SULINDAC tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Major Pharmaceuticals

INN (Међународно име):

SULINDAC

Састав:

SULINDAC 150 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 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

Резиме производа:

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. Store in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Major Pharmaceuticals
----------
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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 takes 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 healthcare provider about all of your
medical conditions, includi

Карактеристике производа

SULINDAC- SULINDAC TABLET
MAJOR PHARMACEUTICALS
----------
SULINDAC TABLETS USP, 150 MG AND 200 MG
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
Gastrointestinal Risk
•
DESCRIPTION
Sulindac is a non-steroidal, anti-inflammatory indene derivative
designated chemically as (Z)-5-fluoro-
2-methyl-1-[[ρ-(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:
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
WARNINGSANDPRECAUTIONS).
Sulindac is contraindicated in the setting of coronary artery bypass
graft (CABG) surgery
(see CONTRAINDICATIONSANDWARNINGS).
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.)
20
17
3
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Sulindac is a non-stero