Indocid


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indomethacin (indometacin (UK))

Apo-Indomethacin (CA), Flexin, Indameth (CA), Indocid-R (UK), Indomax SR (UK), Indocid (CA), Indocid PDA (UK), Indocin SR, Indolar SR (UK), Indotec (CA), Novo-Methacin (CA), Nu-Indo (CA), Pardelprin (UK), Pro-Indo (CA), Ratio-Indomethacin (CA), Rheumacin (CA), Rhodacine (CA), Rimacid (UK), Sandoz Indomethacin (CA), Slo-Indo (UK)

Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID)

Therapeutic class: Anti-inflammatory, analgesic, antipyretic

Pregnancy risk category B (third trimester: D)

FDA Box 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, and may be greater in patients who have cardiovascular disease or risk factors for it.

• Drug is contraindicated for perioperative pain in setting of coronary artery bypass graft surgery.

• 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 therapy and without warning. Elderly patients are at greater risk.

Action

Unknown. Thought to inhibit cyclo-oxygenase, an enzyme needed for prostaglandin synthesis.

Availability

Capsules: 25 mg, 50 mg

Capsules (sustained-release): 75 mg

Oral suspension: 25 mg/5 ml

Indications and dosages

Rheumatoid arthritis; osteoarthritis; ankylosing spondylitis

Adults: 25 to 50 mg P.O. two or three times daily, not to exceed 200 mg daily; or one 75-mg sustained-release capsule P.O. once or twice daily

Acute gouty arthritis

Adults: 50 mg P.O. t.i.d. until pain is tolerable; then reduce dosage rapidly and, finally, discontinue drug. Don't give sustained-release form.

Acute bursitis or tendinitis of shoulder

Adults: 75 to 150 mg P.O. daily in three or four divided doses. Discontinue once inflammation is controlled.

Off-label uses

• Bartter's syndrome

• Pericarditis

Contraindications

• Hypersensitivity to drug, its components, or other NSAIDs

• Active GI bleeding

• Concurrent diflunisal use

Precautions

Use cautiously in:

• severe cardiovascular, renal, or hepatic disease

• history of ulcer disease

• elderly patients

• pregnant or breastfeeding patients

• children ages 14 and younger (efficacy not established).

Administration

• Give with food, full glass of water, or antacids to reduce GI upset.

• Don't open or crush capsules.

• For arthritis, give up to 100 mg of daily dose at bedtime as needed to reduce nighttime pain and morning stiffness.

• Don't give sustained-release form to patients with gouty arthritis.

Adverse reactions

CNS: headache, dizziness, drowsiness, fatigue, vertigo, depression, seizures

EENT: tinnitus

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

Other: allergic reactions including anaphylaxis

Interactions

Drug-drug. Antihypertensives, diuretics: decreased efficacy of these drugs

Corticosteroids, other NSAIDs: additive adverse GI reactions

Cyclosporine: increased risk of nephrotoxicity

Diflunisal: potentially fatal GI hemorrhage

Lithium, methotrexate, zidovudine: increased risk of toxicity from these drugs

Probenecid: increased risk of indomethacin toxicity

Drug-diagnostic tests. Dexamethasone suppression test: false-negative result

Drug-herbs. Anise, arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, ginkgo, ginseng: increased bleeding risk

Patient monitoring

• Assess for dizziness, drowsiness, headache, fatigue, and exacerbation of depression, epilepsy, or parkinsonism.

• Monitor for drug efficacy, indicated by improved joint mobility, pain relief, and decreased inflammation.

• Monitor urine output for marked reduction.

• Watch for signs and symptoms of GI bleeding and ulcers.

Patient teaching

• Tell patient to take with food, full glass of water, or antacid to reduce GI upset.

• Advise patient not to open or crush capsules.

