ETODOLAC- etodolac tablet, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Bryant Ranch Prepack

INN (Rahvusvaheline Nimetus):

ETODOLAC

Koostis:

ETODOLAC 400 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Bryant Ranch Prepack
----------
Medication Guide
for
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 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 use 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 medicines should not be us

Toote omadused

ETODOLAC- ETODOLAC TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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 and the 400 mg and 600 mg tablets
contain Al