ETODOLAC tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Proficient Rx LP

INN (국제 이름):

ETODOLAC

구성:

ETODOLAC 400 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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: 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 coronary artery bypass graft (CABG) surgery (see WARNINGS ).

제품 요약:

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 20, 30, 60 and 90 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 Relabeled by: PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. M 7/2015

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

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:
•
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
medical condit

제품 특성 요약

ETODOLAC- ETODOLAC TABLET, FILM COATED
PROFICIENT RX LP
----------
ETODOLAC TABLETS USP
0892
1893
RX ONLY
1.
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).
•
•
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.
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
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).
17
21
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflam