SULINDAC tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Bryant Ranch Prepack

INN (mednarodno ime):

SULINDAC

Sestava:

SULINDAC 200 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 tablets, USP are indicated for acute or long-term use in the relief of signs and symptoms of the following: - Osteoarthritis Osteoarthritis - Rheumatoid arthritis** Rheumatoid arthritis** - Ankylosing spondylitis Ankylosing spondylitis - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) - Acute gouty arthritis 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/an

Povzetek izdelek:

NDC: 63629-3208-1: 30 Tablets in a BOTTLE NDC: 63629-3208-2: 60 Tablets in a BOTTLE NDC: 63629-3208-3: 20 Tablets in a BOTTLE NDC: 63629-3208-4: 14 Tablets in a BOTTLE NDC: 63629-3208-5: 90 Tablets in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Bryant Ranch Prepack
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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 a NSAIDs?
Do not take NSAIDs:
• if you have had an asthma a

Lastnosti izdelka

SULINDAC- SULINDAC TABLET
BRYANT RANCH PREPACK
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SULINDAC TABLETS, USP
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.
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, USP is available in 150 mg and 200 mg tablets for oral
administration. Each
tablet contains the following inactive ingredients: magnesium
stearate, microcrystalline
cellulose, starch (corn) and stearic acid.
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:
C
H
FO S M.W. 356.42
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, ana