarrhea (3-9%)

            Dizziness (3-9%)

            Dyspepsia (3-9%)

            Headache (3-9%)

            Nausea (3-9%)

            Rash (3-9%)

            Abdominal cramps (1-3%)

            Anorexia (1-3%)

            Edema (1-3%)

            Nervousness (1-3%)

            Pruritus (1-3%)

            Tinnitus (1-3%)

            Vomiting (1-3%)

            <1%

            Hypersensitivity reactions (including anaphylaxis, angioedema, bronchospasm, dyspnea) Sulindac therapy should be discontinued & not reinstituted if unexplained fever or other evidence of hypersensitivity occurs

            Thrombocytopenia

            Ecchymosis

            Purpura

            Leukopenia

            Agranulocytosis

            Neutropenia

            Bone marrow depression

            CHF (<1%)

            Hematuria (<1%)

            Renal impairment (including renal failure)

            Interstitial nephritis

            Nephrotic syndrome

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & 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 & stroke)

            Gastrointestinal Risk

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

            Contraindications

            Absolute: ASA allergy, nursing mother, hypersensitivity

            Relative: Bleeding disorder, duodenal/gastric/peptic ulcer, renal calculus, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

            Cautions

            Asthma (bronchial), cardiac disease, CHF, 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

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            Pregnancy & Lactation

            Pregnancy Category: B; D if used for prolonged periods, or near term (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)

            Lactation: not known if distributed in milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

            May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation.  These effects may contribute to its anti-inflammatory activity

            Pharmacokinetics

            Half-life: Sulindac (8 hr); sulfide metabolite (16.4 hr)

            Peak Plasma Time: 2 hr (sulindac); 5-6 hr (sulfide metabolites)

            Concentration: 3-6 mcg/mL

            Excretion: Urine (50%); feces (25%)

            Bioavailability: 90%

            Protein Bound: Approx 93% (sulindac); approx 98% (sulfide metabolite)

            Metabolism: Hepatic reduction; significant enterohepatic circulation

            Metabolites: Sulfide and sulfone metabolites

            Dialyzable: Unknown

            Enzymes inhibited: Cyclooxygenase

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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