ETODOLAC tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

ETODOLAC

Composition:

ETODOLAC 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets, USP are indicated: For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac. Etodolac 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, PRE-EXISTING ASTHMA). Etodolac tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Product summary:

Etodolac Tablets, USP are available as: 400 mg Tablets (White to off-white, oval, unscored, film-coated tablets, imprinted "APO 041" on one side and "400" on the other side.) 500 mg tablets (White to off-white, oval, unscored, film-coated tablets imprinted "APO 102" on one side and "500" on the other side.) Store at 20° to 25°C (68° to 77°F); excursions permitted from 15°C to 30° (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. ETODOLAC TABLETS, USP 400 mg and 500 mg Manufactured by Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for Apotex Corp. Weston, Florida 33326

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
DIRECT RX
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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 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
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
you:
have liver or kidney problems
h

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
DIRECT RX
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ETODOLAC
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 is 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 a greater risk
for serious gastrointestinal (GI) events (see WARNINGS).
Etodolac is a member of the pyranocarboxylic acid group of
nonsteroidal anti-inflammatory drugs
(NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers.
Etodolac 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 of the base is 287.37. It has a pKa of 4.65 and an
n-octanol:water partition coefficient
of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3,
and it has the following
structural formula:
[etodolac-01]
Each etodolac tablet, USP is for oral administration, contains 400 mg
or 500 mg of etodolac. In
addition, each tablet contains the following inactive ingredients:
crospovidone, hydroxypropyl
cellulose, hypromellose, magnesium stearate, methylcellulose,
polyethylene glycol and titanium
dioxide.
Pharmacodynamics
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antipyretic activities in animal models. The mechanism of action
of etodolac, like that of other
NSA