ETODOLAC- etodolac tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

Etodolac

Composition:

Etodolac 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets are indicated: - For relief of signs and symptoms of juvenile arthritis. - For relief of the signs and symptoms of rheumatoid arthritis. - For relief of the signs and symptoms of osteoarthritis. Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release tablets should not be given to patients who have experienced asthma, urticaria, or 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, Preexisting Asthma ). Etodolac extended-release tablets are contr

Product summary:

Etodolac extended-release tablets are available as: 400 mg tablets (pink, round, bi-convex, film coated tablet engraved with "T400" on one side and plain on the other side). 500 mg tablets (green, oblong, normal convex, film coated tablet engraved with "T500" on one side and plain on the other side). 600 mg tablets (grey, oval, bi-convex, film coated tablet engraved with "T600" on one side and plain on the other side). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature.] Protect from excessive heat and humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600
mg

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ETODOLAC-
etodolac tablet, extended release  Lake
Erie Medical & Surgical Supply DBA Quality Care Products
LLC
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Medication Guidefor Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a
list of prescription NSAID medicines.)
What is the most important information
I should know about medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance
of a heart attack or stroke that can lead to death. This
chance increases:

with longer use of NSAID medicines
in people who have heart disease

NSAID medicines should never be used
right before or after a heart surgery called a "coronary
artery bypass graft (CABG)."
NSAID medicines

Read the complete document

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, EXTENDED RELEASE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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ETODOLAC
EXTENDED-RELEAS E
TABLETS, 400 MG, 500
MG AND 600 MG
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk.
(See WARNINGS and CLINICAL TRIALS).
Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg are
contraindicated for the
treatment of peri-operative pain in the setting of coronary artery
bypass graft (CABG) surgery
(see 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 events. (See WARNINGS).
DESCRIPTION
Etodolac Extended-Release Tablets contain etodolac, which is a member
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. It 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 is 287.37. Its molecular formula is C
H NO and it has the following structural
formula:
17
21
3
The inactive ingredients in etodolac extended-release tablets include:
HPMC 2910, Hydroxypropyl
Methylcellulose, Lactose Anhydrous, Magnesium Stearate,
Microcrystalline Cellulose, PEG 8000,
Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In
addition, the 500 mg and 600 mg
tablets contain Indigo Carmine Lake