ETODOLAC tablet, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

NORTHSTAR RX LLC

SNN (starptautisko nepatentēto nosaukumu):

Etodolac

Kompozīcija:

Etodolac 400 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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: 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 contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Produktu pārskats:

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° 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).

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

AC- ETODOLAC TABLET, EXTENDED RELEASE
NORTHSTAR RX LLC
----------
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
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 healthcare provider about all of y

Produkta apraksts

ETODOLAC- ETODOLAC TABLET, EXTENDED RELEASE
NORTHSTAR RX LLC
----------
ETODOLAC
EXTENDED-RELEASE
TABLETS, 400 MG,
500 MG AND 600 MG
RX ONLY
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, 400 mg, 500 mg and 600 mg are
contraindicated in the setting of coronary artery bypass graft (CABG)
surgery
(see CONTRAINDICATIONS and 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:
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
17
21
3
addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake
and the 400 mg
and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F.
L