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:

Amneal Pharmaceuticals NY 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) surgery (see WARNINGS ).

Product summary:

Etodolac Tablets USP, 400 mg are supplied as peach, oval shaped, film-coated tablets engraved with "AC01" on one side and plain on the other side. They are available as follows: Bottle of 100 Tablets:                         NDC 69238-1342-1 Etodolac Tablets USP, 500 mg are supplied as blue, oval shaped, film-coated tablets engraved with "AC11" on one side and plain on the other side. They are available as follows: Bottle of 100 Tablets:                         NDC 69238-1343-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Preserve in tight containers. Store tablets in original container until ready to use. Dispense in light-resistant container. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2021-04

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
Amneal Pharmaceuticals NY 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"
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o 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 you

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
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 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 is member of the pyranocarboxylic acid group of nonsteroidal
anti-
inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP 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:
17
21
3
_Each Tablet, for oral administration, contains 400 mg or 500 mg of
Etodolac, USP. In_
_addition, each tablet contains the following inactive ingredients:_
hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
povidone, sodium starch glycolate and titanium dioxide. Each 400 mg
tablet also
contains iron oxide re