INDOMETHACIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

INDOMETHACIN

Sammensetning:

INDOMETHACIN 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

   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 [

Produkt oppsummering:

Product: 63629-1780 NDC: 63629-1780-4 90 CAPSULE in a BOTTLE NDC: 63629-1780-1 20 CAPSULE in a BOTTLE NDC: 63629-1780-5 21 CAPSULE in a BOTTLE NDC: 63629-1780-2 30 CAPSULE in a BOTTLE NDC: 63629-1780-3 60 CAPSULE in a BOTTLE

Autorisasjon status:

New Drug Application

Preparatomtale

INDOMETHACIN- INDOMETHACIN CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
INDOMETHACIN PAS 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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1965
WARNING: RISK OF SERIOUD 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 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
Boxed Warning 04/2016
Warnings and Precautions, Cardiovascular Thrombotic Events ( 5.1 )
04/2016
Warnings and Precautions, Heart Failure and Edema ( 5.5 ) 04/2016
INDICATIONS AND USAGE
Indomethacin Capsules, USP are non steroidal anti-inflammatory drug
indicated for ( 1 )
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
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
flares of chronic disease; moderate to