INDOMETHACIN- indomethacin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc.

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

   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 )]       Risk Summary Use of NSAIDs, including indomethacin capsules, during the third trimester of pregnancy increases the ri

Product summary:

   Indomethacin Capsules are supplied containing 25 mg or 50 mg of indomethacin. The 25 mg capsule is a hard-shell gelatin capsule with an opaque pink cap and an opaque white body debossed with "HP/10" on both the body and cap. They are supplied in bottles of 100 and 1000 as follows: NDC 23155-010-01 bottles of 100 NDC 23155-010-10 bottles of 1000 The 50 mg capsule is a hard-shell gelatin capsule with an opaque pink cap and an opaque white body debossed with "HP/11" on both the body and cap. They are supplied in bottles of 100 and 500 as follows: NDC 23155-011-01 bottles of 100 NDC 23155-011-05 bottles of 500 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

New Drug Application

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN CAPSULE
HERITAGE PHARMACEUTICALS INC.
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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; mod