ETODOLAC tablet, film coated, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

St. Mary's Medical Park Pharmacy

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Carefully consider the potential benefits and risks of etodolac extended-release tablets, USP and other treatment options before deciding to use etodolac extended-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets, USP 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

Dettagli prodotto:

Etodolac Extended-release Tablets USP, 500 mg are grey-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "272" on one side and plain on other side and are supplied as follows: NDC 60760-298-15 BOTTLES OF 15 Storage: 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 with a child-resistant closure.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

St. Mary's Medical Park Pharmacy
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Medication Guide
For Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Etodolac
(e-TOE-doe-lak)
Extended-release Tablets, USP
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 a 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 a 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:
○ 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 have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDS, tell your h

Scheda tecnica

ETODOLAC- ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE
ST. MARY'S MEDICAL PARK PHARMACY
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ETODOLAC EXTENDED-RELEASE TABLETS, USP
CARDIOVASCULAR THROMBOTIC EVENTS
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
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 EXTENDED-RELEASE TABLETS ARE CONTRAINDICATED IN THE SETTING
OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY [ _SEE CONTRAINDICATIONS AND WARNINGS AND
PRECAUTIONS_ ] _._
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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
AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI
BLEEDING ARE AT GREATER
RISK FOR SERIOUS GI EVENTS [ _SEE WARNINGS AND PRECAUTIONS_].
DESCRIPTION
Etodolac extended-release tablets, USP 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. Etodolac, USP is a white to
off-white crystalline powder, 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. 287.36
Each etodolac extended-release tablet, USP intended for oral
administration contains 400 mg or 500 mg
or 600 mg of etodolac. In addition, each tablet contains the following
inactive ingredients: disodium
hydrogen phos