INDOMETHACIN capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Carilion Materials Management

INN (Међународно име):

INDOMETHACIN

Састав:

INDOMETHACIN 75 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Carefully consider the potential benefits and risks of Indomethacin Extended-release Capsules USP 75 mg and other treatment options before deciding to use Indomethacin Extended-release Capsules USP 75 mg. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (See ). WARNINGS Indomethacin Extended-release Capsules USP 75 mg has been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin Extended-release Capsules USP 75 mg are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients fo

Резиме производа:

NDC:68151-1733-8 in a BOTTLE of 1 CAPSULE, EXTENDED RELEASES

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
Carilion Materials Management
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MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Non-steroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• This risk may happen early in treatment and may increase:
Increased risk of a heart attack or stroke that
can lead to death.
° with increasing doses of NSAIDs
° with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
"coronary artery bypass graft (CABG)’’.
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
° anytime during use
° without warning symptoms
° that may cause death
The risk of getting an ulcer or bleeding increases with:
° past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
° taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
° increasing doses of NSAIDs
° longer use of NSAIDs
° smoking
° drinking alcohol
° older age
° poor health
° advanced liver disease
° bleeding problems
NSAIDs should only be used:
° exactly as prescribed
° at the lowest dose possible for your treatment
° for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provide

Карактеристике производа

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
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INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 MG RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
• 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 and ).
WARNINGSPRECAUTIONS
• Indomethacin Extended-release Capsules are contraindicated in the
setting of coronary artery
bypass graft (CABG) surgery (See and ). CONTRAINDICATIONSWARNINGS
GASTROINTESTINAL RISK
• 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
DESCRIPTION:
Indomethacin Extended-release capsules USP 75 cannot be considered a
simple analgesic and should
not be used in conditions other than those recommended under .
INDICATIONS AND USAGE
Indomethacin is a nonsteroidal, anti-inflammatory, indole derivative
designated chemically as 1-(4-
chlorobenzoyl)-5-methoxy-2-methyl-1 -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: _H_
Each extended-release capsule, for oral administration contains 75 mg
of indomethacin. In addition, each
capsule contains the following inactive ingredients: corn starch, D&C
Yellow# 10, gelatin, mannitol,
povidone, sucrose, talc, and titanium dioxide.
This product meets USP Drug Release Test 2 Specifications.
CLINICAL PHARMACOLOGY:
Indomethacin is a nonsteroidal drug with anti-inflammatory,
antipyretic and analgesic properties. Its
mode of action, like that of other ant