• Inform breastfeeding patient that indomethacin enters breast milk and may cause seizures in infant. Advise her to use a different infant feeding method during therapy.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, balance, and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

indomethacin

(in-doe-meth-a-sin) ,

Apo-Indomethacin

(trade name),

Indameth

(trade name),

Indocid

(trade name),

Indocin

(trade name),

Indocin I.V

(trade name),

Indocin PDA

(trade name),

Indocin SR

(trade name),

Novo-Methacin

(trade name),

Nu-Indo

(trade name)

Classification

Therapeutic: antirheumatics
Pregnancy Category: B (first trimester)

Indications

Oral: Inflammatory disorders including:
  • Rheumatoid arthritis,
  • Gouty arthritis,
  • Osteoarthritis,
  • Ankylosing spondylitis.
Generally reserved for patients who do not respond to less toxic agents. Intravenous: Alternative to surgery in the management of patent ductus arteriosus (PDA) in premature neonates.

Action

Inhibits prostaglandin synthesis. In the treatment of PDA, decreased prostaglandin production allows the ductus to close.

Therapeutic effects

Oral: Suppression of pain and inflammation.
Intravenous: Closure of PDA.

Pharmacokinetics

Absorption: Well absorbed after oral administration in adults, incomplete oral absorption in neonates.
Distribution: Crosses the blood-brain barrier and the placenta. Enters breast milk.
Protein Binding: 99%.
Metabolism and Excretion: Mostly metabolized by the liver.
Half-life: Neonates <2 weeks: 20 hr; >2 weeks: 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

Contraindications/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; Pediatric: ↑ risk of necrotizing enterocolitis and bowel perforation in premature infants with PDA.
Use Cautiously in: Severe cardiovascular, renal, or hepatic disease;History of ulcer disease;Epilepsy;Hypertension; Obstetric: Not recommended during 2nd half of pregnancy (potential for causing premature closure of ductus arteriosus); Lactation: Usually compatible with breast feeding (AAP); Geriatric: ↑ risk of adverse reactions.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)
  • drowsiness (most frequent)
  • headache (most frequent)
  • psychic disturbances (most frequent)

Ear, Eye, Nose, Throat

  • blurred vision
  • tinnitus

Cardiovascular

  • hypertension
  • edema

Gastrointestinal

    PO:
  • drug-induced hepatitis (life-threatening)
  • gi bleeding (life-threatening)
  • constipation (most frequent)
  • dyspepsia (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • discomfort
  • necrotizing enterocolitis

Genitourinary

  • cystitis
  • hematuria
  • renal failure

Dermatologic

  • rashes

Fluid and Electrolyte

  • hyperkalemia
  • IV:
  • dilutional hyponatremia
  • IV:
  • hypoglycemia

Hematologic

  • thrombocytopenia
  • blood dyscrasias
  • prolonged bleeding time

Local

  • phlebitis at IV site

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use with aspirin may ↓ effectiveness.Additive adverse GI effects with aspirin, other NSAIDs, corticosteroids, or alcohol.Chronic use of acetaminophen ↑ risk of adverse renal reactions.May ↓ effectiveness of diuretics or antihypertensives.May ↑ hypoglycemia from insulins or oral hypoglycemic agents.May ↑ risk of toxicity from lithium or zidovudine (avoid concurrent use with zidovudine).↑ risk of toxicity from methotrexate.Probenecid ↑ risk of toxicity from indomethacin.↑ risk of bleeding with cefotetan, cefoperazone, valproic acid, thrombolytics, warfarin, and drugs affecting platelet function including clopidogrel, ticlopidine, abciximab, eptifibatide, or tirofiban.↑ risk of adverse hematologic reactions with antineoplastics or radiation therapy.↑ risk of nephrotoxicity with cyclosporine.Concurrent use with potassium-sparingdiuretics may result in hyperkalemia.May ↑ levels of digitalis glycosides, methotrexate, lithium, and aminoglycosides when used IV in neonates.↑ bleeding risk with anise, arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, ginkgo, Panax ginseng.

