INDOMETHACIN- indomethacin suppository

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cosette Pharmaceuticals, Inc.

INN (nemzetközi neve):

Indomethacin

Összetétel:

Indomethacin 50 mg

Az alkalmazás módja:

RECTAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Carefully consider the potential benefits and risks of indomethacin 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 is indicated 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 tendonitis). - 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 like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma

Termék összefoglaló:

Indomethacin Suppositories, 50 mg each, are white, opaque, rectal suppositories and are supplied in boxes of 30 (NDC 0713-0176-30)

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

INDOMETHACIN - INDOMETHACIN SUPPOSITORY
COSETTE PHARMACEUTICALS, INC.
----------
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 a greater
risk. (See WARNINGS).
Indomethacin is contraindicated for the treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
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 suppositories, for rectal use, contain 50 mg of
indomethacin and the following inactive
ingredients: butylated hydroxyanisole, butylated hydroxytoluene,
edetic acid, glycerin, polyethylene
glycol 3350, polyethylene glycol 8000, purified water and sodium
chloride. 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. Indomethacin is practically
insoluble in water and sparingly soluble
in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly
acidic media and decomposes in strong
alkali.
The structural formula is:
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of other anti-inflammatory
drugs, is not known. However, its
therapeutic action is not due to pituitary-adrenal stimulation.
Indomethacin is a potent inhibitor of prostaglandin synthesis _in
vitro. _Concentrations are reached during
therapy which have been demonstrated to have an effect _in v