ETODOLAC capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

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 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 capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: - Osteoarthritis - Rheumatoid arthritis • For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. 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 WARNINGS )

Product summary:

Etodolac Capsules, USP are available as: 200 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap.  “APO 039” is imprinted on each capsules in black ink) - in bottles of 100, NDC 60505-0039-1 300 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap.  “APO 040” is imprinted on each capsules in black ink) - in bottles of 100, NDC 60505-0040-1 Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container [see USP]. Dispense with Medication Guide available at www1.apotex.com/products/us APOTEX INC. ETODOLAC CAPSULES, USP 200 mg and 300 mg Apotex Inc. Toronto, Ontario Canada  M9L 1T9 Apotex Corp. Weston, Florida 33326 Revised: December 2021 Rev. 9

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ETODOLAC- ETODOLAC CAPSULE
Apotex Corp.
----------
MEDICATION GUIDE
for
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Medication Guide available at www1.apotex.com/products/us
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. 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 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 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 had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before tak

Summary of Product characteristics

ETODOLAC- ETODOLAC CAPSULE
APOTEX CORP.
----------
ETODOLAC CAPSULES, USP
200 AND 300 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 capsule, USP is for oral administration, contains 200 mg
or 300 mg of
etodolac. In addition, each capsule contains the following inactive
ingredients: black iron
oxide, black SW-9008/SW-9009, colloidal silicon dioxide,
croscarmellose sodium, gelatin,
lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and
titanium dioxide.
17
21
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, an