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:

Aidarex Pharmaceuticals LLC

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: - For acute and long-term use in the management of signs and symptoms of the following:  1. Osteoarthritis  2. Rheumatoid arthritis -  1. Osteoarthritis -  2. 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 , Preexisting Asthma). Etodolac tablets are contraindicated for

Product summary:

Etodolac tablets USP, 400 mg are available as pink, capsule-shaped, film-coated tablets debossed “93” on one side and “892” on the other side, in bottles of 20,30,60,90 and 120. Etodolac tablets USP, 500 mg are available as blue, oval, film-coated tablets debossed “93” on one side and “1893” on the other side, in bottles of 30 and 60. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. K 10/2009

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aidarex Pharmaceuticals LLC
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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 can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicine should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID med

Summary of Product characteristics

ETODOLAC- ETODOLAC TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
ETODOLAC TABLETS USP
0892
1893
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction (MI), 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).
Etodolac tablets 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 (GI) events (see WARNINGS).
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-
inflammatory drug.
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of
non-steroidal anti-inflammatory drugs
(NSAIDs). Each tablet 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.
It has a pKa
of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH
7.4. It has the following structural
formula:
C
H NO M.W. 287.37
The inactive ingredients in etodolac tablets include: colloidal
silicon dioxide, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, sodium starch glycolate, titanium dioxide, FD&C Red No. 40,
and FD&C Blue No. 2. The
400 mg tablet also contains D&C Yellow No. 10.
1
1
17
21
3
C