ETODOLAC tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)

Disponibbli minn:

Teva Pharmaceuticals USA, Inc.

INN (Isem Internazzjonali):

ETODOLAC

Kompożizzjoni:

ETODOLAC 400 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets are indicated: - For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis - Osteoarthritis - Rheumatoid arthritis - For the management of acute pain Etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. Etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other 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 tablets are contraindicated in the setting of corona

Sommarju tal-prodott:

Etodolac tablets USP, 400 mg are available as pink, capsule-shaped, film-coated tablets debossed “93” on one side and “892” on the other side, in bottles of 100. NDC 0093-0892-01. Etodolac tablets USP, 500 mg are available as blue, oval, film-coated tablets debossed “93” on one side and “1893” on the other side, in bottles of 100. NDC 0093-1893-01. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND . LTD . Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. M 7/2015

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Teva Pharmaceuticals USA, 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”,
“anticoagulants”, “SSRIs”, or
“SNRIs”
•
increasing
doses of
NSAIDs
•
older age
•
longer use
of NSAIDs
•
poor health
•
smoking
•
advanced liver
disease
•
drinking
alcohol
•
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

Karatteristiċi tal-prodott

ETODOLAC- ETODOLAC TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
ETODOLAC TABLETS USP
0892
1893
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).
Etodolac 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 (GI) events (see WARNINGS).
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of
non-steroidal anti-inflammatory drugs
(NSAIDs). Each tablet contains etodolac for oral administration.
Etodolac is a racemic mixture of [+]S
and [-]R-enantiomers. Etodolac is a white or almost white crystalline
powder, 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.
It has a pKa
of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH
7.4. It has the following structural
formula:
C
H NO M.W. 287.37
The inactive ingredients in etodolac tablets include: colloidal
silicon dioxide, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, sodium starch glycolate, titanium dioxide, FD&C Red No. 40,
and FD&C Blue No. 2. The
400 mg tablet also contains D&C Yellow No. 10.
CLINICAL PHARMACOLOGY
17
21
3
PHARMACODYNAMICS
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inf