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:

NuCare 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: - 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 ). - In the setting of coronary artery bypass graft (CABG) surgery (see

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 60, NDC 66267-095-60 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
NuCare Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
for
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
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 heart attack or stroke that can lead to death.
Increased risk of heart attack or stroke
that can lead to death.
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after 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:
•
at 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 medicines 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 a NSAIDs?
Do not take an NSAIDs:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or a

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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.
CLINICAL PHARMACOLOGY
17
21
3
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antipyretic act