INDOMETHACIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Indomethacin (UNII: XXE1CET956) (Indomethacin - UNII:XXE1CET956)

Available from:

RedPharm Drug Inc.

INN (International Name):

Indomethacin

Composition:

Indomethacin 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules have 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 , an

Product summary:

Indomethacin Capsules USP, 25 mg are available as a white to off-white powder filled light green opaque capsules, imprinted "TEVA" and "4029" in black ink, containing 25 mg of indomethacin USP, packaged in bottles of 15 capsules. PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Manufactured in India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. B 6/2010 INDOMETHACIN CAPSULES USP

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

INDOMETHACIN - INDOMETHACIN CAPSULE
RedPharm Drug Inc.
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
•
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This
chance increases:
•
NSAID medicines should never be used right before or after a heart
surgery called a "coronary
artery bypass graft (CABG)."
•
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
The chance of a person getting an ulcer or bleeding increases with:
•
NSAID medicines should only be used:
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines should not be used by pregnant
women late in their
pregnancy.
•
if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs)?
Serious side effects include:
Other side effects include:
•
heart attack
•
stroke
•
high blood pressure
•
heart failure from body
swelling (fluid reten

Summary of Product characteristics

INDOMETHACIN - INDOMETHACIN CAPSULE
REDPHARM DRUG INC.
----------
INDOMETHACIN CAPSULES USP
RX ONLY
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 is available in 25 mg and 50 mg capsules for oral
administration. Inactive ingredients
include: black iron oxide, corn starch, D and C Yellow No. 10, FD and
C Green No. 3, gelatin, lactose
monohydrate, lecithin, propylene glycol, shellac, silicon dioxide,
stearic acid, and titanium dioxide.
May also contain: D and C Red No. 7 calcium lake, FD and C Blue No. 1
aluminum lake, FD and C Blue
No. 2 aluminum lake and sodium lauryl sulfate. 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-adren