section name header

Pronunciation

in-doe-METH-a-sin

Classifications

Therapeutic Classification: antirheumatics, ductus arteriosus patency adjuncts (IV only ), nonopioid analgesics

Pharmacologic Classification: nonsteroidal anti inflammatory drugs nsaids

Indications

BEERS REMS


Action

  • Inhibits prostaglandin synthesis. In the treatment of PDA, decreased prostaglandin production allows the ductus to close.
Therapeutic effects:
  • PO: Suppression of pain and inflammation.
  • IV: Closure of PDA.

Pharmacokinetics

Absorption: Well absorbed after oral administration in adults; incomplete oral absorption in neonates.

Distribution: Crosses the blood-brain barrier.

Protein Binding: 99%.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-Life: Neonates <2 wk: 20 hr; Neonates >2 wk: 11 hr; Adults: 2.6–11 hr.

Time/Action Profile

ROUTEONSETPEAKDURATION
PO (analgesic)30 min0.5–2 hr4–6 hr
PO-ER (analgesic)30 minunknown4–6 hr
PO (anti-inflammatory)up to 7 days1–2 wk4–6 hr
PO-ER (anti-­inflammatory)up to 7 days1–2 wk4–6 hr
IV (closure of PDA)up to 48 hrunknownunknown

Contraind./Precautions

Contraindicated in:

  • Hypersensitivity;
  • Known alcohol intolerance (suspension);
  • Cross-sensitivity may exist with other NSAIDs, including aspirin;
  • Active GI bleeding;
  • Ulcer disease;
  • Proctitis or recent history of rectal bleeding;
  • Intraventricular hemorrhage;
  • Thrombocytopenia;
  • Coronary artery bypass graft surgery;
  • Recent MI;
  • HF;
  • OB: Avoid use after 30 wk gestation (may cause premature closure of fetal ductus arteriosus);
  • Pedi: risk of necrotizing enterocolitis and bowel perforation in premature infants with PDA.

Use Cautiously in:

  • Severe renal impairment;
  • Severe hepatic impairment;
  • Cardiovascular disease or risk factors for cardiovascular disease (may risk of serious cardiovascular thrombotic events, MI, and stroke, especially with prolonged use or use of higher doses);
  • History of long duration of NSAID use, smoking, alcohol use, advanced liver disease, coagulopathy, or poor general health ( risk of GI bleeding);
  • History of peptic ulcer disease and/or GI bleeding;
  • Bleeding tendency or concurrent anticoagulant therapy;
  • Seizure disorders;
  • Hypertension;
  • OB: Use at or after 20 wk gestation may cause fetal renal impairment leading to oligohydramnios and, possibly neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible;
  • Geri: Appears on Beers list. risk GI bleeding or peptic ulcer disease in older adults. Avoid chronic use unless other alternatives are not effective and the patient can take a gastroprotective agent; avoid short-term use in combination with oral or parenteral corticosteroids, anticoagulants, or antiplatelet agents unless other alternatives are not effective and the patient can take a gastroprotective agent.

Adv. Reactions/Side Effects

Interactions

Drug-drug:

Drug-Natural Products:

Route/Dosage

Anti-inflammatory

  • PO (Adults ): Arthritis (immediate release): 25–50 mg 2–4 times daily (max dose = 200 mg/day). A single bedtime dose of 100 mg may alternatively be used; Arthritis (extended release): 75 mg once or twice daily (max dose = 150 mg/day). Gout: 100 mg initially, followed by 50 mg 3 times daily for relief of pain; then further.
  • PO (Children >2 yr): 1–2 mg/kg/day in 2–4 divided doses (not to exceed 4 mg/kg/day or 150–200 mg/day).

PDA Closure

  • IV (Neonates ): Treatment: 0.2 mg/kg initially, then 2 subsequent doses at 12–24 hr intervals of 0.1 mg/kg if age <48 hr at time of initial dose; 0.2 mg/kg if 2–7 days at initial dose; 0.25 mg/kg if age >7 days at initial dose. Prophylaxis: 0.1–0.2 mg/kg initially, then 0.1 mg/kg every 12–24 hr for 2 doses.

Availability

(Generic available)
  • Capsules: 25 mg; 50 mg
  • Extended-release capsules: 75 mg
  • Oral suspension fruit mint, pineapple, coconut, mint flavors: 25 mg/5 mL
  • Powder for injection: 1 mg/vial
  • Rectal suppository: 50 mg ; 100 mg

Assessment

  • Monitor for rhinitis, asthma, and urticaria. Patients who have asthma, aspirin-induced allergy, and nasal polyps are at risk for developing hypersensitivity reactions.
  • Assess for SJS, TEN, and generalized bullous fixed drug eruption. Discontinue indomethacin at 1st sign of rash and treat as indicated.
  • Monitor BP during initiation and periodically thereafter.
  • Arthritis: Assess limitation of movement and pain; note type, location, and intensity before and 1–2 hr after administration.
  • PDA: Monitor respiratory status, HR, BP, echocardiogram, and heart sounds routinely throughout therapy.
    • Monitor intake and output. Fluid restriction is usually instituted throughout therapy.
  • Acute pain: Assess type, location, and intensity of pain prior to and 2 hr (peak) following administration.

