INDOMETHACIN capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

RedPharm Drug, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Indomethacin capsules are indicated for: 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) Acute gouty arthritis Indomethacin capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions (5.7,5.9) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7,5.8) ] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] 8.1 Pregnancy Risk Summary Use of NSAIDs, including indomethacin capsules, during the third trimester of pregnancy increases the risk of p

Podsumowanie produktu:

Indomethacin Capsules USP, 25 mg are off-white to light yellow, free flowing granular powder filled in size '3' hard gelatin capsules with green colored cap imprinted with "293" in black ink and green colored body imprinted with "25 mg" in black ink and are supplied as follows: NDC 68382-293-01 in bottle of 100 capsules NDC 68382-293-05 in bottle of 500 capsules NDC 68382-293-10 in bottle of 1000 capsules NDC 68382-293-30 in cartons containing 100 (10 X 10) unit-dose blisters Indomethacin Capsules USP, 50 mg are off-white to light yellow, free flowing granular powder filled in size '1' hard gelatin capsules with green colored cap imprinted with "294" in black ink and green colored body imprinted with "50 mg" in black ink and are supplied as follows: NDC 68382-294-01 in bottle of 100 capsules NDC 68382-294-05 in bottle of 500 capsules NDC 68382-294-10 in bottle of 1000 capsules NDC 68382-294-30 in cartons containing 100 (10 X 10) unit-dose blisters Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container using a child-resistant closure.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

INDOMETHACIN- INDOMETHACIN CAPSULE
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal 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:
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 provider about all of your
medical conditions, including if
you:
have liver or kidney problem

Charakterystyka produktu

INDOMETHACIN- INDOMETHACIN CAPSULE
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
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 Warnings and
Precautions (5.1) ].
Indomethacin capsules are contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery [see Contraindications (4) and Warnings and Precautions (5.1)
].
Gastrointestinal Bleeding, Ulceration, and Perforation
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 [see Warnings and Precautions (5.2) ].
CLOSE
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INDOMETHACIN CAPSULES
safely and effectively. See full prescribing information for
INDOMETHACIN CAPSULES.
INDOMETHACIN capsules, for oral use
Initial U.S. Approval: 1965
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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 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
a