Indomethacin - (in-doe-meth′a-sin) - Indocid A, Indocin, Indocin SR
Classification: ANALGESIC, NONSTEROIDAL ANTI-INFLAMMATORY (NSAID)
Therapeutic: ANALGESIC, NSAID; ANTIRHEUMATIC
Prototype: Ibuprofen
Pregnancy Category: B first and second trimester; D third trimester
AVAILABILITY
Capsule; sustained release capsule; oral suspension; suppositories; solution for injection
ACTION & THERAPEUTIC EFFECT
Potent nonsteroidal compound that competes with COX-1 and COX-2 enzymes, thus interfering with formation of prostaglandin. Appears to reduce motility of polymorphonuclear leukocytes, development of cellular exudates, and vascular permeability in injured tissue resulting in its anti-inflammatory effects. Inhibition of prostaglandins is thought to promote closure of the patency of the ductus arterious.
Antipyretic and anti-inflammatory actions may be related to its ability to inhibit prostaglandin biosynthesis. It is a potent analgesic, anti-inflammatory, and antipyretic agent. Promotes closure of persistent patent ductus arteriosus.
USES
Palliative treatment in active stages of moderate to severe rheumatoid arthritis, ankylosing rheumatoid spondylitis, acute gouty arthritis, and osteoarthritis of hip in patients intolerant to or unresponsive to adequate trials with salicylates and other therapy. Also used IV to close patent ductus arteriosus in the premature infant.
UNLABELED USES
To relieve biliary pain and dysmenorrhea, Paget’s disease, athletic injuries, juvenile arthritis, idiopathic pericarditis.
CONTRAINDICATIONS
Allergy to indomethacin, aspirin, or other NSAID; nasal polyps associated with angioedema; history of recurrent MGI lesions; perioperative pain with CABG; pregnancy (D third trimester), lactation.
CAUTIOUS USE
History of psychiatric illness, epilepsy, parkinsonism; impaired renal or hepatic function; hypertension; history of ulcer disease or GI bleeding; infection; coagulation disorders; Muncontrolled infections; coagulation Mdefects, CHF, fluid retention; older adults, persons in hazardous occupations; pregnancy (category B first and second trimester); children Mless than 14 y except for use in premature infants for patent ductus arteriosus.
ROUTE & DOSAGE
Rheumatoid Arthritis
Adult: PO 25–50 mg b.i.d or t.i.d. (max: 200 mg/day) or 75 mg sustained release 1–2 × day
Pediatric Arthritis
Child: PO 1–2 mg/kg/day in 2–4 divided doses (max: 4 mg/kg/ day) or 150–200 mg/day
Acute Gouty Arthritis
Adult: PO/PR 50 mg t.i.d. until pain is tolerable, then rapidly taper
Bursitis
Adult: PO 25–50 mg t.i.d. or q.i.d. (max: 200 mg/day) or 75 mg sustained release 1–2 × day
Close Patent Ductus Arteriosus
Premature neonate: IV Younger than 48 h: 0.2 mg/kg followed by 2 doses of 0.1 mg/kg q12–24h; 2–7 days: 0.2 mg/kg followed by 2 doses of 0.2 mg/kg q12–24h; younger than 7 days: 0.2 mg/kg followed by 2 doses of 0.25 mg/ kg q12–24h
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Indomethacin Uses, Dosage, Side Effects |
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ADMINISTRATION
Oral
- Give immediately after meals, or with food, milk, or antacid (if prescribed) to minimize GI side effects.
Rectal
- Indomethacin rectal suppository use is contraindicated with history of proctitis or recent bleeding.
Intravenous
PREPARE: Direct: Dilute 1 mg with 1 mL of NS or sterile water for injection without preservatives. Resulting concentration (1 mg/mL) may be further diluted with an additional 1 mL for each 1 mg to yield 0.5 mg/mL.
ADMINISTER: Direct: Give by direct IV with a single dose given over 20–30 min.
INCOMPATIBILITIES: Y-site: Amino acid, calcium gluconate, cimetidine, dobutamine, dopamine, gentamicin, levofloxacin, tobramycin, tolazoline.
- Avoid extravasation or leakage; drug can be irritating to tissue.
- Discard any unused drug, since it contains no preservative.
- Store oral and rectal forms in tight, light-resistant containers unless otherwise directed. Do not freeze.
