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indomethacin (Rx)Brand and Other Names:Indocin, Indocin SR, more...Tivorbex

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 20mg (Tivorbex)
  • 25mg
  • 40mg (Tivorbex)
  • 50mg

capsule, extended-release

  • 75mg

powder for injection

  • 1mg

oral suspension

  • 25mg/5mL

suppository

  • 50mg
more...

Inflammatory/Rheumatoid Disorders

Immediate release: 25-50 mg PO/PR q8-12hr; not to exceed 200 mg/day

Extended release: 75-150 mg/day PO in single daily dose or divided q12hr; not to exceed 150 mg/day

Bursitis/Tendinitis

Immediate-release: 75-150 mg/day PO/PR divided q6-8hr

Extended-release: 75-150 mg/day PO in single daily dose or divided q12hr

Acute Gouty Arthritis

50 mg PO/PR q8hr for 3-5 days; reduced once pain is under control

Nephrogenic Diabetes Insipidus

2 mg/kg/day PO divided q8hr

Pain

Tivorbex: Indicated for mild-to-moderate acute pain

20 mg PO TID or 40 mg PO BID/TID

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Dosage Forms & Strengths

capsule

  • 25mg
  • 50mg

capsule, extended-release

  • 75mg

powder for injection

  • 1mg

oral suspension

  • 25mg/5mL

suppository

  • 50mg
more...

Inflammatory/Rheumatoid Disorders

<2 years: Safety and efficacy not established

2-14 years: 1-2 mg/kg/day PO divided q6-12hr; not to exceed 4 mg/kg/day or 150-200 mg/day 

>14 years: 25-50 mg IR PO/PR q8-12hr; not to exceed 200 mg/day; 75-150 mg/day ER PO in single daily dose or divided q12hr; not to exceed 150 mg/day

Closure of Ductus Arteriosus

Neonates <28 days: 0.2 mg/kg IV over 20-30 minutes initially, THEN 2 subsequent doses, depending on postnatal age 

Doses 2 and 3 (<48 hours): 0.1 mg/kg IV over 20-30 minutes at 12 and 24hr intervals

Doses 2 and 3 (2-7 days): 0.2 mg/kg IV over 20-30 minutes at 12 and 24hr intervals

Doses 2 and 3 (>7 days): 0.25 mg/kg IV over 20-30 minutes at 12 and 24hr intervals

After dose 3 (infants <1.5 kg): 0.1-0.2 mg/kg IV over 20-30 minutes once daily for 3-5 days

Monitor renal function (drug is renally excreted); decreased renal function more likely in elderly

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) producing mostly central nervous system (CNS) adverse reactions in elderly

Lowest dose and frequency recommended

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Interactions

Interaction Checker

indomethacin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Transient renal insufficiency (40%)

            Jaundice (≤15%)

            Elevated liver function test values (≤15%)

            Headache (12%)

            1-10%

            Dizziness (3-9%)

            Dyspepsia (3-9%)

            Epigastric pain (3-9%)

            Indigestion (3-9%)

            Nausea (3-9%)

            Symptomatic upper GI ulcers, gross bleeding/perforation (4% of patients treated for 1 year; 1% of patients treated for 3-6 months).

            Abnormal pain/cramps/distress (<3%)

            Constipation (1-3%)

            Depression (1-3%)

            Diarrhea (1-3%)

            Fatigue (1-3%)

            Somnolence (1-3%)

            Tinnitus (1-3%)

            Vertigo (1-3%)

            <1%

            Acute interstitial nephritis with hematuria/proteinuria

            Acute respiratory distress

            Agranulocytosis

            Angioedema

            Aplastic anemia

            Asthma

            Bone marrow depression

            Congestive heart failure (CHF)

            Hemolytic anemia

            Leukopenia

            Macular and morbilliform eruptions

            Pulmonary edema

            Thrombocytopenia

            Thrombocytopenic purpura

            Ulcerative stomatitis

            Urticaria

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, 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

            Contraindications

            Absolute

            • Hypersensitivity
            • Aspirin allergy
            • History of aspirin triad
            • Preoperative pain associated with CABG surgery

            Relative

            • Bleeding disorder
            • Duodenal/gastric/peptic ulcer
            • Stomatitis
            • Ulcerative colitis
            • Upper GI disease
            • Late pregnancy (may cause premature closure of ductus arteriosus)

            Neonates

            • Renal impairment
            • Untreated infection
            • Necrotizing enterocolitis
            • Active bleeding (GI bleeding or intracranial hemorrhage)
            • Thrombocytopenia
            • Congenital heart disease where patent ductus arteriosus is necessary

            Cautions

            Use caution in patients with history of bronchospasm, cardiac disease, CHF, hypertension, hepatic or renal impairment

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

            Prolonged use may cause corneal deposits and retinal disturbances; discontinue if visual changes observed

            Risk of aggravation of psychiatric disturbances, epilepsy, fluid retention, or Parkinson disease

            Reduction in cerebral blood flow associated with rapid IV infusion

            Serious skin adverse events (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) reported; discontinue is symptoms occur

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            Pregnancy & Lactation

            Pregnancy category: C

            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 approximately 2.6% of controls

            Lactation: Drug enters breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)

            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.

            more...
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            Pharmacology

            Mechanism of Action

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

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

            Absorption

            Bioavailability: ~100%

            Onset: 30 min

            Duration: 4-6 hr

            Peak plasma time: 0.5-2 hr; 1.67 hr (Tivorbex)

            Peak plasma concentration: 1.2 mcg/mL (20 mg PO); 0.8-2.5 mcg/mL (25 mg PO); 2.4 mcg/mL (40 mg PO); 2.5-4 mcg/mL (50 mg PO)

            Tivorbex

            • When taken under fasted conditions, a 20% lower dose of indomethacin in Tivorbex 40 mg capsules resulted in a 21% lower mean systemic exposure (AUCinf) and an equivalent mean peak concentration (Cmax) compared to 50 mg indomethacin IR capsules
            • The median time to reach peak concentrations (Tmax) was 1.67 hr and 2.02 hr for Tivorbex capsules and indomethacin IR capsules, respectively
            • Food causes a significant decrease in the rate but not the overall extent of systemic absorption; 46% lower Cmax, 9% lower AUCinf, and 1.33 hr delayed Tmax (1.67 hr during fasted vs 3 hr during fed)

            Distribution

            Protein bound: 99%

            Vd: 0.34-1.57 L/kg

            Metabolism

            Metabolized in liver

            Metabolites: Desmethyl, desbenzoyl, desmethyl-desbenzoyl

            Enzymes inhibited: COX-1, COX-2

            Elimination

            Half-life: 4.5 hr (prolonged in neonates)

            Excretion: Urine (60%), feces (>33%)

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            Administration

            Oral Administration

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

            Tivorbex: Food causes a significant decrease in the rate but not the overall extent of systemic absorption and 1.33 hr delayed Tmax (1.67 hr during fasted vs 3 hr during fed)

            IV Incompatibilities

            Y-site: Amino acid injection, calcium gluconate, cimetidine, dobutamine, dopamine, gentamicin, levofloxacin, tobramycin, tolazoline

            IV Preparation

            Reconstitute just before administration

            Discard any unused portion

            Do not use preservative-containing diluents for reconstitution

            IV Administration

            Infuse over 20-30 min at concentration of 0.5-1 mg/mL in preservative-free SWI or NS

            Avoid bolus administration or infusion via umbilical catheter into vessels near superior mesenteric artery; this may cause vasoconstriction and can compromise blood flow to intestines

            Do not administer intra-arterially

            IV Storage

            Store below 30°C (86°F)

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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