SULINDAC tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

PD-Rx Pharmaceuticals, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: - Osteoarthritis - Rheumatoid arthritis* - Ankylosing spondylitis - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) - Acute gouty arthritis Sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see DESCRIPTION ). Sulindac tablets 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 ). - In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS ].

Резиме производа:

Sulindac tablets USP are supplied as follows: Sulindac tablets, 150 mg, yellow, round, unscored, debossed MP 112 NDC 72789-373-01 Bottles of 100 NDC 72789-373-82 Bottles of 500 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

SULINDAC- SULINDAC TABLET
PD-Rx Pharmaceuticals, Inc.
----------
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", "anti-coagulants", "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 healthcare provider abo

Карактеристике производа

SULINDAC- SULINDAC TABLET
PD-RX PHARMACEUTICALS, INC.
----------
SULINDAC TABLETS USP
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 tablets are available in 150 and 200 mg tablets for oral
administration. Each
tablet contains the following inactive ingredients: magnesium
stearate, microcrystalline
cellulose, and pregelatinized starch.
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 tablets are a non-steroidal