ETODOLAC tablet, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Etodolac (UNII: 2M36281008) (Etodolac - UNII:2M36281008)

متاح من:

Proficient Rx LP

INN (الاسم الدولي):

Etodolac

تركيب:

Etodolac 400 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets are indicated: Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release 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-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma ). Etodolac extended-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

ملخص المنتج:

Etodolac extended-release tablets are available as: 400 mg tablets (pink, round, bi-convex, film coated tablet engraved with "T400" on one side and plain on the other side). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat and humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Proficient Rx LP
----------
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: 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.
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:The risk of getting an
ulcer or bleeding increases
with:
•
anytime during use
•
without warning symptoms
•
that may cause death
•
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 after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including if
yo

خصائص المنتج

ETODOLAC- ETODOLAC TABLET, EXTENDED RELEASE
PROFICIENT RX LP
----------
ETODOLAC
EXTENDED-RELEASE
TABLETS, 400 MG, 500
MG AND 600 MG
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Etodolac Extended-Release Tablets contain etodolac, which is a member
of the pyranocarboxylic acid
group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet
contains etodolac for oral
administration. Etodolac is a racemic mixture of [+]S and
[-]R-enantiomers. It is a white crystalline
compound, insoluble in water, but soluble in alcohols, chloroform,
dimethyl sulfoxide, and aqueous
polyethylene glycol.
The chemical name is (±)
1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The
molecular weight is 287.37. Its molecular formula is C
H NO and it has the following structural
formula:
The inactive ingredients in etodolac extended-release tablets include:
HPMC 2910, hydroxypropyl
methylcellulose, lactose anhydrous, magnesium stearate,
microcrystalline cellulose, PEG 8000,
polydextrose FCC, povidone, titanium dioxide and triacetin. In
addition, the 500 mg and 600 mg tablets
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).
Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg are
contraindicated in the
setting of coronary artery bypass graft (CABG) surgery (see
CONTRAINDICATIONS
and WARNINGS).
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).
17
21
3
contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain
Allura Red AC Lake and Sunset
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