INDOMETHACIN ER- indomethacin capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Apotheca, Inc.

INN（国際名）:

INDOMETHACIN

構図:

INDOMETHACIN 75 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS) Indomethacin has been found effective in active stages of the following: - 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 is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic/Anaphylactoid Reactions

製品概要:

Manufactured by KVK-Tech Inc.Indomethacin Extended-release Capsules USP 75 mg are supplied as yellow opaque cap, natural body with black imprint K-16 on both cap and body, filled with white pellets.  Available as follows: NDC 12634-160-91 Blister Pack UD 1's NDC 12634-160-54 Blister Pack Card of 14 NDC 12634-160-55 Blister Pack Card of 15 NDC 12634-160-57 Blister Pack Card of 20 NDC 12634-160-25 Blister Pack Card of 25 NDC 12634-160-59 Blister Pack Card of 30 NDC 12634-160-97 Bottle of 7 NDC 12634-160-00 Bottle of 10 NDC 12634-160-84 Bottle of 14 NDC 12634-160-85 Bottle of 15 NDC 12634-160-80 Bottle of 20 NDC 12634-160-79 Bottle of 25 NDC 12634-160-71 Bottle of 30 NDC 12634-160-60 Bottle of 60

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Apotheca, Inc.
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Please ask your Pharmacist for a complete medication guide for this
prescription.
Revised: 4/2010
Document Id: 543aa8e5-219e-41d8-8ffa-9ae1446d3391
Set id: 6569dfd1-0164-4241-b508-ccd540d1e858
Version: 2
Effective Time: 20100416
Apotheca, Inc.

製品の特徴

INDOMETHACIN ER - INDOMETHACIN CAPSULE
APOTHECA, INC.
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INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
BOXED WARNING
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(SEE WARNINGS).
Indomethacin is contraindicated for the treatment of perioperative
pain in the setting of
coronary artery bypass graft (CABG) surgery (SEE WARNING).
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk
for serious gastrointestinal events (SEE WARNINGS).
DESCRIPTION
Indomethacin Capsules, USP for oral administration are provided in one
dosage strengths which contain
75 mg of indomethacin. Indomethacin is a non-steroidal
anti-inflammatory indole derivative designated
chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1_H_-indole-3-acetic acid.
The structural formula is:
C
H ClNO M.W. 357.79
Manufacture KVK-Tech. Inc. Each extended release capsule contains 75
mg of Indomethacin. In addition
each capsule contains the following inactive ingredients:
corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose,
talc, and titanium dioxide.
Manufacture Sandoz, Inc.Each extended-release capsule, for oral
administration contains 75 mg of
indomethacin. In addition, each capsule contains the following
inactive ingredients: D and C yellow No.
10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum
lake, FD and C blue No. 2
19
16
4
aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No.
3, ethylcellulose, gelatin,
lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate,
corn starch, sucros