ETODOLAC tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)

Available from:

Eon Labs, 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 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: Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in 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 is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Etodolac Tablets USP, for oral administration, are available as: 400 mg : White, oval, unscored, film-coated tablets, debossed “E 140” on one side and plain on the other side and supplied as: NDC 0185-0675-01 bottles of 100 NDC 0185-0675-05 bottles of 500 NDC 0185-0675-10 bottles of 1000 500 mg : White, oval, unscored, film-coated tablets, debossed “E 139” on one side and plain on the other side and supplied as: NDC 0185-0687-01 bottles of 100 NDC 0185-0687-05 bottles of 500 NDC 0185-0687-10 bottles of 1000 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Store tablets in original container until ready to use. KEEP TIGHTLY CLOSED. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- etodolac tablet, coated
Eon Labs, Inc.
----------
Medication Guide
FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
ETODOLAC TABLETS, USP
(ee-toe-DOE-lak)
What is the most important information I should know about medicines
called Non-Steroidal 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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
older age
o
longer use of NSAIDs
o
poor health
o
smoking
o
advanced liver disease
o
drinking alcohol
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 prov

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, COATED
EON LABS, INC.
----------
ETODOLAC TABLETS, USP
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Etodolac tablets, USP are a member of the pyranocarboxylic acid group
of nonsteroidal
anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP
for oral
administration. Etodolac, USP 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 and 500 mg of
etodolac, USP. In
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 are 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 greater risk for serious
gastrointestinal (GI) events (see WARNINGS).
17
21
3
addition, each tablet contains the following inactive ingredients:
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
povidone, sodium
starch glycolate (potato), talc and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflamm