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:

Apotex Corp.

INN (International Name):

ETODOLAC

Composition:

ETODOLAC 400 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 - 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.) -in bottles of 100, NDC 60505-0041-1 500 mg tablets (White to off-white, oval, unscored, film-coated tablets imprinted "APO 102" on one side and "500" on the other side.) -in bottles of 100, NDC 60505-0102-1 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container [see USP]. Dispense with Medication Guide available at www1.apotex.com/products/us APOTEX INC. ETODOLAC TABLETS, USP 400 mg and 500 mg Apotex Inc. Toronto, Ontario Canada M9L 1T9 Apotex Corp. Weston, Florida 33326 Revised: December 2021 Rev. 9

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
Apotex Corp.
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Medication Guide available at www1.apotex.com/products/us
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

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
APOTEX CORP.
----------
ETODOLAC TABLETS, USP
400 MG AND 500 MG
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 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).
DESCRIPTION
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 C
H
NO , and it has the following structural formula:
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.
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21
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic, and antipyretic activities in an