INDOMETHACIN EXTENDED-RELEASE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Keltman Pharmaceuticals Inc.

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended-release capsules have been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules is not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of ind

Product summary:

Indomethacin extended-release capsules 75 mg is supplied as green and clear capsules, imprinted E 720. They are supplied by Keltman Pharmaceuticals Inc. as follows: Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Keltman Pharmaceuticals 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:
• with longer use of NSAID medicines
• in people who have heart disease
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:
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called "corticosteroids" and "anticoagulants"
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
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 a 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 no

Summary of Product characteristics

INDOMETHACIN EXTENDED-RELEASE - INDOMETHACIN EXTENDED-RELEASE CAPSULE
KELTMAN PHARMACEUTICALS INC.
----------
INDOMETHACIN EXTENDED-RELEASE CAPSULES USP
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
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 cannot be considered a simple analgesic and should not be
used in conditions other than
those recommended under INDICATIONS AND USAGE.
Indomethacin is a nonsteroidal, 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:
Each extended-release capsule, for oral administration contains 75 mg
of indomethacin. In addition, each
capsule contains the following inactive ingredients: D&C yellow No.
10, D&C yellow No. 10
aluminum lake, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum
lake, FD&C red No. 40
aluminum lake, FD&C green No. 3, ethylcellulose, gelatin, lactose
monohydrate, povidone, silicon
dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and
titanium dioxide.
This product meets USP Drug Release Test 2 Specifications.