Lab Test Considerations:

  • Evaluate BUN, serum creatinine, CBC, potassium, and liver function tests periodically in patients receiving prolonged therapy.
    • May alter blood glucose values.
    • May hemoglobin, hematocrit, leukocytes, platelets, and CCr. Bleeding time may be prolonged for several days after last dose.
    • May cause in urine glucose and protein concentrations.

Implementation

  • If prolonged therapy is used, dose should be to the lowest level that controls symptoms to minimize risk of cardiovascular thrombotic events.
  • PO: Administer after meals, with food, or with antacids to GI irritation. DNC: Do not break, crush, or chew sustained-release capsules.
    • Shake suspension before administration. Do not mix with antacid or any other liquid.

IV Administration:

  • IV Push: Reconstitution: Reconstitute with 1–2 mL of preservative-free 0.9% NaCl or sterile water. Reconstitute immediately before use and discard any unused solution. Do not dilute further or admix. Concentration: 0.5–1 mg/mL.
  • Rate: Administer over 20–30 min. Do not administer via umbilical catheter into vessels near the superior mesenteric artery, as these can cause vasoconstriction and compromise blood flow to the intestines. Do not administer intra-arterially.
  • Y-Site Compatibility:
    • aminophylline
    • ascorbic acid
    • atropine
    • bumetanide
    • caffeine citrate
    • cefazolin
    • cefotaxime
    • cefoxitin
    • ceftazidime
    • ceftriaxone
    • cefuroxime
    • chloramphenicol
    • cisplatin
    • clindamycin
    • cyanocobalamin
    • cyclosporine
    • dexamethasone
    • digoxin
    • enalaprilat
    • ephedrine
    • epoetin alfa
    • fentanyl
    • fluconazole
    • folic acid
    • furosemide
    • ganciclovir
    • heparin
    • hydrocortisone
    • imipenem/cilastatin
    • insulin regular
    • ketorolac
    • lidocaine
    • mannitol
    • metoclopramide
    • metoprolol
    • multivitamins
    • nafcillin
    • nitroglycerin
    • nitroprusside
    • penicillin G
    • pentobarbital
    • phenobarbital
    • phytonadione
    • potassium chloride
    • procainamide
    • sodium bicarbonate
    • theophylline
  • Y-Site Incompatibility:
    • amikacin
    • atracurium
    • aztreonam
    • benztropine
    • buprenorphine
    • butorphanol
    • calcium chloride
    • calcium gluconate
    • cefotetan
    • chlorpromazine
    • dactinomycin
    • dantrolene
    • daunorubicin
    • diazepam
    • diazoxide
    • diphenhydramine
    • dobutamine
    • dopamine
    • doxycycline
    • epinephrine
    • erythromycin
    • esmolol
    • etoposide
    • famotidine
    • gentamicin
    • glycopyrrolate
    • haloperidol
    • hydralazine
    • isoproterenol
    • labetalol
    • levofloxacin
    • magnesium sulfate
    • meperidine
    • midazolam
    • minocycline
    • morphine
    • nalbuphine
    • norepinephrine
    • ondansetron
    • oxytocin
    • paclitaxel
    • pantoprazole
    • papaverine
    • pentamidine
    • phenylephrine
    • phenytoin
    • prochlorperazine
    • promethazine
    • propranolol
    • protamine
    • pyridoxine
    • succinylcholine
    • sufentanil
    • thiamine
    • tobramycin
    • trimethoprim/sulfamethoxazole
    • vancomycin
    • vasopressin
    • verapamil

Patient/Family Teaching

  • Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
  • Advise patient to take this medication with a full glass of water and to remain in an upright position for 15–30 min after administration.
  • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications. Avoid concurrent use of alcohol, aspirin and other NSAIDs.
  • Caution patient to wear sunscreen and protective clothing to prevent photosensitivity reactions.
  • Advise patient to inform health care provider of medication regimen before treatment or surgery.
  • Inform patient of risk of MI and stroke. Use lowest effective dose for shortest time. Advise patient to notify health care provider immediately if signs and symptoms (shortness of breath or trouble breathing, chest pain, weakness in one part or side of body, slurred speech, swelling of the face or throat) occur.
  • Advise patient to notify health care provider promptly if signs or symptoms of GI toxicity (abdominal pain, black stools) occur.
  • Instruct patient to notify health care provider immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms), rash, itching, chills, fever, muscle aches, visual disturbances, weight gain, edema, or persistent headache occurs.
  • Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise women to avoid indomethacin in the 3rd trimester of pregnancy (after 29 wk); may cause premature closure of the fetal ductus arteriosus. Use of indomethacin after 20 wk may cause fetal renal dysfunction leading to oligohydramnios. May cause temporary infertility in women.

Evaluation/Desired Outcomes

  • Decrease in severity of mild to moderate pain.
    • Improved joint mobility. Partial arthritic relief is usually seen within 2 wk, but maximum effectiveness may require up to 1 mo of continuous therapy. Patients who do not respond to one NSAID may respond to another.
  • Successful PDA closure.

US Brand Names

Indocin, Tivorbex

Code

NDC Code