INDOMETHACIN capsule, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

INN (Mezinárodní Name):

INDOMETHACIN

Složení:

INDOMETHACIN 75 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Indomethacin extended-release 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) Indomethacin extended-release 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)] Risk Summary Use of NSAIDs, including indomethacin extended-release capsules, can cause premature closure of the fetal ductus arteriosus and feta

Přehled produktů:

NDC: 63629-3201-1: 30 Capsules in a BOTTLE NDC: 63629-3201-2: 60 Capsules in a BOTTLE NDC: 63629-3201-3: 14 Capsules in a BOTTLE NDC: 63629-3201-4: 10 Capsules in a BOTTLE NDC: 63629-3201-5: 7 Capsules in a BOTTLE NDC: 63629-3201-6: 15 Capsules in a BOTTLE NDC: 63629-3201-7: 20 Capsules in a BOTTLE NDC: 63629-3201-8: 90 Capsules in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Bryant Ranch Prepack
----------
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 cond

Charakteristika produktu

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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._
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (5.10)
04/2021
Warnings and Precautions, Fetal Toxicity (5.11) 04/2021
INDICATIONS AND USAGE
Indomethacin extended-release capsules are a nonsteroidal
anti-inflammatory drug 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). (1)
DOSAGE AND ADMINISTRATION
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
f