indomethacin

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;
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); Avoid use in patients with recent MI or HF
History of ulcer disease;
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 ⬆ ⬇

CV: edema, HF, hypertension, MI

Derm: rash

EENT: blurred vision, tinnitus

Endo: IVhypoglycemia

F and E: hyperkalemia, IVdilutional hyponatremia

GI: constipation, dyspepsia, nausea, vomiting, discomfort, POGI BLEEDING, HEPATOTOXICITY, necrotizing enterocolitis, PANCREATITIS

GU: cystitis, hematuria, renal failure

Hemat: blood dyscrasias, prolonged bleeding time, thrombocytopenia

Local: phlebitis at IV site

Neuro: dizziness, drowsiness, headache, psychic disturbances, STROKE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

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 anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs.
↑risk of adverse hematologic reactions with antineoplastics or radiation therapy.
↑risk of nephrotoxicity with cyclosporine.
Concurrent use with potassium-sparing diuretics may result in hyperkalemia.
May ↑ levels of digoxin, methotrexate, lithium, and aminoglycosides when used IV in neonates.

Drug-Natural Products:

↑bleeding risk with anise, arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, ginkgo, Panax ginseng.

Availability ⬆ ⬇

(Generic available)

Capsules: 25 mg; 50 mg
Extended-release capsules: 75 mg
Oral suspensionfruit mint, pineapple, coconut, mint flavors: 25 mg/5 mL
Powder for injection: 1 mg/vial
Rectal suppository: 50 mg; 100 mg

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.

US Brand Names ⬆ ⬇

Indocin, ~~Tivorbex~~

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.

Classifications ⬆ ⬇

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

Pharmacologic Classification: nonsteroidal anti inflammatory drugs nsaids

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 ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO (analgesic)	30 min	0.5–2 hr	4–6 hr
PO-ER (analgesic)	30 min	unknown	4–6 hr
PO (anti-inflammatory)	up to 7 days	1–2 wk	4–6 hr
PO-ER (anti-inflammatory)	up to 7 days	1–2 wk	4–6 hr
IV (closure of PDA)	up to 48 hr	unknown	unknown

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 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 immediately if signs and symptoms of cardiovascular thrombotic events (shortness of breath or trouble breathing, chest pain, weakness in one part or side of body, slurred speech); hepatotoxicity (nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, "flu-like" symptoms) occur or if rash, itching, chills, fever, muscle aches, visual disturbances, weight gain, edema, abdominal pain, black stools, or persistent headache occurs.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional 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.
PDA: Explain to parents the purpose of medication and the need for frequent monitoring.

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Indications ⬇

Contraind./Precautions ⬆ ⬇