ADVERSE EFFECTS (≥1%)
Body as a Whole: Hypersensitivity (rash, purpura, pruritus, urticaria, angioedema, angiitis, rapid fall in blood pressure, dyspnea, asthma syndrome in aspirin-sensitive patients), edema, weight gain, flushing, sweating.CNS: Headache, dizziness, vertigo, light-headedness, syncope, fatigue, muscle weakness, ataxia, insomnia, nightmares, drowsiness, confusion, coma, convulsions, peripheral neuropathy, psychic disturbances (hallucinations, depersonalization, depression), aggravation of epilepsy, parkinsonism.CV: Elevated BP, palpitation, chest pains, tachycardia, bradycardia, CHF. Special Senses: Blurred vision, lacrimation, eye pain, visual field changes, corneal deposits, retinal disturbances including macula, tinnitus,hearing disturbances, epistaxis. GI: Nausea, vomiting, diarrhea, anorexia, bloating, abdominal distention, ulcerative stomatitis, proctitis, rectal bleeding, GI ulceration, hemorrhage, perforation, toxic hepatitis. Hematologic: Hemolytic anemia, aplastic anemia (sometimes fatal), agranulocytosis, leukopenia, thrombocytopenic purpura, inhibited platelet aggregation. Urogenital: Renal function impairment, hematuria, urinary frequency; vaginal bleeding, breast changes. Skin: Hair loss, exfoliative dermatitis, erythema nodosum, tissue irritation with extravasation. Metabolic: Hyponatremia, hypokalemia, hyperkalemia, hypoglycemia or hyperglycemia, glycosuria (rare).
DIAGNOSTIC TEST INTERFERENCE
Increased AST, ALT, bilirubin, BUN; positive direct Coombs’ test.
INTERACTIONS
Drug: ORAL ANTICOAGULANTS, heparin, alcohol may prolong bleeding time; may increase lithiumtoxicity; effects of ORAL ANTICOAGULANTS, phenytoin, SALICYLATES, SULFONAMIDES, SULFONYLUREASincreased because of protein-binding displacement; increased toxicity including GI bleeding withSALICYLATES, NSAIDs; may blunt effects of ANTIHYPERTENSIVES and DIURETICS. Herbal: Feverfew,garlic, ginger, ginkgo may increase bleeding potential.
PHARMACOKINETICS
Absorption: Completely absorbed from GI tract. Onset: 1–2 h. Peak: 3 h. Duration: 4–6 h. Metabolism:In liver. Elimination: Primarily in urine. Half-Life: 2.5–124 h.
NURSING IMPLICATIONS
Black Box Warning
Indomethacin has been associated with increased risk of serious, potentially fatal GI bleeding and cardiovascular events (e.g., MI & CVA); risk may increase with duration of use and may be greater in the older adult and those with risk factors for CV disease.
Assessment & Drug Effects
- Monitor for therapeutic effectiveness: In acute gouty attack, relief of joint tenderness and pain is usually apparent in 24–36 h; swelling generally disappears in 3–5 days. In rheumatoid arthritis: Reduced fever, increased strength, reduced stiffness, and relief of pain, swelling, and tenderness.
- Monitor for and report promptly S&S of CV thrombotic events (i.e., angina, MI, TIA, or stroke).
- Monitor for and report promptly S&S of GI ulceration or bleeding. Significant GI bleeding may occur without prior warning.
- Observe patients carefully; instruct to report adverse reactions promptly to prevent serious and sometimes irreversible or fatal effects.
- Monitor weight and observe dependent areas for signs of edema in patients with underlying cardiovascular disease.
- Monitor I&O closely and keep prescriber informed during IV administration for patent ductus arteriosus. Significant impairment of renal function is possible; urine output may decrease by 50% or more. Also monitor BUN, serum creatinine, glomerular filtration rate, creatinine clearance, and serum electrolytes.
- Monitor lab tests: Periodic renal function, LFTs, CBC with differential, BP and HR, visual and hearing acuity.
Patient & Family Education
- Stop taking drug and report promptly to prescriber if you experience S&S of GI ulceration: Stomach pain, frequent indigestion and nausea, bloody or tarry stools, vomit with blood or coffee- ground appearance.
- Stop taking drug and report promptly to prescriber if you experience chest pain, shortness of breath, weakness, slurring of speech, or other signs of a cardiac or neurologic problem.
- Do not take aspirin or other NSAIDs; they increase possibility of ulcers.
- Note: Frontal headache is the most frequent CNS adverse effect; if it persists, dosage reduction or drug withdrawal may be indicated. Take drug at bedtime with milk to reduce the incidence of morning headache.
- Do not drive or engage in other potentially hazardous activities until response to drug is known.
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