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:

Preferred Pharmaceuticals Inc.

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: 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 ).

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.) 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 Revised: July 2016 Rev. 4 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
----------
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.
1.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
1.
anytime during use
2.
without warning symptoms
3.
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
med

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
----------
ETODOLAC TABLETS, USP
400 MG AND 500 MG
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
1.
2.
GASTROINTESTINAL RISK
1.
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.
CLINICAL PHARMACOLOGY
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).
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).
17
21
3
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antip