SULINDAC tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Epic Pharma, LLC

INN (International Name):

SULINDAC

Sammensetning:

SULINDAC 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 , and PRECAUTIONS – Preexisting Asthma ). Sulindac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Produkt oppsummering:

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: NDC 42806-018-01 in bottles of 100. NDC 42806-018-05 in bottles of 500. NDC 42806-018-10 in bottles of 1000. 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: NDC 42806-011-01 in bottles of 100. NDC 42806-011-05 in bottles of 500. NDC 42806-011-10 in bottles of 1000. Storage Store in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Sulindac-Tablet.pdf Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev.01-2023-00 MF018REV01/23 OE1000

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Epic Pharma, LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.epic-pharma.com/medguide/Sulindac-Tablet.pdf
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 a

Preparatomtale

SULINDAC- SULINDAC TABLET
EPIC PHARMA, LLC
----------
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
_PHARMACODYNAMICS_
Sulindac is a non-steroid