INDOMETHACIN- indomethacin capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Eon Labs, Inc.

INN (nemzetközi neve):

INDOMETHACIN

Összetétel:

INDOMETHACIN 75 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Indomethacin extended-release capsules are indicated for: Indomethacin extended-release is contraindicated in the following patients: Risk Summary Use of NSAIDs, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including indomethacin extended-release, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of indomethacin extended-release in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. In animal reproduction studies retarded fetal ossification was observed with administration of indomethacin to mice and ra

Termék összefoglaló:

Indomethacin Extended-Release Capsules, USP, for oral administration, are available as 75 mg Green and clear capsules, imprinted “E 720” and are supplied as NDC 0185-0720-60 bottles of 60 (as unit of use) NDC 0185-0720-01 bottles of 100 NDC 0185-0720-05 bottles of 500 NDC 0185-0720-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. KEEP TIGHTLY CLOSED.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
Eon Labs, Inc.
----------
MEDICATION GUIDE
for
Non-Steroidal 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:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs ○ older age
o
longer use of NSAIDs ○ poor health
o
smoking ○ advanced liver disease
o
drinking alcohol ○ bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 provider about a

Termékjellemzők

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
EON LABS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INDOMETHACIN EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INDOMETHACIN EXTENDED-RELEASE
CAPSULES.
INDOMETHACIN EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1965
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Indomethacin extended-release capsules are a nonsteroidal
anti-inflammatory drug indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 75 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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 (5.1)
Indomethacin extended-release capsules are contraindicated in the
setting of coronary artery bypass graft
(CABG) surgery (4, 5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI)
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 and patients with a
prior history of peptic ulcer disease and/or
GI bleeding are at greater risk for serious GI events (5.2)
Moderate to severe rheumatoid arthritis including acute flares of
chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis) (1)
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals (2.1)
The dosage for moderate to severe rheumatoid arthritis including acute
flares of chronic disease; m