SULINDAC tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

SULINDAC (UNII: 184SNS8VUH) (SULINDAC - UNII:184SNS8VUH)

Verfügbar ab:

Lake Erie Medical DBA Quality Care Products LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis** 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5. Acute gouty arthritis **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care). Sulindac is contraindicated in patients with known hypersensitivity to sulindac or the excipients (see DESCRIPTION ). Sulindac should not be given to patients

Produktbesonderheiten:

Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows: 55700-682-60 Storage Store in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature]. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Revised January 2016 MF018REV01/16 OE1000

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your heal

Fachinformation

SULINDAC- SULINDAC TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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SULINDAC TABLETS USP, 150 MG AND 200 MG RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
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 (see
WARNINGS AND PRECAUTIONS).
Sulindac tablets are contraindicated in the setting of coronary artery
bypass graft (CABG)
surgery (see CONTRAINDICATIONS AND 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
Sulindac is a non-steroidal, anti-inflammatory indene derivative
designated chemically as (Z)-5-fluoro-
2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1
_H_-indene-3-acetic acid. It is not a salicylate,
pyrazolone or propionic acid derivative. Its empirical formula is C
H
FO
S, with a molecular
weight of 356.42. Sulindac, a yellow crystalline compound, is a weak
organic acid practically insoluble
in water below pH 4.5, but very soluble as the sodium salt or in
buffers of pH 6 or higher.
Sulindac is available in 150 and 200 mg tablets for oral
administration. Each tablet contains the
following inactive ingredients: magnesium stearate, microcrystalline
cellulose, plasdone and sodium
starch glycolate.
Following absorption, sulindac undergoes two major biotransformations
- reversible reduction to the
sulfide metabolite, and irreversible oxidation to the sulfone
metabolite. Available evidence indicates
that the biological activity resides with the sulfide metabolite.
The structural formulas of sulindac and its metabolites are:
20
17
3
CLINICAL PHARMACOLOGY
_PHARMACODYN