ODAN-INDOMETHACIN

2 CONTRAINDICATIONS ODAN-INDOMETHACIN is contraindicated in:  the peri-operative setting of coronary artery bypass graft surgery (CABG). Although indomethacin has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.

 the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition  women who are breast-feeding, because of the potential for serious adverse reactions in nursing infants  severe uncontrolled heart failure ODAN-INDOMETHACIN 6  patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

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1 Adverse Reaction Overview The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

The following table (Table 2) presents adverse reactions for indomethacin capsules. The incidence was obtained from 33 double-blind controlled clinical trials reported in the literature (1, 092 patients). The adverse reactions reported with indomethacin capsules may occur with the use of the suppositories.

Table 2:

Most Common Clinical Trial Adverse Drug Reactions (3%-9% and >1%) Body System Incidence 3-9% Incidence > 1% Gastrointestinal Nausea with or without vomiting. ), development of ulcerative colitis and regional ileitis, ulcerative stomatitis, toxic hepatitis and jaundice (some fatal cases have been reported).

Central Nervous System Anxiety (includes nervousness), muscle weakness, involuntary muscle movements, insomnia, hebetude, psychic disturbances (including psychotic episode), mental confusion, drowsiness, lightheadedness, syncope, paresthesia, aggravation of epilepsy and parkinsonism, depersonalization, coma, peripheral neuropathy, convulsions, dysarthria.

Dermatologic Pruritus, rash; urticaria, petechiæ or ecchymosis, exfoliative dermatitis, erythema nodosum, loss of hair, Stevens Johnson syndrome, erythema multiforme, toxic epidermal necrolysis. Cardiovascular Hypertension, hypotension, tachycardia, chest pain, congestive heart failure, arrhythmia, palpitations Special Senses Ocular - corneal deposits and retinal disturbances including those of the macula have been reported in some patients on prolonged therapy with indomethacin, blurred vision, diplopia, hearing disturbances, deafness Hematologic Leukopenia, bone marrow depression, anemia secondary to obvious or occult gastrointestinal bleeding, aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenic purpura, disseminated intravascular coagulation Genitourinary Hematuria, vaginal bleeding, proteinuria, nephrotic syndrome, interstitial nephritis, BUN elevation, renal insufficiency, including renal failure.

1 Special Populations 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ....................................................................................

1 Pediatrics ...................................................................................................... 2 Geriatrics ...................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................

1 Dosing considerations .................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................ 4 Administration .............................................................................................

5 Missed Dose ................................................................................................. 1 Special Populations .................................................................................... 1 Pregnant Women ...........................................................................

2 Breast-feeding................................................................................ 3 Pediatrics ........................................................................................ 4 Geriatrics ........................................................................................

17 8 ADVERSE REACTIONS .............................................................................................. 1 Adverse Reaction Overview ....................................................................... 2 Clinical Trial Adverse Reactions .................................................................

3 Less Common Clinical Trial Adverse Reactions .......................................... 5 Post-Market Adverse Reactions ................................................................. 20 9 DRUG INTERACTIONS ..................................................................................................

1 Special Populations 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ....................................................................................

1 Pediatrics ...................................................................................................... 2 Geriatrics ...................................................................................................... 5