Indomethacin

Indomethacin · oral capsule, extended release

NSAID

OFF-LABELNot in the FDA label for this product

Non-necrotizing anterior scleritis, diffuse or nodular

25 mg PO QID, the initiating oral regimen reported in the cited review; no fixed course length is given, and the review advises reassessing for escalation if inflammation has not improved after 1 to 2 weeks.

Retrospective · no RCTs exist

Retrospective evidence only; there is no randomized trial of any oral NSAID in scleritis. Among 392 patients with noninfectious anterior scleritis at two tertiary centers, NSAIDs were the treatment used in 144 (36.7%), and successful NSAID response was associated with idiopathic diffuse or nodular disease carrying a low degree of scleral inflammation, 2+ or less (OR 2.89, P < 0.001), and with disease free of ocular complications (OR 3.13, P < 0.001), while successful treatment with immunomodulatory therapy was instead associated with necrotizing scleritis (OR 4.73, P = 0.026) and with diffuse or nodular scleritis carrying a systemic association (OR 1.57, P = 0.047).

Sainz de la Maza M, Molina N, Gonzalez-Gonzalez LA, Doctor PP, Tauber J, Foster CS. Scleritis therapy. Ophthalmology. 2012;119(1):51-58 (retrospective case series, PubMed indexes it as Journal Article, Multicenter Study). Dose and the 1 to 2 week reassessment point from Abdel-Aty A, Gupta A, Del Priore L, Kombo N. Management of noninfectious scleritis. Ther Adv Ophthalmol. 2022;14:25158414211070879 (review), which reports indomethacin 25 mg four times a day as the initiating regimen in the Jabs series.

Contraindications

Known hypersensitivity, including anaphylactic reactions and serious skin reactions, to indomethacin or any components of the drug product

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

In the setting of coronary artery bypass graft (CABG) surgery

Available Forms

30 extended release capsules / 75mg

Mechanism of Action

Nonselective inhibitor of cyclooxygenase 1 and 2, blocking prostaglandin synthesis; the anti-inflammatory and analgesic effect is systemic, and the same loss of prostaglandin signaling accounts for its gastrointestinal and renal toxicity.

Warnings & Precautions

Cardiovascular thrombotic events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. The risk may occur early in treatment and may increase with duration of use.
Gastrointestinal bleeding, ulceration and perforation: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.
Hepatotoxicity: Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart failure and edema: Avoid use in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Exacerbation of asthma related to aspirin sensitivity: Monitor patients with preexisting asthma without aspirin sensitivity.
Serious skin reactions: Discontinue at first appearance of skin rash or other signs of hypersensitivity.

Common Side Effects

The most common adverse reactions, at an incidence of 3% or more, are headache, dizziness, dyspepsia and nausea.

Pregnancy & Lactation

Pregnancy: NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment, so limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy.

Lactation: Based on available published clinical data, indomethacin may be present in human milk, so weigh the benefits of breastfeeding against the mother's clinical need and any potential adverse effects on the breastfed infant.

Pediatric Use

≥15 years