SULINDAC- sulindac tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Golden State Medical Supply, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 1 - 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 Asth

Podsumowanie produktu:

Sulindac tablets USP are supplied as follows: Sulindac tablets, 150 mg, yellow, round, unscored, debossed MP 112 Bottles of 100 NDC 60429-697-01 Bottles of 180 NDC 60429-697-18 Bottles of 500 NDC 60429-697-05 Sulindac tablets, 200 mg, yellow, round, scored, debossed MP 116 Bottles of 100 NDC 60429-698-01 Bottles of 180 NDC 60429-698-18 Bottles of 500 NDC 60429-698-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Golden State Medical Supply, Inc.
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Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID 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 call 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 or intestines:
•
any time 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 "SRNIs"
•
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
•
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?
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart by

Charakterystyka produktu

SULINDAC- SULINDAC TABLET
GOLDEN STATE MEDICAL SUPPLY, 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
_Warning 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-s