INDOMETHACIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)

Available from:

Teva Pharmaceuticals USA Inc

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN CAPSULE
TEVA PHARMACEUTICALS USA INC
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INDOMETHACIN CAPSULES USP
RX ONLY
WARNING
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Indomethacin is available in 25 mg and 50 mg capsules for oral
administration. Inactive ingredients
include: black iron oxide, corn starch, D&C Yellow No. 10, FD&C Green
No. 3, gelatin, lactose
monohydrate, lecithin, propylene glycol, shellac, silicon dioxide,
stearic acid, and titanium dioxide.
May also contain: D&C Red No. 7 calcium lake, FD&C Blue No. 1 aluminum
lake, FD&C Blue No. 2
aluminum lake and sodium lauryl sulfate. Indomethacin is a
nonsteroidal anti-inflammatory indole
derivative designated chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1_H_-indole-3-acetic acid.
Indomethacin is practically insoluble in water and sparingly soluble
in alcohol. It has a pKa of 4.5 and is
stable in neutral or slightly acidic media and decomposes in strong
alkali. The structural formula is:
C
H CINO M.W. 357.79
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction, and
stroke, which can be
fatal. This risk may occur early in treatment and may increase with
duration of use (see
WARNINGSandPRECAUTIONS).
Indomethacin is contraindicated in the setting of coronary artery
bypass graft (CABG)
surgery (see CONTRAINDICATIONS and WARNINGS).
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.
Elderly patients are
at greater risk for serious gastrointestinal events (see WARNINGS).
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CLINICAL PHARMACOLOGY
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of other anti-inflammatory
drugs, is not known. However, its
therapeutic action is not due to pituitary-adrenal st