ETODOLAC capsule 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:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Etodolac

Composition:

Etodolac 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and 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 Capsules and Tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac. Etodolac Capsules and 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

Product summary:

Etodolac Capsules and Tablets, USP are available as: Etodolac Capsules, USP 200 mg capsules (dark pink gelatin capsule, with black imprint "ETO 200 MG" on cap and body, white to off-white powder filling) 300 mg capsules (light pink gelatin capsule, with black imprint "ETO 300 MG" on cap and body, white to off-white powder filling) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] protected from moisture . Etodolac Tablets, USP 400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain) 500 mg tablets (blue, oval shaped, film coated tablet engraved with "TARO" on one side and "89" engraved on the other side) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Store tablets in original container until ready to use. Dispense in light-resistant container. Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: March 2021 5201500-0321-9

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC TABLET, FILM COATED
Taro Pharmaceuticals U.S.A., Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: March 2021
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 NS

Summary of Product characteristics

ETODOLAC- ETODOLAC CAPSULE
ETODOLAC- ETODOLAC TABLET, FILM COATED
TARO PHARMACEUTICALS U.S.A., INC.
----------
ETODOLAC CAPSULES AND TABLETS, USP
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 capsules, 200 mg and 300 mg, and 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 capsules and tablets, USP are members of the pyranocarboxylic
acid group of
nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule
contains
etodolac for oral administration. 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:
17
21
3
_Each Capsule, for oral administration, contains 200 or 300 mg of
Etodolac. In addition,_
_each capsule contains the following inactive ingredients:_ Ammonium
Hydroxide USP,
Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200
mg only), Ethyl