Route/Dosage

Anti-inflammatory
Oral (Adults) Antiarthritic—25–50 mg 2–4 times daily or 75-mg extended-release capsule once or twice daily (not to exceed 200 mg or 150 mg of SR/day). A single bedtime dose of 100 mg may be used. Antigout—100 mg initially, followed by 50 mg 3 times daily for relief of pain, then ↓ further.
Oral (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
Intravenous (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 q 12–24 hr for 2 doses.

Availability (generic available)

Capsules: 25 mg, 50 mg
Sustained-release capsules: 75 mg
Oral suspensionfruit mint, pineapple coconut mint flavors: 25 mg/5 mL
Rectal suppository: 50 mg
Powder for injection: 1 mg/vial

Nursing implications

Nursing assessment

  • Patients who have asthma, aspirin-induced allergy, and nasal polyps are at increased risk for developing hypersensitivity reactions. Monitor for rhinitis, asthma, and urticaria.
  • Arthritis: Assess limitation of movement and pain—note type, location, and intensity before and 1–2 hr after administration.
  • PDA: Monitor respiratory status, heart rate, BP, echocardiogram, and heart sounds routinely throughout therapy.
    • Monitor intake and output. Fluid restriction is usually instituted throughout therapy.
  • Lab Test Considerations: Evaluate BUN, serum creatinine, CBC, serum potassium levels, and liver function tests periodically in patients receiving prolonged therapy.
    • Serum potassium, BUN, serum creatinine, AST, and ALT tests may show ↑ levels. Blood glucose concentrations may be altered. Hemoglobin and hematocrit concentrations, leukocyte and platelet counts, and CCr may be ↓.
    • Urine glucose and urine protein concentrations may be ↑.
    • Leukocyte and platelet count may be ↓. Bleeding time may be prolonged for several days after discontinuation.

Potential Nursing Diagnoses

Acute pain (Indications)
Impaired physical mobility (Indications)

Implementation

  • If prolonged therapy is used, dose should be reduced to the lowest level that controls symptoms.
  • Oral: Administer after meals, with food, or with antacids to decrease GI irritation. Do not break, crush, or chew sustained-release capsules.
    • Shake suspension before administration. Do not mix with antacid or any other liquid.
  • Intravenous Administration
  • pH: 6.0–7.5.
  • Diluent: Preservative-free 0.9% NaCl or preservative-free sterile water. Reconstitute with 1 or 2 mL of diluent.Concentration: 0.5–1 mg/mL. Reconstitute immediately before use and discard any unused solution. Do not dilute further or admix. 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.
  • Rate: Administer over 20–30 min. Avoid extravasation, as solution is irritating to tissues.
  • Y-Site Compatibility: furosemide, insulin, nitroprusside, potassium chloride, sodium bicarbonate
  • Y-Site Incompatibility: calcium gluconate, cimetidine, dobutamine, dopamine, gentamicin, levofloxacin, tobramycin, tolazoline

Patient/Family Teaching

  • 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.
    • Instruct patient to take medication exactly as directed. Take missed doses as soon as remembered if not almost time for next dose. Do not double doses.
    • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to medication is known.
    • Caution patient to avoid the concurrent use of alcohol, aspirin, other NSAIDs, acetaminophen, or other OTC medications without consulting health care professional.
    • Caution patient to wear sunscreen and protective clothing to prevent photosensitivity reactions.
    • Advise patient to inform health care professional of medication regimen before treatment or surgery.
    • Instruct patient to notify health care professional if rash, itching, chills, fever, muscle aches, visual disturbances, weight gain, edema, abdominal pain, black stools, or persistent headache occurs.
  • PDA: Explain to parents the purpose of medication and the need for frequent monitoring.

Evaluation/Desired Outcomes

  • Decrease in severity of 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.

Indocid

A brand name for INDOMETHACIN (indometacin).