ETODOLAC tablet, film coated, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Physicians Total Care, Inc.

INN（国際名）:

ETODOLAC

構図:

ETODOLAC 400 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 contrain

製品概要:

Etodolac extended-release tablets, 400 mg, are available as orange, film-coated, oval-shaped tablets, debossed “1122” on one side and “93” on the other. They are available in Etodolac extended-release tablets, 500 mg, are available as gray, film-coated, oval-shaped tablets, debossed “7172” on one side and “93” on the other. They are available in Etodolac extended-release tablets, 600 mg, are available as light blue, film-coated, oval-shaped tablets, debossed “1118” on one side and “93” on the other. They are available in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat and humidity. 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 Rev. H 5/2008 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Physicians Total Care, Inc.
----------
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 medicines 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. NSA

製品の特徴

ETODOLAC - ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
ETODOLAC EXTENDED-RELEASE TABLETS
1122
7172
1118
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.)
Etodolac extended-release 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 events. (See WARNINGS.)
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-
inflammatory drug.
DESCRIPTION
Etodolac extended-release tablets contain etodolac, which 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. 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. It
has the
following structural formula:
C
H NO M.W. 287.37
The inactive ingredients in etodolac extended-release tablets are
calcium phosphate dibasic anhydrous,
carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose,
hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl
sulfate, and titanium dioxide. In
addition, the following colorants are used: 400 mg table