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:

Bayshore Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - 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 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, Pre-existing Asthma ). - In the setting of coronary artery bypass graft (CABG) surg

Product summary:

Etodolac tablets USP, 400 mg are available as beige colored, oval shaped tablets debossed BY7 on one side and plain on other side. Etodolac tablets USP, 500 mg are available as blue colored, oval shaped tablets debossed BY8 on one side and plain on other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store tablets in original container until ready to use. Dispense in a tight, light-resistant container as defined in the USP, with a child resistant closure. Manufactured by: Aizant Drug Research Solutions Pvt. Ltd. Dulapally Village, Quthubullapur Mandal, Hyderabad, Telangana 500100, India. Distributed by: Bayshore Pharmaceuticals LLC. 788 Morris Turnpike, Suite 200, Short Hills, New Jersey 07078. Revised:  04/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
Bayshore Pharmaceuticals, LLC
----------
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
•
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 a

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
BAYSHORE PHARMACEUTICALS, LLC
----------
ETODOLAC TABLETS USP, 400 MG AND 500 MG
ETODOLAC TABLETS USP
BAYSHORE PHARMACEUTICALS LLC.
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 tablets, 400 mg and 500 mg 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.)
DESCRIPTION
Etodolac tablets, USP are members of the pyranocarboxylic acid group
of nonsteroidal
anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for
oral administration.
Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac
USP 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 tablet, for oral administration, contains 400 mg or 500 mg of
etodolac USP. In
addition, each tablet contains the following inactive ingredients:
hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
17
21
3
polyethylene glycol, povidone, sodium starch glycolat